The Restful Jaw Device: A New Way to Support and Protect the Jaw During Third Molar Extractions
Phase: NA
Conditions: Impacted Third Molar Tooth, Temporomandibular Disorder
Sponsor: University of Minnesota

The Restful Jaw Device: A New Way to Support and Protect the Jaw 
Version 5.0 
During Third Molar Extractions  
August 06, 2020 
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The Restful Jaw Device: A New Way to Support 
and Protect the Jaw During Third Molar 
Extractions 
 
 
NIDCR Protocol Number: 18-065-E 
NIDCR Grant Number: 4R44-DE-026663-02 
Principal Investigator: Eric L. Schiffman, DDS, MS 
NIDCR Program Official: Dena Fischer, DDS, MSD, MS 
NIDCR Medical Monitor: Kevin McBryde, MD 
Sponsor: The Restful Jaw Co, LLC 
 
 
Draft or Version Number:  5.0 
6 August 2020 
 

The Restful Jaw Device: A New Way to Support and Protect the Jaw 
Version 5.0 
During Third Molar Extractions  
August 06, 2020 
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Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
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STATEMENT OF COMPLIANCE 
The study will be conducted in accordance with the International Council for 
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. 

The Restful Jaw Device: A New Way to Support and Protect the Jaw 
Version 5.0 
During Third Molar Extractions  
August 06, 2020 
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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. 
 
Study Principal Investigator: 
Signed: 
 
Date:  
 
Name: Dr. Eric Schiffman, DDS, MS 
 
Title: Co-Founder, The Restful Jaw Company, LLC 
 
Clinical Site Principal Investigator/ University of Minnesota 
Signed: 
 
Date:  
 
Name:  Dr. Rachel Uppgaard, DDS 
 
Title: Clinical Assistant Professor/Oral & Maxillofacial Surgeon 
 
Clinical Site Principal Investigator/ HealthPartners Institute 
Signed: 
 
Date:  
 
Name: Dr. D. Brad Rindal, DDS 
 
Title: Associate Dental Director Research, HealthPartners Dental Group  
 
 

The Restful Jaw Device: A New Way to Support and Protect the Jaw 
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During Third Molar Extractions  
August 06, 2020 
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Clinical Site Co-Investigator/ University of Minnesota 
Signed: 
 
Date:  
 
Name: Dr. Robert Nadeau, DDS 
 
Title: Clinical Assistant Professor/ Oral & Maxillofacial Surgeon 
 
Clinical Site Co-Investigator/ University of Minnesota 
Signed: 
 
Date:  
 
Name: Dr. Tudor Stiharu, DDS 
 
Title: Oral & Maxillofacial Surgeon 
 
Clinical Site Co-Investigator/ University of Minnesota 
Signed: 
 
Date:  
 
Name:  
 
Title: Oral & Maxillofacial Surgeon 
 
Clinical Site Co-Investigator / University of Minnesota 
Signed: 
 
Date:  
 
Name:  
 
Title: Oral & Maxillofacial Surgeon 
 
 

The Restful Jaw Device: A New Way to Support and Protect the Jaw 
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During Third Molar Extractions  
August 06, 2020 
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Clinical Site Co-Investigator / HealthPartners  
Signed: 
 
Date:  
 
Name: Dr. Robert D. Rupprecht, DDS 
 
Title: Oral & Maxillofacial Surgeon  
 
Clinical Site Co-Investigator / HealthPartners 
Signed: 
 
Date:  
 
Name: Dr. Elisabeth Peterson, DDS 
 
Title: Oral & Maxillofacial Surgeon 
 
 

The Restful Jaw Device: A New Way to Support and Protect the Jaw 
Version 5.0 
During Third Molar Extractions  
August 06, 2020 
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TABLE OF CONTENTS 
PAGE 
STATEMENT OF COMPLIANCE .................................................................................................. I 
SIGNATURE PAGE ...................................................................................................................... II 
TABLE OF CONTENTS ................................................................................................................ V 
LIST OF ABBREVIATIONS ....................................................................................................... VIII 
PROTOCOL SUMMARY .............................................................................................................. X 
1 
KEY ROLES AND CONTACT INFORMATION .................................................................... 1 
2 
INTRODUCTION: BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE ......... 4 
2.1 
Background Information ........................................................................................... 4 
2.2 
Rationale .................................................................................................................. 5 
2.3 
Potential Risks and Benefits ..................................................................................... 6 
2.3.1 
Potential Risks .............................................................................................. 6 
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 ....................................................................................................... 8 
4 
STUDY DESIGN ................................................................................................................ 10 
5 
STUDY ENROLLMENT AND WITHDRAWAL ................................................................... 13 
5.1 
Subject Inclusion Criteria ........................................................................................ 13 
5.2 
Subject Exclusion Criteria ...................................................................................... 14 
5.3 
Strategies for Recruitment and Retention .............................................................. 15 
5.4 
Treatment Assignment Procedures ........................................................................ 15 
5.4.1 
Randomization Procedures ........................................................................ 15 
5.4.2 
Masking Procedures ................................................................................... 16 
5.5 
Subject Withdrawal ................................................................................................. 16 
5.5.1 
Reasons for Withdrawal ............................................................................. 16 
5.5.2 
Handling of Subject Withdrawals or Subject Discontinuation of Study 
Intervention ................................................................................................. 17 
5.6 
Premature Termination or Suspension of Study .................................................... 17 
6 
STUDY INTERVENTION ................................................................................................... 19 
6.1 
Study Product Description ...................................................................................... 19 
6.1.1 
Acquisition .................................................................................................. 21 
6.1.2 
Formulation, Packaging, and Labeling ....................................................... 21 
6.2 
Accountability Procedures for the Study Product ................................................... 27 
7 
STUDY SCHEDULE .......................................................................................................... 28 
7.1 
Screening ............................................................................................................... 28 
7.2 
Enrollment/Baseline ............................................................................................... 28 
7.3 
Intermediate Follow-up ........................................................................................... 29 
7.4 
Final Study Follow-up ............................................................................................. 29 

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7.5 
OMS and DA Data Collection ................................................................................. 29 
7.6 
Withdrawal From Study .......................................................................................... 30 
7.7 
Unscheduled Visit ................................................................................................... 30 
8 
STUDY PROCEDURES /EVALUATIONS ......................................................................... 31 
8.1 
Study Procedures/Evaluations ............................................................................... 31 
9 
ASSESSMENT OF SAFETY .............................................................................................. 33 
9.1 
Specification of Safety Parameters ........................................................................ 33 
9.1.1 
Unanticipated Problems ............................................................................. 33 
9.1.2 
Adverse Events .......................................................................................... 33 
9.1.3 
Serious Adverse Events ............................................................................. 33 
9.2 
Time Period and Frequency for Event Assessment and Follow-Up ....................... 34 
9.3 
Characteristics of an Adverse Event ...................................................................... 34 
9.3.1 
Relationship to Study Intervention .............................................................. 34 
9.3.2 
Expectedness of AEs ................................................................................. 35 
9.3.3 
Severity of Event ........................................................................................ 35 
9.4 
Reporting Procedures ............................................................................................ 35 
9.4.1 
Unanticipated Problem Reporting to IRB and NIDCR ................................ 35 
9.4.2 
Reporting of SAEs and AEs to FDA ........................................................... 36 
9.5 
Halting Rules .......................................................................................................... 36 
10 
STUDY OVERSIGHT ......................................................................................................... 38 
11 
CLINICAL SITE MONITORING .......................................................................................... 39 
12 
STATISTICAL CONSIDERATIONS ................................................................................... 40 
12.1 
Study Hypotheses .................................................................................................. 40 
12.2 
Sample Size Considerations .................................................................................. 40 
12.3 
Planned Interim Analyses (if applicable) ................................................................ 41 
12.3.1 Safety Review ............................................................................................. 41 
12.3.2 Efficacy Review .......................................................................................... 41 
12.4 
Final Analysis Plan ................................................................................................. 41 
13 
SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/DOCUMENTS .................. 44 
14 
QUALITY CONTROL AND QUALITY ASSURANCE ......................................................... 45 
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 
15.6 
Future Use of Stored Specimens and Other Identifiable Data ............................... 47 
16 
DATA HANDLING AND RECORD KEEPING .................................................................... 48 
16.1 
Data Management Responsibilities ........................................................................ 48 
16.2 
Data Capture Methods ........................................................................................... 48 
16.3 
Types of Data ......................................................................................................... 49 
16.4 
Schedule and Content of Reports .......................................................................... 49 
16.5 
Study Records Retention ....................................................................................... 50 

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16.6 
Protocol Deviations ................................................................................................ 50 
17 
PUBLICATION/DATA SHARING POLICY ......................................................................... 52 
18 
LITERATURE REFERENCES ........................................................................................... 53 
SUPPLEMENTAL MATERIALS .................................................................................................. 55 
APPENDICES ............................................................................................................................. 56 
APPENDIX A: SCHEDULE OF EVENTS ................................................................................... 57 
 

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LIST OF ABBREVIATIONS 
AE 
Adverse Event/Adverse Experience 
ASA 
American Society of Anesthesiologists 
CFR 
Code of Federal Regulations 
CRF 
Case Report Form 
DCC 
Data Coordinating Center 
EC 
Experimental Care 
eCRF 
Electronic Case Report Form 
FDA 
Food and Drug Administration 
FFR 
Federal Financial Report 
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act 
ICF 
Informed Consent Form 
ICH 
International Council for Harmonisation 
ICMJE 
International Committee of Medical Journal Editors 
IRB 
Institutional Review Board 
ISM 
Independent Safety Monitor 
MOP 
Manual of Procedures 
N 
Number (typically refers to subjects) 
NIDCR 
National Institute of Dental and Craniofacial Research, NIH, DHHS 
NIH 
National Institutes of Health 
OCTOM 
Office of Clinical Trials Operations and Management, NIDCR, NIH 
OHRP 
Office for Human Research Protections 
OMS 
Oral and Maxillofacial Surgeons 
PHI 
Protected Health Information 
PI 
Principal Investigator 
QA 
Quality Assurance 
QC 
Quality Control 
RJ2 
Restful Jaw/ jaw support device 
SAE 
Serious Adverse Event/Serious Adverse Experience 
TMD 
Temporomandibular Disorders 
UP 
Unanticipated Problem 
UC 
Usual Care 
US 
United States 

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WHO 
World Health Organization 
 

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August 06, 2020 
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PROTOCOL SUMMARY 
Title: 
The Restful Jaw Device: A New Way to Support and Protect the Jaw 
During Third Molar Extractions 
Précis: 
During mandibular 3rd molar (wisdom tooth) extractions, when 
a downward force is placed on the patient's jaw, the patient 
must tense his/her jaw muscles to oppose it. Patients under 
moderate/deep sedation or general anesthesia cannot tense 
their muscles to counter this downward force to prevent injury 
to the jaw including the temporomandibular joint (TMJ). Bite 
blocks hold the patient's mouth open but do not counter this 
downward force on the mandible. In this two-arm parallel 
randomized clinical trial (RCT) design, 294 patients undergoing 
3rd molar extractions with moderate/deep sedation or general 
anesthesia will be randomly allocated to Usual Care (UC) or 
Experimental Care (EC). The study intervention for EC is use 
of the Restful Jaw version 2 (RJ2) device, which supports the 
jaw during the extractions, with concurrent use of a bite block. 
The study control is UC, which involves the dental assistant 
supporting the jaw during the extractions with concurrent use 
of a bite block. Patients will report temporomandibular 
disorders (TMD) pain via questionnaires at baseline and the 1-, 
3-, and 6-month follow-up time points.  
  
Objectives: 
 
Primary: In patients undergoing mandibular 3rd molar 
extractions with moderate/deep sedation or general 
anesthesia, compare the incidence of TMD pain within a 6-
month follow-up period between the two groups:  
•  UC group, using a bite block and with hand support 
of the jaw, and  
• EC group, using a bite block and the RJ2 device to 
support the jaw.   
 
The primary outcome is the incidence of TMD pain within a 6-
month follow-up period (binary dependent variable). 
The secondary objectives of this study are to: 

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1. Compare the incidence of TMD pain between UC and 
EC groups using an alternate assessment instrument to 
identify TMD pain within a 6-month follow-up period  
2. Compare TMD pain intensity between the UC and EC 
groups within a 6-month follow-up period: at 1-, 3- and 6 
months. 
3. Compare TMJ noise, pain characteristics (e.g., location 
in temple or jaw, and occurrence with wide opening of 
mouth) and change in jaw pain since it started, within a 
6-month follow-up period: at 1-, 3- and 6 months. 
4. (Exploratory Objective) Describe the experiences of 
surgeons and dental assistants with the new device at 
mid-way through recruitment of patients and at the end 
of recruitment. 
Population: 
Approximately 294 healthy, consenting adult patients, age 18-
30, requiring surgical removal of bilateral mandibular 3rd molars 
(concurrent maxillary 3rd molar extractions allowed).  
Number of Sites: 
Approximately 4 clinical sites and 1 data coordinating center 
(DCC). 
Description of  
Intervention: 
The RJ2 device is used to support the jaw during dental 
procedures including surgical removal of 3rd molars (wisdom 
teeth) with moderate/deep sedation or general anesthesia. The 
device is designed to counter the downward forces placed on 
the mandible by clinicians during dental procedures and 
prevent jaw hyperextension (opening too wide) while providing 
a secure, stable jaw position. The RJ2 device has been 
determined by the Food and Drug Administration (FDA) to be a 
non-significant risk device. 
Study Duration: 
Approximately 36 months. 
Subject 
Participation 
Duration: 
Approximately 6 months. 
Estimated Time to 
Complete 
Enrollment: 
Approximately 14 months. 

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Schematic of Study Design: 
 
 
Patient 
Enrollment 
 
 
Procedure 
Day 
Visit 1, Day 0 
 
 
  
 
 
 
Procedure 
Day 
Visit 1, Day 0 
 
 
 
Procedure 
Day 
Visit 1, Day 0 
 
Procedure 
Day 
Visit 1, Day 0 
 
 
1-Month Time  
Point; Day 30 
+2 weeks 
 
3-Month Time  
Point; Day 90 
± 2 weeks 
 
 
6-Month Time Point;  
Day 180  
±2 weeks  
 
Patient presents to oral surgery office for a consultation prior to surgery or is 
screened over the phone. Screening Questionnaire is reviewed for inclusion/exclusion 
criteria.  
 
Patient completes informed consent, demographic and contact information and 
Patient Baseline Questionnaire via electronic data capture.   
N = Approximately 294 subjects requiring bilateral mandibular 3rd molar extraction 
OMS confirms subject consent electronically. Patient confirms baseline data entered 
electronically.  
At 3-Months Post Baseline:  
Patient completes the Patient 3-Month Follow-up Questionnaire. 
 
At 1-Month Post Baseline:  
Patient completes the Patient 1-Month Follow-up Questionnaire. 
 
Randomize 
Usual 
Care 
147 subjects 
Experimental 
Care 
147 subjects 
At 6-Months Post Baseline:  
Patient completes the Patient 6-Month Follow-up Questionnaire. 
 
OMS completes TMJ assessment, and device is placed on those in the 
Experimental Care group 
OMS completes Doctor Surgery Questionnaire 

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1 KEY ROLES AND CONTACT INFORMATION 
Principal 
Investigator:   
Eric Schiffman, DDS, MS  
Co-Founder, The Restful Jaw Company, LLC  
Professor, University of Minnesota 
6-320 Moos Tower 
School of Dentistry 
Minneapolis, MN 55108 
Phone: 612 624 3130 
Fax: 612 626 0138 
Email: eric@restfuljaw.com 
 
 
Medical Monitor: 
Kevin McBryde, MD 
NIH/NIDCR/DER 
6701 Democracy Boulevard, Room 638 
Bethesda, MD 20892-4878 
Phone: 301 594 0170  
Email address: mcbrydekd@mail.nih.gov  
 
NIDCR Program 
Official:   
Dena Fischer, DDS, MSD, MS 
NIH/NIDCR/DER 
6701 Democracy Boulevard, MSC 4878 
Bethesda, MD 20892-4878  
Phone: 301 594 4876 
Email address: dena.fischer@nih.gov 
 
 
Clinical Site 
Investigators: 
Site Principal Investigator:  Dr. Rachel Uppgaard, DDS 
 
University of Minnesota School of Dentistry 
Oral and Maxillofacial Surgery, 7-174 Moos Tower 
515 Delaware St SE 
Minneapolis, MN 55455-0357 
Phone: 612.624.7937 
Email address: uppg0003@umn.edu 
 
Site Principal Investigator:  Dr. Brad D. Rindal, DDS 
Senior Investigator, HealthPartners Institute 
Associate Dental Director Research, HealthPartners Dental   
Group 
8170 33rd Ave S 
Bloomington, MN 55425 

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Email address: donald.b.rindal@healthpartners.com 
Dr. Robert Nadeau, DDS 
University of Minnesota School of Dentistry 
Oral and Maxillofacial Surgery 
7-001 Moos Tower 
515 Delaware St SE 
Minneapolis, MN 55455-0357 
Email address: nade0016@umn.edu 
 
Dr. Tudor Stiharu 
Metro Dentalcare Specialty Center Burnsville 
14344 Burnhaven Dr.  
Burnsville, MN 55306 
Phone: 612.638.1238 
Fax: 952.898.4109 
Email address: TStiharu@metro-dentalcare.com 
 
Dr. Robert Rupprecht 
HealthPartners Como Clinic, Oral Surgery Department 
2500 Como Ave  
St. Paul, MN 55108 
Phone:651.647.2500 
Fax: 651.632.8984 
Email address:  robert.d.rupprecht@healthpartners.com 
   
     
Dr. Elisabeth Peterson 
HealthPartners Como Clinic, Oral Surgery Department 
2500 Como Ave 
St. Paul, MN 55108 
HealthPartners Eden Prairie Clinic, Oral Surgery Department 
8455 Flying Cloud Dr.  
Eden Prairie MN 55344 
Phone: Como/ 651.647.2500  Eden Prairie/ 952.883.9040 
Fax: Como/ 651.632.8984 
Email address: elisabeth.m.peterson@healthpartners.com 
 
Institutions: 
Data Coordinating Center (DCC) 
HealthPartners Institute DCC, MS 23301A 
8170 33rd Ave S 

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Bloomington, MN 55445 
Contact person: Jeanette Ziegenfuss, PhD 
Senior Manager Principal Survey Sciences Research Center 
Phone: 952.967.5020 
Fax: 952 883 5004 (ATTN: Data Coordinating Center) 
Email address: jeanette.y.ziegenfuss@HealthPartners.com 
  
Other Key 
Personnel: 
Ana Miriam Velly, DDS, PhD 
Epidemiologist, Associate Professor McGill University 
Jewish General Hospital  
3755 Cote Ste Catherine, Suite A.017 
Montreal, Quebec, Canada, H3T 1E2 
Phone: 514 340 8222 ext 2932  
Fax: 514 340 7514 
Email address: ana.velly@mcgill.ca 
  
James S. Hodges, PhD 
Statistician, Professor, University of Minnesota 
Division of Biostatistics 
School of Public Health 
2221 University Ave SE 
Room 200 University Office Plaza 
Minneapolis, MN 55455 
Phone: 612.626.9626  
Email address: hodge003@umn.edu 
 
Karen Kloser 
President & CEO, The Restful Jaw Company, LLC 
Grant Principal Investigator 
1596 Northrop St. 
St. Paul, MN 55108 
Phone: 651.964.2529 
Email address: karen@restfuljaw.com 
 

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2 INTRODUCTION: BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE  
2.1 
Background Information 
 
Dental procedures can cause jaw pain, discomfort and fatigue from opening the mouth 
too long or too wide, or by placing too much force on the jaw. (1-15) Opening too wide 
can also cause hyperextension of the jaw. During and after long dental procedures, 
patients frequently report jaw pain, fatigue, or discomfort. This pain and dysfunction 
characterizes temporomandibular disorders (TMD), which can be short-term or may 
become chronic. TMD occurrence is frequently associated with trauma from dental 
procedures, including 3rd molar extractions. (1-15) Also, dental procedures may 
aggravate pre-existing subclinical TMD symptoms. (16) 
 
Over 10 million 3rd molars (wisdom teeth) are extracted from about 5 million people in 
America each year.(1) More than 11 million patient days of “standard discomfort or 
disability” – pain, swelling, bruising and malaise – result postoperatively.(1) Although the 
American Association of Oral and Maxillofacial Surgeons guidelines state that consent 
forms for 3rd molar extractions should include injury to the temporomandibular joint 
(TMJ) or associated muscles(17), there are few reports of the trauma to the TMJ or jaw 
muscles from this procedure.(1) One of the best studies assessing development of TMD 
after 3rd molar extractions is a large prospective cohort study of young adults.(3) Huang 
et al. assessed the onset of jaw joint symptoms (i.e., TMJ noise and jaw pain) in 
individuals who had 3rd molar extractions compared to those who did not. Of the 517 
participants with follow-up data, 39% (n = 201) had a total of 720 3rd molars extracted, 
with 68% reporting that 'intravenous sedation' or general anesthesia was used. Among 
patients undergoing 3rd molar removal, the rate of TMD lasting more than 1 month was 
34.3 per 100 person-years compared to 8.8 among those who did not have 3rd molar 
extractions. The relative risk of developing TMD was 3.8 and the rate of TMD reported 
by patients undergoing this surgery was greater than 30%. This study's findings are 
limited by its low follow-up rate (40 to 50% for follow-up questionnaires at different 
intervals). Further, a retrospective study reported that almost a quarter of new onset 
TMD cases in young adults were associated with 3rd molar removal.(2) In a cross-
sectional study of patients aged 18.7 + 1.1 years, the occurrence of 3rd molar 
extractions was significantly associated with TMD (P<0.001). (7) Finally, in an age and 
sex matched case-control study, at 6 months follow-up, patients who had 3rd molar 
extractions had significantly more TMJ and jaw muscle pain than controls who did not 
have this surgery (P<0.05). (6) These findings suggest removing 3rd molars is 
associated with development of TMD and that this patient safety issue is not addressed 
by current methods to protect the jaw during this surgery. Providing better support for 

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the jaw during 3rd molar extractions to prevent hyperextension and excessive force on 
the jaw would be expected to alleviate the physical stress on the jaw and reduce patient 
suffering and jaw injury. (18, 19) 
 
2.2 
Rationale 
This study will test whether the new RJ2 device, when supporting the jaw during 
surgical removal of 3rd molars, reduces the incidence of TMD pain compared to usual 
care where the dental assistant supports the jaw. Hypothesis: The risk of developing 
TMD pain in patients undergoing 3rd molars (wisdom teeth) removal in the experimental 
care (EC) group will be statistically lower than in the usual care (UC) group within the 6-
month follow-up interval. 
 
Rationale: When a downward force is placed on the patient’s jaw to surgically remove 
the mandibular (lower) 3rd molars, the patient must tense his/her jaw muscles to oppose 
it. This can result in jaw pain, discomfort or fatigue, especially if the force is high or 
prolonged. Patients under moderate/deep sedation or general anesthesia cannot tense 
their muscles to counter this downward force to prevent injury to the jaw. Bite blocks 
hold the patient’s mouth open but do nothing to counter this downward force on the jaw. 
Opening a patient’s mouth too wide can cause jaw hyperextension; a long extraction 
procedure time can also lead to injury of the jaw. This can result in patient suffering, lost 
time for the dentist to manage the symptomatic patient, and potential medico-legal 
problems. Currently, oral and maxillofacial surgeons (OMSs) when surgically removing 
3rd molars (wisdom teeth) with moderate/deep sedation or general anesthesia have at 
least 2 dental assistants present. The first dental assistant provides suction and gives 
the surgical instruments to the surgeon. The second dental assistant is a certified 
anesthesia dental assistant who monitors the patient’s vitals as well as oxygen and 
carbon dioxide levels while providing the patient with medications intravenously. This 
second dental assistant also inserts the bite block and then stands behind the chair and 
places their hands on both sides of the jaw to support it and oppose the downward force 
on the patient’s jaw during the extractions. If additional intravenous medications are 
needed during the surgery, the surgery has to stop (lost time) and the OMS or the first 
dental assistant supports the jaw until the second dental assistant completes the 
medication administration. Based on clinical experience, the second dental assistant 
often experiences fatigue and pain in their hands, arms, neck and shoulders during long 
or difficult procedures, which can affect his/her ability to support the jaw. Given the 
second dental assistant's many duties and responsibilities, it is hard for the assistant to 
provide constant good jaw support while anticipating the direction and amount of force 
placed by the OMS on the patient’s jaw during 3rd molar surgical removal. This may 

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explain the finding that almost a quarter of new onset of TMD cases in young adults is 
associated with 3rd molar removal.2 This patient safety issue can be addressed during 
3rd molar surgical removal by using a bite block to hold the mouth open and 
concurrently using a jaw support device under the jaw to provide a stable counter force 
to downward forces on the jaw, thus preventing jaw hyperextension and injury to the 
jaw. This would also free the second dental assistant from holding the jaw so he/she 
can concentrate on his/her other duties, which would improve patient safety.  
 
The currently patented Restful Jaw® 1 (RJ1) device is designed to support the jaw 
when downward forces are placed on it and it has been shown to significantly reduce 
jaw pain during dental procedures (restfuljaw.com).18,19 However, significant changes 
have been recommended by users of the RJ1 device who utilize moderate/deep 
sedation or general anesthesia. We have addressed these concerns and suggested 
changes in Phase I of this small business grant with an innovative design for the new 
Restful Jaw 2 (RJ2) device (see Section 6 for a description of the new device). These 
changes included providing support on both sides of the jaw which mimics the dental 
assistant’s placement of his/her hands. Also, the device attaches to the dental chair 
head post so the only contact to the patient is under his/her jaw. Finally, if the device 
needs to be removed from the patient during the procedure, the dental assistant 
presses on the foot pedal or the quick release control box and this deactivates the 
device so it can be quickly removed from the surgical field and away from the patient. 
Specifically, in Phase I step 1 of this grant, the OMSs and dental assistants (DAs) 
provided us with critiques of the prototypes of the RJ2 device. Then during Phase I step 
2, they used a working prototype of the device on consenting patients having 3rd molar 
surgical removal with moderate/deep sedation or general anesthesia and provided 
additional feedback on the device. We continued this process to the point of saturation 
where we are confident the device is satisfactory for use in the oral surgery environment 
with the minor modifications which have been incorporated in the design.  
2.3 
Potential Risks and Benefits 
2.3.1 
Potential Risks 
There are potential risks of using the RJ2 device. If excessive force is placed on the 
device by the OMS, then the device could slide to a slightly different position. However, 
as soon as this force is stopped, then the device will stop moving. There is potential that 
the device could malfunction and lose pressure during the procedure. If this occurs, the 
passively controlled arms will fall away from the patient’s jaw which could also 
compromise the support of the patient’s jaw. To mitigate these risks, the dental 
assistant will be present behind the dental chair to support the jaw. Patients have similar 

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risk of jaw injury when their jaw is supported only by the dental assistant’s hands since 
their hands can slip in position if excessive force is placed on the jaw, and their 
supporting arms and hands can become fatigued during procedures compromising their 
ability to support the jaw. In addition, patients could report that the padded jaw brace 
when placed under their jaw feels uncomfortable. If this occurs, then the dental 
assistant can reposition the brace to a position that is comfortable. There are no other 
anticipated safety risks to participating in this study beyond those risks inherent in 3rd 
molar extractions with moderate/deep sedation or general anesthesia. Patients do not 
receive 3rd molar extractions as a study procedure. Consequently, risks of 3rd molar 
extraction with moderate/deep sedation or general anesthesia will be discussed with the 
patient as part of normal clinical care and are not considered to be study-associated. 
Finally, if any adverse event (AE) occurs, then it will be documented and assessed by 
the study team.  
2.3.2 
Potential Benefits 
This trial may ascertain whether use of the RJ2 device provides a more effective way to 
support the jaw that reduces the incidence of TMD pain compared to the dental 
assistant supporting the jaw for patients having removal of 3rd molars. 
 

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3 OBJECTIVES 
3.1 
Study Objectives 
Primary: In patients undergoing mandibular 3rd molar extractions with moderate/deep 
sedation or general anesthesia, compare the incidence of TMD pain within a 6-month 
follow-up period between the two groups: 
 
1. UC group, using a bite block and with hand support of the jaw, and  
2. EC group, using a bite block and the RJ2 device to support the jaw.   
The secondary objectives of this study are to: 
1. Compare the incidence of TMD pain between UC and EC groups using an 
alternate assessment instrument to identify TMD pain within a 6-month follow-up 
period  
2. Compare TMD pain intensity between the UC and EC groups within a 6-month 
follow-up period: at 1-, 3- and 6 months. 
3. Compare TMJ noise, pain characteristics (e.g., location in temple or jaw, and 
occurrence with wide opening of mouth) and change in jaw pain since it started, 
within a 6-month follow-up period: at 1-, 3- and 6 months. 
4. (Exploratory Objective) Describe the experiences of surgeons and dental 
assistants with the new device at mid-way through recruitment of patients and at 
the end of recruitment. 
3.2 Study Outcome Measures 
3.2.1 Primary 
The primary outcome is the incidence of TMD pain within a 6-month follow-up period 
(binary dependent variable).  TMD pain is deemed to have occurred if the patient's self 
report in the Patient 1-, 3- and 6-month Follow-up Questionnaires endorses either or 
both of the following questions: Pain in jaw with wide opening, or pain in temples, jaw 
joints or jaw muscles.3 The primary analysis will include all available follow-up measures 
(1, 3, and 6 months) for each patient to estimate the incidence of TMD pain.  
 
3.2.2 Secondary 
1. The incidence of TMD pain, as measured with the validated TMD Pain Screener 
Questionnaire22 (binary dependent variable), will be compared between the UC and 
EC groups within a 6-month follow-up period based on patients’ self report in the 

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Patient 1-, 3- and 6-month Follow-up Questionnaire.  
2. TMD pain intensity, as measured with the validated Characteristic Pain Index 
(CPI) within a 6-month follow-up period (treated as a continuous measure), will be 
compared between the UC and EC groups based on patients’ self report in the 
Patient 1-, 3- and 6-month Follow-up Questionnaire.  
3. The UC and EC groups will be compared for TMJ noise, pain characteristics (e.g., 
location in temple or jaw, and occurrence with wide opening of mouth) and change in 
jaw pain since it started, within a 6-month follow-up period based on patients’ self 
report in the Patient 1-, 3- and 6-month Follow-up Questionnaire.  
4. A final secondary outcome is descriptive:  a summary of the experiences of 
surgeons and dental assistants with the new RJ2 device at mid-way through 
recruitment of patients and at the end of recruitment based on their self report in the 
Doctor Questionnaire Regarding Use of the Device and Dental Assistant 
Questionnaire Regarding Use of the Device, respectively.  
 

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4 STUDY DESIGN 
• Study design  
This is a multicenter, two-arm, parallel RCT design in which approximately 
294 patients undergoing 3rd molar (wisdom teeth) extraction will be 
randomized to either UC or EC, with data obtained at baseline, and at 1-, 3- 
and 6-months follow-up after surgery. Patients in the EC (study intervention) 
arm will undergo 3rd molar extraction with the RJ2 device supporting the jaw 
and concurrent use of a bite block. Patients in the UC (study control) arm will 
undergo 3rd molar extraction with the dental assistant supporting the jaw and 
concurrent use of a bite block. 
 
The study will be conducted at the following sites: 
• University of Minnesota School of Dentistry, Moos Tower, Oral 
Surgery surgical suite; 7th floor Moos Tower, 515 Delaware St SE, 
Minneapolis, MN 55455.  
• HealthPartners Como Clinic, Oral Surgery Department, 2500 Como 
Ave, St. Paul, MN 55108 
• HealthPartners Eden Prairie Clinic, 8455 Flying Cloud Dr. Eden 
Prairie, MN 55344  
• Metro Dentalcare Specialty Center Burnsville, 14344 Burnhaven 
Dr., Burnsville, MN 55306 
 
• Study population 
Approximately 294 healthy (ASA 1 & II), consenting adult patients, age 18-30, 
requiring surgical removal of bilateral mandibular 3rd molars (concurrent 
maxillary 3rd molar removal allowed). All patients presenting to participating 
surgeons’ practices for surgical removal of their 3rd molars will be considered 
for eligibility. See eligibility criteria described in Section 5. 
Approximately seven (7) OMS will participate in the study. They represent 
three diverse practice settings; the University of Minnesota Dental School 
Department of Oral Surgery, HealthPartners (a large group practice) and a 
private practice setting. All surgeons are board certified and currently treat 
patients with 3rd molar extractions. Dental assistants at each of these sites will 
be invited to participate in the study.  
 

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• Data Collection 
Patient-reported data will be collected via tablets, smart-phones, or 
computers at baseline during in-office visit(s) with the surgeons. To assist 
with in-office data collection, participating OMS will be offered tablets. OMS, 
dental assistants, and patients will provide baseline and follow-up data 
directly into the electronic data capture (EDC) system that is maintained by 
the HealthPartners Data Coordinating Center (DCC); data can be entered via 
tablets, smart-phones, or computers. After baseline, patient-reported data will 
be ascertained independent of office visits, and all follow-up patient, OMS and 
dental assistant data collection will be managed by HP DCC.  Follow-up 
contacts to non-responders will also be managed by the DCC.  
• Overview of Study Schedule  
 
 
• The electronic data system used to collect patient and OMS/dental 
assistant data will be assessed for acceptability and compatibility prior 
to administration of any questionnaires. 
• OMS and their office staff will receive study training from the Study 
Coordinator (SC), after which the OMS is authorized to begin enrolling 
study patients. 
• An in-office patient log will be kept regarding the reason patients were 
excluded or declined to participate.  
• Once the patient is screened using the Screening Questionnaire that 
comprises the inclusion and exclusion criteria, patients who are eligible 
will be invited to participate in the study. Potential patients who are 
interested in study participation will undergo consent procedures. 
• Patients will complete these baseline forms and questionnaire before 
surgery: Patient Contact and Patient Demographics information, and 
Patient Baseline Questionnaire.  
• Randomization procedures will occur, and patients will receive their 
randomized assignment. 
• The OMS will complete the Doctor Surgery Questionnaire after 
completing the 3rd molar extractions.  
• At 1, 3, and 6 months post-baseline, patients will complete follow-up 
assessments via an online questionnaire. Non-responders will be 
followed up with email, telephone, and/or texting. All patients will be 
followed up regardless of whether they report TMD pain at any follow-
up. 

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• Midway through and at the end of the enrollment phase of the study, 
the OMS and dental assistants will complete a questionnaire regarding 
their experience with the use of the device.  
• Approximately 3 months into recruitment, Dr. Schiffman, Ms. Kloser, 
study engineers and OMS will meet to discuss their experience with 
using the device. 
First Month Follow-up of Study Patients by study staff 
Patients will receive emails with active links to the online web-based Patient One-month 
Follow-up Questionnaire for electronic completion. The DCC will attempt email, 
telephone and/or text contact for non-responders to remind them to complete the 
questionnaires online or over the telephone. Completion of questions over the 
telephone is an option for those patients who do not complete the form by close of data 
collection window.   
Months 3 and 6 Follow-up of Study Patients by study staff 
Similar procedures, as in the first month time point, will be repeated at months 3 and 6.  

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5 STUDY ENROLLMENT AND WITHDRAWAL 
The target sample size for this study is 294 patients. To meet this target, we 
anticipate that 500 patients will need to be screened.  Enrollment will include 
patients who present to the participating oral & maxillofacial clinics for surgical 
removal of mandibular bilateral 3rd molars (concurrent removal of maxillary 3rd 
molars is allowed). Each OMS will enroll no more than 60 patients into the trial. 
5.1 
Subject Inclusion Criteria 
In order to be eligible to participate in this study, a patient must meet all of the following 
criteria: 
• Between 18 to 30 years of age at time of enrollment; 
 
• Willing to provide informed consent to be randomized to either using the device 
or not when having surgical removal of 3rd molars with moderate/deep sedation 
or general anesthesia; 
 
• Requires surgical removal of bilateral mandibular 3rd molars with moderate/deep 
sedation or general anesthesia; concurrent maxillary 3rd molars removal allowed; 
 
• American Society of Anesthesiologists (ASA) Physical Status category 1 (normal 
healthy patient) or Category 2 (patient with mild systemic disease); 
 
• Available to be contacted for study purposes by e-mail, phone and/or text; 
 
• Willing to provide contact information for one other person who will know the 
patient’s whereabouts in the event the patient cannot be reached. This contact 
information must be different from the patient’s contact information;  
 
• 
Willing to comply with all study procedures and be available for the six month 
duration of data collection. 
 
In order to participate in this study, dental assistants must meet all the following 
criteria: 
 
• Holds a certification as a dental assistant 
 
• Willing to provide informed consent according to their IRB requirements and 
procedures. 

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• Willing to comply with all study procedures. 
 
• Willing to provide feedback on the device at the midpoint and end of the data 
collection. 
 
In order to participate in this study, OMS must meet all the following criteria: 
 
• Willing to provide consent according to their IRB requirements and procedures. 
  
• Has the ability to receive emails and access online surveys. 
 
• Willing to comply with all study procedures and be available for the duration of 
the study. 
 
• Successfully completed a CODA certified program in advanced specialty 
education program in oral and maxillofacial surgery. 
 
• Currently certified in moderate/deep sedation or general anesthesia. 
 
• Currently certified in Advanced Cardiovascular Life Support (ACLS). 
 
5.2 
Subject Exclusion Criteria 
Patients who meet any of the following criteria will be excluded from participation in this 
study: 
• In the past 3 months, reports the presence of TMD pain in their temples, jaw 
joints or jaw muscles; 
 
• Contraindication(s) for moderate/deep sedation or general anesthesia; 
  
• Any condition or situation the surgeon determines that would prevent the patient 
from participating in this study; 
 
• Inability to understand study procedures or provide consent in English; 
 
• Device does not fit mandible; 
 
• Supernumerary 3rd molars present.  

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5.3 
Strategies for Recruitment and Retention 
All patients presenting to participating surgeons’ practices will be considered for 
eligibility. For patients without TMD pain in the last 3 months, the surgeons or their 
office staff will discuss the study and review eligibility criteria with the patient. Patients 
who meet eligibility criteria and consent to participate in the study will complete their 
baseline data collection forms, undergo randomization procedures, and then have their 
3rd molars surgically removed.  
Patients will be told that their treatment will not be affected by participation in the study 
except that they will be randomized to UC or EC.  
Patient retention is important to this study, and follow-up data will be collected 
independently of in-office visits. Study patients will be asked to complete follow-up 
assessments online at 1-, 3-, and 6- months after the baseline visit. Patients will be paid 
$125 total for completed questionnaires; $25 at baseline, $25 at 1-month follow-up, $25 
at 3-month follow-up and $50 at the 6-month follow-up. 
Study patients will be contacted by email prior to each data collection time point at 1-, 3-
, and 6-months post-surgery. The initial email contact for each survey period will contain 
the request to complete the questionnaire and an active link to the online web-based 
questionnaire. Email, telephone and/or text follow-up attempts will be implemented for 
non-responders. The HealthPartners DCC will email, call and/or text patients who do not 
complete the follow-up questionnaires by the close of the target data collection window 
to encourage them to complete surveys. When contacted, patients will be given the option 
to complete the questionnaire by telephone with the DCC. 
5.4 
Treatment Assignment Procedures 
The specific randomization procedure and methods are described below.  Generally, 
participants will be randomized between the two study treatments, stratified by surgeon 
(7 surgeons and thus 7 strata total).  This stratification addresses variation between 
surgeons in surgical technique and variation between practices in postoperative 
rehabilitation protocol.   
 
5.4.1 
Randomization Procedures  
 
The OMS or dental assistant will provide a participant with the randomization 
assignment after the participant's eligibility is confirmed and his/her consent is obtained.  
The random assignment will be obtained from the study tablet used by the OMS or 
dental assistant. The study tablet, which will be programmed by the HP DCC, will 
(among other things) use randomized treatment assignments from a stratum-specific 

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(i.e., surgeon-specific) sequence of randomized assignments created as described in 
the following paragraph.  Each surgeon-specific randomization sequence will be loaded 
into the tablet by the programmer at the HP DCC in such a way that it will be impossible 
for clinical study personnel, in particular for the OMS or dental assistant to access this 
sequence or to infer any treatment assignment in the sequence until the moment that 
assignment is given to a particular participant.   
 
For each stratum (i.e., surgeon), the randomization sequence will be created by the 
project statistician using custom-written code in the R system (R Foundation for 
Statistical Computing, Vienna, Austria, https://www.R-project.org/), as follows:  The 
sequence will use randomized permuted blocks of size 2 and 4, in each of which the 
two treatments are present equally often.  The R code will first generate a random 
sequence of block lengths, so that study personnel will never be able to tell which block 
they are in, and then in each block, the treatment assignments will be randomly 
permuted, so that each sequence of possible treatments within a block is equally 
probable.   
5.4.2 
Masking Procedures  
In this RCT, it is not feasible to blind patients, surgeons, or dental assistants to 
treatment after the intervention assignments have occurred, so they will not be blinded.  
It is, however, feasible to mask the sequence of treatment assignments until the 
moment each assignment is made, and this will be done, as described in Section 5.4.1, 
above. 
 
The DCC will also be un-blinded to treatment arm assignment.  However, study staff 
and investigators will not have access to any interim outcome data.  Unmasking 
procedures during the surgery will not be necessary as the patient, surgeon, and dental 
assistants will be un-blinded to the treatment group for each patient.  The patient’s 
record in the OMS office will include documentation of study participation and their 
group assignment (i.e., UC versus EC). 
 
5.5 
Subject Withdrawal 
5.5.1 
Reasons for Withdrawal 
Patients may withdraw voluntarily from participation in the study at any time upon 
request, including at baseline and at any follow-up time points. 
An investigator may terminate a study patient’s participation in the study if: 

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• Any clinical adverse event (AE) or other medical condition or situation occurs 
such that continued participation in the study would not be in the best interest of 
the patient. All patients who provide consent and are randomized to one of the 
treatment arms will remain in the study even if they are not able to follow through 
with their group assignment through the completion of the surgical procedure. 
This includes an event that occurs during the surgical removal of their 3rd molars 
that precludes completion of the surgical procedure at that time. Only patients 
who no longer consent to provide data will be withdrawn.  
• The patient meets an exclusion criterion (either newly developed or not 
previously recognized) that precludes further study participation. 
• If an enrolled patient declines to provide any of the essential baseline data on 
the Patient Contact Form, the Patient Demographics Form, and/or the Baseline 
Patient Questionnaire, this decision will be considered a voluntary withdrawal 
from the study by the patient and the PI will withdraw the patient from the study.  
5.5.2 
Handling of Subject Withdrawals or Subject Discontinuation of Study 
Intervention 
All patients who provide consent and are randomized to one of the treatment arms will 
continue to provide data unless and until they explicitly withdraw their consent for further 
data collection. Only participants who no longer consent to provide data will be excluded 
from further data collection, and data collected during the duration of their participation 
will be included.  
 
For patients who cease to receive their assigned treatment or who withdraw from study 
participation, the date and reason for this change in status will be recorded. Patients who 
have withdrawn consent for study participation may continue to receive usual care as 
patients of the participating OMS.   
 
OMS will not replace patients who have withdrawn from the study; the study's sample 
size was chosen to account for 10% of patients not providing follow-up data. 
 
If any OMS or DA withdraws from study participation, he/she will be replaced, and the 
replacement(s) will be trained on study procedures prior to participating in the trial. 
5.6 
Premature Termination or Suspension of Study 
This study may be suspended or prematurely terminated if there is sufficient reasonable 
cause.  Written notification, documenting the reason for study suspension or 

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termination, will be provided by the suspending or terminating party to the investigator, 
funding agency and regulatory authorities.  If the study is prematurely terminated or 
suspended, the principal investigator will promptly inform the IRB and will provide the 
reason(s) for the termination or suspension.  
Circumstances that may warrant termination include, but are not limited to: 
• Determination of unexpected, significant, or unacceptable risk to patients. 
• Insufficient adherence to protocol requirements. 
• Data that are not sufficiently complete and/or evaluable.  
• Determination of futility. 

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6 STUDY INTERVENTION 
6.1 
Study Product Description 
Description of the Restful Jaw Device (RJ2) 
The RJ2 device is used to support the jaw during dental procedures including surgical 
removal of 3rd molars (wisdom teeth) with moderate/deep sedation or general 
anesthesia. The device is designed to counter the downward forces placed on the 
mandible by clinicians during dental procedures and prevent jaw hyperextension 
(opening too wide) while providing a secure, stable jaw position.  
Figure 1 shows a side view of the device mounted to the head rest post with the jaw 
brace (#5) under the patient’s jaw  
Figure 1. Side view of device mounted to the chair head rest 
 
The device is designed to replicate the dental assistant’s shoulders, arms, 
wrists and hands.  The device has 5 components (see Figure 1): the first 
component is the mounting assembly that attaches the device to the dental 
head rest post (Figure 1. #1). The second component is the split sphere 
assembly which replicates the movements of the dental assistant’s shoulder 
(Figure 1. #2). The third component is the “arm” of the device, replicating the 
dental assistant’s arms, which can be rotated and moved in and out of the split 
ball assembly (Figure 1. #3). The fourth component is the ball joint assembly 
which replicates movements in the dental assistant’s wrist (Figure 1. #4). The 
fifth component is the padded jaw brace assembly that replicates the dental 
 
 
 
 

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assistant’s hands (Figure 1. #5).  Please refer below to the “Instructions for 
Use” for more details regarding the device. 
This device requires pressurized air to operate. Air hoses are provided with the 
device to connect it to the air supply in the surgical suite. If there is no air supply 
available, then a free-standing air compressor or pressurized tank is used. The 
control box that sits on the floor is where the air into and out of the device is 
controlled. The air hoses from the air compressor or tank connect to the “input” 
port on the control box. The 4 “output” ports on the control box connect, via hoses, 
to the shoulder and end of each arm (Figure 2, purple circles). 
 
Figure 2. Device Air Valves 
 
 
 
A foot switch is used to activate the device (pressurize the system) and to 
deactivate the device (remove pressure from the system). The foot switch is 
attached via tubing to the control box port. A pressure gauge is present on the 
control box to verify the pressure in the system. An emergency stop (e-stop) 
button is also present on the control box in the event of an emergency to evacuate 
all air from the system. 
Use of the device 
When using the device, the dental assistant stands behind the chair and holds the 
“wrists” and “hands” of the device in each hand. The dental assistant then moves 
the jaw braces into place relative to the patient’s jaw with no air pressure in the 
system. When there is no air pressure present, the “shoulder”, arm”, “wrist”, and 

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“hand” move freely without resistance. When the brace is positioned correctly on 
the patient’s jaw, the dental assistant presses on the foot switch to pressurize the 
system with air. This pneumatically locks all parts into the desired position. When 
removing the device, the dental assistant stands behind the chair and holds the 
brace with their hand and pushes on the foot switch to eliminate the pressure in 
the system. Then the assembly can be freely moved and placed behind the dental 
chair. There is also an e-stop button on the control box that can be used to 
evacuate the air in the system whereby the assembly is again de-activated and can 
be moved. 
 
6.1.1 
Acquisition 
The device will be provided to the participating OMS by the sponsor. The study 
engineer and study coordinator will bring the device to the OMS’s office, set it up and 
provide instruction on use of the device. The office will also receive a FDA Label and 
Instructions for the device.  
6.1.2 
Formulation, Packaging, and Labeling 
Label and Instructions for Use of the Jaw Support Device 
 INTENDED FOR PREMARKET PRACTITIONER PREFERENCE TESTING ONLY 
 
MANUFACTURED and Packed by:  
Lab 651 
550 Vandalia Street 
Suite 224 
Saint Paul, MN 55108 
 
DISTRIBUTED BY: 
The Restful Jaw Company, LLC 
1596 Northrop St. 
St. Paul, MN 55108 
 
For product or technical information, contact 1-651-964-2529. 
 
CONTENTS: 1 Jaw Support Device 
 
CAUTION: INVESTIGATIONAL DEVICE. LIMITED BY US FEDERAL LAW TO 
INVESTIGATIONAL USE. 

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INTENDED PURPOSE: 
This device is for use during the premarket clinical investigation to support the mandible 
of a patient during oral and maxillofacial surgical procedures including surgical removal 
of third molars with moderate to deep sedation or general anesthesia.  
 
USE:  
This device is fully assembled when shipped. To use, the device MUST be securely 
attached to the dental chair head rest post. See the chair manufacturer’s instructions for 
removing and reinserting the chair head rest post.   
 
The device requires air pressure to operate. Air hoses are provided with the device to 
connect it to the air supply in the operatory. If there is no air supply available, then a 
free-standing air compressor or pressurized tank is used. The air hoses are attached to 
the back of the chair where quick disconnect fittings are provided to hold them in place.  
 
ATTACHING THE DEVICE TO THE CHAIR 
1. Remove the head rest post from the chair. 
2. Hold the device with the three black knobs facing you. Turn the center black knob 
to loosen the head rest mounting plate. See red circle on Figure 1a.  
3. Slide the device onto the head rest post so that the knobs are facing away from 
the front of the head rest towards the back of the chair as shown in Figure 1a.  
4. Adjust the position of the device on the head rest post so the device shoulders 
(shown in Figure 1a in a yellow circle) can rotate freely below the arm rest pads 
as shown in the blue circles in Figure 1a. If needed, remove the arm rest pads 
from the head rest. 
5. Hand-tighten the center black knob securely to lock the position of the device on 
the head rest post.  
6. Slide the head rest post back onto the chair. Make any adjustments so the device 
is positioned evenly on the chair head rest post. Note: The device can contact 
the top of the chair.  
7. Once in position, follow chair manufacturer’s instructions to lock the head rest 
post onto the chair, commonly a large knob on the back of the chair. Once the 
head rest is locked, check that you can still freely rotate the arms without 
obstruction from the chair or arm rest pads. 
8. Ensure a tight fit of the device on the post AND the post in the chair before using 
the device on any patient. Tighten as needed. Before every procedure always 
tighten the middle black knob securely. See red circle on Figure 1a. 

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9. See Figure 1b for a view of the device from the front when the device is in place 
on the chair and the patient. 
 
FIGURE 1a: Jaw Support Device                          FIGURE 1b: Jaw Support Device  
     (Back View)                                                      (Front View) 
 
 
               
 
 
 
 
CONNECTING THE DEVICE TO AIR 
1. Turn on the in-office air compressor, or if using a free-standing air compressor 
turn it on and charge to maximum tank pressure. A pressurized free-standing 
tank can also be used. Connect the air compressor or tank hose to the ‘supply’ 
port on the device control box shown in the orange circle on Figure 2. Note: The 
control box is strapped to the back of the chair. 
2. Attach air hoses to all four air intake connectors on the shoulder and the end of 
each arm. See purple circles in Figure 3.  
3. Connect air hoses to control box ‘output’ ports shown in purple-dashed circles in 
Figure 2.  
4. Connect the input and output of hoses of the foot switch (Figure 4) to their 
respective ports on the control box shown in the blue square Figure 2. The foot 
switch will be used to lock and unlock the arms (Figure 4). 
 
 
 
 
 
 

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FIGURE 2 Control Box  
 
 
 
 
FIGURE 3 Device Air Ports 
  
 
 
 
FIGURE 4 Foot Switch 
 
  
POSITIONING THE DEVICE ON THE PATIENT ON BOTH SIDES OF THE 
MANDIBLE  
1. Seat the patient in the chair. 
2. Adjust the head rest position as needed. Ensure the arm rests do not inhibit 
motion of the shoulder joints (see blue circles in Figure 1a). 

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3. Loosen the left and right knobs shown in green circles in Figure 1a. 
4. Rotate the left shoulder part so the arm will extend slightly above the patient’s left 
shoulder. Tighten left knob. 
5. Repeat #3 and 4 with right shoulder.  
6. Stand behind the patient and position both padded jaw braces at the same time 
under the mandible on both sides. Figure 5 shows the approximate position of 
the brace on the patient. 
7. Press the foot switch to secure the device’s position on the patient. 
 
FIGURE 5 Bilateral Mandible Support  
 
 
  
 
 
 
 
 
REMOVING THE DEVICE 
1. To remove the device, press the foot switch to release pressure in the arms. This 
will make the arms relax. 
2. Slide the arms back to their original position near head rest.  
3. Loosen the left and right knobs shown in Figure 1a, and rotate the arms back to 
the stored position behind the chair. Figure 6 shows the right arm in stored 
position. 
 
 
 
 

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FIGURE 6: Device in Stored Position 
 
STORAGE 
1. The device can be stored on the head rest post with the arms slid back and 
folded in a 90º angle as shown in Figure 6. 
2. It can also be completely removed from the chair and stored in a dry place at 
room temperature for future use. 
3. Review the chair manufacturer’s instructions for removing and re-inserting the 
head rest on the chair post.  
 
MAINTAINANCE AND INFECTION CONTROL  
Disposable pads are placed on the jaw brace. If bodily fluids are present on the device, 
thoroughly clean all surfaces of blood and other bodily fluids using a standard EPA-
registered low or intermediate level disinfectant clinic wipes, or sprays, on all surfaces in 
contact with the patient, clinician or bodily fluids. The padding on the jaw braces should 
be discarded and replaced after each use. 
 
PRECAUTIONARY STATEMENTS  
If excessive force is placed on the device by the surgeon, then the device could slide to 
a slightly different position. However, as soon as this force is stopped, then the device 
will stop moving. If the device malfunctions and loses pressure during the procedure, 
the passively controlled arms will fall away from the patient’s jaw; and the clinician or 
dental assistant need to be immediately available to provide support for the patient’s 
jaw. 
 
A red emergency air release valve is located on the back side of the control box and 
should be pushed in the event of an emergency and/or if the foot switch is 
malfunctioning to evacuate all air from the system.  
 
Do not use on any patient where the device cannot be positioned correctly or 
appropriately adjusted on them for stability and support of the mandible. 

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PROCEDURES TO FOLLOW IN THE EVENT OF PATIENT EMERGENCY 
Remove device from patient contact: 
1. If this is an emergency, support the patient’s jaw and then press the foot switch. 
This will release air from the arms which will lose pressure and become relaxed. 
2. Slide the arms back to their original position near head rest.  
3. Loosen the right and left knobs turning the green-circled knobs as shown in 
Figure 1a.  
4. Rotate the arms back behind the chair as shown in the stored position in Figure 
6. 
5. Follow clinic’s protocol for emergencies.   
 
6.2 
Accountability Procedures for the Study Product 
The device will be set up for the OMS and will be removed by the study engineer and/or 
the study coordinator.  

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7 STUDY SCHEDULE 
7.1 
Screening 
 
Patients who are planning to undergo mandibular 3rd molar surgical removal with 
moderate/deep sedation or general anesthesia at the office of a participating OMS will 
be screened for possible study participation; this may occur in the OMS office prior to or 
on the day of the surgery, or screening may occur over the phone. Office staff will 
review inclusion/exclusion criteria with the patient via the Screening Questionnaire to 
determine if the patient meets eligibility criteria for the trial. A laminated version of 
eligibility criteria (see Section 5) as well as a picture of the device will be available for 
use by the OMS, dental assistants or office staff when discussing the study with the 
patient.  
The procedures listed below are consistent with those included in the Schedule of Events 
(Appendix A). 
7.2 
Enrollment/Baseline 
If eligible and interested in study participation, the patient will undergo consent 
procedures via tablet technology. A designated office staff member, most likely the 
OMS, will execute the consent process according to IRB requirements.  
If an enrolled patient declines to provide any of the essential baseline data on the 
Patient Contact Information, Patient Demographics, and/or the Baseline Patient 
Questionnaire, this decision will be considered a voluntary withdrawal from the study 
(see Section 5.5.1). 
Enrollment/Baseline Visit (Visit 1, Day 0) 
• Verify, obtain and document consent from potential patient via electronic data 
capture consent form based on IRB requirements.  
• Verify and document Health Insurance Portability and Accountability Act (HIPAA) 
authorization for use of the patient’s Personal Health Information (PHI) in 
Research, based on IRB requirements. 
• Patient completes patient contact information, patient demographics information, 
and Baseline Patient Questionnaire.  
• Record results of TMD examination from OMS on Doctor Surgery Questionnaire. 

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• After a patient eligibility is confirmed and they have provided consent, the 
patient’s random assignment to EC or UC is then automatically available to the 
OMS and their dental assistant on the tablet. The patient is then informed of their 
group assignment.  
• OMS completes usual care extraction of 3rd molars with moderate/deep sedation 
or general anesthesia and bite block. If patient is randomized into the UC group, 
the procedure will be completed with a bite block and a DA holding the jaw. If 
patient is randomized into the EC group, the procedure will be completed with a 
bite block and the RJ2 device.  
• OMS completes Doctor Surgery Questionnaire. 
7.3 
Intermediate Follow-up  
Follow-up 1 at 1-Month (Day 30 +2 weeks) 
• Patients will complete their Patient One-Month Follow-up Questionnaire one-
month post baseline independent of an in-office visit. 
Follow-up 2 at 3-Months (Day 90 ± 2 weeks) 
• Patients will complete their Patient Three-Month Follow-up Questionnaire three- 
month post baseline independent of an in-office visit. 
7.4 
Final Study Follow-up 
Follow-up 3 at 6-Months (Day 180 ± 2 weeks) 
• Patients will complete their Patient Six-Month Follow-up Questionnaire six- 
months post baseline independent of an in-office visit. 
7.5 
OMS and DA Data Collection 
Middle of Enrollment Data Collection (when participating office has reached 
middle of patient enrollment) 
• OMS completes mid-data collection Doctor Questionnaire Regarding Use of 
Device. 
• DA completes mid-data collection Dental Assistant Questionnaire Regarding Use 
of Device. 

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End of Enrollment Data Collection (when participating office has completed 
patient enrollment) 
• OMS completes Doctor Questionnaire Regarding Use of Device at the end of 
patient enrollment. 
• DA completes Assistant Questionnaire Regarding Use of Device at the end of 
patient enrollment. 
7.6 
Withdrawal From Study 
• Record date and reason for withdrawal. 
• Consistent with Section 5.5.2, the only evaluations and data collection authorized 
will be information needed to address an unanticipated problem or other safety 
issue that may have led to his/her withdrawal from the study. 
7.7 
Unscheduled Visit 
For the purpose of the study, the patient does not need to see the surgeon after their 3rd 
molars are surgically removed. However, the patient may return to the OMS with 
concerns after surgical removal of their 3rd molars, including that they are having TMD 
pain. If the OMS determines that the concern is related only to 3rd molar removal, as 
described in their inter-office consent form for 3rd molar removal, then they will manage 
the patient for this. This includes the presence of TMD pain. If the OMS cannot 
determine if the concern is related to the study or believes it is related to the study, 
including use of the device, then they will inform the study coordinator who will discuss 
this event with the project PI. If they deem the event to be an adverse event related to 
the study, then it will be reported as described in Section 9.4. 
 

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8 STUDY PROCEDURES /EVALUATIONS 
8.1 
Study Procedures/Evaluations 
OMS and DAs – Training: 
• The study coordinator will visit each OMS office, review the study protocol 
and Manual for Surgeons and Dental Assistants and demonstrate how to use 
the device. OMS will be consented, when required by their IRB, at the time of 
study training. For those dental assistants who are willing to participate, 
consent will be obtained by the study coordinator at the time of training. 
 
• OMS and dental assistants will be formally and uniformly trained on site by 
the research coordinator in the dental office where the device will be 
employed prior to any procedure being performed by the OMS.  
 
Patients – Baseline: 
• Patients who have consented to study participation will provide contact 
information for study follow-up, demographic information and a baseline 
questionnaire, which will assess: 1) presence of any TMJ noise in past 3 
months, 2) presence of any jaw or temple pain, 3) current pain or discomfort 
associated with their wisdom teeth, 3) Presence of any oral habits, and 4) and 
general health status.  
 
• Patient will be randomized to: 1) Usual Care (UC) with a bite block and hand 
support of the jaw, or 2) Experimental Care (EC) with a bite block and the 
Restful Jaw device to support the jaw. 
 
• The device will be positioned (EC group only) and placed prior to the surgical 
procedure.  
 
OMS – Baseline: 
• The OMS will complete the Doctor Surgery Questionnaire for each of the 
consented patients in both the EC and UC groups after the surgery is 
completed. The target is to have the OMS complete the questionnaire on the 
day of the surgery. This questionnaire assesses: 1) TMD pain present in the 
last 3 months, 2) any TMJ noise present, 3) information on surgical 
procedures (e.g., teeth extracted, eruption status, presence of pericoronitis or 

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infection, reason for extraction, procedure employed for removal, estimate of 
time to extract the tooth and sequence of extractions). In addition, if the 
device was used, OMS will record whether the use of the device was 
discontinued during the surgery. 
 
Patient – Follow-up: 
• At 1, 3, and 6 months post-baseline, patients will complete follow-up 
questionnaires via an online questionnaire, which will assess: 1) presence of 
TMJ noise, 2) presence of jaw or temple pain including frequency, duration, 
intensity, 3) pain-related disability; 4) factors that increase or decrease their 
pain, and 4) whether the jaw pain is getting better, worse or staying the same.  
 
OMS and DAs – During data collection phase: 
• Both the OMS and any DA(s) who assisted in the procedure(s) and was 
responsible for using the device during the procedure, and consented to study 
participation, will each complete a questionnaire about their experience with 
the jaw support device once during recruitment and once at the end of 
recruitment. This questionnaire assesses; 1) use of the device compared to a 
dental assistant holding the jaw, 2) ease and stability of device use, 3) 
provider’s comfort and posture when using the device, 4) fit and manipulation 
of device before and during procedure, 5) ease of removal of device, 6) 
efficiency of procedure with device, 7) interference with working field when 
device is used, 8)airway support with device, 9) impact of dental assistant’s 
other duties with use of the device, 10) use of device in future, 11) thoughts 
on minimizing injury during procedures, 12) overall opinion of device and 13) 
any suggestions for modification of the device.   

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9 ASSESSMENT OF SAFETY  
9.1 
Specification of Safety Parameters 
Safety monitoring for this study will focus on unanticipated problems (UPs) involving 
risks to participants, including UPs that meet the definition of a serious adverse event 
(SAE). 
9.1.1 
Unanticipated Problems 
The Office for Human Research Protections (OHRP) considers UPs 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. 
Per the definition, only a subset of adverse events would be characterized as UPs. 
There are other types of incidents, experiences, and outcomes that are not considered 
adverse events (AEs), but are characterized as UPs (e.g., breach of confidentiality or 
other incidents involving social or economic harm). 
9.1.2 
Adverse Events 
An AE 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 participation in the 
research, whether or not considered related to the subject’s participation in the 
research. 
9.1.3 
Serious Adverse Events 
A SAE is one that meets one or more of the following criteria: 
• Results in death 

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• 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 
UPs will be recorded in the data collection system throughout the study.  
 
The PI will record all safety 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. Events will be followed for outcome information 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. 

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9.3.2 
Expectedness of AEs 
The PI will be responsible for determining whether an AE is expected or unexpected.  
An AE 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.   
9.3.3 
Severity of Event 
The following scale will be used to grade AEs: 
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 
9.4.1 
Unanticipated Problem Reporting to IRB and NIDCR 
Incidents or events that meet the OHRP criteria for UPs require the creation and 
completion of a UP report form.  OHRP recommends that investigators include the 
following information when reporting an adverse event, or any other incident, 
experience, or outcome as a UP to the IRB: 
• appropriate identifying information for the research protocol, such as the title, 
investigator’s name, and the IRB project number; 
• a detailed description of the AE, incident, experience, or outcome;  
• an explanation of the basis for determining that the AE, incident, experience, or 
outcome represents a UP;  
• a description of any changes to the protocol or other corrective actions that have 
been taken or are proposed in response to the UP. 
To satisfy the requirement for prompt reporting, UPs will be reported using the following 
timeline:   
• UPs 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.  

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• Any other UP will be reported to the IRB and to NIDCR within 2 weeks of the 
investigator becoming aware of the problem.  
• All UPs should be reported to appropriate institutional officials (as required by an 
institution’s written reporting procedures), and OHRP within one month of the 
IRB’s receipt of the report of the problem from the investigator. 
All UPs, including UPs that are SAEs, will be reported to NIDCR through the Rho 
Product Safety centralized reporting system: 
• Product Safety Fax Line (US):  1-888-746-3293 
• Product Safety Fax Line (International):  919-287-3998 
• 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):   
• US:  1-888-746-7231 
• International: 919-595-6486 
For any UP meeting the SAE criteria, the study surgeon will complete a Serious 
Adverse Event Form and will submit via fax or email within the timelines stated in 
Section 9.4.1 to NIDCR’s centralized safety system via Rho Product Safety. 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. 
9.4.2 
Reporting of SAEs and AEs to FDA 
The FDA determined that the RJ2 device is a non-significant risk (NSR) device, and 
thus the FDA determined that an IDE application is not required to be submitted or 
approved by the FDA. The FDA further stated that IRB approval of the investigation as a 
NSR study must be obtained. Therefore, reporting of SAEs and AEs will be to the 
University of Minnesota and HealthPartners IRBs. NIDCR will be copied on any reports.  
9.5 
Halting Rules 
For monitoring purposes, all AEs will be recorded throughout the trial, and the DCC will 
track all AEs, including all SAEs.   

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Decisions about stopping the trial will be made either by the investigators or by the 
NIDCR in consultation with the Medical Monitor. A formal stopping rule will use the 
group sequential method of Lan and DeMets, described in more detail in Section 12.3.2, 
applied separately to the two outcomes "Any AE" and "Any SAE", with P-values 
computed comparing the groups according to these outcomes using Fisher's exact test.  
As noted in 12.3.2 regarding efficacy, the exact sequential monitoring plan must be 
reviewed and approved by the NIDCR in consultation with the MMOR before any interim 
formal tests occur.   
The investigators can stop enrollment in the study at any time based on the occurrence 
of an AE or UP that they deem of sufficient concern.   
 

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10 STUDY OVERSIGHT 
NIDCR’s Medical Monitor reviewed this clinical trial based upon the trial study design 
described in the grant application and the non-significant risk (NSR) letter from the FDA 
that was provided by Dr. Schiffman to NIDCR. In addition to the PI’s responsibility for 
oversight, it has been determined that the trial will be overseen via Medical Monitor 
Oversight Reporting (MMOR). The MMOR will be requested at 6-month intervals during 
the data collection phase of the trial. NIDCR’s program officer, Dr. Dena Fischer, will 
provide more information about timelines for reporting after the clinical trial is activated. 
 

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11 CLINICAL SITE MONITORING 
Clinical site monitoring will not be conducted for this trial. The NIDCR reserves the right 
to conduct independent audits as necessary. 
Quality and integrity of study data and data collection methods will primarily involve 
quality management (QM) procedures to ensure adherence to human subject 
protections, including completeness of consenting procedures, and completeness and 
accuracy of data collection. These QM procedures are detailed in the protocol, Sections 
14 and 16, as well as the Manual of Procedures (MOP). 
 

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12 STATISTICAL CONSIDERATIONS 
12.1 
Study Hypotheses 
The risk of developing TMD pain in patients undergoing 3rd molars removal in the EC 
group will be statistically lower within the 6-month follow-up interval than in the UC 
group.  
12.2 
Sample Size Considerations 
This study’s sample size is based on the incidence of TMD pain following 3rd molar 
removal reported by Huang et al.3 That observational study reported that among 
patients undergoing 3rd molar removal, the incidence of jaw joint symptoms lasting 
more than 1 month was 34.3 per 100 person-years. Among those who did not have a 
3rd molar extraction, the rate was 8.8, for a relative risk of 3.8. The incidence of TMD 
pain reported by patients undergoing surgery was over 30%.  
Primary analysis.  We present a conservative power calculation that assumes we have 
a single binary outcome (TMD pain yes vs. no) instead of the three measures per 
person we will collect.  The calculations shown below assume two-sided tests and a 
false positive rate of 5% (alpha = 0.05).   
Table 1 shows that 132 patients per group 
gives 80% power to detect a conservative 
relative risk of 2.0. To estimate this, we 
considered a TMD pain incidence of 14% 
and alpha (type I error) 5%. Table 1's 
incidences and relative risks are based on 
data from Huang et al .3 Note that Huang et 
al. reported TMD pain incidence over 30%; 
the current study will have adequate power if the control group's TMD pain incidence is 
much lower.3 We will randomize 294 subjects into the study. Assuming 10% loss to 
follow-up (90% retention), the total sample size will be 264 (132 per group). The 
assumed retention of 90% is a conservative estimate based on Dr. Schiffman's 
experience in his previous RCT, where 98 of 106 (92%) TMD participants completed 
their 5-year follow-up visit. 20 Therefore, we anticipate, with patient incentives, that we 
will obtain 90% or more retention at the 6-month follow-up.  
 
Table 1. Sample size per group 
TMD pain 
incidence 
Relative risk 
2.0 
2.5 
3.0 
14% 
132 
65 
39 
20% 
81 
38 
22 
25% 
58 
26 
14 
30% 
42 
18 
9 

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12.3 
Planned Interim Analyses (if applicable) 
No interim analyses are planned.  
12.3.1 Safety Review 
If the device becomes loose or excessive force is placed on it during the procedure, 
there is a potential risk this could compromise the support of the patient’s jaw, resulting 
in jaw injury.  
While the proposed intervention does not include changes to practice that may harm 
patient participants, a special focus will be the safety of patients exposed to the study 
intervention.  
We have no specific outcome measures related to safety but participating surgeons will 
be required to record all AEs, including SAEs, according to procedures specified in 
Section 9.2 
 
12.3.2 Efficacy Review 
Interim analyses are not planned for this clinical trial. However, should it be determined 
that an interim analysis should occur, the exact sequential monitoring plan must be 
reviewed and approved by the NIDCR in consultation with the MMOR before any interim 
formal tests occur. For the repeated tests of efficacy, we will use the group sequential 
method of Lan and DeMets 21 for which neither the number of tests nor the increments 
between tests needs to be pre-specified. The approach requires specification of a so-
called alpha spending function, chosen to give a low probability of stopping in the early 
formal analyses.  We will propose the well-known O'Brien-Fleming spending function 
with total alpha 0.05.   
12.4 
Final Analysis Plan 
All analyses will be by intention-to-treat, with participants included in the group (UC or 
EC) to which they were randomly assigned.   
Primary analysis. The primary outcome is incidence of TMD pain within a 6-month 
follow-up period (a binary dependent variable). The incidence of TMD pain post-
surgically will be compared between UC and EC groups.   This primary TMD outcome is 
deemed to have occurred if the patient's self report in the Patient 1-, 3- and 6-month 
Follow-up Questionnaires endorses either or both of the following questions: Pain in jaw 
with wide opening, or pain in temples, jaw joints or jaw muscles.3 The primary analysis 
will include all available follow-up measures (1, 3, and 6 months) for each participant to 

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estimate incident TMD pain. The UC and EC groups will be compared using an analysis 
that has the form of logistic regression, but which accounts for correlation of visits within 
participants using generalized estimating equations (GEE) with each participant being a 
cluster. The analysis will include group (UC vs. EC), which tests whether the two groups 
differ in overall frequency of TMD pain; time (1, 3, and 6 months, as a categorical 
factor); and their interaction (i.e., the time-by-group interaction), which tests for different 
patterns of change over time in frequency of TMD pain.  
In the event of noteworthy amounts of missing data (e.g., patients lost to follow-up or 
questionnaires not completed), we will check the primary analysis by using standard 
multiple imputation methods, as implemented in the most recent version of the SAS 
software (SAS Institute Inc., Cary NC, v. 9.4 or higher), to multiply impute missing data 
and perform tests.  Specifically, we will use SAS's FCS method to create 20 "complete" 
datasets and otherwise use the defaults in SAS's procedures.   
Secondary analysis. The primary analysis will not include adjusters, as the 
randomization should balance the groups. As a check on this, an adjusted version of the 
primary analysis will include adjusters differing substantially between the two 
randomized groups, selected from the list of potential adjusters given below (see 
"Potential Adjusters", below).  
Other secondary analyses are as follows: 
1. The incidence of TMD pain, as measured with the validated TMD Pain Screener 
Questionnaire22 (binary dependent variable), will be compared between the UC and 
EC groups within a 6-month follow-up period based on patients’ self report in the 
Patient 1-, 3- and 6-month Follow-up Questionnaire. These analyses will have the 
same form as the primary analysis.   
2. TMD pain intensity, as measured with the validated Characteristic Pain Intensity 
(CPI) within a 6-month follow-up period (treated as a continuous measure), will be 
compared between the UC and EC groups based on patients’ self report in the 
Patient 1-, 3- and 6-month Follow-up Questionnaire. Unadjusted and adjusted 
analyses (using adjusters selected as described above) will be performed using 
GEE as in the primary analysis.   
3. Baseline characteristics, specifically all of the potential adjusters listed below (see 
"Potential Adjusters", below), will be compared between the UC and EC groups.  
Analyses will use t-tests, possibly after transforming the measure because it has a 
skewed distribution, Chi-squared test and Fisher's Exact Test. 

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4. The UC and EC groups will be compared for TMJ noise, pain characteristics (e.g., 
location in temple or jaw, and occurrence with wide opening of mouth) and change in 
jaw pain since it started, within a 6-month follow-up period based on patients’ self 
report in the Patient 1-, 3- and 6-month Follow-up Questionnaire.  These analyses 
will have the same form as the primary analysis. 
5. A descriptive summary of the experiences of surgeons and dental assistants with 
the new device at mid-way through recruitment of patients and at the end of 
recruitment based on their self report in the Doctor Questionnaire Regarding Use of 
the Device and Dental Assistant Questionnaire Regarding Use of the Device, 
respectively,  
All analyses will use SAS version 9.4 or later (SAS Institute Inc., Cary, NC). All tests will 
use a significance threshold of 0.05 (2-tailed).  
Potential adjusters:  The following characteristics will be compared between the UC and 
EC groups as potential adjusters:  
 
• Patient demographics 
• Baseline patient-reported symptoms (e.g., TMJ noise, pain or discomfort around 
wisdom teeth, frequency of oral habits as measured with the Oral Behaviors 
Checklist (OBC), and health status; see Patient Baseline Questionnaire. 
• Baseline clinical findings by the surgeon (e.g., TMJ noise, eruption status, 
pericoronitis, soft-tissue infection, reason for extraction, difficulty of extraction, 
length and duration of the surgery, and pain or discomfort around third molars); 
see Doctor Surgery Questionnaire.  
• Procedural characteristics, identified by the surgeon (e.g., type of extraction, 
amount of bone removal, use of grafting); see Doctor Surgery Questionnaire.  
 

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13 SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/DOCUMENTS 
Each participating office will maintain appropriate medical and research records for this 
study, in compliance with ICH E6, Section 4.9 and regulatory and institutional 
requirements for the protection of confidentiality of subjects.  Study staff will permit 
authorized representatives of NIDCR and regulatory agencies to examine (and when 
required by applicable law, to copy) research records for the purposes of quality 
assurance reviews, audits, and evaluation of the study safety, progress and data 
validity.   
The following will be considered source documents maintained by the DCC via 
electronic data management system or paper:  
• Surgeon log of eligible and ineligible patients who did not enter study 
• OMS consent (if applicable) 
• Dental Assistant consent 
• Patient consent 
• Patient HIPAA 
• Patient contact information 
• Patient demographics information 
• Patient Baseline Questionnaire 
• Patient One-Month Follow-up Questionnaire 
• Patient Three-Month Follow-up Questionnaire 
• Patient Six-Month Follow-up Questionnaire 
• Screening Questionnaire 
• Doctor Surgery Questionnaire 
• Doctor Questionnaire Regarding Use of Device 
• Dental Assistant Questionnaire Regarding Use of Device 
 

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14 QUALITY CONTROL AND QUALITY ASSURANCE 
Data collection for this trial will occur via an electronic data capture (EDC) system that 
employs on-screen data validation and alerts. In addition, key data elements may need 
to be double entered, or reviewed and affirmed, to confirm correct data entry.  
Prior to EDC system development, the system specifications will be carefully evaluated 
by the study team, DCC, and other stakeholders as necessary (e.g., NIDCR program 
official). Prior to study launch, the EDC system will undergo user acceptance testing, 
which will be documented in the Test Summary Report. Further, a data management 
plan developed by the DCC details quality management procedures including the 
development of data quality checks in the database system and processes related to 
quality review and management of data entered.  
The architecture of the EDC system and rigorous testing of it prior to study launch 
provide built-in procedures for maintaining data quality. Additionally, the DCC will 
produce reports, periodic (at least monthly) and real-time, to monitor data quality. For 
example, this includes monitoring to ensure present and valid entries in given data 
fields. Report design will consider available resources in the NIDCR Toolkit for Clinical 
Researchers (e.g., the NIDCR Quality Management Subject Participant Data Review 
Tool).  
 

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15 ETHICS/PROTECTION OF HUMAN SUBJECTS 
15.1 
Ethical Standard 
The PI 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.  
15.2 
Institutional Review Board 
The protocol, informed consent form(s), recruitment materials, and all subject materials 
will be submitted to the IRB at the University of Minnesota and HealthPartners for 
review and approval.  Approval of both the protocol and the consent form must be 
obtained before any patient 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 
patients and their families, if applicable.  A consent form describing in detail the study 
procedures and risks will be given to the patient. Consent forms will be IRB-approved, 
and the patient is required to read and review the document or have the document read 
to him or her.  The OMS and staff, with appropriate training, will explain the research 
study to the patient and answer any questions that may arise. The patient will sign the 
informed consent document prior to any study-related assessments or procedures.  
Patients 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.  A copy of the informed consent document will be 
given to patients for their records.  The rights and welfare of the patients 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. When consenting the OMS 
(when applicable) and dental assistants, they will be informed that their participation is 
voluntary and employment is not contingent on participation.  
The consent process will be documented in the clinical or research record.   

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15.4 
Exclusion of Women, Minorities, and Children (Special Populations) 
Racial and ethnic minorities will be included in the study at least proportional to the 
composition in the dentist’s patient population. Individuals of any sex or racial/ethnic 
group may participate.  Patients 18 – 30 years of age will be included in this study. 
15.5 
Subject Confidentiality 
Patient confidentiality is strictly held in trust by the investigators, study staff, and the 
sponsor(s) and their agents.  This confidentiality is extended to any study information 
relating to patients. 
The study protocol, documentation, data, and all other information generated will be 
held in strict confidence.  No information concerning the study or the data will be 
released to any unauthorized third party without prior written approval of the sponsor. 
The study monitor or other authorized representatives of the sponsor may inspect all 
study documents and records required to be maintained by the investigator, including 
but not limited to, dental records (office, clinic, or hospital) for the study patients.  The 
clinical study site will permit access to such records. 
The security features of the data capture system will enforce strict limits on data access 
for various members on the team. The system will be configured to give study personnel 
“minimum necessary” access to data given the role of the person in the project. 
Certificate of Confidentiality: To further protect the privacy of study participants, the NIH 
will issue a Certificate of Confidentiality. This certificate protects identifiable research 
information from forced disclosure. It allows the investigator and others who have 
access to research records to refuse to disclose identifying information on research 
participation in any civil, civil, criminal, administrative, legislative, or other proceeding, 
whether at the federal, state, or local level. By protecting researchers and institutions 
from being compelled to disclose information that would identify research subjects, 
Certificates of Confidentiality help achieve the research objectives and promote 
participation in studies by helping assure confidentiality and privacy to subjects. 
15.6 
Future Use of Stored Specimens and Other Identifiable Data 
No identifiable data will be maintained after this study beyond what is required by the 
FDA.  
 

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16 DATA HANDLING AND RECORD KEEPING 
The study team is responsible for ensuring the accuracy, completeness, legibility, and 
timeliness of the data reported.  All source documents should be completed in a manner 
to ensure accurate interpretation of data. The investigators will maintain adequate case 
histories of study subjects, including accurate case report forms (CRFs) and source 
documentation. 
Only study personnel (i.e., PI, Co-Investigator’s, study statistician, study coordinator, 
and DCC personnel) will have access to the study data elements in the study database 
as described in Section 16.3 Types of Data. All study personnel will have completed the 
human subjects’ protection training elements as required by their IRB. 
16.1 
Data Management Responsibilities 
Data collection and accurate documentation are the responsibility of the study staff 
under the supervision of the PI.  All source documents must be reviewed by the study 
team, who will ensure that they are accurate and complete. The DCC will provide 
support and processes to allow for accuracy and completeness of data collected. AEs 
must be recorded by the OMS and staff, and all UPs must be reviewed by the OMS and 
staff.   
The DCC will be responsible for developing, monitoring, maintaining, locking, and 
closing databases capturing study data. In collaboration with the study team, the DCC 
will conduct quality control and quality assurance measures to monitor and maintain 
study data quality. Participating OMS and office staff will be trained on the EDC system 
by the study coordinator prior to patient enrollment.  
 
16.2 
Data Capture Methods 
This study will utilize a centralized electronic data capture (EDC) system, developed 
and maintained by the DCC, for practitioners and patients to enter data onto web-based 
CRFs. The EDC system employs on-screen data validation utilizing univariate and 
multivariate alerts, as needed, including valid-value, valid-range, and missing-value 
alerts. These validations will prevent users from continuing with study data collection if 
invalid or missing data entries are provided.  
The EDC system provides comprehensive and extensible support for both 
Authentication and Authorization through role-based access control. Access to the EDC 
system will be available to specific study team members, site study staff and DCC study 
staff. Staff eligible to access the web application will be assigned an application-specific 

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user account and will create a unique password to access the application. All access to 
the systems is based on authorization by the PI and/or the DCC manager or their 
delegates. Access to sections within the EDC application will be role-based, thereby 
limiting the user’s access only to pertinent information for their role with patients at their 
assigned study site. 
Practitioner- and patient-entered information on CRFs through the application is 
transmitted to and stored in the EDC system essentially in real time. While practitioners 
can access the web application, and practitioners and patients can access web-based 
CRFs, only key study and DCC staff will have direct access to core EDC system and its 
data. Therefore, each user of the EDC system is permitted access to only the minimum 
necessary data required to fulfill their role in the study. 
16.3 
Types of Data 
The OMS or their DA will complete the: 
• Screening Questionnaire 
• Doctor Surgery Questionnaire 
• Doctor Questionnaire Regarding Use of Device 
• Dental Assistant Questionnaire Regarding Use of Device 
The patients will complete: 
• Patient Contact Information 
• Patient Demographics 
• Patient Baseline Questionnaire 
• Patient 1-, 3- and 6-Month Follow-up Questionnaires.  
16.4 
Schedule and Content of Reports 
Reports to monitor enrollment will be produced at least monthly during the participant 
enrollment period, until enrollment targets are attained and enrollment is closed and will 
be provided to the PI, study team and NIDCR. These reports will contain accrual 
information in aggregate and by important data variables of interest. These reports will 
also contain separate sections for each site and the surgeons in each site. 
Reports will also be developed to describe protocol deviations, UPs, quality 
management/monitoring and identified study challenges and solutions.  

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The MMOR will be produced approximately every six months after enrollment begins until 
data collection is completed. The exact timeline for the report will be decided by NIDCR. 
The purpose is to review cumulative enrollment data, participant safety and protocol 
adherence, and data integrity. The progress report will provide study site status, 
enrollment and retention status, status of outcome measures, and major protocol changes 
since last reported, protocol deviations, UPs, quality management/monitoring and 
identified study challenges and solutions.  
Reports to assess study retention will be produced at least monthly until data collection 
is complete and will be provided to the PI, study team and NIDCR. These reports will 
provide ongoing monitoring of participant retention. Retention data will be closely 
monitored overall, by region, and by practice, and futility analyses will be performed as 
needed. For patients who are lost to follow-up, reports to assess reasons for loss will be 
produced following the data collection period for each study follow-up assessment. 
The procedure for locking the database prior to final analysis will be detailed in the study 
Data Management Plan. Briefly, the data will be locked and final datasets will be 
generated at the end of the study.  Prior to locking the database, the DCC Data Manager 
or designee will ensure all data is complete and clean and will obtain approval from the 
PI to proceed with the data lock. The date and time of database lock will be documented.     
16.5 
Study Records Retention 
Study records will be maintained for at least 3 years from the date that the grant federal 
financial report (FFR) is submitted to the NIH. 
Study documents should be retained for a minimum of 3 years after the last approval of 
a marketing application in an ICH region and until there are no pending or contemplated 
marketing applications in an ICH region or until at least 2 years have elapsed since the 
formal discontinuation of clinical development of the investigational product.  These 
documents should be retained for a longer period, however, if required by FDA or local 
regulations.  No records will be destroyed without the written consent of the sponsor, if 
applicable.  It is the responsibility of the sponsor to inform the investigator when these 
documents no longer need to be retained. 
16.6 
Protocol Deviations 
A protocol deviation is any noncompliance with the clinical study protocol, Good Clinical 
Practice, or Manual for Surgeons and Dental Assistants requirements.  The 
noncompliance may be on the part of the patient, the investigator, or study staff.  As a 
result of deviations, corrective actions may be developed by the study staff and should 
be implemented promptly. 

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These practices are consistent with investigator and sponsor obligations in ICH E6: 
• Compliance with Protocol, Sections 4.5.1, 4.5.2, 4.5.3, and 4.5.4. 
• Quality Assurance and Quality Control, Section 5.1.1 
• Noncompliance, Sections 5.20.1 and 5.20.2. 
All deviations from the protocol must be addressed in study subject source documents 
and reported to the local IRB(s), according to their requirements. Deviations must also 
be reported to NIDCR at the timeframe for which the deviations are reported to the local 
IRB(s).   
 
 
 

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17 PUBLICATION/DATA SHARING POLICY 
This study will comply with the NIH Public Access Policy, which ensures that the public 
has access to the published results of NIH funded research. It requires scientists to 
submit final peer-reviewed journal manuscripts that arise from NIH funds to the digital 
archive PubMed Central upon acceptance for publication. 
The International Committee of Medical Journal Editors (ICMJE) member journals have 
adopted a clinical trials registration policy as a condition for publication.  The ICMJE 
defines a clinical trial as any research project that prospectively assigns human subjects 
to intervention or concurrent comparison or control groups to study the cause-and-effect 
relationship between a medical intervention and a health outcome.  Medical 
interventions include drugs, surgical procedures, devices, behavioral treatments, 
process-of-care changes, and the like.  Health outcomes include any biomedical or 
health-related measures obtained in patients or participants, including pharmacokinetic 
measures and adverse events. The ICMJE policy requires that all clinical trials be 
registered in a public trials registry such as ClinicalTrials.gov, which is sponsored by the 
National Library of Medicine.  Other biomedical journals are considering adopting similar 
policies. For interventional clinical trials performed under NIDCR grants and cooperative 
agreements, it is the grantee’s responsibility to register the trial in an acceptable 
registry, so the research results may be considered for publication in ICMJE member 
journals.  The ICMJE does not review specific studies to determine whether registration 
is necessary; instead, the committee recommends that researchers who have questions 
about the need to register err on the side of registration or consult the editorial office of 
the journal in which they wish to publish. 
U.S. Public Law 110-85 (Food and Drug Administration Amendments Act of 2007 or 
FDAAA), Title VIII, Section 801 mandates that a "responsible party" (i.e., the sponsor or 
designated principal investigator) register and report results of certain "applicable 
clinical trials."  
Trials of Devices: Controlled trials with health outcomes of a product subject to FDA 
regulation (other than small feasibility studies) and pediatric postmarket surveillance 
studies. 
NIH grantees must take specific steps to ensure compliance with NIH implementation of 
FDAAA. 

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18 LITERATURE REFERENCES 
1. Friedman JW. The prophylactic extraction of third molars: A public health hazard. Am 
J Public Health. 2007;97(9):1554-1559. 
 
2. Huang GJ, Rue TC. Third-molar extraction as a risk factor for temporomandibular 
disorder. J Am Dent Assoc. 2006;137(11):1547-1554. 
 
3. Huang GJ, Cunha-Cruz J, Rothen M, et al. A prospective study of clinical outcomes 
related to third molar removal or retention. Am J Public Health. 2014;104(4):728-734. 
 
4. Huang GJ, Drangsholt MT, Rue TC, Cruikshank DC, Hobson KA. Age and third molar 
extraction as risk factors for temporomandibular disorder. J Dental Res. 2008;87(3):283-
287. 
 
5. Huang GJ, LeResche L, Critchlow CW, Martin MD, Drangsholt MT. Risk factors for 
diagnostic subgroups of painful temporomandibular disorders (TMD). J Dent Res. 
2002;81(4):284-288. 
 
6. Juhl GI, Jensen TS, Norholt SE, Svensson P. Incidence of symptoms and signs of 
TMD following third molar surgery: A controlled, prospective study. J Oral Rehabil. 
2009;36(3):199-209. 
 
7. Akhter R, Hassan NM, Ohkubo R, Tsukazaki T, Aida J, Morita M. The relationship 
between jaw injury, third molar removal, and orthodontic treatment and TMD symptoms 
in university students in japan. J Orofac Pain. 2008;22(1):50-56. 
 
8. Velly AM, Gornitsky M, Philippe P. Contributing factors to chronic myofascial pain: A 
case-control study. Pain. 2003;104(3):491-499. 
 
9. Okeson JP. Bell's orofacial pains: The clinical management of orofacial pain, sixth 
edition. Vol 6. Illinois: Quintessence Publishing; 2005. 
 
10. Pullinger AG, Monteiro AA. History factors associated with symptoms of 
temporomandibular disorders. J Oral Rehabil. 1988;15(2):117-124. 
 
11. LeResche L, Mancl LA, Drangsholt M, Huang G, Von Korff M. Predictors of onset of 
facial pain and temporomandibular disorders in early adolescence. Pain. 
2007;129(3):269-278. 

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12. Plesh O, Gansky SA, Curtis DA, Pogrel MA. The relationship between chronic facial 
pain and a history of trauma and surgery. Oral Surg Oral Med Oral Pathol Oral Radiol 
Endod. 1999;88(1):16-21. 
 
13. Butler JH, Folke LE, Bandt CL. A descriptive survey of signs and symptoms 
associated with the myofascial pain-dysfunction syndrome. J Am Dent Assoc. 
1975;90(3):635-639. 
 
14. Fricton JR, Kroening R, Haley D, Siegert R. Myofascial pain syndrome of the head 
and neck: A review of clinical characteristics of 164 patients. Oral Surg Oral Med Oral 
Pathol. 1985;60(6):615-623. 
 
15. Sahebi S, Moazami F, Afsa M, Nabavi Zade MR. Effect of lengthy root canal therapy 
sessions on temporomandibular joint and masticatory muscles. J Dent Res Dent Clin 
Dent Prospects. 2010;4(3):95-97. 
 
16. Humphrey SP, Lindroth JE, Carlson CR. Routine dental care in patients with 
temporomandibular disorders. J Orofac Pain. 2002;16(2):129-134. 
 
17. American Association of Oral and Maxillofacial Surgeons. Parameters of care: 
Clinical and practice guidelines for oral and maxillofacial surgeons. 2012. Available at 
http://www.mfch.cz/doc/ParCare2012Complete.pdf  
 
18. Fernandes P, Velly AM, Anderson GC. A randomized controlled clinical trial 
evaluating the effectiveness of an external mandibular support device during dental care 
for patients with temporomandibular disorders. Gen Dent. 2013;61(6):26-31. 
 
19. Zucuskie T. A controlled clinical trial of the usefulness of an external mandibular 
support device during routine dental care. Minneapolis: University of Minnesota; 1996. 
 
20. Schiffman EL, Look JO, Hodges JS, et al. Randomized effectiveness study of four 
therapeutic strategies for TMJ closed lock. Journal of Dental Research. 2007;86(1):58-
63. 
21. Lan KKG, DeMets DL. Design and analysis of group sequential tests based on the 
type 1 error spending rate function. Biometrika. 1987;74:149- 154. 
 
22. Gonzalez YM, Schiffman E, Gordon SM, et al. Development of a brief and effective 
temporomandibular disorder pain screening questionnaire: Reliability and validity. J Am 
Dent Assoc. 2011;142(10):1183-1191.  

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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. 
• Manual for Surgeons and Dental Assistants 
• Case report forms 
• Quality Management Plan  
• Data Management Plan 
 

The Restful Jaw Device: A New Way to Support and Protect the Jaw 
Version 5.0 
During Third Molar Extractions  
August 06, 2020 
 ________________________________________________________________________________________________________  
 
 _____________________________________________________________________________________________  
Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
56 
 
APPENDICES 
These documents are officially affiliated with the protocol and will be submitted to the 
IRB as a part of the protocol. As such, changes to these items require a protocol 
amendment.  
• Appendix 1: Schedule of Events 
• Appendix 2: Consent Form(s) 
 

The Restful Jaw Device: A New Way to Support and Protect the Jaw 
Version 5.0 
During Third Molar Extractions  
August 06, 2020 
 ________________________________________________________________________________________________________  
 
 _____________________________________________________________________________________________  
Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
57 
 
APPENDIX A: SCHEDULE OF EVENTS 
 
Procedures 
Oral surgery screening  
Baseline 
1-month follow-up 
+2 weeks 
3-month follow-up 
± 2 weeks 
6-month follow-up 
± 2 weeks 
Middle of data collection 
device evaluation   
End of data collection 
device evaluation   
Assessment of Eligibility 
X 
X 
 
 
 
 
 
Administration of consent 
 
X 
 
 
 
 
 
Patient contact information  
 
X 
 
 
 
 
 
Patient demographics  
 
X 
 
 
 
 
 
Patient Baseline Questionnaire  
 
X 
 
 
 
 
 
Randomization 
 
X 
 
 
 
 
 
Oral Exam (not a study directed 
procedure) 
 
X 
 
 
 
 
 
Treatment administered by the OMS 
(not a study directed procedure) 
 
X 
 
 
 
 
 
Doctor Baseline Questionnaire 
 
X 
 
 
 
 
 
Patient Follow-up Questionnaires 
 
 
X 
X 
X 
 
 
OMS & DA middle of data collection 
evaluation of device questionnaire 
 
 
 
 
 
X 
 
OMS & DA end of data collection 
evaluation of device questionnaire 
 
 
 
 
 
 
X