The ARMOR Trial: Commensal Oral Microbiota as a Trigger of Oral Mucositis Severity
Phase: NA
Conditions: Head and Neck Cancer, Oral Mucositis
Sponsor: University of Pennsylvania

 ________________________________________________________________________________________________________  
IRB# 832750 UPCC# 06319 
 
  
The ARMOR Trial 
 Commensal Oral Microbiota as a Trigger of Oral 
Mucositis Severity 
 
 
 
 
NIDCR Protocol Number: 18-042-E 
NIDCR Grant Number:  1U01DE027637 
UPenn IRB Number: 832750 
 
Principal Investigator:  Patricia Corby, DDS, MS 
Sub-Investigator: Alexander Lin, MD 
 
NIDCR Program Official:  Dena Fischer, DDS, MSD, MS 
NIDCR Medical Monitor: Kevin McBryde, MD 
 
4 January 2022 
Version 11 
 
 
 
 
 
 

The ARMOR Trial: Commensal Oral Microbiota as a Trigger of Oral Mucositis Severity Version 11.0 Protocol 832750
 
4 January 2022 
 ___________________________________________________________________________________________  
Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
1 
 
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 ARMOR Trial: Commensal Oral Microbiota as a Trigger of Oral Mucositis Severity Version 11.0 Protocol 832750
 
4 January 2022 
 ___________________________________________________________________________________________  
Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
2 
 
 
 
 
SIGNATURE PAGE 
 
The signature below constitutes the approval of this protocol and the attachments 
provides the necessary assurances that this trial will be conducted according to all 
stipulations of the protocol, including all statements regarding confidentiality, and 
according to local legal and regulatory requirements and applicable US federal 
regulations and ICH guidelines. 
 
 
Principal Investigator or Clinical Site Investigator: 
 
 
 
Signed: 
 
Date: January 19, 2022 
 
Name: Dr. Patricia Corby 
 
Title: Principal Investigator 
 
Signed: 
 
 
 
 
Date: 
 
 
 
January 19, 2022 
 
Name: Dr. Alexander Lin 
 
Title: Co-Principal Investigator 
 
 
 

The ARMOR Trial: Commensal Oral Microbiota as a Trigger of Oral Mucositis Severity Version 11.0 Protocol 832750
 
4 January 2022 
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Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
3 
TABLE OF CONTENTS 
PAGE 
SIGNATURE PAGE ........................................................................................................................................ 2 
TABLE OF CONTENTS .................................................................................................................................. 3 
LIST OF ABBREVIATIONS ............................................................................................................................ 6 
PROTOCOL SUMMARY ................................................................................................................................ 8 
1. 
KEY ROLES AND CONTACT INFORMATION ................................................................ 12 
2. 
BACKGROUND AND SCIENTIFIC RATIONALE ............................................................ 13 
2.1. 
BACKGROUND INFORMATION ....................................................................................... 13 
2.2. 
PRELIMINARY DATA .................................................................................................... 13 
2.3. 
RATIONALE ................................................................................................................ 15 
2.4. 
STUDY POTENTIAL RISKS AND BENEFITS ..................................................................... 16 
2.4.1. POTENTIAL RISKS ....................................................................................................... 16 
2.4.2. POTENTIAL BENEFITS ................................................................................................. 16 
3. 
OBJECTIVES .................................................................................................................. 17 
3.1. 
PRIMARY OBJECTIVE .................................................................................................. 17 
3.2. 
SECONDARY OBJECTIVES ........................................................................................... 17 
3.3. 
EXPLORATORY OBJECTIVE .......................................................................................... 17 
3.4. 
STUDY OUTCOME MEASURES ..................................................................................... 17 
3.4.1. PRIMARY OUTCOME ................................................................................................... 17 
3.4.2. SECONDARY OUTCOMES ............................................................................................ 18 
4. 
STUDY DESIGN .............................................................................................................. 20 
5. 
STUDY ENROLLMENT AND WITHDRAWAL ................................................................. 21 
5.1. 
SUBJECT INCLUSION CRITERIA .................................................................................... 21 
5.2. 
SUBJECT EXCLUSION CRITERIA ................................................................................... 21 
5.3. 
STRATEGIES FOR RECRUITMENT AND RETENTION ........................................................ 22 
DSMB RECOMMENDATIONS REGARDING ENROLLMENT (12/10/2020): ....................................... 25 
5.4. 
TREATMENT ASSIGNMENT AND RANDOMIZATION PROCEDURES ..................................... 26 
5.5. 
BLINDING PROCEDURES ............................................................................................. 26 
5.6. 
SUBJECT WITHDRAWAL .............................................................................................. 26 
5.6.1. HANDLING OF SUBJECT WITHDRAWALS OR SUBJECT DISCONTINUATION OF STUDY 
INTERVENTION ....................................................................................................................... 26 
5.7. 
PREMATURE TERMINATION OR SUSPENSION OF STUDY ................................................ 27 
6. 
STUDY INTERVENTION .................................................................................................. 28 
6.1. 
STUDY PROCEDURAL INTERVENTION DESCRIPTION ...................................................... 28 
6.2. 
ADMINISTRATION OF PROCEDURAL INTERVENTION ....................................................... 28 
6.3. 
PROCEDURES FOR TRAINING OF CLINICIANS ON PROCEDURAL INTERVENTION AND 
MONITORING TREATMENT FIDELITY ......................................................................................... 29 
6.4. 
ASSESSMENT OF SUBJECT COMPLIANCE WITH STUDY PROCEDURAL INTERVENTION....... 29 
6.5. 
CONCOMITANT MEDICATIONS/TREATMENTS AND REFERRALS FOR CARE ....................... 29 
7. 
STUDY SCHEDULE ........................................................................................................ 31 
7.1. 
SCREENING AND BASELINE (SCREENING: DAY -60 TO -1; BASELINE: DAY -21 TO -1 
RELATIVE TO INTERVENTION VISIT 1) ....................................................................................... 31 
7.2. 
INTERVENTION VISITS (VISITS 1, 3, 5, 7, 9) ................................................................... 32 
7.3. 
INTERVENTION VISITS (VISITS 2, 4, 6, 8) ...................................................................... 33 
7.4. 
POST-INTERVENTION VISIT – FOLLOW UP VISIT (DAY 86+/- 7 DAYS) .............................. 34 
7.5. 
POST-INTERVENTION VISIT – FINAL STUDY VISIT (DAY 140 +/- 21 DAYS) ....................... 34 
7.6. 
CLINICAL FOLLOW-UP ................................................................................................. 35 

The ARMOR Trial: Commensal Oral Microbiota as a Trigger of Oral Mucositis Severity Version 11.0 Protocol 832750
 
4 January 2022 
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Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
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7.7. 
WITHDRAWAL VISIT .................................................................................................... 35 
7.8. 
UNSCHEDULED VISIT .................................................................................................. 35 
7.9. 
MISSED VISIT ............................................................................................................. 35 
8. 
OVERVIEW OF STUDY PROCEDURES/EVALUATIONS ............................................... 37 
8.1. 
STUDY PROCEDURES/EVALUATIONS ............................................................................ 37 
8.2. 
QUESTIONNAIRES ....................................................................................................... 38 
8.3. 
BLOOD DRAW ............................................................................................................ 38 
8.4. 
LABORATORY PROCEDURES/EVALUATIONS .................................................................. 38 
8.4.1. SPECIAL ASSAYS OR PROCEDURES ............................................................................. 38 
8.4.2. SPECIMEN PREPARATION, HANDLING, AND STORAGE ................................................... 39 
8.4.3. SPECIMEN SHIPMENT ................................................................................................. 39 
8.5. 
BIOBANKING FOR FUTURE RESEARCH .......................................................................... 39 
8.5.1. STORAGE AND CONFIDENTIALITY OF SAMPLES ............................................................. 39 
8.5.2. WITHDRAWAL OF SAMPLES ......................................................................................... 40 
9. 
ASSESSMENT OF SAFETY ............................................................................................ 41 
9.1. 
SPECIFICATION OF SAFETY PARAMETERS .................................................................... 41 
9.1.1. UNANTICIPATED PROBLEMS ........................................................................................ 41 
9.1.2. ADVERSE EVENTS ...................................................................................................... 41 
9.1.3. SERIOUS ADVERSE EVENTS ........................................................................................ 42 
9.2. 
TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-UP ................... 42 
9.3. 
CHARACTERISTICS OF AN ADVERSE EVENT .................................................................. 42 
9.3.1. RELATIONSHIP TO STUDY INTERVENTION ..................................................................... 42 
9.3.2. EXPECTEDNESS OF SAES ........................................................................................... 43 
9.3.3. SEVERITY OF EVENT ................................................................................................... 43 
9.4. 
UNANTICIPATED PROBLEM REPORTING ........................................................................ 43 
9.5. 
SERIOUS ADVERSE EVENT REPORTING ....................................................................... 44 
9.6. 
HALTING RULES ......................................................................................................... 44 
10. STUDY OVERSIGHT ....................................................................................................... 45 
11. CLINICAL SITE MONITORING ........................................................................................ 46 
12. STATISTICAL CONSIDERATIONS ................................................................................. 47 
12.1. STUDY HYPOTHESES .................................................................................................. 47 
12.2. SAMPLE SIZE CONSIDERATIONS .................................................................................. 47 
12.3. PLANNED INTERIM ANALYSES ...................................................................................... 48 
12.3.1. SAFETY REVIEW ......................................................................................................... 48 
12.4. ANALYSIS PLAN .......................................................................................................... 49 
13. SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/DOCUMENTS ................. 51 
14. QUALITY CONTROL AND QUALITY ASSURANCE ...................................................... 52 
14.1. STAFF TRAINING......................................................................................................... 52 
14.2. VISIT-LEVEL QUALITY CONTROL .................................................................................. 52 
14.3. CASE REPORT FORMS ................................................................................................ 53 
14.4. BIOSPECIMENS ........................................................................................................... 53 
14.5. SEMIANNUAL QUALITY CONTROL ................................................................................. 53 
15. ETHICS/PROTECTION OF HUMAN SUBJECTS ............................................................ 55 
15.1. ETHICAL STANDARD ................................................................................................... 55 
15.2. INSTITUTIONAL REVIEW BOARD ................................................................................... 55 
15.3. INFORMED CONSENT PROCESS ................................................................................... 55 
15.4. EXCLUSION OF WOMEN, MINORITIES, AND CHILDREN (SPECIAL POPULATIONS) .............. 55 

The ARMOR Trial: Commensal Oral Microbiota as a Trigger of Oral Mucositis Severity Version 11.0 Protocol 832750
 
4 January 2022 
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Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
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15.5. SUBJECT CONFIDENTIALITY ......................................................................................... 55 
15.6. CERTIFICATE OF CONFIDENTIALITY .............................................................................. 57 
15.7. FUTURE USE OF STORED SPECIMENS AND OTHER IDENTIFIABLE DATA .......................... 57 
16. DATA HANDLING AND RECORD KEEPING .................................................................. 58 
16.1. DATA MANAGEMENT RESPONSIBILITIES ....................................................................... 58 
16.2. DATA CAPTURE METHODS .......................................................................................... 58 
16.3. TYPES OF DATA ......................................................................................................... 58 
16.4. SCHEDULE AND CONTENT OF REPORTS ....................................................................... 58 
16.5. STUDY RECORDS RETENTION ..................................................................................... 59 
16.6. PROTOCOL DEVIATIONS .............................................................................................. 59 
16.7. PUBLICATION/DATA SHARING POLICY ........................................................................... 59 
17. LITERATURE REFERENCES ......................................................................................... 61 
APPENDICES ............................................................................................................................................... 64 
 
 
 

The ARMOR Trial: Commensal Oral Microbiota as a Trigger of Oral Mucositis Severity Version 11.0 Protocol 832750
 
4 January 2022 
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Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
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LIST OF ABBREVIATIONS 
ADL 
Activities of Daily Living 
AE 
Adverse Event/Adverse Experience 
AJCC - TNM 
American Joint Committee on Cancer - TNM Classification of Malignant 
Tumors 
ANC 
Absolute Neutrophil Count  
ARMOR 
Commensal Oral Microbiota as a Trigger of Oral Mucositis Severity 
CBC 
Complete Blood Count testing 
CFR 
Code of Federal Regulations 
chemoRT 
Chemoradiation therapy 
CMP 
Clinical Monitoring Plan 
CROMS 
Clinical Research Operations and Management Support 
CTCAE 
Common Terminology Criteria for Adverse Events 
CQMP 
Clinical Quality Management Plan 
DHHS 
Department of Health and Human Services 
DSMB 
Data and Safety Monitoring Board 
EORTC QLQ- 
 C-30 
European Organization for Research and Treatment of Cancer Quality of 
Life Questionnaire  
EORTC QLQ-
H&N35 
European Organization for Research and Treatment of Cancer Quality of 
Life Questionnaire with the additional Head & Neck specific module  
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
GEE 
General Estimating Equation 
H&N 
Head and Neck 
HIV 
Human Immunodeficiency Virus 
HNSCCs 
Head and Neck Squamous Cell Carcinomas 
ICH 
International Council for Harmonisation 
IMRT 
Intensity-modulated radiation therapy 
IRB 
Institutional Review Board 
MASCC/ISOO 
Multinational Association of Supportive Care in Cancer and International 
Society of Oral Oncology  
MOP 
Manual of Procedures 
MSD 
MesoScale Discovery 

The ARMOR Trial: Commensal Oral Microbiota as a Trigger of Oral Mucositis Severity Version 11.0 Protocol 832750
 
4 January 2022 
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Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
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NIDCR 
National Institute of Dental and Craniofacial Research, NIH, DHHS 
NIH 
National Institutes of Health 
NYU 
New York University 
UPenn 
University of Pennsylvania, School of Dental Medicine  
OCTOM 
Office of Clinical Trials Operations and Management 
OHRP 
Office for Human Research Protections 
OM 
Oral Mucositis 
OMDP-IG 
Oral Mucosal Deterging and Dental Prophylaxis (Intervention Group) 
PHI 
Protected Health Information 
PI 
Principal Investigator 
QM 
Quality Management 
QOL 
Quality of life 
RT 
Radiation Therapy 
SAE 
Serious Adverse Event/Serious Adverse Experience 
SOC-OH 
Standard of Care Oral Hygiene (Control Group) 
SOC 
Standard of Care  
US 
United States 
WHO 
World Health Organization 
 
 
 
 
 
 
 

The ARMOR Trial: Commensal Oral Microbiota as a Trigger of Oral Mucositis Severity Version 11.0 Protocol 832750
 
4 January 2022 
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Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
8 
PROTOCOL SUMMARY 
Title: 
The ARMOR Trial: Commensal Oral Microbiota as a Trigger of Oral Mucositis Severity 
Précis: 
This is a prospective, single blind, two arm, randomized, controlled trial to test the 
efficacy of an oral care protocol to treat oral mucositis (OM) in patients receiving 
radiation (RT) or chemoradiation (chemoRT) for head and neck cancer. This trial 
will also measure salivary proinflammatory cytokines, and evaluate other clinical 
effects of the intervention during cancer therapy. In addition, oral mucosal swabs 
will be collected for the future characterization of changes in the microbiome 
associated with OM severity.  
 
Patients will be randomized in a 1:1 ratio to two different oral care protocols within 
4 strata defined by type of RT (Proton beam therapy (Protons)) vs intensity-
modulated radiation therapy (IMRT) and cancer treatment (RT versus chemoRT). 
Eligible subjects will be assigned to receive either the Oral Mucosal Deterging 
and Dental Prophylaxis protocol (OMDP) or a Standard of Care Oral Hygiene 
protocol (SOC-OH). Prior to randomization, all enrolled subjects will receive a 
baseline dental prophylaxis and fluoride varnish application prior to start of RT or 
chemoRT to ensure that all subjects enter the study with comparable oral health. 
Subjects assigned to OMDP will receive the OMDP Protocol (Oral Mucosal 
Deterging and Dental Prophylaxis) at weekly intervention visits. Subjects 
randomized to the SOC-OH will receive oral health instructions following the 
American Dental Association Guidelines1  and will have their teeth cleaned 
(brushed) during weekly intervention visits; no treatment to the oral mucosa will 
be provided to this group.  
 
At each bi-weekly study visit, study assessments will include the collection of 
saliva and oral mucosal swabs, an oral exam and OM assessment, and the 
completion of questionnaires. During the course of the study, subjects will attend 
one baseline visit, up to 9 intervention visits, and follow-up visits approximately 1 
month and 3 months after completion of RT.  Local supportive care, including 
normal saline rinses, topical anesthetics, mixed medication mouthwashes (e.g. 
Magic Mouthwash), feeding tubes, and pain management will be allowed 
according to each recruitment site’s standard of care procedures.  

The ARMOR Trial: Commensal Oral Microbiota as a Trigger of Oral Mucositis Severity Version 11.0 Protocol 832750
 
4 January 2022 
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Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
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Objectives: 
Primary Objective: To test the efficacy of the OMDP protocol compared to 
SOC-OH on OM severity in head and neck cancer patients undergoing RT 
or chemoRT.  
The primary outcome measure is OM severity as measured by the World 
Health Organization’s Oral Toxicity Scale (WHO OTS). 
Secondary Objectives:   
1) To compare changes in salivary proinflammatory cytokines 
between the OMDP and SOC-OH groups.  
2) To evaluate differences between the OMDP and SOC-OH groups in 
the following clinical indicators: a) duration of and time to onset of 
severe OM, b) salivary hypofunction, c) average mouth and throat 
soreness [MTS], and d) quality of life and function [EORTC QLQ 30 
and EORTC QLQ HN35].  
 
The secondary outcome measures are changes in: salivary 
proinflammatory cytokines, duration and time to onset of severe OM, OM 
severity as measured by the Common Terminology Criteria for Adverse 
Events (CTCAE), salivary hypofunction, symptoms, quality of life, and 
function. 
 
Exploratory Objective. To estimate progression-free survival and overall 
survival by intervention group.  
 
The central hypothesis is that a weekly regimen of targeted professional 
oral care during anti-cancer treatment prevents harmful ecological shifts in 
the oral cavity and consequently reduces the duration and severity of OM, 
reduces OM local inflammation, and improves oral health, thereby 
improving overall quality of life during cancer treatment. The rationale is 
that the cleansing of dead, damaged, or infected oral mucosa tissues in 
combination with mechanical removal of dental plaque and calculus in the 
oral cavity to facilitate biofilm disruption and endotoxin flushing during 
RT/chemoRT treatment, improves the healing potential of the oral tissues 
and suppresses OM severity.  
 
Population: 
A total of 120 male and female subjects (N=120) aged 18 years and older 
who will undergo different modalities of RT [IMRT or Protons] with or 
without combined chemotherapy for head and neck cancer will be 
enrolled.  
Phase: 
II 

The ARMOR Trial: Commensal Oral Microbiota as a Trigger of Oral Mucositis Severity Version 11.0 Protocol 832750
 
4 January 2022 
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Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
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Clinical 
Center (s): 
Hospital of the University of Pennsylvania 
Perelman Center for Advanced Medicine 
3400 Civic Center Blvd 
Philadelphia, PA 19104 
Perelman School of Medicine, University of Pennsylvania 
 
Department of Oral & Maxillofacial Surgery 
Perelman Center for Advanced Medicine 
3400 Civic Center Blvd., 4th Floor South Pavilion  
Philadelphia, PA 19104 
School of Dental Medicine, University of Pennsylvania  
 
Number of 
Core 
Laboratories: 
 
Statistical  
Center: 
Two core laboratories:  
The Forsyth Institute 
National Institute of Nursing Research (NINR) 
 
NYU Langone Health, School of Medicine 
Description of  
Intervention: 
The study intervention will consist of weekly visits during which a dental 
professional will administer the OMDP intervention protocol. The OMDP 
comprises a professional dental prophylaxis including periodontal surface 
debridement (a light-touch, gentle form of instrumentation performed with 
an ultrasonic instrument to promote plaque removal, to facilitate biofilm 
disruption and endotoxin flushing, but yet with the preservation of the 
periodontal cementum) followed by cleansing and deterging of the oral 
mucosal surfaces using a soft bristled manual toothbrush and a deterging 
agent. 
 
The standard of care intervention for the control group will consist of 
weekly visits at which subjects will receive oral health instructions and 
have their teeth brushed.  
Study 
Duration: 
Approximately 5 years 
Subject 
Participation 
Duration: 
Approximately 5 months 
Estimated 
Time to 
Complete 
Enrollment: 
Approximately 3.5 years 

The ARMOR Trial: Commensal Oral Microbiota as a Trigger of Oral Mucositis Severity Version 11.0 Protocol 832750
 
4 January 2022 
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Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
11 
 
SCHEMATIC OF STUDY DESIGN: 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
OMDP-IG  
SOC-OH 
Within 4 strata defined by   
type of RT (Proton vs IMRT) and   
cancer treatment (RT versus chemoRT). 
Random: 1:1 
VISIT 3 (Day 14 ± 3 days) 
AEs, oral exam, mucositis assessment, saliva and oral swab collection, 
questionnaires, study intervention. 
VISIT 1 (Day 0, up to 5 
days after the start of 
RT 
Randomization - AEs, oral exam, mucositis assessment, saliva, and oral swab 
collection, questionnaires, study intervention.  
VISIT 5 (Day 28 ± 3 days) 
AEs, oral exam, mucositis assessment, saliva and oral swab collection, 
questionnaires, study intervention. 
POST RT VISIT 
AEs, oral exam (including perio 
assessment),  saliva and oral swab 
collection, questionnaires, study 
intervention if needed. 
VISIT 7 (Day 42 (± 3 days) 
AEs, oral exam, mucositis assessment, saliva and oral swab collection, 
questionnaires, study intervention. 
VISIT 9 (Day 56 ± 3 days) 
AEs, oral exam, mucositis assessment, saliva and oral swab collection, 
questionnaires, study intervention. 
Study intervention and 
mucositis assessment 
VISIT 2 (Day 7 ± 3 days) 
Study intervention and 
mucositis assessment 
VISIT 4 (Day 21 ± 3 days) 
Study intervention and 
mucositis assessment 
VISIT 6 (Day 35 ± 3 days) 
Study intervention and 
mucositis assessment 
VISIT 8 (Day 49 ± 3 days) 
Screening (Day -60 to -1) 
Baseline (Day -21 to -1) 
Must occur prior to 
randomization. 
A. Obtain informed consent. Screen potential subjects by inclusion and 
exclusion criteria, obtain history, vital signs, oral exam. 
*B. Saliva and oral swab collection, questionnaires, perio assessment, dental 
prophylaxis. Blood draw**. 
Screening and Baseline can happen at the same visit, however 
*Assessments in “B” must be done within the Baseline window. 
**Blood draw may occur any time prior to the start of RT. 
Visit 11 (Day 140 ± 21 days) 
VISIT 10 (Day 86 ± 7 
days) 
AEs, oral exam, mucositis assessment 

The ARMOR Trial: Commensal Oral Microbiota as a Trigger of Oral Mucositis Severity Version 11.0 Protocol 832750
 
4 January 2022 
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Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
12 
1. KEY ROLES AND CONTACT INFORMATION 
Program Principal 
Investigator 
Contact PI 
 
 
 
 
 
 
 
Program Co-Principal 
Investigator 
Patricia Corby, DDS, MS 
Associate Dean for Translational Research 
Associate Professor 
Department of Oral Medicine  
University of Pennsylvania School of Dental Medicine 
Email: patcorby@UPenn.edu 
Phone: 215-898-1162 
240 South 40th Street 
Philadelphia, PA 19104 
 
Alexander Lin, M.D. 
Associate Professor 
Vice Chair of Faculty Affairs 
Chief, Head and Neck Cancer Section 
Medical Director, Roberts Proton Therapy Center 
Department of Radiation Oncology 
Perelman School of Medicine, University of Pennsylvania 
Email: alexander.lin@uphs.UPenn.edu 
Fax: 215-349-5445 
Phone: 215-662-3198 
NIDCR Medical 
Monitor: 
Kevin McBryde, MD 
NIH/NIDCR/DER 
6701 Democracy Boulevard, Room 638 
Bethesda, MD 20892-4878 
Phone: 301 594 0170  
Email: mcbrydekd@mail.nih.gov 
NIDCR Program 
Official:   
Dena Fischer, DDS, MDS, MS 
National Institute of Dental and Craniofacial Research/NIH 
6701 Democracy Blvd, MSC 4878 
Bethesda, MD 20892-4878 
Phone: (301) 594-4876 
Email: dena.fischer@nih.gov