Good Oral Health - A Bi-level Intervention to Improve Older Adult Oral Health
Phase: NA
Conditions: Gingivitis
Sponsor: UConn Health

Title: Good Oral Health - A Bi-level Intervention to Improve Older Adult Oral Health 
Trial Number: 14-188-6 
Date: January 18, 2021 
 
 
 
Contents 
Protocol with statistical analysis 
Consent forms: Campaign Committee Consent, Motivational Interviewing followed by 
Campaign Condition and Campaign followed by Motivational Interviewing Condition 

Title: Good Oral Health - A Bi-level Intervention to Improve Older Adult Oral Health 
Trial Number: 14-188-6 
Date: January 18, 2021 
 
 

IRB Review 
IRB NUMBER: 14-188-6 
IRB APPROVADL rDafAt T1E.6: 01/03/2019 
12/14/2018 
Good Oral Health: A Bi-level Intervention to Improve Older Adult Oral Health 
Protocol #14-046-E 
 
 
 
 
 
Good Oral Health: A Bi-level Intervention 
to Improve Older Adult Oral Health 
 
NIDCR Protocol Number: 14-046-E 
NIDCR Grant Number: DE024168 
Principal Investigators: Susan Reisine and Jean Schensul 
NIDCR Program Official: Melissa Riddle, Ph.D. 
NIDCR Medical Monitor: Kevin D. McBryde, MD 
 
Draft: 1.6 
 
January 3, 2019 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

IRB Review 
IRB NUMBER: 14-188-6 
IRB APPROVADL rDafAt T1E.6: 01/03/2019 
12/14/2018 
Good Oral Health: A Bi-level Intervention to Improve Older Adult Oral Health 
Protocol #14-046-E 
i 
 
 
 
 
STATEMENT OF COMPLIANCE 
 
The study will be conducted in accordance with the International Conference on 
Harmonisation guidelines for Good Clinical Practice (ICH E6), the Code of Federal 
Regulations on the Protection of Human Subjects (45 CFR Part 46), and the NIDCR 
Clinical Terms of Award. All personnel involved in the conduct of this study have 
completed human subjects protection training. 

IRB Review 
IRB NUMBER: 14-188-6 
IRB APPROVADL rDafAt T1E.6: 01/03/2019 
12/14/2018 
Good Oral Health: A Bi-level Intervention to Improve Older Adult Oral Health 
Protocol #14-046-E 
ii 
 
 
 
SIGNATURE PAGE 
 
The signature below constitutes the approval of this protocol and the attachments, and 
provides the necessary assurances that this trial will be conducted according to all 
stipulations of the protocol, including all statements regarding confidentiality, and 
according to local legal and regulatory requirements and applicable US federal 
regulations and ICH guidelines. 
 
Principal Investigators: 
 
Signed: 
Date: 
 
Name: 
Susan Reisine 
 
Title: 
Professor Emeritus, University of Connecticut 
 
 
 
 
Signed: 
Date: 
Name: 
Title: 
Jean Schensul 
Senior Scientist, Institute for Community Research 

IRB Review 
IRB NUMBER: 14-188-6 
IRB APPROVADL rDafAt T1E.6: 01/03/2019 
12/14/2018 
Good Oral Health: A Bi-level Intervention to Improve Older Adult Oral Health 
Protocol #14-046-E 
iii 
 
 
 
TABLE OF CONTENTS 
PAGE 
STATEMENT OF COMPLIANCE ................................................................................................... I 
SIGNATURE PAGE ...................................................................................................................... II 
TABLE OF CONTENTS ............................................................................................................... III 
LIST OF ABBREVIATIONS .......................................................................................................... VI 
PROTOCOL SUMMARY ............................................................................................................ VIII 
SCHEMATIC OF STUDY DESIGN: ............................................................................................. XI 
1 
KEY ROLES AND CONTACT INFORMATION .................................................................... 1 
2 
INTRODUCTION: BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE ......... 3 
2.1 
Background Information ........................................................................................... 3 
2.2 
Rationale .................................................................................................................. 4 
2.3 
Potential Risks and Benefits ..................................................................................... 7 
2.3.1 Potential Risks .............................................................................................. 7 
2.3.2 Potential Benefits .......................................................................................... 7 
3 
OBJECTIVES ....................................................................................................................... 8 
3.1 
Study Objectives....................................................................................................... 8 
3.2 
Study Outcome Measures ........................................................................................ 8 
3.2.1 Primary ......................................................................................................... 8 
3.2.2 Secondary .................................................................................................... 9 
3.2.3 Mediators ...................................................................................................... 9 
3.2.4 Moderator Variables ................................................................................... 11 
4 
STUDY DESIGN ................................................................................................................ 12 
5 
STUDY ENROLLMENT AND WITHDRAWAL ................................................................... 17 
5.1 
Subject Inclusion Criteria ........................................................................................ 17 
5.2 
Subject Exclusion Criteria ....................................................................................... 17 
5.3 
Strategies for Recruitment and Retention ............................................................... 18 
5.4 
Treatment Assignment Procedures ........................................................................ 19 
5.4.1 Randomization Procedures ........................................................................ 19 
5.5 
Subject Withdrawal ................................................................................................. 19 
5.5.1 Reasons for Withdrawal .............................................................................. 19 
5.5.2 Handling of Subject Withdrawals or Subject Discontinuation of Study 
Intervention ................................................................................................. 19 
5.6 
Premature Termination or Suspension of Study ..................................................... 19 
6 
STUDY INTERVENTION ................................................................................................... 21 
6.7 
Study Behavioral or Social Intervention(s) Description ........................................... 21 
7 
STUDY SCHEDULE .......................................................................................................... 28 
7.1 
Screening ............................................................................................................... 28 
7.2 
Enrollment/Baseline ............................................................................................... 28 
7.3 
Intermediate Visits .................................................................................................. 28 
7.4 
Final Study Visit ...................................................................................................... 28 
8 
STUDY PROCEDURES/EVALUATIONS ........................................................................... 29 

IRB Review 
IRB NUMBER: 14-188-6 
IRB APPROVADL rDafAt T1E.6: 01/03/2019 
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Good Oral Health: A Bi-level Intervention to Improve Older Adult Oral Health 
Protocol #14-046-E 
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8.1 
Study Procedures/Evaluations ............................................................................... 29 
9 
ASSESSMENT OF SAFETY .............................................................................................. 30 
9.1 
Specification of Safety Parameters ........................................................................ 30 
9.1.1 Unanticipated Problems ............................................................................. 30 
9.1.2 Adverse Events .......................................................................................... 31 
9.1.3 Serious Adverse Events ............................................................................. 32 
9.2 
Time Period and Frequency for Event Assessment and Follow-Up ....................... 32 
9.3 
Characteristics of an Adverse Event ...................................................................... 33 
9.3.1 Relationship to Study Intervention .............................................................. 33 
9.3.2 Expectedness of SAEs ............................................................................... 33 
9.3.3 Severity of Event ........................................................................................ 34 
9.4 
Reporting Procedures ............................................................................................ 34 
9.4.1 Unanticipated Problem Reporting to IRB and NIDCR ................................ 34 
9.4.2 Serious Adverse Event Reporting to NIDCR .............................................. 34 
9.5 
Halting Rules .......................................................................................................... 35 
10 
STUDY OVERSIGHT ......................................................................................................... 36 
11 
CLINICAL SITE MONITORING .......................................................................................... 37 
12 
STATISTICAL CONSIDERATIONS ................................................................................... 38 
12.1 
Study Hypotheses .................................................................................................. 38 
12.2 
Sample Size Considerations .................................................................................. 38 
12.4 
Final Analysis Plan ................................................................................................. 39 
13 
SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/DOCUMENTS .................. 43 
14 
QUALITY CONTROL AND QUALITY ASSURANCE ......................................................... 44 
15 
ETHICS/PROTECTION OF HUMAN SUBJECTS ............................................................. 46 
15.1 
Ethical Standard ..................................................................................................... 46 
15.2 
Institutional Review Board ...................................................................................... 46 
15.3 
Informed Consent Process ..................................................................................... 46 
15.4 
Exclusion of Women, Minorities, and Children (Special Populations) .................... 47 
15.5 
Subject Confidentiality ............................................................................................ 47 
16 
DATA HANDLING AND RECORD KEEPING .................................................................... 49 
16.1 
Data Management Responsibilities ........................................................................ 49 
16.2 
Data Capture Methods ........................................................................................... 50 
16.3 
Types of Data ......................................................................................................... 50 
16.4 
Schedule and Content of Reports .......................................................................... 50 
16.5 
Study Records Retention ....................................................................................... 50 
16.6 
Protocol Deviations ................................................................................................ 51 
17 
PUBLICATION POLICY ..................................................................................................... 52 
18 
LITERATURE REFERENCES ........................................................................................... 55 
SUPPLEMENTAL MATERIALS .................................................................................................. 66 
APPENDICES ............................................................................................................................. 67 
APPENDIX A: SCHEDULE OF EVENTS ................................................................................... 67 
APPENDIX B: EXTERNAL APPENDIX TABLE OF CONTENTS ............................................... 69 

IRB Review 
IRB NUMBER: 14-188-6 
IRB APPROVADL rDafAt T1E.6: 01/03/2019 
12/14/2018 
Good Oral Health: A Bi-level Intervention to Improve Older Adult Oral Health 
Protocol #14-046-E 
v 
 
 
 

IRB Review 
IRB NUMBER: 14-188-6 
IRB APPROVADL rDafAt T1E.6: 01/03/2019 
12/14/2018 
Good Oral Health: A Bi-level Intervention to Improve Older Adult Oral Health 
Protocol #14-046-E 
vi 
 
 
 
LIST OF ABBREVIATIONS 
 
ADL 
Activity of Daily Living 
AE / SAE 
Adverse Event / Serious Adverse Event 
AMI 
Adapted Motivational Interviewing 
CA 
Campaign 
CDC 
Centers for Disease Control and Prevention 
CES-D 
Center for Epidemiologic Studies - Depression Scale 
DAS 
Dental Anxiety Scale 
 
FAQs 
Frequently Asked Questions 
GEE 
GI 
General Estimating Equations 
Gingival Index 
GLMM 
General Linear Mixed Model 
GOH 
Good Oral Health 
GOHAI 
General Oral Health Assessment Inventory 
ICF 
Informed Consent Form 
ICR 
Institute for Community Research 
IM 
Integrated Model of Behavioral Prediction 
IRB 
Institutional Review Board 
MFFD 
Modified Fractional Factorial Design 
NIDCR 
National Institute of Dental and Craniofacial Research, NIH 
NIH 
National Institutes of Health 
OCTOM 
Office of Clinical Trials Operations and Management, NIDCR, NIH 
OH 
Oral Health 
OHRQoL 
Oral Health Related Quality of Life 
OHRSA 
Oral Health Research Strategic Alliance 
OHRP 
Office for Human Research Protections 
PHI 
Protected Health Information 
PI 
Principal Investigator 
PM 
Practice to Mastery 
PMS 
Practice to Mastery Score 
Pro-GOH 
Project Good Oral Health 
QDS 
Questionnaire Development System 
SDM 
University of Connecticut School of Dental Medicine 

IRB Review 
IRB NUMBER: 14-188-6 
IRB APPROVADL rDafAt T1E.6: 01/03/2019 
12/14/2018 
Good Oral Health: A Bi-level Intervention to Improve Older Adult Oral Health 
Protocol #14-046-E 
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SOP 
Standard Operating Procedure 
SPSS 
Statistical Package for the Social Sciences 
TPB 
Theory of Planned Behavior 
TRA 
Theory of Reasoned Action 
UCHC 
University of Connecticut Health Center 
UPIRSO 
Unanticipated Problem Involving Risk to Subjects or Others 
US 
United States 
WHO 
World Health Organization 

IRB Review 
IRB NUMBER: 14-188-6 
IRB APPROVADL rDafAt T1E.6: 01/03/2019 
12/14/2018 
Good Oral Health: A Bi-level Intervention to Improve Older Adult Oral Health 
Protocol #14-046-E 
viii 
 
 
 
PROTOCOL SUMMARY 
 
Title: 
Good Oral Health: A Bi-level Intervention to improve older adult 
oral health 
 
Précis: 
This study will test an intervention designed to change oral 
health norms and reduce disparities in oral health among 
vulnerable adults residing in publicly funded senior housing in 
Central Connecticut. The intervention model is based on 
Fishbein’s modified theory of reasoned action operationalized 
through Adapted Motivational Interviewing and Practice-to- 
Mastery (AMI-PM). The intervention includes two components: 
1) a face to face administration of the AMI-PM, a participatory 
counseling model, and 2) a targeted building-level campaign 
(CA) consisting of up to three half-day oral health events with 
skills development through practice to mastery (PM) to parallel 
the individual intervention (CA+PM), all based on the study’s 
conceptual model. The study uses a modified fractional factorial 
design to evaluate the face to face and campaign components 
separately and in different additive sequences. Six buildings will 
be paired in three dyads. The buildings in each dyad will be 
randomized to either having the AMI-PM intervention first 
followed by CA+PM or to having the CA+PM first followed by 
AMI-PM. Sixty residents will be recruited in each building for a 
total of 360 participants. There will be four assessments: 
 
1) T0 will include a survey, oral hygiene skills assessment and 
clinical assessment of the Gingival Index and Plaque Score. 
The survey will provide data on the conceptual domains that are 
the target of the tailored intervention; 
 
2) T1 will follow the AMI-PM or CA+PM (depending on 
condition) and will include the survey, oral hygiene skills 
assessment and clinical assessment of the Gingival Index and 
Plaque Score. This assessment will occur 1-3 months after the 
AMI-PM or CA+PM; 
 
3) T2 will follow the AMI-PM or CA+PM and will include the 
survey, oral hygiene skills assessment and clinical assessment 
of the Gingival Index and Plaque Score. This assessment will 
occur 1-3 months after the AMI-PM or CA+PM. 
 
4) T3 will include oral hygiene skills assessment and clinical 
assessment of the Gingival Index and Plaque Score. This will 

IRB Review 
IRB NUMBER: 14-188-6 
IRB APPROVADL rDafAt T1E.6: 01/03/2019 
12/14/2018 
Good Oral Health: A Bi-level Intervention to Improve Older Adult Oral Health 
Protocol #14-046-E 
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occur 16-18 months after study entry. We will use general linear 
mixed models (GLMM) or general estimating equations (GEE), 
respectively, to fit a model with intervention and period effects 
using the MIXED procedure in SAS. 
 
Objectives: 
Primary Objectives: 
 
1. To assess the separate and combined effectiveness of two 
components of a cognitive/behavioral intervention that together 
improve oral hygiene behaviors and oral hygiene status; 
 
2. To assess whether differential sequenced combinations of 
these components has a differential effect on behavioral and 
clinical outcomes; 
 
3. To investigate the mediation effects of cognitive/behavioral 
factors in changing clinical outcomes. 
 
Primary Outcome Measures: Plaque Scores and Gingival Index 
 
Secondary Outcome Measure: Oral Health Related Quality of 
Life 
 
Population: 
Sample size: 360 
 
Gender: Males and Females 
 
Age: Children and adults aged 18-61 with disabilities and those 
aged 62 and older who meet income guidelines and may have 
chronic health conditions with quotas of 52 people 62> and 8 
people <61 in cycles II and III established by NIDCR in October, 
2016 
 
Demographic group: Vulnerable adults or children; we will 
recruit from low income senior housing in Central Connecticut. 
Residents must meet income guidelines and be over the age of 
62 or be disabled adults or children. 
 
General health status: The participants are independent living 
older adults residing in low income senior housing. Residents 
include vulnerable adults over age 21 and individuals meeting 
the NIH definition of children ages 18-21. 
 
Geographic location: Central Connecticut 

IRB Review 
IRB NUMBER: 14-188-6 
IRB APPROVADL rDafAt T1E.6: 01/03/2019 
12/14/2018 
Good Oral Health: A Bi-level Intervention to Improve Older Adult Oral Health 
Protocol #14-046-E 
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Phase: 
not applicable 
 
Number of Sites: 
6 recruitment sites (housing for seniors and disabled 
individuals); The University of Connecticut School of Dental 
Medicine and the Institute for Community Research are 
coordinating sites. 
 
Description of 
Intervention: 
The intervention includes two components: 1) a face to face 
administration of the AMI-PM, a participatory counseling model, 
and 2) a targeted building-level campaign consisting of up to 
three half-day oral health events, all based on the study’s 
conceptual model. 
 
Study Duration: 
60 months 
 
Subject 
Participation 
Duration: 
16-18 months 
 
Estimated Time to 
Complete 
Enrollment: 
approximately 36 months 

IRB Review 
IRB NUMBER: 14-188-6 
IRB APPROVADL rDafAt T1E.6: 01/03/2019 
12/14/2018 
Good Oral Health: A Bi-level Intervention to Improve Older Adult Oral Health 
Protocol #14-046-E 
xi 
 
 
 
SCHEMATIC OF STUDY DESIGN: 
 
 
Prior to 
Enrollment 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
T0 - Baseline 
 
 
 
 
T1 
 
 
T2 
 
 
 
T3 
6 buildings randomize within 3 matched pairs of 
buildings 
Condition 1 – 
3 “A” Buildings, n=180 
participants; 60 per building 
per cycle 
Condition 2 – 
3 “B” Buildings, n=180 
participants; 60 per building 
per cycle 
Final Assessments 
We will use general linear mixed models (GLMM) 
or general estimating equations (GEE) to fit a 
model with intervention and period effects using 
the MIXED procedure in SAS. Customized 
contrasts can be constructed to make 
comparisons between time points. Path analyses 
will be conducted to assess mediating effects of 
cognitive/behavioral factors 
Oral Health-related Quality of Life, Clinical Assessment and Skills Assessment– 6-7 months post T2 (AB/BA) 
AMI – up to 45 days post T1 (BA); CA – 2-5 months post T1 (AB) 
Follow-up Survey, Clinical Assessment, and Skills Assessment – 1-3 months post campaign (AB); 
1-3 months post AMI (BA) 
AMI – up to 45 days post T0 (AB); CA – 3-6 months post study entry (BA) 
Follow-up Survey, Clinical Assessment, and Skills Assessment – 1-3 months post AMI AB; 
1-3 months post campaigns BA 
Total N: 360; Obtain informed consent. Screen potential subjects by inclusion and exclusion criteria; 
obtain history, document. 

IRB Review 
IRB NUMBER: 14-188-6 
IRB APPROVADL rDafAt T1E.6: 01/03/2019 
12/14/2018 
Good Oral Health: A Bi-level Intervention to Improve Older Adult Oral Health 
Protocol #14-046-E 
1 
 
 
 
 
1 KEY ROLES AND CONTACT INFORMATION 
 
Principal 
Investigators: 
Susan Reisine, Ph.D., Professor Emeritus 
University of Connecticut School of Dental Medicine 
263 Farmington Avenue, MC3910 
Farmington, CT 06030-3910 
PH: 860 679-3823 
FAX: 860 679-1342 
reisine@uchc.edu/reisinest@gmail.com 
 
Jean J. Schensul, Ph.D., Senior Scientist and Founding Director 
Institute for Community Research 
146 Wyllys Street 
Hartford, CT 06106-5128 
PH: 860 278-2044 x227 
FAX: 860 278-2141 
jean.schensul@icrweb.org/Jschensu@aol.com 
 
Medical Monitor: 
Kevin D. McBryde, MD 
Medical Officer 
Division of Extramural Research 
6701 Democracy Blvd., Rm. 638 
Bethesda, MD 20892-4878 
Telephone: 301-594-0170 
Fax: 301-480-8319 
mcbrydekd@mail.nih.gov 
 
NIDCR Program 
Official: 
Melissa Riddle, Ph.D. as of Oct. 2017 
6701 Democracy Blvd. 
Bethesda, MD, 20892 
H: 301:594-4814 
riddleme@mail.nih.gov 
 
University of Connecticut School of Dental Medicine 
263 Farmington Avenue, MC3910 
Farmington, CT 06030-3910 
Susan Reisine, Ph.D., Professor Emeritus 
PH: 860 679-3823 
FAX: 860 679-1342 
reisine@uchc.edu 
 
Institute for Community Research 
146 Wyllys Street 
Hartford, CT 06106-5128 
Jean J. Schensul, Ph.D., Senior Scientist and Founding Director 
PH: 860 278-2044 x227 
FAX: 860 278-2141 
Institutions: 

IRB Review 
IRB NUMBER: 14-188-6 
IRB APPROVADL rDafAt T1E.6: 01/03/2019 
12/14/2018 
Good Oral Health: A Bi-level Intervention to Improve Older Adult Oral Health 
Protocol #14-046-E 
2 
 
 
 
 
 
Other Key 
Personnel: 
jean.schensul@icrweb.org 
 
Rajesh Lalla, D.D.S., Co-Investigator 
University of Connecticut School of Dental Medicine 
263 Farmington Avenue, MC 1605 
Farmington, CT 06030-3910 
PH: 860 679-8007 
FAX: 860-676-3454 
lalla@uchc.edu 
 
Kim Radda, R.N. M.A., Co-Investigator and IRB administrator at ICR 
Institute for Community Research 
146 Wyllys Street 
Hartford, CT 06106-5128 
PH: 860 278-2044 
FAX: 860 278-2141 
kim.radda@icrweb.org 

IRB Review 
IRB NUMBER: 14-188-6 
IRB APPROVADL rDafAt T1E.6: 01/03/2019 
12/14/2018 
Good Oral Health: A Bi-level Intervention to Improve Older Adult Oral Health 
Protocol #14-046-E 
3 
 
 
 
 
2 INTRODUCTION: BACKGROUND INFORMATION AND SCIENTIFIC 
RATIONALE 
 
2.1 
Background Information 
Older adults have a high prevalence of preventable and treatable oral health problems, 
and oral health disparities among impoverished older adults and adults with disabilities 
from all racial/ethnic backgrounds are striking, particularly with respect to African 
Americans and Latinos (Griffin, Jones, Brunson, Griffin, Bailey, 2012). Oral health is 
recognized as related to general health; thus, improving oral health can achieve 
improved overall health, which is critically important for racial/ethnic minority populations 
who also suffer from disproportionate rates of cardiovascular disease and diabetes. The 
development of a low cost intervention, conducted in locations where older and disabled 
adults live, that can develop potentially sustainable normative support for oral health, 
hygiene and change specific oral health practices (brushing, flossing, cleaning mouth 
and tongue, etc.) can reduce short and longer term psychosocial and economic costs 
associated with chronic illness and disability. Reducing persistent oral health disparities 
among vulnerable low income older adults and adults with disabilities is a central 
objective in Healthy People 2020 (healthypeople.gov/2020/about/default.aspx) and is a 
priority of state health departments and Area Agencies on Aging. Limited knowledge of 
oral health in general and related prevention and treatment alternatives, cultural 
differences in language and perception of oral health problems, and structural barriers 
to care such as insurance gaps, limited personal mobility and transportation, and 
inadequate culturally relevant public health education combine to increase oral health 
disparities in vulnerable populations. In 2009, NIH held its first conference to address 
ways of crafting and evaluating cognitive and behavioral interventions to address these 
issues. The conference specifically emphasized the importance of theoretical framing 
and tailored interventions to meet individual participant needs. 
 
To address oral health disparities among older adults, a partnership of the University of 
Connecticut School of Dental Medicine, the Institute for community Research and the 
North Central Area Agency on Aging developed and received funding for two studies led 
by investigators Reisine and Schensul. Together, these projects developed the 
capacity, materials, design and infrastructure for the expansion of the pilot, entitled 
“Good Oral Health – A Bi-level Approach to Improve Older Adult Oral Health” 
 
Building Collaborative Research Infrastructure to Reduce Oral Health Disparities among 
Low Income Older Adults (1 RC4 DE021324) built associations with 15 low income 
senior housing buildings in Meriden (3), Hartford (8) and New Britain (4) through 
contacts with management and building committees and presentations. Overall building 
demographics were: 64% - Private; 36% -Public; 52% - Hispanic, 29% - African- 
American/Caribbean, 19% - Non-Hispanic White. The project also allowed us to 

IRB Review 
IRB NUMBER: 14-188-6 
IRB APPROVADL rDafAt T1E.6: 01/03/2019 
12/14/2018 
Good Oral Health: A Bi-level Intervention to Improve Older Adult Oral Health 
Protocol #14-046-E 
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develop health education materials, together with building residents based on the notion 
of FAQs. The final FAQs were formatted into a booklet for use in the pilot study. 
 
Our successful pilot intervention Changing Oral Health Norms and Hygiene Practices 
among Vulnerable Older Adults supported by NIDCR #R34 DE022271 (2011-2013) was 
based on Fishbein’s modified theory of reasoned action called Integrated Model (IM) of 
Behavioral Prediction (Fishbein, 2008) operationalized through Adapted Motivational 
Interviewing (AMI) and Bandura’s notions of self-efficacy and skills reinforcement 
operationalized through Practice-to-Mastery or PM (Liska, 1984; Connor, 2010). The 
pilot study was conducted in a single building of approximately 200 apartments in the 
Greater Hartford Area. It included two components offered sequentially, a face to face 
intervention (the AMI) with practice of oral hygiene skills to mastery (PM), and two 
campaign fairs promoted by a small committee of building residents. Post intervention, 
participants (n=30) demonstrated a significant improvement in the Plaque Scores from a 
mean score at baseline of 84% (sd=11.8%) to 58% (sd=31.2%) at follow-up (p<0.001) 
and the Gingival Index from a mean baseline score of 1.2 (sd=0.56) to a mean follow-up 
score of 0.54 (sd=0.47), p<0.001. Differences in P-M skills scores from pre to post 
instruction in brushing and flossing, part of the AMI-PM session showed significant 
improvement. Brushing scores increased from 1.9 (fair/poor) prior to the AMI-PM 
session to 2.9 (good/excellent; p<0.001) after and flossing skills improved from 1.7 to 
2.7 (p<0.001). In the intervention group, we found significant mean decreases 
(improvements) from pre to post in several important cognitive domains including 
perceived risk of oral disease which decreased from a mean of 2.5 to 2.0 (sd=.70 for 
both, p=.04) self-management worries which decreased from a mean of 1.36 (sd=.66) to 
0.57 (sd=.97); p=.002) and self-management fears which decreased from a mean of 2.2 
(sd=.81) to 1.53 (sd=.97; p=.001). In contrast, non-AMI respondents showed mean 
increases (deterioration) from pre to post in all three domains. 
 
The pilot intervention evaluated the outcomes of both intervention components together. 
The proposed study uses a modified fractional factorial design (MFFD), a design 
approach developed to maximize capacity and cost effectiveness of testing intervention 
designs with multiple components which are found to be effective, but in which the 
interactivity of the components to produce positive outcomes is not well understood 
(Chakraborty, Collins, Strecher, Murphy, 2009; Collins, 2013; Nair, Strecher, Fagerlin, 
Ubel, Resnicow, Murphy, et al. 2008; Collins, Dziak, Li, 2009; Collins, Murphy, Nair, 
Strecher, 2005). Thus, the study is designed to evaluate the face to face and campaign 
components against each other, and in different additive sequences to determine which 
component has better short term outcomes, and whether sequencing components 
makes a difference in the final outcome. 
 
2.2 
Rationale 
A search of the literature on disparities in geriatric oral health, state reports and local 
agency agendas point to significant gaps and needs to be addressed in this study. 
There are great disparities in oral health of older adults and those with disabilities 
including the high prevalence of decay, periodontal disease, edentulism, unmet 

IRB Review 
IRB NUMBER: 14-188-6 
IRB APPROVADL rDafAt T1E.6: 01/03/2019 
12/14/2018 
Good Oral Health: A Bi-level Intervention to Improve Older Adult Oral Health 
Protocol #14-046-E 
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treatment needs and impaired quality of life associated with oral health conditions 
among older adults (Anders & Davis, 2010; Appollonio, Carabellese, Frattola, 
Trabucchi, 1997; Jensen, Saunders, Thierer, Friedman, 2008; Petersen, Yamamoto, 
2005; Ritchie, Joshipura, Silliman, Miller, Douglas, 2005; Slade, Spencer, Locker, Hunt, 
Strauss, Beck, 1996) and adults with disabilities (Anders & Davis, 2010). Further there 
are significant disparities in burden of oral disease, oral health care, and oral health 
related quality of life by race/ethnicity, social class, and medical, functional and 
psychological comorbidities (Appollonio, Carabellese, Frattola, Trabucchi, 1997; 
Jensen, Saunders, Thierer, Friedman, 2008; Petersen, Yamamoto, 2005; Ritchie, 
Joshipura, Silliman, Miller, Douglas, 2005; Slade, Spencer, Locker, Hunt, Strauss, Beck, 
1996; Ahluwalia &, Sadowsky, 2003; Ahluwalia, 2004, Lamster & Northridge, 2008; 
Petersen, 1990). Oral health is reciprocally related to systemic health (Kandelman, 
Petersen, Ueda, 2008) and systemic health conditions and physiological declines 
associated with aging can, in turn, have deleterious effects on oral health. Improving 
oral health in vulnerable older adults should have a significant impact on the reduction 
of disparities in other systemic health conditions. Oral health disparities affect ethnic 
and ethnic and racial minorities and low income populations and have a greater effect 
on quality of life among older African Americans compared to Whites on every 
dimension, but particularly in psychological discomfort, pain and functional limitations 
(Ahluwalia &, Sadowsky, 2003; Locker & Slade, 1994; Makhija, Gilbert, Boykin, Litaker, 
Allman, Baker, et al. 2006; Sheiham, Steele, Marcenes, Lowe, Finch, Bates, et al., 
2001; Gerdin, Einarson, Jonsson, Aronsson, Johansson, 2005). Improving oral health 
related quality of life should be an important objective of oral health interventions. 
There are studies that show that significant reductions in plaque and gingivitis can be 
achieved with manual tooth brushing (van der Weijden & Hioe, 2005; Robinson, 
Deacon, Deery, Heanue, Walmsley, Worthington, et al., 2005 Robinson, Deacon, 
Deery, Heanue, Walmsley, Worthington, et al., 2005 Jönsson, Ohrn, Lindberg, 
Oscarson, 2010;Jönsson, Lindberg, Oscarson, Öhrn; 2006) and one study 
demonstrates the importance of motivational interviewing in achieving these outcomes. 
These studies also provide the basis for estimating effect sizes for the current 
intervention. However other research indicates that both brushing and knowledge are 
not sufficient to result in long term improvements in oral hygiene. Without good 
behavioral self-management, the effects of clinical interventions are not persistent 
(Korber, 2006; Ajzen, 1980) and require cognitive-behavioral understanding and 
knowledge, daily attention to oral hygiene, and a pro-oral health environment. 
 
Fishbein’s integrated model of behavioral prediction, the IM is built on extensive 
empirical evidence supporting its ability to explain and predict health behaviors. The 
utility of the IM model in guiding prevention programming is supported by a substantial 
body of literature on factors contributing to improved oral health and prevention of 
periodontal disease of older adults above and beyond knowledge. These include oral 
health knowledge, locus of control, self-efficacy, social norms, intentionality of action 
and behavioral practice with a trusted role model. To it we have added an additional 
measure missing in the literature, on fears and concerns about oral health and hygiene 

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self-management. Understanding the contribution of oral health fears to oral hygiene is 
important in ensuring prevention-oriented oral health self-management. To address this 
gap, we have developed a new measure of oral health fears through formative research 
in the study population. 
 
In addition, the IM model emphasizes the importance of social norms which are widely 
recognized to influence individual behavior (Cialdini & Trost, 1998). There is no 
research on social norms related to oral health, especially among older adults. Analysis 
of survey data on social supports for oral health information seeking and the results of 
analysis of the domain content/delivery of the AMI point to lack of social support for 
obtaining oral hygiene information. 
 
Combined with Bandura’s notions of self-efficacy and skills practice (Tedesco, Keffer, 
Fleck-Kandath, 1991; Bandura, 1989) and the additional conceptual domains identified 
above, the MI offer a cognitive behavioral approach to understanding and 
operationalizing an intervention to improve oral health self-management behaviors. In 
this study, it will be operationalized at the individual level through Adapted Motivational 
Interviewing (AMI), a scripted, standardized and measurable motivational interviewing 
approach and Practice-to-Mastery (PM) and at the group level through participant- 
driven campaigns (CA) with MI driven messages based on domains in the theoretical 
model (figure 1) and opportunities for Practice-to-Mastery (PM) embedded the 
campaigns. 
 
Recognizing that individual level interventions have limited capacity to sustain change, 
many researchers propose multi-component, multi-level intervention approaches in 
producing both better immediate outcomes, and higher potential for sustainability 
(Schensul & Trickett, 2009; Trickett, 2009; DiClemente, Salazar, Crosby, 2007; 
Manhart, Holmes, 2005; Sallis, Cervero, Ascher, Henderson, Kraft, Kerr, 2006; van 
Empelen, Kok, van Kesteren, van den Borne, Bos, Schaalma, 2003; Trickett, Beehler, 
Deutsch, Green, Hawe, McLeroy, et al., 2011; Albarracin, Rothman, Di Clemente, del 
Rio, 2010; Albarracin, Tannenbaum, Glasman, Rothman, 2010; Latkin, Weeks, 
Glasman, Galletly, Albarracin, 2010; Schensul, Radda, Coman, Vazquez, 2009; 
Schensul, Trickett, 2009). Patrick, et al.(2006) are among those who argue for the need 
for multilevel approaches to improve oral health, particularly among ethnic minorities. 
A multilevel approach that supports and reinforces the same predictors and oral health 
practices both publicly, through resident led activities, and in individually through a 
tailored intervention should maximize outcome effects in a residential social 
environment and pave the way for future sustainability. 
 
The pilot study on which the current protocol is based was structured as a bi-level 
intervention, delivered at the individual and at the “building” level. The pilot intervention 
was delivered as a “package” without differentiating the contributions of each 
component to the outcomes. Further, the pilot study did not allow us to assess whether 
the order of administration of the main components (individual versus group/community) 
made a difference in outcome. The study sample was too small to explore fully the 

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interaction of cognitive and behavioral domains in contributing to clinical outcomes. The 
design of the proposed expansion study will allow us to address these limitations. 
 
2.3 
Potential Risks and Benefits 
 
2.3.1 
Potential Risks 
Risks to respondents from participation in this study are minimal. General risks might 
include: a) discomfort in presenting/discussing oral health conditions and behaviors; b) 
negative responses to oral health peer advocate committee members by building 
residents; c) possible loss of confidentiality if Campaign Committee members reveal any 
personal communications between themselves and residents related to opinions or 
questions related to oral health. These events have not occurred in previous studies. 
Risks associated with the oral health screening include some discomfort from the 
assessment. If a participant experiences sensitivity to the gum region, the topical 
anesthetic benzocaine 20% will be applied with a cotton swab to the cheek and gum 
side of the gum tissue prior to the screening exam. In the event that a dental condition 
discovered during the screening exam requires emergent/urgent evaluation or care, the 
participant will be notified immediately of the findings and will be referred immediately 
for treatment. 
 
2.3.2 
Potential Benefits 
Individual participants may benefit from the clinical evaluation, and referral for further 
evaluation or treatment for dental, periodontal and soft tissue problems. The subjects 
will be notified of the findings of the oral health screening during the AMI-PM 
intervention, and any concerns or obstacles to improved oral health self-management 
will be addressed; thus participants may be able to improve their own self-care and 
prevent or reduce plaque accumulation and gum inflammation. Building residents will 
have the opportunity to reinforce their knowledge and oral health management 
behaviors in three campaigns (fairs) where they can obtain expert consultation for 
specific queries. Residents have the opportunity to play a leadership role in their 
building. 

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3 OBJECTIVES 
 
3.1 
Study Objectives 
1. To assess the separate and combined effectiveness of two components of a 
cognitive/behavioral intervention that, together, improve oral hygiene behaviors 
and oral hygiene status. 
 
2. To assess whether differential sequenced combinations of these components has 
a differential effect on behavioral and clinical outcomes.. 
 
3. To investigate the mediation effects of cognitive/behavioral factors in changing 
clinical outcomes. The following figure presents the conceptual model with 
moderators, intervention variables, mediators and outcome variables. 
 
Figure 1. Conceptual Model 
 
 
 
 
3.2 
Study Outcome Measures 
 
3.2.1 
Primary 
The primary outcome measure is the clinical assessment of oral hygiene status: 
 
Plaque Score: We will use a plaque scoring scheme developed by O’Leary (O'Leary, 
Drake, Naylor, 1972). This index consists of dichotomous presence or absence scores 
for plaque on each tooth surface. The supragingival bacterial plaque will be assessed 
with the use of erythrosine disclosing solution in six surfaces of each tooth. The non- 
toxic vegetable-based solution will be applied to the teeth by the examining hygienist. 
The number of surfaces stained red will be calculated over the total number of surfaces 
and the plaque score will be expressed as a percentage of surfaces with plaque as a 
Behavioral 
Intention 
Oral Health Self- 
Management 
Intentionality 
Cognitive/Behavioral 
Mediators 
Oral Health Knowledge 
Oral Health Beliefs(Self-efficacy,    
 
Locus of control) 
Perceived risk of OH 
consequences 
OH social support 
Oral Hygiene Behaviors 
Oral Health Self-management 
Fears and Worries 
Oral Health norms (importance 
of OH behaviors) 
Intervention 
Number of AMI 
Focal Points /% 
talking points 
addressed in 
intervention 
Exposure to 
norm based 
campaigns 
Recognition and 
Salience of 
Campaign 
Messages 
Background/ 
Moderators 
Demographics 
Health Status 
ADLs 
CES-D 
Self-assessed Oral 
Health Status 
Outcomes 
Plaque Score 
Gingival Index 
GOHAI 
(secondary) 

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ratio. We used this measure in the pilot study and demonstrated significant reductions in 
plaque after the intervention. 
 
Gingival Index: The Gingival Index (GI) (Loe & Silness, 1963) will be used to assess 
the gingival status related to six surfaces of each tooth. Each surface is scored for 
gingival inflammation: 0=no visual signs of inflammation; 1=slight change in color and 
texture of the gingiva but no bleeding; 2=visual sign of inflammation and bleeding upon 
swiping; 3=overt inflammation and spontaneous bleeding. The index is calculated by 
summing each surface GI and dividing by the total number of surfaces (mean value). 
Individual scores are summed to obtain a mean. Again, we used this measure in the 
pilot study and demonstrated significant reductions in the Gingival Index after the 
intervention. 
 
3.2.2 
Secondary 
Oral Health Related Quality of Life (OHRQoL): We will use the General (Geriatric) 
Oral Health Assessment Inventory (GOHAI), a commonly used 12-item measure initially 
developed for older adults that has been used with low income populations (Atchison & 
Dolan, 1990). The GOHAI was translated into Spanish and back translated for the pilot 
study and was found to be acceptable across the racial/ethnic spectrum. 
 
The GOHAI will be administered as part of the survey at T0 through T3. Research staff 
will be trained in administering the GOHAI as part of the general training in 
administering the survey. An objective of the study is to assess how the interventions 
and sequencing of the interventions affect OHRQOL and whether mediators 
differentially affect OHRQOL outcomes. Our primary outcomes are plaque scores and 
gingival index, but we expect that the interventions will have beneficial effects on 
OHRQOL as participants gain confidence and improve their oral health skills and 
experience better oral hygiene leading to better oral health. As Broder and others state, 
measures of OHRQOL are “congruent with patient-centered care… can help identify 
participant strengths and weakness…more accurately reflects risks and benefits of the 
intervention… and helps in defining clinically meaningful change”. 
 
The mean score at baseline for the intervention group was 30.7 (sd=10.3), which 
indicates relatively poor OHRQOL as compared to other studies. The mean score at 
follow-up was 29.9 (sd=9.9) which was not a significant change. We would not 
anticipate significant changes in such a short period, but we could observe larger 
changes over a longer time period. Cronbach alpha was 0.76. 
 
3.2.3 
Mediators 
Cognitive and Behavioral Mediators (Cronbach’s alphas based on pilot sample 
N=84) 

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Oral health knowledge: Oral health knowledge is a 7-item true/false test based on 
previously developed knowledge test used with low income older African Americans 
(Slaughter & Evans, 2007) (Alpha=.66). 
 
Oral health beliefs/norms: The Dental Coping Beliefs Scale (Wolfe, Stewart, Maeder, 
Hartz, 1996; Wolfe, Stewart, Hartz, 1991; Wardh & Sorensen, 2005) is a 26-item scale 
consisting of four subscales, Oral Health Beliefs, Internal Locus of Control, External 
Locus of Control, and Self-Efficacy. The scales were adapted in the pilot study and 
used to measure oral health beliefs, locus of control, and self-efficacy, key domains in 
the study model (Alpha = .61). 
 
Oral Health Norms: We will measure social norms with a scale that measures the 
perceived importance of oral hygiene behavior (Alpha =.68 with 1 item deleted). 
 
Oral Health Social Support: These are two questions asking how building residents 
participants can obtain oral health information; and from how many others who regularly 
work in or visit the building participants can obtain oral health information (Likert scale: 
none,1-2, 3-4, 5 or more). 
 
Perceived Oral Health Risks: This is a five-item scale that assesses perceived risk of 
oral heal problems, including getting cavities, toothaches, gum problems, oral cancer 
and oral health problems that would cause a visit to the hospital. Participants rate the 
likelihood of having these problems on a four-point Likert scale, 1 (very unlikely) to 4 
(very likely). Chronbach Alpha = 0.83. 
 
Oral hygiene behaviors: A measure consisting of questions that assess oral health 
self-management behavior including frequency and timing of brushing, flossing teeth, 
cleaning dentures (3 items, Alpha =.71). 
 
Oral health self-management fears and worries: A scale was developed from 
formative data collected through our prior studies and evaluated during the pilot 
consisting of items identified by residents in focus group sessions related to worries and 
fears about conducting oral hygiene behaviors. Dental Worries Scale (23 items) 
Alpha=.90; Dental Fears (4 items) Alpha = .75. 
 
Oral Health Self-Management Intentionality: Intention to perform the oral health self- 
management behaviors, a critical component of the IM model, will be assessed using 
the protocol described by Ajzen and Fishbein (1980) and Tedesco, et al. (1991) and 
adapted based on formative data. Participants will be asked to rate their intention to 
brush and floss daily using a five item four point Likert scale Alpha=.81.3.2.4 
Intervention Variables 
 
Exposure to norms based campaign: Dosage will be assessed by: (a) reported 
attendance at each campaign activity (three), and (b) number of activities respondent 
participated in at each event (passport). 

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Number of focal points addressed in intervention: This is a count based on 
respondents’ score below the cutoff points for main cognitive and behavioral domains 
measured and addressed in the intervention. 
 
3.2.4 
Moderator Variables 
Demographic background information: Items include age, gender, building, length of 
time in building, length of time in U.S., marital status, race and ethnicity, current living 
arrangement, times moved in the past year, work status, religious engagement, income 
and income satisfaction, language use, telephone, transportation availability, home care 
and health insurance. 
 
Health status: This will be measured by: (a) subjective health status, a single item, 
shown to be a valid measure of health status across ethnic groups, (b) an index 
assessing current health status based on self-report of diagnosis on 13 health problems 
common in older adults and used in earlier ICR studies, (c) a composite measure of 
physical health distress based on degree to which each problem prevents participation 
in normal daily activities. 
 
Self-assessed Oral health status: measured with a five point Likert scale assessing 
subjective oral health status (Locker et al., 2000). 
 
Activities of Daily Living: Activities of Daily Living (ADLs) a widely used measure of 
the functional status of an individual, It consists of 8 behaviors that indicate ability to 
take care of personal basic needs (Katz , 1983; Lawton & Brody, 1969) 
 
CES-D. This is the 10-item short version of the CES-D Screening Instrument that 
measures depressive symptoms in community populations. The Spanish version of the 
10-item CES-D has been validated for use with Puerto Rican older adults and has been 
used in several studies of older adults, including in public housing, in the study area 
(Radloff & Rae, 1979; Irwin, Artin, Oxman, 1999; Mahard, 1988; Robison, Gruman, 
Gaztambide, Blank, 2002; Robison, Schensul, Coman, Diefenbach, Radda, 
Gaztambide, et al., 2009; Diefenbach, Disch, Robison, Baez, Coman, 2009). 

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4 STUDY DESIGN 
 
Overall Design: The study utilizes a modified fractional factorial design (MFFD) which 
compares the short term outcomes of the two intervention components: the tailored 
individual level brief intervention (AMI-PM) and the group level Campaign including 
embedded oral health skills development through practice-to-mastery (CA+PM). It also 
evaluates the effects of differential sequencing of these modes of delivery components 
in relation to short and longer term outcomes. Finally, it evaluates intervention 
mechanisms through mediational modeling of the cognitive and the behavioral 
components over time. The two intervention components are the individualized AMI-PM 
(Component A), and the group CA+PM (Component B). To evaluate sequencing we will 
randomize pairs of senior residences into two conditions: Condition 1 and Condition 2. 
Buildings in Condition 1 will initiate with Component A, followed by Component B. 
Buildings in Condition 2 will initiate with Component B, followed by Component A. This 
study design will allow us to compare the AMI-PM outcomes to CA+PM short term 
outcomes, and to determine which condition sequence (A+B or B+A) will produce the 
best clinical outcomes. Each of 3 cycles of Condition 1 (A+B) compared to Condition 2 
(B+A) will take place over a 16-18 month period each in two matched buildings with an 
N of 60 per building (N per cycle of 120; total N for all three cycles approximately 360). 
We anticipate an attrition rate of approximately 25% and a final N of approximately 270 
by the T3 measure, 135 in Condition 1 and 135 in Condition 2. Primary outcomes are 
improvements in gingival health and decreases in plaque scores. 
 
A description of the study population: Participants will be recruited from low income 
senior housing in Central Connecticut. The population consists of independent living 
older adults many of whom have chronic health conditions. Residents also include 
adults less than 62 years of age residing in these buildings who are disabled. Residents 
must meet income guidelines and be over the age of 62 or be disabled children and 
adults between the ages of 18 and 61. 
 
Methods for collecting data for assessment of study objectives:  Data collection 
will consist of clinical assessment, and surveys evaluating changes in cognitive domains 
(See Section 16). 
 
Clinical Assessments: Clinical assessments will be conducted to collect data on 
Plaque Scores and Gingival Index, described in Section 3.2.1. Trained and calibrated 
licensed hygienists will conduct the exams under the supervision of Dr. Lalla. 
 
Referrals for Emergent Dental Needs: Emergent dental needs are not uncommon in 
this population; when found, they will be referred to the University of CT. School of 
Dental Medicine or to the nearest Community Health Center. Emergent dental needs 
include inability to eat due to tooth or mouth pain, visual swelling of the face or mouth, 
fever of >100.5 of probable dental origin, and oral lesion located in a high oral cancer 
risk area. Once participants have been treated for the emergent dental issue they will 
be offered the opportunity to continue with the study. Emergent needs will be ranked 

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using the system employed by the NHANES dental teams: Level 1 - participant should 
see a dentist immediately; Level 2 - participant should see a dentist within the next 2 
weeks; Level 3 - participant should see a dentist at his/her earliest convenience; Level 4 
– participant should continue with his/her regular routine. The form is included in the 
appendix. 
 
Training and Calibration of clinical assessments (Adapted from National Health and 
Nutrition Examination Survey Dental Examiners Procedures Manual 
 
Training is divided into three phases as follows: 
1. The instructional phase in which examination team members are familiarized with 
research examination procedures and criteria for research assessments. 
2. The standardization phase in which they are trained to use standard procedures 
and apply standard criteria for the oral health assessments. 
3. The calibration phase in which the degree of correlation within and among the 
examiners and the standard examiner is measured. 
 
Instruction 
 
The instructional phase of the training sequence was conducted by Ruth Goldblatt DMD 
who served as the initial Clinical Director, and standardized examiner or gold standard, 
with experience as a researcher and examiner on the previous pilot study. Rajesh Lalla, 
DDS is the current Clinical Director and will conduct the instructional phase with any 
new dental hygienists who join the study. He has appropriate experience both as a 
researcher and clinician. Instructions are to be conducted in each type of oral health 
assessment (Gingival Index and Plaque Score). The trainer presents lectures on criteria 
for each of the oral health assessments to be used in the study. Lectures are 
accompanied by slides depicting a wide variety of possible observations and illustrating 
application of assessment criteria to those observations. The lecture-slide presentations 
on each assessment are followed by instructions on data recording for that assessment. 
Although the instructional phase consists primarily of lectures and slide presentations, 
some demonstrations of examination technique and equipment use are conducted. All 
phases of the training and calibration will be redone anytime there is a change in clinical 
examiners. 
 
Standardization 
 
The second phase of training is devoted to standardization. During this phase of 
training, the standard examiner reviews examination procedures and techniques and 
the criteria for each assessment, stressing the importance of consistency and uniformity 
among all examiners and the standard examiner in performing the examination and in 
applying the criteria to observations. Rationale for differences between a research 
examination and a diagnostic examination are discussed and professional ethics of 

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research examinations reviewed. A demonstration of the examination by the standard 
examiner and practice examinations by the examiners being trained is among the 
salient features of this phase. Standardization of all examiners will be achieved by 
examining 4 patients in the field replicating research subjects and conditions. 
Discussion will occur to aid standardization. The Clinical Director (standard examiner) 
will monitor and referee examinations and discussion of observations during these 
sessions. 
 
Calibration 
 
The reliability of the assessments is measured by determining the degree to which 
examiners can produce uniform and consistent results when performing independent 
replicate examinations without discussion. In this phase of training, the standard 
examiner and all examiners in training will each examine 4 patients who are similar in 
demographics to the study population. The standard examiner monitors the calibration 
session without discussing observations with any of the examiners. 
 
Data from the calibration sessions are analyzed to measure correlation within and 
between each examiner and the standard examiner (e.g., Kappa and McNemar’s Test). 
If correlations between each of the examiners and the standard examiner are not within 
acceptable ranges or some examiners are consistently higher or lower than the 
standard examiner (i.e., significant McNemar’s test) additional training sessions will be 
scheduled. 
 
Monitoring and Recalibration 
 
Continual gathering of clean, reliable data in a consistent and uniform manner is one of 
the main objectives of the clinical control trial. Several quality control procedures will be 
carried out periodically to assure continuing quality of data gathered by the dental team 
throughout the duration of the study. As in the initial calibration, the standard examiner 
and all examiners will each examine 4 patients who are similar in demographics to the 
study population. Recalibration will occur prior to or at the beginning of each study 
cycle. 
 
Expert Replication and Monitoring Field Operations 
 
During the field operations, examiners and recorders should periodically review their 
training manuals to prevent deviation, or “drift” from the standards achieved during the 
training period. Particular attention should be devoted to uniform adherence to the 
criteria for making correct decisions about observations such as scoring of gingival 
indices and presence or absence of plaque. Strict compliance with infection control 
procedures is another important consideration for dental teams. In order to help the 
dental teams maintain their standards, the clinical director for the study will make 
periodic visits to field personnel to observe their performance and offer feedback on the 
results of their examinations. Field observations occur twice per assessor for each time 

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point. Observation and matched scoring for GI and Plaque Score occur once per 
assessor per time point. The standard examiner will choose one patient per each of the 
dental hygienists on whom the examination will be replicated. The replicated exam will 
be completed in paper format and compared to the one entered on the computer so as 
not to confound the data collection for the study. The purpose of these so called “expert 
replications” is to determine whether the examiners are maintaining the examination 
standards achieved during training, and to measure the degree of deviation, if any, from 
those standards. If correlation between the standard examiner and the field examiner is 
not within acceptable limits, retraining will be conducted. 
 
Annual Retraining 
 
The long duration of the study (5 years) requires the need for regularly scheduled 
retraining periods. In addition to the regularly scheduled recalibration sessions with the 
standard examiner, there will be an annual retraining session for each dental examiner, 
also conducted by the standard examiner. 
 
Training and Calibration of Oral Hygiene Skills Assessment (Practice to Mastery 
and T0 – T3). 
 
Training is divided into two phases as follows: 
1. 
The instructional phase in which research interventionists and dental hygienists 
are familiarized with oral hygiene instruction and oral hygiene practice to mastery 
skill assessment scale. 
2. 
The standardization phase in which the interventionists and dental hygienists are 
trained to use standard procedures and apply standard criteria for the oral 
hygiene skills assessment (and oral hygiene instruction for the interventionists). 
 
Instruction 
 
The instructional phase of the training sequence was conducted by Ruth Goldblatt DMD 
who served as the initial Clinical Director, and standardized examiner or gold standard, 
with experience as a researcher and examiner on the previous pilot study. Rajesh Lalla, 
DDS is the current Clinical Director and will conduct the instructional phase with any 
new intervention staff or dental hygienist who join the study. He has appropriate 
experience both as a researcher and clinician. Instructions will be given regarding the 
Oral Hygiene Skills Assessment Evaluation Form and each mastery level on the form. 
Demonstrations will be given using the tooth brushing models. Although the instructional 
phase consists primarily of lecture, slide presentations and video clips, some 
demonstrations of examination technique and models are conducted. All phases of the 
training and calibration will be redone anytime there is a change in field staff during the 
study. 
 
Standardization 

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The second phase of training is devoted to standardization. During this phase of 
training, the standard examiner reviews oral hygiene instruction procedures and 
techniques used in oral hygiene education and the criteria for each assessment, 
stressing the importance of consistency and uniformity among all examiners and the 
standard examiner in performing the examination and in applying the criteria to 
observations. Rationale for differences between simple oral hygiene instruction and the 
practice to mastery evaluation are discussed and reviewed. A demonstration of the 
practice to mastery evaluation by the standard examiner and a rehearsal practice to 
mastery by the examiners being trained is among the salient features of this phase. 
Standardization of all examiners will be achieved by assessing the same 4 subjects in 
the field, replicating actual research conditions. Discussion will occur to aid 
standardization. The Clinical Director (standard examiner) will monitor and referee 
examinations and discussion of observations during these sessions. 
 
Annual Retraining 
The long duration of the study (5 years) requires the need for regularly scheduled 
retraining periods. There will be an annual retraining session for all study staff 
conducting the Oral Hygiene Skills Assessment, conducted by the Clinical Director. 
 
In addition to the clinical and skills assessments, there will be annual retraining sessions 
for all study staff on the conduct of the survey and AMI process, conducted by the study 
PIs. 

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5 STUDY ENROLLMENT AND WITHDRAWAL 
 
The Pro-GOH target population consists of residents living in buildings housing older 
adults and disabled adults in Central Connecticut, including the towns of Hartford, New 
Britain, and Meriden. Based on previous studies in these buildings, we anticipate that 
the population in the study buildings overall will consist of approximately 40% African 
American/Caribbean, 45% Latino (mainly Puerto Rican) and 10-15% other ethnic (Euro- 
American and Polish) residents. Approximately 13% will be under 62 years of age and 
will have some form of disability. All buildings are located in low income or working class 
neighborhoods that are medically and socially disadvantaged. Residents often lack 
access to regular health care and are at high risk for a variety of health and mental 
health problems. 
 
We will select, match and work in three pairs of buildings of 100 – 250 apartments each. 
Six buildings have agreed to participate (See letters of support). Our goal in selection of 
buildings is to achieve a representative sample of residents that approximate the 
ethnic/racial balance identified above. One building in each pair will be randomly 
assigned to each condition. 
 
5.1 
Subject Inclusion Criteria 
Inclusion criteria are: 
 
a) Disabled children and adults aged 18 years and above, and adults 62 and above, 
including both male and female building residents, and minorities and non-minorities; 
restricted to 13.33% under the age of 62 in Cycles II and III by NIDCR as of Oct. 2017. 
 
b) Permanent residence in sample buildings; 
 
c) Independent of conservator; 
 
d) Must be able to speak English or Spanish; 
 
e) Judged competent to participate (based on ability to respond correctly to key 
questions about information covered during administration of informed consent. 
 
f) Have two or more remaining natural teeth. 
 
5.2 
Subject Exclusion Criteria 
Exclusion criteria are: 
 
a) Considered by research staff to be cognitively unable to give informed consent; 
 
b) Exhibition of continued disruptive behavior while participating in the project; 

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c) History of infective endocarditis, and/or prosthetic cardiac valve replacement in past 6 
months, insertion of an arterial stent in past 6 weeks, myocardial infarction (heart attack) 
in past 6 weeks; 
 
d) Under conservatorship; 
 
e) Fewer than two natural teeth; 
 
f) Currently on dialysis 
 
5.3 
Strategies for Recruitment and Retention 
During the first five months of each full intervention cycle 120 residents will be enrolled 
into the study, 60 in each condition to which their building has been randomly assigned. 
Research team members will introduce the study in each of the buildings to tenants’ 
associations and onsite managers, soliciting their support for the study. They will 
conduct 2 presentations 2 weeks apart to inform residents of the study, recruit and 
enroll potential participants, and within 2 – 3 days schedule appointments to conduct 
baseline surveys and clinical assessments. Participants will be recruited, enrolled, 
consented and scheduled for surveys during the first five months regardless of 
sequence of intervention. Thus, the timing of all surveys and clinical assessments will 
be the same for both buildings. Research team members will establish a base in a 
central location in each of the buildings from which to continue recruiting, place 
informational posters in elevators and in other public locations, actively recruit through 
engaging people in public spaces, and organizing weekly activities such as bingo 
games through which recruitment and enrolment will occur. These strategies were very 
successful in the pilot study. At the same time, 5 - 10 resident volunteers will be invited 
to join a campaign committee to co-plan and facilitate three building-wide campaigns. 
Based on prior experience we estimate overall attrition to be approximately 25%. 
Retention. Retention in the study will be accomplished: 
a) Through continuous presence in the intervention buildings 
 
b) Repeated contact through face to face communication and fliers with intervention 
participants throughout the delivery of each component, 
 
c) Active telephone and mail reminders in advance of scheduled appointments for 
surveys, clinical assessments, individual AMI-PM session and campaigns. 
 
We will retain people in the study who, for medical or travel reasons, missed no more 
than one intervention, one assessment time point, or one intervention and one 
assessment time point. 

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Based on prior studies in senior housing, these methods have demonstrated 
intervention acceptability and are expected to result in almost 100% retention among 
those residents who are not ill, have not passed away, and have not moved elsewhere. 
 
5.4 
Treatment Assignment Procedures 
Study implementation will take place over a five year period with buildings in pairs of 2 
(matched and randomized to condition 1 (AMI-PM followed by CA+PM) or condition 2 
(CA+PM followed by AMI-PM). 
 
See Appendix A for details. 
 
5.4.1 
Randomization Procedures 
Buildings will be paired on the basis of their age, ethnicity and gender characteristics 
and randomized by a statistician. Individual participants will not be randomized. 
 
5.5 
Subject Withdrawal 
All participants will be told during the consent process that 1) their participation is 
voluntary; 2) they are free to withdraw from the study at any time; 3) withdrawal from the 
study will not affect their opportunity to participate in other studies conducted by the 
research partners; 4) there will be no penalty or loss of benefits to which they would be 
entitled, and 5) their withdrawal from the study will not affect any present or future care 
received at the University of CT Health Center. 
 
5.5.1 
Reasons for Withdrawal 
Reasons for withdrawal will be recorded in the participant tracking data base. 
 
5.5.2 
Handling of Subject Withdrawals or Subject Discontinuation of Study 
Intervention 
The sample size was powered anticipating an attrition rate of 25% which greatly 
exceeds our experience in the pilot study which was 15%. We do not expect people to 
withdraw because of adverse effects of the interventions. Once we are certain at any 
point in time that a participant has withdrawn or has discontinued, we will retain the 
person in the study up to the point at which they have withdrawn. If they withdraw after 
T1, we will include them in the T1 comparison. If they withdraw after T2 and before T3, 
we will include them in the T2 analysis, but exclude them from the T3 sustainability of 
effect analysis. 
 
5.6 
Premature Termination or Suspension of Study 
This study may be prematurely terminated if, in the opinion of the investigator, the 
sponsor, or the IRB there is sufficient reasonable cause. Written notification, 
documenting the reason for study termination, will be provided to the investigator and/or 

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sponsor by the terminating party. Circumstances that may warrant termination include, 
but are not limited to: 
 
 Determination of unexpected, significant, or unacceptable risk to subjects; 
 Insufficient adherence to protocol requirements; 
 Failure to obtain sufficient follow-up data to evaluate the effectiveness of the 
intervention. 
 
Submission of 6-month NIDCR and Medical Monitor Oversight Reports, and monthly 
progress reports are submitted electronically through UConn Health to the NIDCR 
project officer monthly. No DSMB is required for this study. 
 
 
If the study is prematurely terminated or suspended, the sponsor will promptly inform 
the investigators/institutions, and the regulatory authority(ies) of the termination or 
suspension and the reason(s) for the termination or suspension. The IRB will also be 
informed promptly and provided the reason(s) for the termination or suspension by the 
sponsor or by the investigator/institution, as specified by the applicable regulatory 
requirement(s). 

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6 STUDY INTERVENTION 
 
Study Behavioral or Social Intervention(s) Description 
Conceptual Framework 
The conceptual framework for the study intervention based on an adaptation of 
Fishbein’s MI model utilized in our pilot study is summarized in Figure 1. Moderators 
include: demographic variables, subjective health, activities of daily living (ADLs), 
symptoms of depression (CES-D), self-assessed oral health; Intervention variables are 
the following: cognitive behavioral mediators to be targeted by the intervention include 
oral health knowledge, oral health beliefs, oral health social support, self-reported oral 
hygiene behaviors; oral health self-management worries and fears, oral health norms 
and behavioral intentions. Primary outcome variables are the Plaque Score and 
Gingival Index. Oral Health Quality of Life is a secondary outcome. 
 
Intervention Implementation 
 
The intervention we are proposing is a tailored bi-level intervention with two 
components, an individual level component (component A) with tailored messages 
based on performance on clinical assessment results, ADLs and cognitive domains in 
the survey delivered through adapted motivational interviewing with practice to mastery 
(AMI-PM); and a building level campaign (component B) open to all building residents 
that includes building tailored messages based on cognitive domains and skills 
reinforcement through Practice to Mastery. 
 
Tailored Individual Level Intervention through Adapted Motivational Interviewing: 
(Component A). 
 
The individually tailored individual-level intervention is approximately 45 minutes, and 
will take place within 45 days of administration of the baseline survey and clinical 
assessment in Condition A buildings, and within 45 days of administration of the T1 
survey and clinical assessment in Condition B buildings. Trained project staff will 
administer the intervention. Interventionists will make appointments with residents who 
have completed the baseline assessment, review assessment materials and construct 
the intervention checklist specific to that individual based on findings from the survey 
and the clinical assessment. They will conduct the intervention either in the privacy of 
the resident’s apartment or in a private location within the building. 
 
The AMI-PM approach will address ADL related problems, any cognitive domain for 
which the response is below a designated cutoff, the results of the clinical assessment 
and brushing and flossing skills. The clinical examination will produce information on 
gingivitis and locations demonstrating accumulation of plaque. The survey will produce 
information on ADLs and incorrect beliefs, gaps in knowledge, gaps in self-efficacy and 
limitations in intentions to practice and gaps in reported skills and specific oral hygiene 

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practices. These data will be amalgamated using standardized forms to summarize the 
participant’s cognitive and behavioral status prior to the intervention. The summary will 
be used to conduct the intervention. The AMI intervention for each participant will 
consist of the following: 
 
1. 
Identify the domains that score under the cutoff point and check them on the 
Focal Point form. 
 
2. 
Start the AMI with a discussion with the participant of their own oral health, oral 
health problems, concerns and fears, practices and intentions, challenges in performing 
oral health hygiene. 
 
3. 
Show the participant how their own concerns connect to their survey responses 
and domains requiring intervention. Based on the discussion, identify any other areas 
requiring intervention. 
 
4. 
Address each of the focal points (domains scoring below the cutoff point on the 
survey results), the survey and scripted set of messages for each domain (see 
appendix B) The process calls for correcting misunderstandings, increasing knowledge 
and addressing barriers to intention (cognitive: knowledge, beliefs, attitudes, fears, 
worries, efficacy/locus of control, intention) and dealing with any ADL concerns. 
 
5. 
Show participant results of their own clinical assessment illustrating plaque 
scores. 
 
6. 
Demonstrate on mouth model and through videos correct brushing and flossing. 
 
7. 
Observe participant brushing and flossing on mouth model and score ability on 
P – M form. 
 
8. 
Review ADL needs, reported cognitive and behavioral domains, and behavioral 
skills and build a cognitive behavioral plan together, for participant’s improvement of 
oral health. 
 
9. 
Obtain signature from participant on plan, and make a copy for participant and 
copy for file. 
 
10. 
Participant will be given oral hygiene starter kit (tooth brush, toothpaste, floss, 
floss holder, tongue cleaner, and denture brush and cup if needed), brushing and 
flossing handouts and denture care handout if needed. 
 
Individuals who score below the cutoff point on each of the following domains in the 
survey (see appendix B) will require cognitive / behavioral intervention. 

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All AMIs will be recorded for process documentation purposes. 
 
Domain 
Items 
Cut-off points 
1a. ADLs 
Need help with grooming, dressing, eating, brushing teeth/cleaning dentures. 
Need help on any of these 
2a. Oral 
health 
knowledg 
e 
7-item knowledge test 
<5 correct 
3a. Oral 
health 
self- 
efficacy 
If you brush and floss correctly, you expect fewer dental problems; 
You believe that you know how mouth sores can be treated; 
If someone showed you how to clean your teeth, you would be able to 
practice better oral health care; 
If you knew the facts about dental disease, you would be able to practice 
better oral care; 
You believe you can remove most of plaque to help prevent cavities and gum 
disease; 
Mean of items <3 
(disagree and strongly 
disagree) 
3b. Locus of 
control 
You believe tooth loss is a normal part of growing old 
If response to this item was 
agree or strongly agree) 
4a. Oral 
How important do you think the following behaviors are: 
1 or 2 on any item (Not at 
Health 
Visit the dentist once a year; 
all important; not very 
Norms - 
Brush your teeth at least once a day; 
important) 
Beliefs 
Brush with fluoride toothpaste; 
about 
Floss or clean between teeth at least once a day; 
Impor- 
Check for sores in the mouth 
tance of 
oral 
hygiene 
5a. Oral 
health 
Social 
Support 
Local access to health/oral health information 
If all sources are “0” (none) 
6a. Oral 
hygiene 
behaviors 
How often do you: 
Brush in a day 
<2 times per day 
7a. Perceive 
What are the chances that you will 
Mean <3 (4 - very unlikely; 
d Oral 
Get cavities? 
3 - unlikely; 2 - likely; 1 - 
Health 
Get a toothache? 
very likely) 
Risks 
Have problems with your gums? 
Develop oral cancer? 
Have to go to the hospital for problems related to your teeth, gums or mouth? 
8a. Self- 
How worried are you that: 
Mean <3 for scale (4 = not 
manage 
You cannot clean your dentures properly; 
at all; 3= not much) 
ment 
You can’t control your bad breath 
worries 
Medications you are taking may be affecting your teeth 
If you brush your teeth your gums might get irritated 
You don’t brush your teeth enough 
When you floss there is bleeding 
You don’t brush your teeth properly 
You are not using the correct toothbrush 
You don’t know how to clean your tongue 
You don’t know the best time to go to the dentist 
If you use mouthwash it might dry out your mouth 
Your mouth feels dry all the time 
If you take your dentures out you could lose them 
You might have to get dentures of false teeth made from dead men’s teeth so 
you keep your bad teeth 
If you go to the dentist you might get a mouth or tooth infection or cancer 
You can’t clean the teeth in the back of your mouth 
Your teeth may keep you from socializing 
Your bad teeth are keeping you from eating foods 
Your teeth get discolored 
When you try to brush you feel pain 
When you put your dentures in it hurts 

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9a. Self- 
manage 
ment 
fears 
You are afraid: 
That bleeding gums may be a serious problem; 
You cannot clean your dentures properly; 
Of losing your teeth; 
Of oral cancer: 
That problems with your teeth and gums might affect your general health 
Mean < 3 (4= not at all; 3 = 
not much) 
10a. Oral 
Health 
Self- 
Manage 
ment 
Intention 
ality 
What is the possibility that: 
You will brush your teeth at least twice a day? 
You will floss your teeth or clean between your teeth at least once a day? 
You will clean your mouth daily? 
You will check your mouth for loose teeth? 
You will visit the dentist in the next year for a check-up and screening for oral 
cancer? 
Mean <1 (0= no possibility; 
1= slight possibility) 
11a. Dry 
mouth 
Do you sip liquids to aid in swallowing dry foods? 
Yes 
12a. Diet 
How often do you: 
Eat sweet snacks; 
Eat starchy snacks; 
Suck on hard candies; 
Drink/eat sweets after brushing at night; 
Drink fruit juice on an average day. 
>2-3 times a day on any 
item. 
Clinical 
Assessment 
Plaque Score and Gingival Index 
All participants 
 
 
Practice to Mastery. 
 
The following criteria are defined for practice to mastery scores during the intervention. 
AMI (and for mastery scores during T0, T1, T2 and T3 observation points*)1 
 
Excellent (4): (P-M) Is able to easily use the appropriate oral hygiene aids and correctly 
mimic the instruction from the video/live demonstration without additional instruction. 
(*T0-T3) Is able to easily use the appropriate oral hygiene aids. 
Good (3): (P-M) Is able to use the appropriate oral hygiene aids and requires no more 
than two corrective instructions to correctly mimic the instruction from the video/live 
demonstration. 
(*T0-T3) Is able to use the appropriate oral hygiene aids and would require 
no more than two corrective instructions. 
Fair (2): (P-M) Has difficulty using the appropriate oral hygiene aids and requires three 
or more corrective instructions to correctly mimic the instruction from the video/live 
demonstration. 
(*T0-T3) Has difficulty using the appropriate oral hygiene aids and would 
require three or more corrective instructions. 
Poor (1): (P-M) Does not understand the concepts in the video clips. Uses the incorrect 
brushes to demonstrate on the models. Needs complete instruction or intervention to 
mimic the oral hygiene instruction from the video clip or live demonstration. 
(T0-T3) Does not understand the concepts in correct oral hygiene. Uses 
incorrect brushes to demonstrate on the models. 

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[All] Prior to the Practice to Mastery skills assessment, ask if participant is using any 
modification or adaptive device to his/her toothbrush or denture brush, or using a floss 
handle in order to better clean their teeth/denture/partial. If yes, provide the participant 
with the appropriate adaptive device to use during the skills assessment. [For P-M only] 
If no, and you determine that the client has a physical disability and cannot manage the 
oral hygiene aids due to arthritis for example, then you may suggest the tubing to adapt 
their tooth/denture brush or floss holder. 
 
Behavioral skills assessment form checklist 
Skill 
Mastery 
Level 
Lacks manual dexterity due to 
physical disability (i.e. arthritis, 
stroke)* 
Sensory impairment limiting or 
modifying oral hygiene 
instruction (i.e. visual or aural 
impairment)** 
Code # 
Code 
# 
Comments 
Code 
# 
Comments 
Tooth 
brushing 
Flossing 
Cleaning 
Dentures or 
Partials 
*Dexterity codes: 4 = full dexterity; 3 = good dexterity-can manage well without any help; 2 = 
requires some help, having difficulty if not using any help; 1 = having high level of difficulty in 
demonstrating skills. 
**Sensory impairment (visual or aural) codes: 4 = no sensory problem apparent for either; 3 
= some visual or aural impairment; request for repetition of instructions and vocabulary; some 
difficulty with print size (not related to literacy); 2 = has difficulty hearing and/or can’t see 
instructions at all; 1 = cannot hear sufficiently to respond to a question properly (not a language 
problem), and/or cannot see enough to recognize the pattern of plaque on teeth (not a 
comprehension problem). 
1 We are measuring oral hygiene skills at T0 – T3, but do not intend to use the results as a mediating 
measure in accordance with an NIDCR approved request to remove the OH skills assessment as a 
mediating measure from the study. It was never used as an outcome, but only as a mediator. 
 
Group Level Intervention through Oral Health Campaigns 

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The group level oral health campaign involves volunteer residents as partners in the 
development of the fairs designed to delivery oral hygiene self-management messages 
based on the cognitive domains, ADL related problems in brushing and flossing, and 
brushing and flossing skills, and offer an opportunity to practice brushing and flossing 
on a mouth model to mastery. To fulfill the requirements of the campaign component of 
the study (CA), up to three health fairs will be implemented over approximately a three 
month period. CA+PM procedures include the following: 
 
Identification, Training and Preparation of Pro-GOH Campaign Volunteers. Throughout 
Condition 1 (AMI-PM+CA+PM) and in the first month of Condition 2 (CA+PM+ AMI-PM) 
the study team will recruit 5-10 building residents to facilitate the group intervention. The 
committee will include building residents as role models who are broadly representative 
of the composition of the building by age, ethnicity, gender, ability and language. All 
committees will have bilingual (English/Spanish) capacity. Once recruited, consented 
and enrolled, committee members will meet with study trainers for 2-hour sessions twice 
a week, for a minimum five to six week period, to learn how to implement pro-oral health 
campaigns, to plan for each fair and to work with study interventionists to develop 
campaign materials. The Pro-GOH campaign events follow primary communications 
principles: 
 
a) Message redundancy: same message delivered through different materials (at least 4 
different types of materials in English and Spanish), 
 
b) Multiple channels (messages delivered through oral, visual, written and practice 
means) 
 
c) Multiple exposures (each message will be presented at least twice during each event) 
 
d) Interactivity of residents with each other and oral health study personnel through 
interactive message based games and activities, for learning reinforcement; 
 
e) Delivery of messages through respected role models (building volunteers, 
testimonials and oral health experts). 
 
After each campaign event, research staff and campaign volunteers will reflect on the 
experience and document the results. The specific roles and responsibilities of the 
volunteers, working with study staff, include: a) learning about oral health and good oral 
health hygiene; b) using the Oral Health script materials to prepare messages for their 
fairs, linked to the theoretical domains; c) raising and addressing any concerns they 
might have about oral health promotion; d) agreeing to participate in recruitment of 
residents to fairs events; e) developing the plan and schedule for the fairs , including 
eliciting the support of building management; f) organizing expert presentations on oral 
health; g) arranging oral health good practice testimonials; h) staffing oral health 
practice to mastery tables on brushing, flossing and cleaning dentures; i) organizing 
tables by conceptual domain to deliver messages related to that domain. Delivery may 

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be in different formats (games, contexts, quizzes, bingo etc.); j) helping to set up and 
deliver food and entertainment. 
 
Pro-GOH Campaign Volunteer Training Program. The volunteer training modules are as 
follows: Module 1: building group identity and scope of work (committee roles and 
responsibilities, establishing ground rules and introduction to core theoretical concepts 
guiding the intervention); Module 2: Review of the components of the Pro-GOH 
Campaign, protecting and respecting study participants, effective communication; 
Module 3: oral health and oral health self-management (presentation by collaborating 
dentist), confirmation of campaign event schedule; Module 4: creation of a campaign 
plan (selecting messages for each domain 1 – 12); Module 5: development of campaign 
materials based on module 4; Module 6: preparation for campaign event. Two additional 
sessions will focus on finalizing campaign materials, and practicing testimonials and oral 
health skills demonstrations and instruction on P - M on mouth model. 
 
Standardized components of the Campaign. The core components are developed 
and structured to standardize the pro-oral health campaign, ensure the inclusion of the 
theoretical principles, and prepare for fidelity of implementation. 
 
 Campaign messages: One message per conceptual domain based on domain 
scripts. 
 Campaign Background Materials: include AMI domain specific scripts; Domain 
maps with definitions of domains, fliers and brochures, posters, videos from 
official oral health sites (e.g. NIDCR). 
 Campaign recruitment: Resident volunteers will recruit residents to the campaign 
events using a plan that they devise to market the events and reach all residents 
in the building. They will prepare and post recruitment materials. 
 Pro-GOH Campaign Activity Guide and checklist. 
 The Campaign Passport, a document given to each building resident who 
attends each fair. It will record their name, attendance, duration of stay, and 
stamped evidence of participation at each message station during the fair. 

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7 STUDY SCHEDULE 
 
See Appendix A. 
 
7.1 
Screening 
Building residents will be screened for the inclusion/exclusion criteria at the time of 
recruitment to the study. The IRB has approved a script to be used for screening 
purposes. 
 
7.2 
Enrollment/Baseline 
Section 5, Appendices A and B and MOP. 
 
7.3 
Intermediate Visits 
See above. 
 
7.4 
Final Study Visit 
See above. 

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8 STUDY PROCEDURES/EVALUATIONS 
 
8.1 
Study Procedures/Evaluations 
The study procedures (described in section 3) include clinical assessments to assess 
Plaque Score and Gingival Index; oral health skills assessment/Practice-to-Mastery 
assessment; a survey administered by a research assistant, and recording and hard 
copy and digital documentation of the AMI-PM to assess fidelity of the intervention. 
 
Trained interventionists will administer the AMI-PM. One or more will be fluent in 
Spanish and will undergo extensive training to assure fidelity. All intervention sessions 
will be audio recorded, with participant’s permission. Audio recordings and hard 
copy/digital documentation from 10% of the AMI-PM sessions will be reviewed to 
measure fidelity. 
 
The interventionists will conduct the training sessions for the campaign committee and 
will work with participants on developing campaign messages, materials and activities 
that are consistent with the conceptual model. Examples of materials will be provided to 
committee members based on the pilot study. 
 
Surveys will be administered by trained research assistants, some of whom may be 
social workers, graduate or health professional students. Several will be fluent in 
Spanish. They will be supervised by the survey coordinator and the survey coordinator 
will not be involved in the intervention. 
 
Most of the measures we are using to assess the constructs in the conceptual model 
have been previously developed, standardized and utilized as noted in Section 3. The 
exceptions are the Oral Health Self-Management Fears and Worries scale, the 
Perceived Oral Health Risks Scale and the Oral Health Self-Management Intentionality, 
which have good internal reliability and face validity. This study will provide the 
opportunity to investigate discriminant validity. The oral health skills 
assessment/Practice to Mastery Score is part of the intervention to assess 
improvements in participants’ oral hygiene skills on a typodont during the intervention2. 
 
The primary outcomes are the Gingival Index and Plaque Scores. These are valid and 
reliable measures of oral hygiene. A secondary outcome measure is the OHQOL (Oral 
Health Quality of Life Scale). This is also a well known and utilized validated scale 
widely used with both younger and older adults. The dental hygienists will conduct the 
majority of clinical assessments under the supervision of Dr. Lalla who may conduct 
some of the assessments. All assessors will be calibrated to assure inter-rate and intra- 
rater reliability. 
 
2 We continue to collect OH skills assessment data at four time points, but we do not plan to use the data 
to measure changes in this variable. 

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9 ASSESSMENT OF SAFETY 
 
Participant safety is of paramount importance in conducting our research project. The 
tailored one-on-one and building interventions present minimal risk to the participants. 
The study assessments also present minimal risk to participants. Some participants 
may find some portions of the survey stressful and upsetting. Participants may skip 
sections that are stressful or discontinue the survey at any point. The dental exam may 
present a very minimal risk of infection. If an infection occurs, the dentist on the study 
team will prescribe an antibiotic at the expense of the study. If the participant finds the 
exam painful, topical anesthetic will be applied. The PIs and the dentist will oversee 
safety precautions during the study. Participants with emergent dental treatment needs 
discovered during the dental exam will be referred for immediate treatment. 
Participants will be advised of other treatment needs and will be provided with a referral 
if needed. As with all research projects, reporting of suspected abuse is mandatory and 
participants are informed of this at the time of informed consent. 
 
9.1 
Specification of Safety Parameters 
 
9.1.1 
Unanticipated Problems 
Participation in this study meets minimal risk criteria consistent with 45 CFR 46. Thus, 
safety monitoring for this study will focus on unanticipated problems involving risks to 
subjects, including unanticipated problems that meet the definition of a serious adverse 
event. 
 
The Office for Human Research Protections (OHRP) considers unanticipated problems 
involving risks to subjects or others to include, in general, any incident, experience, or 
outcome that meets all of the following criteria: 
 
• 
unexpected in terms of nature, severity, or frequency given (a) the research 
procedures that are described in the protocol-related documents, such as the 
IRB-approved research protocol and informed consent document; and (b) the 
characteristics of the subject population being studied; 
 
• 
related or possibly related to participation in the research (“possibly related” 
means there is a reasonable possibility that the incident, experience, or outcome 
may have been caused by the procedures involved in the research); and 
 
• 
suggests that the research places subjects or others at a greater risk of harm 
(including physical, psychological, economic, or social harm) than was previously 
known or recognized. 
 
Incidents or events that meet the OHRP criteria for unanticipated problems require the 
creation and completion of an unanticipated problem report form. PIs will complete the 

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following information when reporting an adverse event, or any other incident, 
experience, or outcome as an unanticipated problem to the IRB: 
 
 appropriate identifying information for the research protocol, including the title, 
investigators’ names, and the IRB project number; 
 a detailed description of the adverse event, incident, experience, or outcome; 
 an explanation of the basis for determining that the adverse event, incident, 
experience, or outcome represents an unanticipated problem; 
 a description of any changes to the protocol or other corrective actions that have 
been taken or are proposed in response to the unanticipated problem. 
To satisfy the requirement for prompt reporting, unanticipated problems will be reported 
using the following timeline: 
 
 Unanticipated problems that are serious adverse events will be reported to the 
IRB and to NIDCR within 1 week of the investigator becoming aware of the 
event. 
 Any other unanticipated problem will be reported to the IRB and to NIDCR within 
2 weeks of the investigator becoming aware of the problem. 
 All unanticipated problems should be reported to appropriate institutional officials 
(as required by an institution’s written reporting procedures), the supporting 
agency head (or designee), and OHRP within one month of the IRB’s receipt of 
the report of the problem from the investigator. 
All unanticipated problems will be reported to NIDCR’s centralized reporting system via 
Rho Product Safety: 
 
 Product Safety Fax Line (US): 1-888-746-3293 
 Product Safety Hotline: 1-888-746-7231 
 Product Safety Email: rho_productsafety@rhoworld.com 
General questions about SAE reporting can be directed to the Rho Product Safety Help 
Line (available 8:00AM – 5:00PM Eastern Time): 
 
 
9.1.2 
Adverse Events 
An adverse event is any untoward or unfavorable medical occurrence in a human 
subject, including any abnormal sign (for example, abnormal physical exam or 
laboratory finding), symptom, or disease, temporally associated with the subject’s 

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participation in the research, whether or not considered related to the subject’s 
participation in the research. 
 
9.1.3 
Serious Adverse Events 
A serious adverse event (SAE) is one that meets one or more of the following criteria: 
 
• 
Results in death 
 
• 
Is life-threatening (places the subject at immediate risk of death from the event 
as it occurred) 
 
• 
Results in inpatient hospitalization or prolongation of existing hospitalization 
 
• 
Results in a persistent or significant disability or incapacity 
 
• 
Results in a congenital anomaly or birth defect 
 
• 
An important medical event that may not result in death, be life threatening, or 
require hospitalization may be considered an SAE when, based upon appropriate 
medical judgment, the event may jeopardize the subject and may require medical 
or surgical intervention to prevent one of the outcomes listed in this definition. 
 
9.2 
Time Period and Frequency for Event Assessment and Follow-Up 
Unanticipated problems will be recorded in the data collection system throughout the 
study. 
 
The PI will record all reportable events with start dates occurring any time after informed 
consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day 
of study participation. At each study visit, the investigator will inquire about the 
occurrence of AE/SAEs since the last visit. 
 
Any AE meeting the specified Serious Adverse Event criteria will be submitted on an 
SAE form to NIDCR’s centralized safety system via Rho Product Safety. This report 
may be sent by fax or email. Once submitted, Rho Product Safety will send a 
confirmation email to the investigator within 1 business day. The investigator should 
contact Rho Product Safety if this confirmation is not received. This process applies to 
both initial and follow-up SAE reports. 
 
SAE Reporting Contact Information: 
 
 Product Safety Fax Line (US): 1-888-746-3293 
 Product Safety Hotline: 1-888-746-7231 
 Product Safety Email: rho_productsafety@rhoworld.com 

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General questions about SAE reporting can be directed to the Rho Product Safety Help 
Line (available 8:00AM – 5:00PM Eastern Time): 
 
The study clinician will complete a Serious Adverse Event Form and submit via fax or 
email within the following timelines: 
 
 All deaths and immediately life-threatening events, whether related or unrelated, 
will be recorded on the Serious Adverse Event Form and submitted to Product 
Safety within 24 hours of site awareness. 
 Serious adverse events other than death and immediately life-threatening events, 
regardless of relationship, will be reported by fax within 72 hours of site 
awareness. 
All SAEs will be followed until resolution or stabilization. 
 
9.3 
Characteristics of an Adverse Event 
 
9.3.1 
Relationship to Study Intervention 
To assess relationship of an event to study intervention, the following guidelines are 
used: 
 
1. Related (Possible, Probable, Definite) 
 
a. The event is known to occur with the study intervention. 
 
b. There is a temporal relationship between the intervention and event onset. 
 
c. The event abates when the intervention is discontinued. 
 
d. The event reappears upon a re-challenge with the intervention. 
 
2. Not Related (Unlikely, Not Related) 
 
a. There is no temporal relationship between the intervention and event 
onset. 
 
b. An alternate etiology has been established. 
 
9.3.2 
Expectedness of SAEs 
The NIDCR Medical Monitor and the Study PIs will be responsible for determining 
whether an SAE is expected or unexpected. An adverse event will be considered 
unexpected if the nature, severity, or frequency of the event is not consistent with the 
risk information previously described for the intervention. 

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9.3.3 
Severity of Event 
The following scale will be used to grade adverse events: 
 
1. Mild: no intervention required; no impact on activities of daily living (ADL) 
 
2. Moderate: minimal, local, or non-invasive intervention indicated; moderate impact 
on ADL 
 
3. Severe: significant symptoms requiring invasive intervention; subject seeks 
medical attention, needs major assistance with ADL 
 
9.4 
Reporting Procedures 
The UCHC IRB requires reporting of unexpected adverse events that may represent an 
unanticipated problem involving risks to subjects or others (UPIRSO). Such events are 
to be reported using the Problem Report Form available on the UCHC website. Upon 
review the Institutional Review Board (IRB) may require changes to informed consent 
forms and/or protocols or other actions such as increased monitoring. The IRB makes 
the final determination as to whether an internal adverse event constitutes an 
unanticipated problem and whether changes to the consent and/or protocol are 
required. For external events, the sponsor should indicate if they have deemed the 
event to be a UPIRSO, and if so the IRB is to be informed. 
 
All investigators and study personnel must be familiar with the policy for reporting 
unanticipated problems, inclusive of unexpected adverse events that may be 
unanticipated problems, to the IRB. All policies are available on the UCHC website. 
Such events must be reported using the Problem Report Form within 5 working days (7 
calendar days) of becoming aware of the event. See Section 9.3. 
 
9.4.1 
Unanticipated Problem Reporting to IRB and NIDCR 
Reporting unanticipated problems to the IRB is discussed in Sections 9.1.1 and Section 
4. As with reporting requirements for the IRB, the PI will record all reportable events 
with start dates occurring any time after informed consent is obtained until 7 (for non- 
serious AEs) or 30 days (for SAEs) after the last day of study participation. At each 
study visit, the investigator will inquire about the occurrence of AE/SAEs since the last 
visit. Events will be followed for outcome information until resolution or stabilization. 
These events will be reported in writing to NIDCR within 5 working days for serious 
adverse events and within one month for non-serious adverse events. 
 
9.4.2 
Serious Adverse Event Reporting to NIDCR 
Any AE meeting the specified Serious Adverse Event criteria will be submitted on an 
SAE form to NIDCR’s centralized safety reporting system via 
rho_productsafety@rhoworld.com. See section 9 of the MOP for SAE reporting 
requirements. 

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9.5 
Halting Rules 
Study halting may occur as required by the IRB or NIDCR. The study PIs may 
temporarily suspend enrollment pending review by these authorities if warranted based 
on the presence, type, or frequency of SAEs or other changes in the study protocol 
which may place participants in greater than anticipated risk. 

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10 STUDY OVERSIGHT 
 
The Principal Investigators, Drs. Reisine and Schensul, PIs on the prior NIDCR funded 
studies, will be responsible for study oversight, including monitoring safety, ensuring 
that the study is conducted according to the protocol and ensuring data integrity. The 
PIs will review the data for safety concerns and data trends at regular intervals, and will 
promptly report to the IRB and NIDCR any Unanticipated Problem (UP), protocol 
deviation, or any other significant event that arises during the conduct of the study. 
 
In addition to the PIs responsibility for oversight, study oversight will be under the 
direction of the NIDCR Medical Monitor. The PIs will submit a report every 6 months to 
the NIDCR Medical Monitor for review. This report will include data regarding enrollment 
and retention, unanticipated problems and protocol deviations, outcome measures, 
quality management findings and other relevant parameters. If necessary, additional 
steps may be taken to ensure data integrity and protocol compliance. 
 
The field team will be directed by the intervention coordinator and the survey 
coordinator. Both will work closely with the data analyst who will be responsible for 
tracking field progress and reporting to the study team. The PIs will remain in close 
contact with the field administrative team. 
 
It is our practice for the research team to meet weekly and this group functions as a 
steering committee. We discuss and monitor: the general design and conduct of the 
study: preparation of the essential study documents, including the protocol, protocol 
amendments, MOP and data collection forms; review of data collection practices and 
procedures; changes in study procedures as appropriate; allocation of resources based 
on priorities of competing study demands; review of study progress and implementation 
of necessary steps to ensure the achievement of study goals; review and 
implementation of recommendations from those responsible for safety monitoring. We 
submit a monthly report electronically to the NIDCR program officers to keep them 
advised of our progress. 

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11 CLINICAL SITE MONITORING 
 
Clinical site monitoring will not be done for this study; however, the NIDCR reserves the 
right to conduct independent audits or clinical monitoring as necessary. 

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12 STATISTICAL CONSIDERATIONS 
 
12.1 
Study Hypotheses 
1. The AMI-PM will produce better short term (T1) clinical outcomes than the 
Campaign (CA+PM) (AIM 1). 
 
2. The CA+PM+AMI-PM will produce better mid-term (T2) and long-term (T3) 
clinical outcomes than the AMI-PM+CA+PM (AIM 2). 
 
3. The AMI-PM will produce more change in mediating cognitive domains than the 
CA+PM. 
 
4. Both AMI-PM+CA+PM and CA+PM+AMI-PM will result in no differences in 
change in mediating cognitive domains from T0 to T2. 
 
5. The greater the dosage (proportion of total talking points recorded for all domains 
in a tailored AMI; and exposure to campaign activities and messages), the better 
the outcomes. 
 
6. We will investigate an exploratory hypothesis examining the effects of the 
intervention and sequence on oral health quality of life (a secondary outcome), 
as well as on clinical outcomes. 
 
12.2 
Sample Size Considerations 
Sample size calculations are based on the primary outcomes of continuous measures of 
the Gingival Index and Plaque Scores using estimates of effect and variation from the 
pilot grant. The MFFD design has two sequences, called A:B and B:A, and two periods 
(1 and 2). We will power on the first period, which is essentially a two-arm parallel 
design with randomization at the building level. The study design will recruit N=60/ 
building, with 3 buildings on sequence A:B (N=180) and three on sequence B:A 
(N=180). 
 
Table 
Sample size for a two-group t-test, using a two-sided =0.05 
Outcome 
Source 
Mean 
difference 
Std Dev 
Effect 
Size 
N per 
group 
Power 
Plaque Index 
Pilot 
0.25 
0.34 (pilot) 
0.74 
123 
99 
Gingival Score 
Pilot 
0.66 
0.60 (pilot) 
1.1 
123 
99 
Plaque Index 
Pilot 
0.25 
0.47 (UCL) 
0.53 
123 
98 
Gingival Score 
Pilot 
0.66 
0.81 (UCL) 
0.82 
123 
99 
Plaque Index 
Pilot*.75 
0.20 
0.47 (UCL) 
0.42 
123 
91 
Gingival Score 
Pilot*.75 
0.50 
0.81 (UCL) 
0.62 
123 
99 
UCL= Upper 95% CL of the pilot study SD 

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Attrition: Longitudinal studies must account for attrition. If we assume a conservative 
75% retention rate across the study that would leave us with approximately N=135 per 
intervention group, or N=45 per building. 
 
Effects of intra-class correlation (ICC) within sites: The cluster design can sometimes 
impact the power of a study and our calculations consider this human phenomenon. To 
account for the cluster design, we calculated the effective sample size which is the 
sample size used for power calculations, according to Killip et al. With this design we 
expect to have 6 clusters of N=45 each finish the study, or 135 per sequence. Assuming 
an intracluster correlation coefficient (ICC) of 0.01 or 0.02, which are typical values for 
human subject studies, this gives effective sample sizes closer to 123. The strategy 
therefore is to accordingly adjust the sample sizes used in calculations. As a result, our 
sample size calculations are based on a maximum number of N=123 per intervention 
(not 135) after accounting for loss of power due to intra-class correlation. Using N=123 
per group, our power ranged from 91 to 99 for different scenarios reflecting varied 
assumptions, as shown in the attached memo from September 5, 2016. 
 
Calculation for Primary Outcomes: While the pilot data provide a good starting point for 
sample size estimation, we acknowledge that the study was small and the results 
provide only estimates. To be conservative regarding pilot results, we 1) decreased the 
observed effect size by 25% and 2) used the upper 95% CL of the standard deviation 
for calculations. Employing these two hedges gives protection and helps assure we will 
have sufficient power to detect similar (or smaller) effect sizes with 80% power. With 
N=135 per group our study still has more that 90% power to find detect the mean 
differences (MD) in the table below. 
 
12.4 
Final Analysis Plan 
The usual inspection for outliers and influential data points will be conducted along with 
summary statistics and evaluations of distributions of the data. We have experience with 
the clinical outcome measures, which have approximately normal distributions. In the 
case of non-normal data, we will use standard transformations (e.g., log) or explore 
alternatives (e.g., non-parametric approaches or other distributions such as Poisson). 
 
Period 1: parallel arm phase: Standard approaches for a parallel 2-arm randomized 
study will be conducted for the first period of the sequence, across all buildings. This 
analysis allows direct comparison of the AMI vs. the Campaign approach for clinical 
outcomes (Study Hypothesis #1). 
 
Periods 1 and 2: assessing sequence of interventions: Study Hypothesis #2, which 
sequence gives better clinical outcomes, will be addressed using repeated measures 
models. Depending on whether the outcome is continuous or dichotomous, we use 
general linear mixed models (GLMM) or general estimating equations (GEE), 
respectively, to fit a model with intervention and period effects using the MIXED 
procedure in SAS. Each set of measures from the same person (e.g., gingival 
outcomes) are treated as a correlated cluster of data. An AR-1 correlation structure is 

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likely to be appropriate. Customized contrasts can be constructed to make comparisons 
between time points. Time-varying covariates can be used in these models, and some 
missing data (under MAR or MCAR assumptions where applicable), is allowable. 
 
Baseline & health status variables: As this study randomizes at the level of site and 
individuals are not randomized, we will likely stratify some results (or adjust in models) 
for demographics such as age, gender, marital status and individual characteristics 
such as health status, ADLs, depressive symptoms (CES-D) and oral health status 
(self-assessment). Any variable that shows potential for confounding or effect 
modification will be accounted for appropriately in all stages of the analysis. 
 
Intervention variables: As all subjects are exposed to the same interventions, it is of 
interest to unpack the intervention into 1) dosage (percent of talking points covered for 
all focal points (domains) addressed in the intervention, and 2) exposure to focal point 
messages during campaigns. Study Hypothesis #5, regarding dosage of interventions, 
will be assessed by creating an ordinal scale that measures an individual’s exposure to 
talking points through participation in the AMI and exposure to messages via 
campaigns, thus creating a measure of dosage. We will then assess if dosage predicts 
better outcomes. This can be done directly (e.g., compare mean gingival scores across 
dosage levels with ANOVA) or dosage can be used as a predictor variable in the 
statistical models and causal pathway analyses. Oral health skills/Practice-to-Mastery 
(a 4 point Likert scale) and focal points (count variable) can be analyzed using similar 
techniques and approaches. 
 
MFFD layout: N at the beginning of study 
Sequence 
N 
Building 1 
A:B 
60 
Building 2 
B:A 
60 
Building 3 
A:B 
60 
Building 4 
B:A 
60 
Building 5 
A:B 
60 
Building 6 
B:A 
60 
Secondary Outcome of General Oral Health Assessment Inventory (GOHAI): We will 
conduct a set of secondary analyses with GOHAI as a continuous outcome. It will also 
be incorporated into our statistical/mediator models as predictor to see if it acts as an 
effect modifier. 
 
Cognitive Mediators: The following variables will be incorporated into the causal 
pathway analysis to address example hypotheses #3 and #4: knowledge, oral health 
beliefs/norms, social support, oral hygiene behaviors, fears/worries, practice to mastery, 
and behavioral intentions. We will use longitudinal mediation to compared the efficacy of 
AMI-PM+CA+PM to CA+PM+AMI-PM in terms of whether they differ significantly in the 
amount of change that they engender in the gingival index and plaque score, indirectly 
through the mediators measured in our model. 

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The classical Barron & Kenny (1986) mediation approach to longitudinal mediation 
would examine whether the intervention impacts the levels of our mediators, such as 
beliefs, at T1 (for example), which in turn affect clinical outcome measures resulting 
from participant behaviors as measured by the Gingival index and Plaque Scores at T2. 
Or, simply put, whether levels of self-efficacy at T1 are associated with the levels of 
gingival index scores at T2 indirectly through self-efficacy at T1 (and other mediators 
previously referenced). But, we are interested in examining whether there is a change in 
our mediators over time, and if so, whether this change significantly leads to a change 
in behaviors, as assessed by the Gingival Index and Plaque Scores. Recent 
methodological studies actually show that the analysis of change is more appropriately 
captured by specifying change (differences) in self-efficacy and our other mediators and 
behavioral outcomes between adjacent time points (i.e. T1-T0, and T2-T1) as latent 
difference scores, and explicitly modeling these change scores to represent dynamic 
change, i.e., the impact of change in the mediators on change in the behavioral 
outcomes. 
 
Hypothesis #3 will be tested using latent change score analysis specifying AMI and 
Campaign as predictors of change in behavioral beliefs(ΔBB), OH social support (ΔSS), 
locus of control beliefs(ΔCB), self-efficacy(ΔSE), fears/worries (ΔF/W), social norms 
(ΔSN), and behavioral intentions (ΔBI) from baseline to first and second follow-up. 
 
To test hypothesis #4, we will conduct dynamic mediation using latent change 
(difference) score (LCS) mediation analysis. The analyses will be conducted in Mplus 7 
where change (difference) scores representing differences in each mediator and 
outcome variable from baseline to final follow up (i.e. T1-T0 (ΔT10), and T2-T1(ΔT21) will 
be generated. It is the difference scores of the mediators and outcome variables that 
are modeled. Generally speaking, causal paths specifying latent (true) change, 
represented by change in knowledge, oral health beliefs/norms, OH social support, oral 
hygiene behaviors, fears/worries, oral health practice to mastery skills, and behavioral 
intentions in going from T0 to T1, and T1 to T2 will be specified, to predict change in 
Gingival Index and Plaque Scores at T2 (i.e., ΔGingival Index21, ΔPlaque score21). For 
example, we will test whether change in fears/worries from T0 to T1 significantly 
predicts changes in Gingival Index and Plaque Scores at final follow-up,T2 (ΔGingival 
Index21, ΔPlaque scores21). To assess the impact of the change in self-efficacy (ΔSE), 
on changes in Gingival Index scores (ΔGingival Index), direct and indirect paths from 
change in self-efficacy from baseline to first follow up (ΔSE10) that predict the change in 
Gingival Index at the final follow-up (ΔGingival Index30) will be specified and tested. 
Select direct and indirect paths from change scores of the other mediator variables to 
change scores of behavioral outcomes will also be specified in a similar fashion, and all 
these relationships will be tested simultaneously. 
 
Summary: Using a conservative set of assumptions and based on our own pilot data, 
we have demonstrated, using our pilot data estimates, that we will have sufficient power 
to detect significant changes, using a two-group t-test which makes minimal 

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assumptions about the data. It is worth noting that the proposed statistical models have 
greater power characteristics than the t-tests used to calculate power. 

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13 SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/DOCUMENTS 
 
There are three sources of data for the study which include the survey, the clinical 
assessment of the Gingival Index and Plaque Scores, and campaign 
participation/dosage. The survey will be administered through the Questionnaire 
Development System (QDS) electronic data collection system installed on individual 
password-protected laptop computers, backed up on password-protected flash drives, 
and downloaded each day into a study designated directory and database on a 
password-protected computer by the study data manager. The data directories are 
backed-up automatically each day. Each interviewer will have her/his own designated 
laptop computer and flash drive. Interviewers will check each interview file for missing 
data and completeness before saving to the data directories. 
 
Data from the clinical assessments will be recorded electronically (See Appendix B). 
The oral hygiene skills assessment will be conducted by research staff at the time of the 
clinical assessment and recorded on the data form for the clinical assessment though it 
will not be used for evaluation purposes. Data will be tracked in an ACCESS data file. 
 
Individual Passports for each person attending each of the fairs in the campaign will 
include the person’s name, time of arrival and time of leaving. The passport will collect 
information on what activities they participated in. The Passport will be stamped at 
each activity. Passports will be collected at the end of each fair during the building 
campaign and the number of activities and other data will be recorded in an ACCESS 
file as a measure of dosage of the intervention and linked to the individual’s ID. 

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14 QUALITY CONTROL AND QUALITY ASSURANCE 
 
Quality control and quality assurance begins with adequate training and calibration of 
the interventionists and assessors, both clinical examiners and interviewers. Quality 
assurance is further addressed by monitoring fidelity throughout the study. These 
issues are discussed above. Quality management efforts are outlined in this section 
and in the quality management plan. 
 
Data collection and accurate documentation will be the responsibility of the study staff 
under the direction of the Intervention Director, the Survey Director and the data analyst 
and the supervision of the PIs. All source documents reports will be reviewed by the 
study team and data management staff, who will ensure that they are accurate and 
complete. The data analyst will maintain a tracking database to assure that all 
necessary documents are completed for each participant; follow-up surveys and clinical 
assessments are completed on time; and AMI sessions are completed on schedule. 
This electronic file will include participant names because it is used to track and follow 
participants. It is password protected, kept in a directory that is only accessible to study 
staff, and is only available to study staff and PIs. Additionally, each research record will 
have a checklist on the inside cover to assure that all necessary documents are 
completed for each participant; follow-up surveys and clinical assessments are 
completed on time; and AMI sessions are completed on schedule. The format for both 
files is shown in the appendix. 
 
Survey data collection will be accomplished using the Questionnaire Development 
System (QDS) electronic data collection system installed on individual password- 
protected laptop computers, backed up on password-protected flash drives, and 
downloaded each day into a study designated directory and database on a password- 
protected computer by the study data manager. The data directories are backed-up 
automatically each day. Each interviewer will have her/his own designated laptop 
computer and flash drive. Interviewers will check each interview file for missing data and 
completeness before saving to the data directories. 
 
Additional Quality Assurance Activities 
 
Survey: 
The Screener and Survey in QDS is designed with built in controls to minimize data 
entry errors. The data entry controls will be adjusted during the first few weeks of data 
collection based on the real needs from the field. 
 
Participation process (from initial contact to completion of the study) will be documented 
in a tracking table in Access which allows multiple queries to check data status, 
potential errors and take action to make correction at the earliest stages 
Multi-dimensional data collection forms (e.g. clinical assessment, intervention process 
etc.) will be entered into Access forms. Then they will be imported into either SPSS for 

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quick report. The collection of these data will be tracked in the participation process 
tracking table (Access). 
 
Intervention 
Face to face AMI: The first five audio recorded AMIs will be checked for consistency 
against hard copy (Focal Point record), hard copy plan and Access database digital 
fidelity forms. Thereafter 10% of all audio recorded AMIs will be reviewed and checked 
for fidelity by the study PIs. Areas of inconsistency or incompleteness will be addressed 
through review and retraining. After each AMI is completed, all participant responses 
will be entered into the Access database by the interventionists. The Intervention 
Coordinator will review each AMI record entered into the database to insure that all 
components of the AMI session have been completed and documented. 
 
Campaign fairs: All recording forms (attendance, passport), will be collected, linked to 
enrolled participants, and checked for completeness. Observations will note instances 
of message delivery in general sessions, and participation at PM station. Campaign 
passport data will be recorded for dosage. Documentation will be reviewed after the first 
campaign, and gaps and missing data for participants noted and corrected. 
 
Calibration of clinical assessment: Recalibration will take place and be recorded prior to 
or early during administration of T0 of each cycle (approximately once a year). 
 
Random audits of participant research records will take place every six months to 
assure that all documents are filed properly in the research record. Ten records will be 
selected every six months for review. Corrective actions will be taken if problems are 
found. The IRB/Human Subjects Coordinator also will review all completed consent 
forms on a weekly basis to insure use of current IBR-approved forms that are properly 
signed and dated. Corrective actions will be taken if problems are found. 

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15 ETHICS/PROTECTION OF HUMAN SUBJECTS 
 
15.1 
Ethical Standard 
The investigator will ensure that this study is conducted in full conformity with the 
principles set forth in The Belmont Report: Ethical Principles and Guidelines for the 
Protection of Human Subjects of Research, as drafted by the US National Commission 
for the Protection of Human Subjects of Biomedical and Behavioral Research (April 18, 
1979) and codified in 45 CFR Part 46 and/or the ICH E6; 62 Federal Regulations 25691 
(1997). 
 
15.2 
Institutional Review Board 
The protocol, informed consent form(s), recruitment materials, and all subject materials 
will be submitted to the IRB for review and approval. Approval of both the protocol and 
the consent form must be obtained before any subject is enrolled. Any amendment to 
the protocol will require review and approval by the IRB before the changes are 
implemented in the study. 
 
15.3 
Informed Consent Process 
Informed consent is a process that is initiated prior to the individual agreeing to 
participate in the study and continues throughout study participation. Extensive 
discussion of risks and possible benefits of study participation will be provided to 
subjects and their families, if applicable. A consent form describing in detail the study 
procedures and risks will be given to the subject. Consent forms will be IRB-approved, 
and the subject is required to read and review the document or have the document read 
to him or her. The investigator or designee will explain the research study to the subject 
and answer any questions that may arise. The subject will sign the informed consent 
document prior to any study-related assessments or procedures. Subjects will be given 
the opportunity to discuss the study with their surrogates or think about it prior to 
agreeing to participate. They may withdraw consent at any time throughout the course 
of the study. The rights and welfare of the subjects will be protected by emphasizing to 
them that the quality of their clinical care will not be adversely affected if they decline to 
participate in this study. We also will repeat screening for the eligibility criteria. 
 
All individuals will be consented by trained survey or clinical assessors in the study. 
Participants will be asked to respond to 5 key questions to evaluate whether they 
understand the purpose of the study, what activities their participation entails, risks that 
might be encountered, expected duration of participation, and whether participation is 
voluntary. 
 
Two copies of the consent form will be signed and dated by participant and assessment 
administrator. One is kept in the participant’s hard copy file, and scanned for electronic 
warehousing, and the second is given to the participant. 

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A record of consent administration by date will be kept in the participant’s access form, 
data to be entered by the survey coordinator. 
 
15.4 
Exclusion of Women, Minorities, and Children (Special Populations) 
Women and men and all ethnic and racial minorities will be included in the study. 
Children ages 18-21 are eligible for the study, but given the demographics of the 
residents of the building it will be unlikely that children will be in the study. 
 
15.5 
Subject Confidentiality 
Participant confidentiality is strictly held in trust by the investigators, study staff, and the 
sponsor and its agents. This confidentiality is extended to cover testing of biological 
samples in addition to any study information relating to participants. Data will be 
collected for research purposes only. 
 
The following procedures will be put in place to protect the confidentiality of data. To 
avoid loss of confidentiality, participants' names will not appear on any document 
associated with the project, except for informed consent, HIPAA forms and Campaign 
Passport. Unique ID numbers, not participants' names, will appear on all interview 
records used for computer data entry. Ethnographic observations, field notes and other 
project records will be kept in locked files and in password protected computer files at 
UCHC and ICR, to which only project staff will have access. No records will be kept at 
building sites at any time. Names and apartment numbers, which will be used for 
creating unique identifier lists and for follow-up, will be kept under lock and key at the 
ICR project office, under the direct supervision of the Project Coordinators, and used by 
the project director and field interviewers only. Digital audio-recordings will be uploaded 
daily to password protected computer files, and deleted after the interview has been 
checked for accuracy. All names will be converted to codes and all identifier information 
will be removed from the recording. Therefore, the participant’s name will not be used 
anywhere in the recording. 
 
The study protocol, documentation, data, and all other information generated will be 
held in strict confidence. A subject’s participation in this project will be kept confidential 
within the study team at UCHC and the Institute for Community Research. No 
information concerning the study or the data will be released to any unauthorized third 
party without prior written approval of the PIs and sponsor, and will be shared only in 
aggregated form. Study data will be presented in summary form. Participant names or 
other identifying information will never be included in project data to be presented to the 
public. Therefore, participants will not be identifiable in presentations or publications 
based on this research. 
 
The study monitor or other authorized representatives of the sponsor, and the UCHC 
IRB and Human Subjects Protections Office may inspect all study documents and 
records required to be maintained by the investigator, including but not limited to, 

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medical records (office, clinic, or hospital) for the study participants. The clinical study 
site will permit access to such records. 
 
Knowledge of elder, child or spousal abuse, or participant intent to harm self or 
someone else, or of certain communicable diseases learned during the course of the 
study, is required to be reported to State officials. 

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16 DATA HANDLING AND RECORD KEEPING 
 
16.1 
Data Management Responsibilities 
The Public Health Researcher/Data Analyst is responsible for overseeing all data 
management operations, including data entry, data transfer to main SPSS file, clinical 
assessment data, intervention data, and data tracking file. 
 
The Survey coordinator is responsible for entry of evaluation data into tracking file, data 
collection, survey data checking and transfer from field computers to main SPSS 
storage. The survey coordinator will enter all evaluation data records into main data 
tracking file. 
 
The Intervention coordinator is responsible for coordination and entry of all intervention 
data into intervention data files (Excel or Access). The intervention coordinator will enter 
all intervention data records into main data tracking file. 
 
Dental hygienists will enter all screening data into an Access data base, using 
participant ID numbers. Data will be amalgamated into main study data file by time 
point, by the Data Analyst or supervised staff. 
 
Intervention and evaluation staff will be based at ICR. Oral health dentist and health 
educator () and clinical assessment personnel (dental hygienists) will be based at the 
SDM. Student survey intern personnel from the UCONN Sociology and Anthropology 
departments and School of Social Work will be placed as appropriate at either ICR or 
SDM but field coordinated through ICR under supervision of the survey coordinator. The 
study team will follow procedures for overall coordination established in the pilot study 
through weekly meetings, and electronic information sharing on a daily basis. Surveys 
collected on individually labeled project specific computers will be downloaded to the 
QDS warehouse on a weekly basis and stored in separate files by computer, condition 
and cycle along with fidelity and clinical assessment data. Copies of QDS data collected 
in the field, along with all clinical assessment data will be retained on flash drives linked 
to individualized study computers. Further all survey data collected through QDS will be 
retained in RTF files as backup on flash drives. They will be transferred weekly to file 
storage on the ICR password protected server. Flash drives will be kept by individual 
researchers in a secure place. All study computers will be returned to the ICR office 
daily in accordance with their schedule and kept in a locked office. Study participant 
files will be maintained at ICR and stored electronically in password protected files at 
ICR and SDM. Password protected files will be available only to study team field 
coordinators and PIs. All data, study results etc. will be shared by study partners (ICR 
and SDM) using protected means of transferring de-identified data files. 

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16.2 
Data Capture Methods 
Data will be collected in 4 ways: 
 
a) Survey (cognitive and all reported health related behavior including ADLs, dry 
mouth); 
 
b) Observation methods; 
 
c) Clinical screening forms; 
 
d) Electronic records of intervention administration. 
 
16.3 
Types of Data 
Two classes of data will be collected in this study: a) evaluation data; b) intervention 
data. 
 
The outcome evaluation data to be collected in this study are of two types: clinical 
assessments of gingiva and plaque; and survey assessing ADLs and cognitive 
domains. (As noted earlier we will continue to collect oral hygiene skills data, but will not 
be using the data for outcome analysis.) 
 
The intervention process/fidelity data to be collected in this study will be collected during 
the face to face intervention (AMI-PM) and campaign (CA+PM) and include: 
 
AMI-PM: record of main domains requiring attention in the intervention (Focal point 
record including domains to be addressed, whether they are or not, and whether the 
correct script is delivered for each point); P-M pre and post scores; and participant plan 
of action (copy to participant and for electronic file). 
 
CA+PM: record of exposure to all campaigns through a “passport” recording presence, 
duration, and visits to stations during campaign, including participation in practice to 
mastery. Data will be collected from the passport and entered into the intervention data 
base as presence/absence for each “page” (station), date of fair, time of entry and exit. 
 
16.4 
Schedule and Content of Reports 
The Access data tracking file will allow for weekly and monthly updates of intervention 
and evaluation progress. Reports on enrollment, evaluation (screening, skills 
assessment, clinical assessment and survey), and completion of intervention will be 
provided to the study team initially on a weekly or biweekly basis as needed. 
 
16.5 
Study Records Retention 
For funded grants, documents must be maintained for 7 years after the grant is officially 
closed (1 year at the investigative centers and 6 at the federal records center). 

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16.6 
Protocol Deviations 
The tracking database will be reviewed with the Field Coordinator bimonthly to assure 
adherence with protocols. Protocol deviations will be reported to the IRB within the 
required timeframe. Protocol deviations will also be reported to the NIDCR program 
officer via NIDCR_reports@rhoworld.com, once monthly. Plans to prevent future 
deviations will be developed and implemented. 

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17 PUBLICATION POLICY 
 
NIH Publication Policy 
 
The Director of the National Institutes of Health shall require that all investigators funded 
by the NIH submit or have submitted for them to the National Library of Medicine’s 
PubMed Central an electronic version of their final, peer-reviewed manuscripts upon 
acceptance for publication, to be made publicly available no later than 12 months after 
the official date of publication: Provided, That the NIH shall implement the public access 
policy in a manner consistent with copyright law. 
 
Specifics 
 
1. The NIH Public Access Policy applies to all peer-reviewed articles that arise, in 
whole or in part, from direct costs 1 funded by NIH, or from NIH staff, that are 
accepted for publication on or after April 7, 2008. 
 
2. Institutions and investigators are responsible for ensuring that any publishing or 
copyright agreements concerning submitted articles fully comply with this Policy. 
 
3. PubMed Central (PMC) is the NIH digital archive of full-text, peer-reviewed 
journal articles. Its content is publicly accessible and integrated with other 
databases (see: http://www.pubmedcentral.nih.gov/). 
 
4. The final, peer-reviewed manuscript includes all graphics and supplemental 
materials that are associated with the article. 
 
5. Beginning May 25, 2008, anyone submitting an application, proposal or progress 
report to the NIH must include the PMC or NIH Manuscript Submission reference 
number when citing applicable articles that arise from their NIH funded research. 
This policy includes applications submitted to the NIH for the May 25, 2008 due 
date and subsequent due dates. 
 
Project GOH Publication Policy 
 
Procedures for Approval of Manuscript/Paper/Presentation Project GOH 
 
Acquiring Topic Approval 
 
Any individual seeking to lead author a paper or presentation from this project, will need 
to submit a request for approval from the PIs. In this sheet, following information should 
be provided: 
 
 Paper topic 
 Study hypotheses and expected variables or concepts to be explored 

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 Date of submission to PIs 
 Expected authors in expected authorship order (please see Authorship 
Guidelines below.) 
 
 Expected Journal or Professional Conference to which you will submit 
Paper proposals will be discussed during weekly meetings of the research team. After 
receiving an email from PIs approving the paper proposal, the authors will sign an 
agreement by which they agree to the roles and responsibilities and the authorship 
order. This will help prevent future conflicts and delineate the level of contribution each 
author would be required to make towards the scientific paper/monograph. 
 
Authorship Guidelines 
 
Authorship and Contributorship 
 
According to the International Committee on Medical Journal Ethics (ICMJE), an author 
is defined as one who has made substantial contributions to the conception and 
development of a manuscript. The ICMJE guidelines state that “authorship credit should 
be based on all of the following: 1) substantial contributions to conception and design, 
acquisition of data, or analysis and interpretation of data; 2) drafting the article or 
advising it critically for important intellectual content; and 3) final approval of the version 
to be published”. All other contributors should be listed as acknowledgements. 
 
This means that, while all project staff and investigators may be included as authors on 
any publications produced from this study, they will only be included as an author on 
any given publication or presentation if they meet guidelines for authors as defined by 
these ICMJE guidelines for authors. Otherwise, project investigators and staff, as 
defined above, will be listed as contributors to a given manuscript. HOWEVER, every 
effort will be made to involve all above listed investigators as authors on each paper 
produced from this project. It is the responsibility of the lead author on each given paper 
from this project to ensure such opportunities for involvement are given. A lead author 
must contact each project investigator to invite them to be an author on the paper and 
specify their expected role. 
 
Authorship Order 
 
LEAD/FIRST AUTHOR-- The lead or first author of a given paper or professional 
presentation will lead conceptualization and writing of a given manuscript or 
professional presentation. He or she will also decide authorship involvement and order. 
All of this will be subject to approval from the principal investigators, using the 
procedure outlined in the Procedures for Approval of Manuscript/Paper/ Presentation. It 
is the responsibility of the lead author to ensure that all listed authors on the paper or 
presentation contribute at the level submitted to and approved by the PI. Alteration of 

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authorship order subsequent to this approval will require re-approval by the PI serving 
as senior author on the paper. 
 
SECOND AUTHOR-- The second author of a given paper or professional presentation 
will support the paper with co-conceptualization and extensive writing, such as taking a 
leadership role on writing a section of the paper or presentation. Given the nature of 
partnership between the university and ICR, the second author should be from one of 
these organizations. This approach will increase the collaboration, knowledge, and 
perspectives offered by the paper or presentation. For lead authors with less writing 
experience, inclusion of a more seasoned publication writer is recommended for second 
authors. 
 
SENIOR (LAST) AUTHOR-- Senior authors of papers will be positioned as such due to 
their oversight of the paper/presentation as a whole and their ability to ensure that the 
paper/presentation fits within the overall study and the previous and ongoing papers 
and presentations developed from the initiative. As such, principal investigators are in 
the optimal position to serve as senior author on all papers and presentations produced 
from their respective studies. 
 
Role of the lead author to Pursue the Paper/Presentation Once Approved: A lead 
author of an approved paper or presentation will have SIX MONTHS from the date of 
approval to submit the DRAFT paper or presentation for review. Should the paper or 
presentation not be completed within that SIX MONTHS time frame, rights to lead 
author this work are relinquished. 
 
Obligations to Maintain Author Involvement on a Paper: In accordance with the 
guidelines of most journals, authors are required to share revisions and resubmissions 
with all authors at every resubmission. Nothing should be submitted to any journal or 
any conference without approval from all authors on the paper or presentation; unless 
they agree that you may submit it without their final approval. Each author must be 
provided with a final copy of any submitted manuscript, report or presentation for their 
records. The primary author must also provide each author with a full citation of 
presented or published work. Make sure to include PIs. 
 
Changing Approved Paper Topic, including Hypotheses and Expected Variables 
to be Explored, Authors and Authorship Order, Journal or Conference for 
Submission: Any changes in information provided and approved via this topic approval 
process will require resubmission of the Topic Approval Form with specifications as to 
why these changes are needed. Authors may not alter this information without approval 
from the PI and the senior author. In such intentions, the lead author should discuss 
with other authors and send an email to the PIs and get feedback on the suggested 
change. 

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SUPPLEMENTAL MATERIALS 
 
These documents are relevant to the protocol, but they are not considered part of the 
protocol. They are stored and modified separately. As such, modifications to these 
documents do not require protocol amendments. 

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APPENDICES 
 
APPENDIX A: SCHEDULE OF EVENTS 
 
Building A – Tailored intervention first followed by campaign 
 
Visit 
Activity 
Timing 
Compensation 
1. – T0 
Survey – 1 hour 
Entry to study 
$15.00 
2. – T0 
Clinical assessment, 
skills assessment – 20 
minutes 
Entry to study 
$15.00 
3. 
Tailored educational 
session 45 min – 1 hour 
Up to 45 days post T0 
None 
4. – T1 
Survey – 1 hour 
1-3 months after educational 
session 
$15.00 
5. – T1 
Clinical assessment, 
skills assessment – 20 
minutes 
1-3 months after educational 
session 
$15.00 
3 Campaign 
Events/Oral health fairs 
– 2-3 hours each 
2-5 months after T1 
None 
6. – T2 
Survey– 1 hour 
1-3 months after campaigns 
$15.00 
7. – T2 
Clinical assessment, 
skills assessment – 20 
minutes 
1-3 months after campaigns 
$15.00 
8. – T3 
Clinical assessment, 
skills assessment, 
GOHAI – 20 minutes 
6-7 months after T2 
$20.00 

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Building B – Campaigns first followed by tailored intervention first 
 
Visit 
Activity 
Timing 
Compensation 
1. – T0 
Survey – 1 hour 
Entry to study 
$15.00 
2. – T0 
Clinical assessment , 
skills assessment – 20 
minutes 
Entry to study 
$15.00 
3 Campaign 
Events/Oral health fairs 
– 2-3 hours total 
3-6 months after study entry 
None 
3. – T1 
Survey– 1 hour 
1- 3 months after campaigns 
completed 
$15.00 
4. – T1 
Clinical assessment , 
skills assessment – 20 
minutes 
1- 3 months after campaigns 
completed 
$15.00 
5. 
Tailored educational 
session 45 min. to 1 
hour 
Up to 45 days after T1 
None 
6. – T2 
Survey– 1 hour 
1-3 months after educational 
session 
$15.00 
7. – T2 
Clinical assessment, 
skills assessment – 20 
minutes 
1-3 months after educational 
session 
$15.00 
8. – T3 
Clinical assessment, 
skills assessment, 
GOHAI – 20 minutes 
6-7 months after T2 
$20.00 

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APPENDIX B: EXTERNAL APPENDIX TABLE OF CONTENTS 
 
I. PROTECTION OF HUMAN SUBJECTS 
Section Cover Page 
Study Consent Form – English 
Study Consent Form – Spanish 
Campaign Committee Consent Form – English 
Campaign Committee Consent Form – Spanish 
Authorization to Use and Disclose Protected Health Information for Research 
Purposes (HIPAA) – English 
 
Authorization to Use and Disclose Protected Health Information for Research 
Purposes (HIPAA) – Spanish 
 
Authorization to Photograph/Video/Audiotape – English 
Authorization to Photograph/Video/Audiotape – Spanish 
II. STUDY INTRODUCTION 
Section Cover Page 
Letter of Introduction to Tenant Association – English 
Letter of Introduction to Tenant Association – Spanish 
Building-Wide Invitation to Introductory Presentation Flyer – English 
Building-Wide Invitation to Introductory Presentation Flyer – Spanish 
Introduction to Study (PPT) – English 
Introduction to Study (PPT) – Spanish 
 
III. RECRUITMENT/ENROLLMENT 
Section Cover Page 
Survey Recruitment Flyer – English 
Survey Recruitment Flyer – Spanish 

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Study Eligibility Form – English 
Study Eligibility Form – Spanish 
Participant Enrollment Spreadsheet 
Survey/AMI Telephone Reminder Script - English 
Survey/AMI Telephone Reminder Script - Spanish 
Survey/AMI Appointment Card – English 
Survey/AMI Appointment Card – Spanish 
Campaign Committee Recruitment Flyer – English 
Campaign Committee Recruitment Flyer – Spanish 
IV. INDIVIDUAL INTERVENTION (AMI-PM) 
Section Cover Page 
Focal Points Checklist – English 
Focal Points Checklist – Spanish 
Practice to Mastery Score Sheet – English 
Practice to Mastery Score Sheet – Spanish 
Practice to Mastery Training Guidelines 
Individual Oral Health Plan – English 
Individual Oral Health Plan – Spanish 
Tooth Brushing (video) 
Flossing (video) 
Denture Care (video) 
Brushing (brochure) - English 
Brushing (brochure) - Spanish 
Flossing (brochure) - English 

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Flossing (brochure) - Spanish 
Denture Care (brochure) - English 
Denture Care (brochure) - Spanish 
Pre-Post Plaque Score Sheet - English 
Pre-Post Plaque Score Sheet – Spanish 
Oral Hygiene Skills Assessment Reference List 
 
 
V. GROUP INTERVENTION (Campaign) 
Section Cover Page 
GOH Campaign Committee Training Curriculum 
Training Session Agenda (example) – English 
Training Session Agenda (example) – Spanish 
Ground Rules – English 
Ground Rules – Spanish 
 
Components of the Campaign – English/Spanish 
Good Oral Health “101” (PPT) 
The Purpose and Role of the Campaign Committee/Components of the 
Campaign (PPT) – English 
 
The Purpose and Role of the Campaign Committee/Components of the 
Campaign (PPT) – Spanish 
 
GOH Committee Member Tasks – English/Spanish 
 
Protecting and Respecting Participants in Research Studies – English 
 
V. GROUP INTERVENTION (Campaign) (continued) 
 
Protecting and Respecting Participants in Research Studies – Spanish 
Campaign Committee Training-Keeping Our Mouths Clean and Healthy 

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Oral Health Fair Flyer/Poster – English 
Oral Health Fair Flyer/Poster – Spanish 
Event Program – English 
Event Program – Spanish 
 
Oral Health Message Poster – English 
Oral Health Message Poster – Spanish 
Oral Health Bingo (example) – English/Spanish 
Test Your Oral Health Knowledge – English 
Test Your Oral Health Knowledge – Spanish 
What Is Your Recipe for Good Oral Health? – English 
What Is Your Recipe for Good Oral Health? – Spanish 
Oral Health Wheel of Fortune – English/Spanish 
Oral Health Fair Passport – English 
Oral Health Fair Passport – Spanish 
Oral Health and Diabetes (PPT) 
Campaign Committee Certificate of Completion 
 
Campaign Committee Debriefing Interview Guide – English/Spanish 
 
VI. EVALUATION 
 
Section Cover Page 
Survey – English 
Survey – Spanish 
Clinical Assessment Form 
 
Oral Health Fair Evaluation Form – English 
Oral Health Fair Evaluation Form – Spanish 

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Referral Letter – Dentist - English 
Referral Letter – Dentist - Spanish 
Referral Letter-Participant - English 
Referral Letter-Participant – Spanish 
Authorization for release of Information – English 
Authorization for release of Information - Spanish 
VII. DATA MANAGEMENT 
Section Cover Page 
Participant Data Sheet 
Participant Record Checklist 
Completed Survey/AMI Form 
Basic Oral Health Information Card 
Survey/AMI/Clinical Assessment Schedule Form 
 
VIII. ORAL HEALTH RESEARCH STRATEGIC ALLIANCE (OHRSA) MEMBER LIST 
 
The documents contained in this Appendix were developed for the pilot study, Changing 
Oral Health Norms and Hygiene Practices among Vulnerable Older Adults (NIDCR 
R34DE022271-1), and serve as examples and references. All materials will be revised 
as necessary to conform to the design, methodology and aims of the proposed study, 
and will be submitted for review and approval by the UCHC IRB prior to use. 

IRB Review 
IRB NUMBER: 14-188-6 
IRB APPROVAL DATE: 01/17/2018 
IRB EXPIRATION DATE: 01/16/2019 
Page 1 
Consent Form Campaign Committee-Eng V 1.4 5/8/2017 
 
 
 
Principal Investigator (PI): Susan Reisine, Ph.D. 
Back-up Principal Investigator: Jean Schensul, Ph.D. 
PI Phone Number: 860 679 3823 
Title of Research Study: GOH- Good Oral Health – A Bi-level Intervention to Improve Older 
Adult Oral Health 
 
Expected Duration of Subject’s Participation: Five months – including 6-8 two-hour training 
sessions, 4 two-hour sessions to create campaign materials, and 3 campaign events/oral health 
fairs. 
 
Sponsor: National Institute of Dental and Craniofacial Research 
 
IRB Number: 14-188-6 
 
Name of Research Participant: 
 
 
What Is The Purpose Of This Research Study? 
This study is a collaboration between the University of Connecticut Dental School and the 
Institute for Community Research. The purpose is to improve the ways older adults and adults 
with disabilities care for their teeth and mouths. 
 
Why Am I Invited To Participate? 
You are invited to take part in this study because you are an older adult or a person with a 
disability living in senior housing. 
 
How Many Other People Do You Think Will Participate? 
We estimate that 5 - 10 people will enroll in the Good Oral Health (GOH) Campaign Committee 
at this building. In total we expect about 15-20 people to enroll in the study as members of the 
GOH Campaign Committees at other buildings. We expect that 60 people will enroll in the GOH 
intervention in this building and a total of 360 people from all the buildings in the study. 
 
What Will I Be Asked to Do? 
The specific role of the Campaign volunteers includes: 
• 
learning about oral health and good oral health hygiene; 
• 
raising and addressing any concerns you might have about oral health promotion; 
• 
agreeing to recruit residents to campaign events 
• 
organizing others’ or presenting your own oral health testimonials; 
• 
working with intervention staff on oral health campaign materials; 
• 
staffing information tables and game and poster contest activities at the oral health fairs; 

IRB Review 
IRB NUMBER: 14-188-6 
IRB APPROVAL DATE: 01/17/2018 
IRB EXPIRATION DATE: 01/16/2019 
Page 2 
Consent Form Campaign Committee-Eng V 1.4 5/8/2017 
 
 
 
• 
helping to set up food and entertainment; 
 
The training sessions include: 
• 
Training for your roles as Committee members 
• 
Explanations of the main ideas of the intervention 
• 
Oral health and oral health self management behaviors, including demonstration and 
volunteer practice; 
• 
Review of the components of the Pro-GOH campaign; 
• 
Creation of a Campaign plan. 
 
Additional sessions involve the creation of Pro-GOH campaign materials such as posters, flyers, 
and games in English and Spanish that will include Pro-GOH messages and images portraying 
oral health practices. Project staff will work with you to create these materials. You also will 
help organize and direct 3 campaign events/oral health fairs. After the oral health fairs are 
completed, we will ask you to take part in an interview about your experiences as a member of 
the Good Oral Health Campaign Committee in your building, which will take approximately 30- 
45 minutes and will be audio recorded, with your permission. 
 
 
For How Long Will I be Expected to Participate? 
Participation will last five months. 
 
Is Participation Voluntary? 
Participation in this study is voluntary. Before making a decision about whether to participate in 
this research study, please read this consent form carefully and discuss any questions you have 
with the researcher. You may also want to talk with family members or a friend before making a 
decision. 
 
If you decide to participate in the study, you are free to withdraw from it at any time. If you 
decide not to participate or you withdraw from the study, your decision will not affect your 
present or future medical or dental care you receive at the University of Connecticut Health 
Center/John Dempsey Hospital and there will be no penalty or loss of benefits to which you are 
otherwise entitled. 
 
What Are the Costs To Me For My Participation? 
There will be no cost to you for participating in the research. 
 
What Risks Are Involved If I Choose To Participate? 
The possible risk is that your personal information may be seen or heard by people other than the 
researchers. 
 
What Are the Benefits Of My Participation? 

IRB Review 
IRB NUMBER: 14-188-6 
IRB APPROVAL DATE: 01/17/2018 
IRB EXPIRATION DATE: 01/16/2019 
Page 3 
Consent Form Campaign Committee-Eng V 1.4 5/8/2017 
 
 
 
You will not benefit directly from the information we gather in the study other than learning 
information you did not know about taking care of your oral health. Your contribution may help 
other people to improve their oral health self-care in the future. There is also the possibility that 
no benefit will come from this study. 
 
Will I Be Compensated For My Participation? 
At the end of the campaign activities you will receive $100.00 for your participation on the 
Campaign Committee (attending more than half the sessions and helping with a minimum of one 
of the Campaign events). In addition, you will receive $10.00 upon completion of the interview 
that focuses on your experiences as a Campaign Committee member. Total compensation for all 
activities is $110.00. 
 
I prefer not to receive compensation for this study.   
 
 
If you receive over $600 from participating in research studies over the course of the calendar 
year that money must be reported to the IRS as income. Signing a W-9 may be required. 
 
What Alternative Procedures or Treatments Are Available To Me? 
You have the option not to participate in this study. 
 
How Will My Personal Information Be Protected? 
For you and other building residents who participate in the GOH Campaign Committee, the 
following procedures will be used to protect the confidentiality of your data that will be 
collected. All information related to your participation in this study will be kept in a research 
record. The study staff will keep all study records (including any codes to your data) locked in a 
secure location. All paper documents containing identifiable information (e.g., signed consent 
forms) will be kept in locked files that are separate from other study records. Research records 
will be labeled with a code and all contents of the research record will be labeled with only that 
code. A 6-digit code will be derived from your first and last initial and the month and day you 
were born. A master key that links names and codes will be maintained in a separate and secure 
location. All electronic files (e.g., computerized database, spreadsheet, etc.), including those 
containing identifiable information will be password protected. Any computer hosting such files 
will also have password protection to prevent access by un-authorized users. Data that will be 
shared with others will be coded as described above to help protect your identity. Only 
researchers officially appointed to work on this project, the sponsor and agencies or departments 
with responsibility for research compliance (e.g. FDA) will have access to your information 
while it is stored in an identifiable format. 
 
We will do our best to protect the confidentiality of the information we gather from you but we 
cannot guarantee 100% confidentiality. You should know that the sponsor, NIDCR, the United 
States Department of Health and Human Services, the UCONN Health Center’s Institutional 
Review Board and the Human Subjects Protection Office may inspect records to ensure that the 
study is being done correctly. Also, if during the course of this study we learn of elder, child or 

IRB Review 
IRB NUMBER: 14-188-6 
IRB APPROVAL DATE: 01/17/2018 
IRB EXPIRATION DATE: 01/16/2019 
Page 4 
Consent Form Campaign Committee-Eng V 1.4 5/8/2017 
 
 
 
spousal abuse, the intent to harm yourself or others, or of communicable diseases, we are 
required to report it to State officials. 
 
At the conclusion of this study the researchers may publish their findings. Information will be 
presented in summary format and you will not be identified in any publications or presentations. 
No individual persons will ever be named or referred to in these presentations of intervention 
results. 
 
What If I Decide To Stop Participating on the Campaign Committee? 
You are free to stop taking part in this study at any time. If you decide to stop taking part in the 
study, your relationship with your doctors, dentists or the University of Connecticut Health 
Center will not be affected. If you decide to withdraw we ask that you let us know by calling Dr. 
Susan Reisine at 860-679-3823 or by sending a written notice to Dr. Susan Reisine, 263 
Farmington Ave., MC3910, Farmington, CT 06030. 
 
Can Someone Make Me Stop Participating on the Campaign Committee? 
We may ask you to stop participating in the committee if you miss more than half of the training 
sessions, do not attend any Campaign events, you exhibit continued disruptive behavior while 
participating in the study or if you move out of the building. 
 
What If I Experience An Adverse (Bad) Event Related To My Participation? 
If you have an adverse event you should tell the Principal Investigators as soon as possible. You 
may contact Dr. Susan Reisine at 860-679-3823 or by sending a written notice to her at The 
University of Connecticut School of Dental Medicine, 263 Farmington Ave., MC3910, 
Farmington, CT 06030, or you may contact Dr. Jean J. Schensul at 860-278-2044 ext. 227 or in 
writing at The Institute for Community Research, 2 Hartford Square West, Suite 100, Hartford, 
CT 06106. 
 
The University of Connecticut Health Center (UCHC), the Institute for Community Research 
(ICR) and your building management do not provide insurance coverage to compensate for 
injuries incurred during this research. However, compensation may still be available. A claim 
may be filed against the State of Connecticut seeking compensation. For a description of this 
process contact a representative of the UCHC Institutional Review Board at 860-679-1019 or 
860-679-4851. 
The UCHC does not offer free care. However, treatment for a research related injury can be 
obtained at the UCHC for the usual fee. 
 
What If I Have Questions? 
The Principal Investigators and Co-Investigators are willing to answer any questions you have 
about the research, in English or Spanish. You are encouraged to ask questions before deciding 
whether to take part. You are also encouraged to ask questions during your study participation. 
If you have questions, complaints or concerns about the research, you should call the Principal 

IRB Review 
IRB NUMBER: 14-188-6 
IRB APPROVAL DATE: 01/17/2018 
IRB EXPIRATION DATE: 01/16/2019 
Page 5 
Consent Form Campaign Committee-Eng V 1.4 5/8/2017 
 
 
 
Investigators Dr. Susan Reisine at 860-679-3823 or Dr. Jean Schensul (who speaks Spanish) at 
ICR, 860-278-2044, ext 227; or by sending a written notice to Dr. Susan Reisine, 263 
Farmington Ave., MC3910, Farmington, CT 06030 or Dr. Jean Schensul at ICR, 2 Hartford 
Square West, Hartford, CT 06106. 
 
If you have questions about your rights as a research subject you may contact a coordinator at the 
University of Connecticut Health Center Institution Review Board (IRB) at 860-679-1019 or 
860-679-4851. You may also call a coordinator at the IRB if you want to talk to someone who is 
not a member of the research team in order to pass along any suggestions, complaints, concerns 
or compliments about your involvement in the research, or to ask general questions or obtain 
information about participation in clinical research studies. 
 
Please do not call the IRB number for medical or dental related issues or to schedule or cancel an 
appointment. 
 
Consent To Participation: 
By signing this form you acknowledge that you have read, or have had read to you, this informed 
consent document, have talked with research personnel about this study, have been given the 
opportunity to ask questions and have them satisfactorily answered, and voluntarily consent to 
participate in this project as described in this form. 
By signing this form the individual obtaining consent is confirming that the above information 
has been explained to the subject and that a copy of this document, signed and dated by both the 
person giving consent and the person obtaining consent, along with a copy of the Research 
Participant Feedback Form, will be provided to the participant. 
 
 
Role 
Printed Name 
Signature 
Date 
Time 
Participant 
Person Obtaining Consent 

IRB Review 
IRB NUMBER: 14-188-6 
IRB APPROVAL DATE: 05/17/2018 
Page 1 
Consent Form AB Building-Eng v1.8 5/1/2018 
 
 
 
Principal Investigator (PI): Susan Reisine, Ph.D. 
Back-up Principal Investigator: Jean Schensul, Ph.D. 
PI Phone Number: 860 679 3823 
Title of Research Study: GOH- Good Oral Health – A Bi-level Intervention to Improve Older Adult 
Oral Health 
 
Expected Duration of Subject’s Participation: 8 visits – 3 surveys for about 1 hour each, 1 education 
session for about 1 hour; 4 dental exams and oral hygiene skills assessments for about 20 minutes each; 
and 3 campaign events (or oral health fairs) that last about 2 hours each over about 2 months. The study 
will last 16-18 months at your building.** 
 
Sponsor/Funding Agency: National Institute of Dental and Craniofacial Research 
 
IRB Number: 14-188-6 
 
Name of Research Participant: 
 
 
What Is The Purpose Of This Research Study? 
This study is a collaboration between the University of Connecticut Dental School and the Institute for 
Community Research. The purpose is to improve the ways older adults and adults with disabilities care 
for their teeth and mouths.** 
 
Why Am I Invited To Participate? 
You are invited to take part in this study because you are an older adult or a person with a disability living 
in low income senior housing. 
 
How Many Other People Do You Think Will Participate? 
We estimate that 60 people will enroll for participation at this building. In total we expect about 360 
people to enroll in the study including people at other residences. 
 
How Long Will My Participation In This Study Last? 
You will be asked to meet with research staff for up to eight visits. Three visits for the surveys and one 
visit for the educational session will last about an hour each. Four visits for the dental exam and oral 
hygiene skills assessment will last about 20 minutes each. There will be 3 campaign events or oral health 
fairs at the building which we ask that you attend and complete information about what activities you 
participated in. The following table shows how the visits will occur. 
 
 
 
 
Visit 
Activity 
Timing 
Compensation 
1.-T0 
Survey – 1 hour 
Entry to study 
$15.00 
2.-T0 
Dental exam and assessment 
Entry to study 
$15.00 

IRB Review 
IRB NUMBER: 14-188-6 
IRB APPROVAL DATE: 05/17/2018 
Page 2 
Consent Form AB Building-Eng v1.8 5/1/2018 
 
 
 
of oral hygiene skills on a 
mouth model – 20 minutes 
3. 
Tailored educational session 
Up to 45 days post-T0 
None 
4.-T1 
Survey – 1 hour 
1-3 months after educational session 
$15.00 
5.-T1 
Dental exam and assessment 
of oral hygiene skills on a 
mouth model – 20 minutes 
1-3 months after educational session 
$15.00 
3 Campaign Events/Oral 
health fairs – 2-3 hours 
2-5 months after educational session 
None 
6.-T2 
Survey – 1 hour 
1-3 months after campaigns 
$15.00 
7.-T2 
Dental exam and assessment 
of oral hygiene skills on a 
mouth model – 20 minutes 
1-3 months after campaigns 
$15.00 
8.-T3 
Dental exam, brief survey and 
assessment of oral hygiene 
skills on a mouth model – 20 
minutes 
6-7 months after T2 
$20.00 
 
 
What Are the Costs To Me For Participating In This Study? 
There will be no cost to you for participating in the research 
What Will I Be Asked to Do? 
The study will involve: 
• 
completing questionnaires three times; 
• 
having a dental hygienist examine your mouth four times; 
• 
assessing your oral hygiene skills on a mouth model four times; 
• 
meeting with a health educator for a one-on-one oral health educational session to discuss plans on 
how to take better care of your teeth and mouth and show you how to brush and floss your teeth; 
• 
attending 3 campaign events (oral health fairs) that will take place in your building. 
• 
A dentist from our study may conduct an additional dental exam.** 
 
With your permission the educational session will be audio recorded to assure consistency across 
educators. 
 
 
Procedure 
Mouth examination 
Procedure 
A dental exam is a standard clinical procedure. 
This procedure will be done at your building at 
time that is convenient for you. We will assess 
the health of your gums and look for injuries in 
the mouth. A red dye will be applied to your teeth 
to see the amount of plaque on each tooth. 
Risk - Infection 
The potential risk for infection is minimal and is 
the same as brushing your teeth. If such an 
infection should occur, antibiotics will be 

IRB Review 
IRB NUMBER: 14-188-6 
IRB APPROVAL DATE: 05/17/2018 
Page 3 
Consent Form AB Building-Eng v1.8 5/1/2018 
 
 
 
prescribed without cost to you. The study will pay 
for the antibiotic. 
Safeguard 
Licensed dental hygienists will perform the 
clinical exams under the direction of the Clinical 
Director. Sterile procedures will be observed 
during examinations including use of new latex or 
plastic gloves, disposable instruments for the 
exams and sterile gauzes. 
Cost to Participant 
There will be no cost to you. 
Procedure 
Mouth examination 
Risk - Pain 
Individuals vary in their experience of pain during 
dental exams. 
Safeguard 
If you experience pain, we will numb your gums 
during the dental exam to minimize pain and 
discomfort. Topical anesthetic benzocaine 20% 
will be used. It will be applied with a Q-tip on the 
cheek and tongue side of the gum tissue prior to 
the examination if the area is sensitive. 
Cost 
No cost to participant 
Procedure 
Questionnaire 
Risk - minimal 
There are no physical risks associated with the 
questionnaire. You may feel uncomfortable 
answering some of the questions. Loss of privacy 
is possible if an unauthorized person would hear 
your responses 
Safeguard 
You may always choose not to answer a question 
that makes you feel uncomfortable. 
Questionnaires will be administered in a private 
area to protect privacy. 
Cost to Participant 
No Cost 
Procedure 
Oral Hygiene Skills Assessment 
Risk - none 
There are no risks associated with this 
assessment. You will be asked to show how you 
brush and floss on a mouth model. 
Safeguard 
None needed 
Cost to Participant 
No cost to participant 
Procedure 
Individual level tailored intervention 
An experienced health educator will meet with 
you to discuss how to take better care of your 
teeth and mouth. He or she will ask you about 
what prevents you from taking better care of your 
teeth and mouth and what helps you. The 
educator will help you to improve your own care 
of your mouth and gums based on your dental 

IRB Review 
IRB NUMBER: 14-188-6 
IRB APPROVAL DATE: 05/17/2018 
Page 4 
Consent Form AB Building-Eng v1.8 5/1/2018 
 
 
 
exam and survey responses. The educator will ask 
you to show that you understand clearly how to 
clean your teeth, gums and mouth. You and the 
educator will make a plan together to improve the 
way you take care of your teeth and mouth. The 
educator will show you how to brush and floss 
your teeth. Then, using a mouth model, you will 
practice the brushing and flossing as shown by the 
educator. 
Risk - minimal 
There are no physical risks associated with the 
intervention. You may feel uncomfortable 
answering some of the questions. 
Safeguard 
You can refuse to participate. 
Cost to Participant 
No Cost 
Procedure 
Completing Passports at Oral Health Fairs 
Risk - minimal 
There are no physical risks associated with 
completing the forms. You may feel 
uncomfortable answering some of the questions. 
Safeguard 
You can refuse to complete the forms or refuse to 
answer any of the questions on the forms 
Cost to Participant 
No cost** 
 
 
Is There any Reason Why I May Not Be Eligible to Participate in this Study? 
If you have ever had an infection in your heart, a heart valve replacement in the past 6 months, a stent (a 
small tube that keeps your arteries open) placed in your heart in the past 6 weeks, a heart attack (known as 
an MI) in the past 6 weeks, have fewer than two of your natural teeth, if you have a conservator (a 
guardian appointed by a judge to protect and manage your financial affairs and/or your daily life), or you 
are currently on dialysis (a medical process that takes over the role of your kidneys when they can no 
longer work properly; you have a tube or other form of access through your arm, leg, neck or abdomen) 
you are not eligible to participate. 
 
Is Participation Voluntary? 
Participation in this study is voluntary. Before making a decision about whether to participate in this 
research study, please read and listen to the reading of this consent form carefully and discuss any 
questions you have with the interviewer. You may also want to talk with family members or a friend 
before making a decision. 
 
If you decide to participate in the study, you are free to withdraw from it at any time. If you decide not to 
participate or you withdraw from the study, your decision will not affect your present or future medical or 
dental care you receive at the University of Connecticut Health Center/John Dempsey Hospital or any 
future participation in the Institute for Community Research programs and services and there will be no 
penalty or loss of benefits to which you are otherwise entitled.** 

IRB Review 
IRB NUMBER: 14-188-6 
IRB APPROVAL DATE: 05/17/2018 
Page 5 
Consent Form AB Building-Eng v1.8 5/1/2018 
 
 
 
What Are the Benefits Of Participating In This Study? 
You may benefit from the dental exams. You will be provided with the results of the exams and you will 
be referred for dental care if we find a need for care. You will be responsible for paying for dental care. 
Other people who may have the same oral health problems may benefit in the future. We might find a 
better way to diagnose or treat oral health problems. There is also the possibility that no benefit will come 
from this study. 
 
Will I Be Compensated For Participating In This Study? 
You will receive $15 for each of four clinical exams, $15 for completing each of three surveys and $5 for 
completing one brief questionnaire for a total of $110. 
 
I prefer not to receive compensation for this study.   
 
 
If you receive over $600 from participating in research studies over the course of the calendar year that 
money must be reported to the IRS as income. Signing a W-9 may be required. 
 
What Alternative Procedures or Treatments Are Available To Me? 
You have the option not to participate in this study. 
 
How Will My Personal Information Be Protected? 
The following procedures will be used to protect the confidentiality of your data. The study staff will keep 
all study records (including any codes to your data) locked in a secure location.  Research records or 
study records, where we keep individual research information, are both paper and electronic files. 
Research records will be labeled with a code and all contents of the research record will be labeled with 
only that code. A 6-digit code will be derived from your first and last initial and the month and day you 
were born. A master key that links names and codes will be maintained in a separate and secure location. 
All electronic files (e.g., database, spreadsheet, etc.), including those containing identifiable information, 
will be password protected. Any computer hosting such files will also have password protection to 
prevent access by un-authorized users. Data that will be shared with others will be coded as described 
above to help protect your identity. 
 
We will do our best to protect the confidentiality of the information we gather from you but we cannot 
guarantee 100% confidentiality. You should know that the sponsor, NIDCR, the Department of Health 
and Human Services, the Health Center’s Institutional Review Board and the Human Subjects Protection 
Office may inspect records. They may inspect records to ensure that the study is being done correctly. 
Also, if during the course of this study we learn of elder, child or spousal abuse, the intent to harm 
yourself or others or of communicable diseases we are required to report it to State officials. 
 
At the conclusion of this study the researchers may publish their findings in journals or magazines. 
Information will be presented in summary format and you will never be identified in any publications or 
presentations. 
All information related to your participation in this study will be kept in a research record, apart from 
your medical record. The research record and its contents will be labeled with a code and kept locked in 
file cabinet in the office of the principal investigator. Only researchers officially appointed to work on this 

IRB Review 
IRB NUMBER: 14-188-6 
IRB APPROVAL DATE: 05/17/2018 
Page 6 
Consent Form AB Building-Eng v1.8 5/1/2018 
 
 
 
project, the sponsor and agencies or departments with responsibility for research compliance (e.g. FDA) 
will have access to your information while it is stored in an identifiable format. 
 
Will I Find Out the Results Of This Research Study? 
You will be provided with information if the results apply to you and the health of your teeth and mouth. 
 
What If I Decide To Stop Participating In The Study? 
You are free to stop taking part in this study at any time. If you decide to stop taking part in the study, 
your relationship with your doctors, dentists or the University of Connecticut Health Center will not be 
affected. If you decide to withdraw we ask that you let us know by calling Dr. Susan Reisine at 860 679 
3823 or by sending a written notice to Dr. Susan Reisine, 263 Farmington Ave., MC3910, Farmington, 
CT 06030. 
 
Can Someone Make Me Stop Participating in the Study? 
We may ask you to stop participating if, during the study period, you have a heart valve or joint 
replacement, an infection in your heart, a stent (a small tube that keeps your arteries open) placed in your 
heart, a heart attack (known as an MI), have fewer than two of your natural teeth, if a conservator is 
appointed to you, or you are on dialysis. We also may ask you to stop participating if you no longer live in 
the building, you exhibit continued disruptive behavior while participating in the study or you become 
unable to complete the surveys. 
 
What If I Experience An Adverse (Bad) Event Related To My Participation? 
If you have an adverse event you should tell one of the Principal Investigators as soon as possible. You 
may contact Dr. Susan Reisine at 860-679-3823 or by sending a written notice to her at The University of 
Connecticut School of Dental Medicine, 263 Farmington Ave., MC3910, Farmington, CT 06030, or you 
may contact Dr. Jean J. Schensul (who speaks Spanish) at 860-278-2044 ext. 227 or in writing at The 
Institute for Community Research, 2 Hartford Square West, Suite 100, Hartford, CT 06106. 
 
The University of Connecticut Health Center (UCHC), the Institute for Community Research (ICR) and 
your building management do not provide insurance coverage to compensate for injuries incurred during 
this research. However, compensation may still be available. A claim may be filed against the State of 
Connecticut seeking compensation. For a description of this process contact a representative of the 
UCHC Institutional Review Board at 860-679-1019 or 860-679-4851. 
 
The UCHC does not offer free care. However, treatment for a research related injury can be obtained at 
the UCHC for the usual fee. 
 
What if I Have Questions? 
The Principal Investigators and Co-Investigators are willing to answer any questions you have about the 
research, in English or Spanish. You are encouraged to ask questions before deciding whether to take part. 
You are also encouraged to ask questions during your study participation. If you have questions, 
complaints or concerns about the research, you should call the Principal Investigators Dr. Susan Reisine at 
860-679-3823 or Dr. Jean Schensul (who speaks Spanish) at ICR, 860-278-2044, ext 227; or by sending a 

IRB Review 
IRB NUMBER: 14-188-6 
IRB APPROVAL DATE: 05/17/2018 
Page 7 
Consent Form AB Building-Eng v1.8 5/1/2018 
 
 
 
written notice to Dr. Susan Reisine, 263 Farmington Ave., MC3910, Farmington, CT 06030 or Dr. Jean 
Schensul at ICR, 2 Hartford Square West, Hartford, CT 06106. 
 
If you have questions about your rights as a research subject you may contact a coordinator at the 
Institution Review Board at 860-679-1019 or 860-679-4851. You may also call a coordinator at the 
Institutional Review Board if you want to talk to someone who is not a member of the research team in 
order to pass along any suggestions, complaints, concerns or compliments about your involvement in the 
research, or to ask general questions or obtain information about participation in clinical research studies. 
 
Please do not call the IRB number for medical or dental related issues or to schedule or cancel an 
appointment. 
 
Consent To Participation: 
By signing this form you acknowledge that you have read, or have had read to you, this informed consent 
document, have talked with research personnel about this study, have been given the opportunity to ask 
questions and have them satisfactorily answered, and voluntarily consent to participate in this project as 
described in this form. 
 
By signing this form the individual obtaining consent is confirming that the above information has been 
explained to the subject and that a copy of this document, signed and dated by both the person giving 
consent and the person obtaining consent, along with a copy of the Research Participant Feedback Form, 
will be provided to the participant. 
 
 
Role 
Printed Name 
Signature 
Date 
Participant 
Person Obtaining Consent 

IRB Review 
IRB NUMBER: 14-188-6 
IRB APPROVAL DATE: 05/17/2018 
Page 1 
Consent Form BA Building-Eng v1.8 5/1/2018 
 
 
 
Principal Investigator (PI): Susan Reisine, Ph.D. 
Back-up Principal Investigator: Jean Schensul, Ph.D. 
PI Phone Number: 860 679 3823 
Title of Research Study: GOH- Good Oral Health – A Bi-level Intervention to Improve Older Adult 
Oral Health 
 
Expected Duration of Subject’s Participation: 8 visits – 3 surveys for about 1 hour each; 1 education 
session for about 1 hour; 4 dental exams and oral hygiene skills assessments for about 20 minutes each; 
and 3 campaign events (or oral health fairs) that last about 2 hours each over about 2 months. The study 
will last 16-18 months at your building.** 
 
Sponsor/Funding Agency: National Institute of Dental and Craniofacial Research 
 
IRB Number: 14-188-6 
 
Name of Research Participant: 
 
 
What Is The Purpose Of This Research Study? 
This study is a collaboration between the University of Connecticut Dental School and the Institute for 
Community Research. The purpose is to improve the ways older adults and adults with disabilities care 
for their teeth and mouths.** 
 
Why Am I Invited To Participate? 
You are invited to take part in this study because you are an older adult or a person with a disability living 
in low income senior housing. 
 
How Many Other People Do You Think Will Participate? 
We estimate that 60 people will enroll for participation at this building. In total we expect about 360 
people to enroll in the study including people at other residences. 
 
How Long Will My Participation In This Study Last? 
You will be asked to meet with research staff for up to eight visits. Three visits for the surveys and one 
visit for the educational session will last about an hour each. Four visits for the dental exam and oral 
hygiene skills assessment will last about 20 minutes each. There will be 3 campaign events or oral health 
fairs at the building which we ask that you attend and complete information about what activities you 
participated in. The following table shows how the visits will occur. 
 
 
 
 
 
Visit 
Activity 
Timing 
Compensation 
1.-T0 
Survey – 1 hour 
Entry to study 
$15.00 

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2.-T0 
Dental exam and assessment 
of oral hygiene skills on a 
mouth model – 20 minutes 
Entry to study 
$15.00 
3 Campaign Events/Oral 
health fairs – 2-3 hours 
3-6 months after study entry 
None 
3.-T1 
Survey– 1 hour 
1-3 months after campaigns 
completed 
$15.00 
4.-T1 
Dental exam and assessment 
of oral hygiene skills on a 
mouth model – 20 minutes 
1-3 months after campaigns 
completed 
$15.00 
5. 
Tailored educational session 
Up to 45 days after T1 
None 
6.-T2 
Survey – 1 hour 
1-3 months after educational session 
$15.00 
7.-T2 
Dental exam and assessment 
of oral hygiene skills on a 
mouth model – 20 minutes 
1-3 months after educational session 
$15.00 
8.-T3 
Dental exam, brief survey and 
assessment of oral hygiene 
skills on a mouth model – 20 
minutes 
6-7 months after T2 
$20.00 
 
 
What Are the Costs To Me For Participating In This Study? 
There will be no cost to you for participating in the research 
What Will I Be Asked to Do? 
The study will involve: 
• 
completing questionnaires three times; 
• 
having a dental hygienist examine your mouth four times; 
• 
assessing your oral hygiene skills on a mouth model four times; 
• 
meeting with a health educator for a one-on-one oral health educational session to discuss plans on 
how to take better care of your teeth and mouth and show you how to brush and floss your teeth; 
• 
attending the 3 campaign events (oral health fairs) that will take place in your building. 
• 
A dentist from our study may conduct an additional dental exam.** 
 
With your permission the educational session will be audio recorded to assure consistency across 
educators. 
 
 
Procedure 
Mouth examination 
Procedure 
A dental exam is a standard clinical procedure. 
This procedure will be done at your building at 
time that is convenient for you. We will assess the 
health of your gums and look for injuries in the 
mouth. A red dye will be applied to your teeth to 
see the amount of plaque on each tooth. 

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Risk - Infection 
The potential risk for infection is minimal and is 
the same as brushing your teeth. If such an 
infection should occur, antibiotics will be 
prescribed without cost to you. The study will pay 
for the antibiotic. 
Safeguard 
Licensed dental hygienists will perform the 
clinical exams under the direction of the Clinical 
Director. Sterile procedures will be observed 
during examinations including use of new latex or 
plastic gloves, disposable instruments for the 
exams and sterile gauzes. 
Cost to Participant 
There will be no cost to you. 
Procedure 
Mouth examination 
Risk - Pain 
Individuals vary in their experience of pain during 
dental exams. 
Safeguard 
If you experience pain, we will numb your gums 
during the dental exam to minimize pain and 
discomfort. Topical anesthetic benzocaine 20% 
will be used. It will be applied with a Q-tip on the 
cheek and tongue side of the gum tissue prior to 
the examination if the area is sensitive. 
Cost 
No cost to participant 
Procedure 
Questionnaire 
Risk - minimal 
There are no physical risks associated with the 
questionnaire. You may feel uncomfortable 
answering some of the questions. Loss of privacy 
is possible if an unauthorized person would hear 
your responses 
Safeguard 
You may always choose not to answer a question 
that makes you feel uncomfortable. 
Questionnaires will be administered in a private 
area to protect privacy. 
Cost to Participant 
No Cost 
Procedure 
Oral Hygiene Skills Assessment 
Risk - none 
There are no risks associated with this 
assessment. You will be asked to show how you 
brush and floss on a mouth model. 
Safeguard 
None needed 
Cost to Participant 
No cost to participant 
Procedure 
Individual level tailored intervention 
An experienced health educator will meet with 
you to discuss how to take better care of your 
teeth and mouth. He or she will ask you about 

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what prevents you from taking better care of your 
teeth and mouth and what helps you. The 
educator will help you to improve your own care 
of your mouth and gums based on your dental 
exam and survey responses. The educator will 
ask you to show that you understand clearly how 
to clean your teeth, gums and mouth. You and 
the educator will make a plan together to improve 
the way you take care of your teeth and mouth. . 
A health educator will show you how to brush 
and floss your teeth. Then, using a mouth model, 
you will practice the brushing and flossing as 
shown by the educator. 
Risk - minimal 
There are no physical risks associated with the 
intervention. You may feel uncomfortable 
answering some of the questions. 
Safeguard 
You can refuse to participate. 
Cost to Participant 
No Cost 
Procedure 
Completing Passports at Oral Health Fairs 
Risk - minimal 
There are no physical risks associated with 
completing the forms. You may feel 
uncomfortable answering some of the questions. 
Safeguard 
You can refuse to complete the forms or refuse to 
answer any of the questions on the forms 
Cost to Participant 
No cost** 
 
 
Is There any Reason Why I May Not Be Eligible to Participate in this Study? 
If you have ever had an infection in your heart, a heart valve replacement in the past 6 months, a stent (a 
small tube that keeps your arteries open) placed in your heart in the past 6 weeks, a heart attack (known as 
an MI) in the past 6 weeks, have fewer than two of your natural teeth, if you have a conservator (a 
guardian appointed by a judge to protect and manage your financial affairs and/or your daily life), or you 
are currently on dialysis (a medical process that takes over the role of your kidneys when they can no 
longer work properly; you have a tube or other form of access through your arm, leg, neck or abdomen) 
you are not eligible to participate 
 
Is Participation Voluntary? 
Participation in this study is voluntary. Before making a decision about whether to participate in this 
research study, please read and listen to the reading of this consent form carefully and discuss any 
questions you have with the interviewer. You may also want to talk with family members or a friend 
before making a decision. 
 
If you decide to participate in the study, you are free to withdraw from it at any time. If you decide not to 
participate or you withdraw from the study, your decision will not affect your present or future medical or 
dental care you receive at the University of Connecticut Health Center/John Dempsey Hospital or any 

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future participation in the Institute for Community Research programs and services and there will be no 
penalty or loss of benefits to which you are otherwise entitled.** 
 
What Are the Benefits Of Participating In This Study? 
You may benefit from the dental exams. You will be provided with the results of the exams and you will 
be referred for dental care if we find a need for care. You will be responsible for paying for dental care. 
Other people who may have the same oral health problems may benefit in the future. We might find a 
better way to diagnose or treat oral health problems. There is also the possibility that no benefit will come 
from this study. 
 
Will I Be Compensated For Participating In This Study? 
You will receive $15 for each of four clinical exams, $15 for completing each of three surveys and $5 for 
completing one brief questionnaire for a total of $110. 
 
I prefer not to receive compensation for this study.   
 
 
If you receive over $600 from participating in research studies over the course of the calendar year that 
money must be reported to the IRS as income. Signing a W-9 may be required. 
 
What Alternative Procedures or Treatments Are Available To Me? 
You have the option not to participate in this study. 
 
How Will My Personal Information Be Protected? 
The following procedures will be used to protect the confidentiality of your data. The study staff will 
keep all study records (including any codes to your data) locked in a secure location. Research records or 
study records, where we keep individual research information, are both paper and electronic files. 
Research records will be labeled with a code and all contents of the research record will be labeled with 
only that code. A 6-digit code will be derived from your first and last initial and the month and day you 
were born. A master key that links names and codes will be maintained in a separate and secure location. 
All electronic files (e.g., database, spreadsheet, etc.), including those containing identifiable information, 
will be password protected. Any computer hosting such files will also have password protection to 
prevent access by un-authorized users. Data that will be shared with others will be coded as described 
above to help protect your identity. 
 
We will do our best to protect the confidentiality of the information we gather from you but we cannot 
guarantee 100% confidentiality. You should know that the sponsor, NIDCR, the Department of Health 
and Human Services, the Health Center’s Institutional Review Board and the Human Subjects Protection 
Office may inspect records. They may inspect records to ensure that the study is being done correctly. 
Also, if during the course of this study we learn of elder, child or spousal abuse, the intent to harm 
yourself or others or of communicable diseases we are required to report it to State officials. 
 
At the conclusion of this study the researchers may publish their findings in journals or magazines. 
Information will be presented in summary format and you will never be identified in any publications or 
presentations. 

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All information related to your participation in this study will be kept in a research record, apart from 
your medical record. The research record and its contents will be labeled with a code and kept locked in 
file cabinet in the office of the principal investigator. Only researchers officially appointed to work on this 
project, the sponsor and agencies or departments with responsibility for research compliance (e.g. FDA) 
will have access to your information while it is stored in an identifiable format. 
 
Will I Find Out the Results Of This Research Study? 
You will be provided with information if the results apply to you and the health of your teeth and mouth. 
 
What If I Decide To Stop Participating In The Study? 
You are free to stop taking part in this study at any time. If you decide to stop taking part in the study, 
your relationship with your doctors, dentists or the University of Connecticut Health Center will not be 
affected. If you decide to withdraw we ask that you let us know by calling Dr. Susan Reisine at 860 679 
3823 or by sending a written notice to Dr. Susan Reisine, 263 Farmington Ave., MC3910, Farmington, 
CT 06030. 
 
Can Someone Make Me Stop Participating in the Study? 
We may ask you to stop participating if, during the study period, you have a heart valve or joint 
replacement, an infection in your heart, a stent (a small tube that keeps your arteries open) placed in your 
heart, a heart attack (known as an MI), have fewer than two of your natural teeth, if a conservator is 
appointed to you, or you are on dialysis. We also may ask you to stop participating if you no longer live in 
the building, you exhibit continued disruptive behavior while participating in the study or you become 
unable to complete the surveys. 
 
What If I Experience An Adverse (Bad) Event Related To My Participation? 
If you have an adverse event you should tell one of the Principal Investigators as soon as possible. You 
may contact Dr. Susan Reisine at 860-679-3823 or by sending a written notice to her at The University of 
Connecticut School of Dental Medicine, 263 Farmington Ave., MC3910, Farmington, CT 06030, or you 
may contact Dr. Jean J. Schensul (who speaks Spanish) at 860-278-2044 ext. 227 or in writing at The 
Institute for Community Research, 2 Hartford Square West, Suite 100, Hartford, CT 06106. 
 
The University of Connecticut Health Center (UCHC), the Institute for Community Research (ICR) and 
your building management do not provide insurance coverage to compensate for injuries incurred during 
this research. However, compensation may still be available. A claim may be filed against the State of 
Connecticut seeking compensation. For a description of this process contact a representative of the UCHC 
Institutional Review Board at 860-679-1019 or 860-679-4851. 
 
The UCHC does not offer free care. However, treatment for a research related injury can be obtained at 
the UCHC for the usual fee. 
 
What if I Have Questions? 
The Principal Investigators and Co-Investigators are willing to answer any questions you have about the 
research, in English or Spanish. You are encouraged to ask questions before deciding whether to take part. 
You are also encouraged to ask questions during your study participation. If you have questions, 

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complaints or concerns about the research, you should call the Principal Investigators Dr. Susan Reisine at 
860-679-3823 or Dr. Jean Schensul (who speaks Spanish) at ICR, 860-278-2044, ext 227; or by sending a 
written notice to Dr. Susan Reisine, 263 Farmington Ave., MC3910, Farmington, CT 06030 or Dr. Jean 
Schensul at ICR, 2 Hartford Square West, Hartford, CT 06106. 
 
If you have questions about your rights as a research subject you may contact a coordinator at the 
Institution Review Board at 860-679-1019 or 860-679-4851. You may also call a coordinator at the 
Institutional Review Board if you want to talk to someone who is not a member of the research team in 
order to pass along any suggestions, complaints, concerns or compliments about your involvement in the 
research, or to ask general questions or obtain information about participation in clinical research studies. 
 
Please do not call the IRB number for medical or dental related issues or to schedule or cancel an 
appointment. 
 
Consent To Participation: 
By signing this form you acknowledge that you have read, or have had read to you, this informed consent 
document, have talked with research personnel about this study, have been given the opportunity to ask 
questions and have them satisfactorily answered, and voluntarily consent to participate in this project as 
described in this form. 
 
By signing this form the individual obtaining consent is confirming that the above information has been 
explained to the subject and that a copy of this document, signed and dated by both the person giving 
consent and the person obtaining consent, along with a copy of the Research Participant Feedback Form, 
will be provided to the participant. 
 
Role 
Printed Name 
Signature 
Date 
Participant 
Person Obtaining Consent