An Evaluation of the Efficacy of 3M Dry Mouth Moisturizing Spray on the Relief of Dry Mouth Symptoms
Phase: NA
Conditions: Xerostomia
Sponsor: Solventum US LLC

 
 
 
 
 
 
 
 
Study Title:           An Evaluation of the Efficacy of 3M™ Dry Mouth Moisturizing Spray on the Relief of Dry 
                              Mouth Symptoms 
 
NCT Number:      NCT04186806 
 
Document Date:  11 Jul 2019 

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Clinical Study Protocol 
EM-11-050038 
 
 
Study Number and Protocol Title 
An Evaluation of the Efficacy of 3M™ Dry Mouth 
Moisturizing Spray on the Relief of Dry Mouth 
Symptoms 
 
Principal Investigator 
 
 
Sub-investigator (if applicable) 
 
 
 
 
 
Research Facility 
Yiming Li, DDS, MSD, PhD 
Distinguished Professor and Associate Dean for Research 
 
So Ran Kwon, DDS, MS, PhD, MS 
Professor and Director of Student Research Program 
 
Montry Suprono, DDS, MSD 
Associate Professor and Director of Center for Dental 
Research 
 
Loma Linda University, School of Dentistry 
Chan Shun Pavilion, CSP-A1010 
11175 Campus Street 
Loma Linda, CA 92350 
Telephone: 909-558-8178 
FAX: 909-558-0328 
Email: yli@llu.edu 
 
IRB 
Loma Linda University 
11234 Anderson Street 
Loma Linda, CA 92350 
 
Sponsor 
3M Health Care 
Oral Care Solutions Division 
St. Paul, MN 55144-1000 
 
3M CRA 
Elaine A Egging, MT (ASCP) 
3M Health Care 
3M HCBG Clinical Operations 
3M Center Building 270-4N-01 
St. Paul, MN 55144-1000 
Telephone: 651 737-0263 
Email: eegging@mmm.com 

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3M Medical Monitor 
 Lois Duerst, DDS 
3M Health Care 
3M Center Building 260-02-B-09 
St. Paul, MN 55144-1000 
Telephone: 651-733-0625 
 
 
Approver List (3M Approvers Only): 
Signer 
Role 
Date Signed 
us331056:Egging Elaine A 
Clinical July 11, 2019 10:33:32 AM CDT 
a0592zz:Walters Shelley-Ann Clinical July 11, 2019 10:25:28 AM CDT 
A6T44ZZ:Duerst Lois 
Clinical July 11, 2019 03:08:42 PM CDT 
us251333:Coalwell Brenda C Clinical July 11, 2019 10:40:37 AM CDT 
 
 
3M Confidential 
This document contains confidential information that is the property of 3M and is subject 
to all of the restrictions on use and disclosure contained in the study contract to which this 
is appended. Do not copy, disclose, circulate or use for benefit for any third party without 
written authorization from 3M. 
 
 
cc: Clinical Study Folder 
Investigator Study Documentation File (Regulatory Binder) 

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Table of Contents 
1. 
BACKGROUND INFORMATION ................................................................................................................. 5 
1.1 Name, Description and Intended Use of the Experimental Material ............................... 5 
1.2 Summary of Previous Studies .......................................................................................... 5 
1.3 Risk/Benefit Summary..................................................................................................... 6 
1.4 Investigational Material Application ............................................................................... 7 
1.5 GCP and Regulatory Requirements ................................................................................. 7 
1.6 Study Population .............................................................................................................. 8 
2. 
STUDY OBJECTIVES AND PURPOSE ................................................................................................... 8 
3. 
STUDY DESIGN ............................................................................................................................................... 8 
3.1 Study Type ....................................................................................................................... 8 
3.2 Primary and Secondary Endpoints ................................................................................... 8 
3.3 Randomization and Blinding ........................................................................................... 9 
3.4 Study Materials and Labeling .......................................................................................... 9 
3.4.1 
Investigational Material Labeling.............................................................................................. 10 
3.4.2 
Other Material Labeling ............................................................................................................ 10 
3.5 Study Duration ............................................................................................................... 10 
3.6 Study Termination/Subject Discontinuation or Withdrawal/Subject Revocation of 
Authorization ................................................................................................................. 11 
3.6.1 
Study Termination ..................................................................................................................... 11 
3.6.2 
Subject Discontinuation ............................................................................................................ 11 
3.6.3 
Subject Revocation of Authorization to Use and Disclose PHI ................................................. 12 
3.7 Investigational Material Accountability ........................................................................ 12 
3.8 Randomization and Blinding ......................................................................................... 12 
3.9 Source Data .................................................................................................................... 12 
3.10 Protocol Modifications .................................................................................................. 13 
3.10.1 
Protocol Amendments ............................................................................................................... 13 
3.10.2 
Protocol Deviations ................................................................................................................... 13 
3.11 Computerized Systems .................................................................................................. 14 
4. 
SUBJECT SELECTION .......................................................................................................................... 14 
4.1 Subject Inclusion Criteria .............................................................................................. 14 
4.2 Subject Exclusion Criteria for Start of Wash-In, Water Only Evaluation and Baseline 
Period 1 (Randomization Visit) ..................................................................................... 15 
4.3 Subject Consent ............................................................................................................. 15 
4.4 Subject Authorization for Use and Disclosure of Protected Health Information (PHI).16 
5. 
TREATMENT OF SUBJECTS ...................................................................................................................... 17 
5.1 Treatment(s) to be Administered ................................................................................... 17 
5.2 Medication(s)/Treatment(s) Permitted ........................................................................... 22 

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6. 
ASSESSMENT OF EFFICACY ............................................................................................................... 23 
6.1 Efficacy Parameters ....................................................................................................... 23 
6.2 Assessment Methods ..................................................................................................... 23 
7. 
ASSESSMENT OF SAFETY ................................................................................................................... 26 
7.1 Safety Parameters .......................................................................................................... 26 
7.2 Adverse Events .............................................................................................................. 26 
7.3 Recording and Reporting ............................................................................................... 27 
8. 
STATISTICS .................................................................................................................................................... 27 
8.1 Data Sets Analyzed ........................................................................................................ 27 
8.2 Statistical Methods ........................................................................................................ 28 
8.2.1 
Efficacy Analyses...................................................................................................................... 28 
8.2.2 
Safety Analyses ......................................................................................................................... 29 
8.3 Sample Size Justification ............................................................................................... 29 
8.4 Interim Analyses Planned and Criteria for the Termination of the Study ..................... 30 
8.5 Procedures for Accounting for Missing, Unused, and Spurious Data ........................... 30 
8.6 Deviations to Statistical Plan ......................................................................................... 30 
9. 
MONITORING ......................................................................................................................................... 30 
10. QUALITY CONTROL AND QUALITY ASSURANCE......................................................................... 30 
11. ETHICS .................................................................................................................................................................... 31 
12. DATA HANDLING AND RECORD KEEPING ..................................................................................... 31 
12.1 Study Personnel ............................................................................................................. 31 
12.2 Pre-Study Documentation Requirements ...................................................................... 31 
12.3 Completion of Case Report Forms ................................................................................ 32 
12.4 Final Report ................................................................................................................... 32 
12.5 Records, Reports and Retention Requirements ............................................................. 32 
13. APPENDICES .......................................................................................................................................... 33 
13.1 Appendix A - Study Schedule ....................................................................................... 33 
13.2 Appendix B - Experimental Device Instructions for Use .............................................. 34 
13.3 Appendix C – References .............................................................................................. 36 

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1. Background Information 
 
1.1 
Name, Description and Intended Use of the Experimental Material 
Xerostomia is a subjective sensation of dryness of the mouth. Dry mouth can be a 
symptom or a side effect of other conditions (e.g., diabetes, hypertension, Sjögren’s 
syndrome, stroke). It is also a common side effect of many prescription and 
nonprescription drugs; including drugs used to treat hypertension, depression, 
anxiety, allergies, and colds (decongestants and antihistamines). 
Mouth dryness is commonly associated with oral symptoms such as taste 
disturbances, bad breath and painful mouth ulcers. Dry mouth can also affect oral 
functions such as speech, chewing, and swallowing.1,2 
 
Management includes symptomatic relief and prevention or correction of the sequelae 
of saliva hypofunction, and treatment of any underlying disease. Adequate hydration 
of the oral tissues (frequent sips of water) is the standard treatment of xerostomia.3,4 
Several over-the-counter products (e.g., Biotène®) are also available for treating dry 
mouth symptoms; however, data collected during 3M-hosted focus groups and voice 
of customer activities indicated that there continues to be an increasing demand for 
effective dry-mouth relief products. For this reason, 3M’s Oral Care Solutions 
Division plans to expand their prevention portfolio and has been developing an oral 
spray solution, which is intended to be used to relieve dry mouth symptoms in 
persons with Xerostomia. 
 
The purpose of this clinical trial is to evaluate and validate the performance of the 
experimental mouth spray when used by persons with mild to severe dry mouth 
symptoms. This study is designed to gather data from these individuals regarding 
their opinions about the product’s performance, mouth-feel qualities, and user’s 
willingness to purchase the product when it becomes commercially available. 
 
We hypothesize that the use of 3M™ Experimental Dry Mouth Moisturizing Spray 
will be non-inferior to Biotène (GSK) in alleviating dry mouth symptoms. 
 
1.2 
Summary of Previous Studies 
 

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-
 
 
 
To determine the preliminary flavor selections for the mouth spray, a food product 
development and research company (Merlin Company, Plymouth, MN) was 
employed. They helped in the development of the flavored formulations and 
conducted various taste panel evaluations with professional taste testers to select and 
optimize the flavored formulations. 
 
Subsequent to Merlin’s evaluators making their favorite flavor choices it was 
necessary to confirm the flavored formulations in a xerostomia population. Clinical 
trials were conducted 
 
 in 
healthy 
 volunteers, with 
self-reported moderate to severe dry mouth, to test the prototype formulations. Two 
clinical trials were conducted: 
 
• The first study was based solely on spoon delivery of 4 individual prototype 
formulations to gather taste/flavor preferences to narrow down the flavor 
options for the final product flavor. The formulations were compared to 2 
commercial dry mouth spray formulations. 
• The second study was conducted using a spray delivery system to identify the 
final flavors and to gather preliminary data for immediate dry mouth relief, 
mouth feel of formulation, and usability compared to Biotène. 
 
1.3 
Risk/Benefit Summary 
 
Risks: 
3M™ Dry Mouth Moisturizing Spray is a surface device with limited contact 
duration per use. As it will be used by subjects with mild to severe xerostomia, some 
degree of contact on breached or compromised oral mucosa is expected. Therefore, 
the relevant ISO 10993, ISO 7405, USFDA, and Japan medical device evaluation 
guidance were used in establishing the study design. Subject with breached or 
compromised oral surfaces will evaluate the product for >30 days. 
 
A Diplomate of the American Board of Toxicology has assessed the safety of the 
experimental sample, 3M™ Dry Mouth Moisturizing Spray. Standard risk assessment 
techniques and consideration of internationally recognized guidelines were used in 
this evaluation. The experimental sample, 3M™ Dry Mouth Moisturizing Spray is 
safe for human use in this clinical evaluation based on the 
following considerations: 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 

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1) All of the ingredients in the product are used in food; and 
2) A review of the product ingredient hazards in relation to the exposure during the 
clinical trial 
 
This prototypic device 3M™ Dry Mouth Moisturizing Spray is associated with 
minimum risks. 
 
Risk Minimization 
 
Efforts to minimize risks to study subjects will be made with the following 
approaches: 
• Compliance with ISO 10993 
• Selection of investigators who are experienced dental clinicians 
• Clearly defined inclusion and exclusion criteria will be used to ensure only 
appropriate subjects are enrolled 
• Ensuring that treatment and follow-up of subjects is consistent with 
current dental practice 
• Monitoring of investigational sites and patients 
• Review of reported Adverse Events 
 
Based on the biocompatibility and a general risk review, the possible side effects of 
using the experimental device include: 
• 
Potential stinging or burning sensations associated with the product 
• 
Sloughing of the superficial soft tissues in the oral cavity such as the 
inside surface of the cheeks 
• 
Paresthesia (local numbing for a short period of time) 
• 
Soft tissue erythema and edema 
• 
The product could accidentally be splashed into the eye and minor, limited 
irritation may occur 
• 
Allergic reaction to the product 
 
Benefits: There may be no direct benefits to the participants in this study. However, 
information obtained in this investigation may benefit others in the future. 
 
1.4 
Investigational Material Application 
 
Experimental material will be dispensed by the subject to their own mouth by using a 
spray bottle to deliver the oil-in-water emulsion into the mouth. 
 
1.5 
GCP and Regulatory Requirements 
 
The 3M™ Dry Mouth Moisturizing Spray is a medical device (unclassified). 3M 
Company (Maplewood, MN) has determined this product is a non-significant risk 

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device, based on biocompatibility testing and the 2 taste studies conducted on 3M 
Healthy Volunteers, which had no adverse events reported. This study will be 
conducted in compliance with this protocol and GCP including 45 CFR 160 & 164 
(Authorization for Use/Disclosure of PHI),21 CFR 50 (Informed Consent) and 56 
(IRBs). The experimental device will be used in a manner consistent with its intended 
use, and abbreviated CFR 21 FDA §812.2 regulation applies. The device will be 
registered with the FDA as an unclassified medical device in 2020, subject to 510(k) 
regulatory pathway based on clearance. It is similar to a previously registered 
predicate medical device called Biotène® Moisturizing Mouth Spray (510(k) number 
K123731, K103745). 
 
Prior to FDA approval, a Human Subjects’ Protection Board (IRB) serves as a 
surrogate to the FDA in making a nonsignificant risk determination for review, 
approval, and continuing review in device-related studies. 
A non-significant risk device study may start at the institution as soon as the IRB 
reviews and approves the study. Progress reports or final reports to FDA and an IDE 
application to the FDA are not required. 
 
1.6 
Study Population 
Adults that meet the inclusion/exclusion criteria. 
 
2. 
Study Objectives and Purpose 
 
The purpose of this study is to investigate the efficacy of 3M™ Dry Mouth 
Moisturizing Spray to reduce symptoms of dry mouth for up to 4 hours and after 7 
days of use. In addition, this study aims to support comparative claims. 
 
3. 
Study Design 
 
3.1 
Study Type 
 
The proposed study will be a controlled randomized cross-over design. This study 
will compare 3M™ Dry Mouth Moisturizing Spray to commercialized device (active 
control) and water (inactive control) to determine the effect and changes in the effect 
over time, in subjects experiencing dry mouth symptoms. 
 
3.2 
Primary and Secondary Endpoints 
 
The primary endpoint of this study is reduction in mouth dryness at 15 minutes after 1 
dose of 3M™ Dry Mouth Moisturizing Spray. 
 
We hypothesize that the use of 3M™ Dry Mouth Moisturizing Spray will be non- 
inferior to GSK Biotène® Moisturizing Mouth Spray (Biotene) in alleviating mouth 

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dryness as assessed by the Visual Analog Scale for the duration of 15 minutes after 1 
dose. 
 
The secondary endpoints are to: 
• Mouth dryness evaluated using a Visual Analog Scale, at 5-, 30-, 60-, 120- 
and 240-minutes post 1 dose of use to determine whether 3M™ Dry Mouth 
Moisturizing Spray is equally effective to the prototype Biotène® control. 
• Evaluate the clinical safety of the 3M Dry Mouth Moisturizing Spray. 
• Determine product usability, acceptability and preference using patient 
questionnaires. 
• Compare 3M™ Dry Mouth Moisturizing Spray to Biotene® and water. 
 
3.3 
Randomization and Blinding 
All subjects completing the wash-in procedures and meeting inclusion/exclusion 
criteria will undergo a pre-study 5-hour visit (the day before randomization) to assess 
the effect of water on their dry mouth symptoms. The subjects will return the next 
day for confirmation that inclusion/exclusion criteria and the wash-in procedures 
continue to be met or followed. Eligible subjects will be randomized at this baseline 
visit in a 1:1 ratio to one of two treatment orders: A->B (AB) or B->A (BA). The 
order of product usage will be assigned in sealed envelopes created from a 
randomization schedule generated by the study statistician. 
 
Due to the obvious differences in products and the dispensing spray bottles, blinding 
of subject to treatment order will not be possible. In addition, no attempt will be made 
to blind subjects when given a single dose of water the day before randomization. 
 
All clinical oral examinations performed post-randomization will be conducted with 
the evaluator blinded to subject’s product use assignment. Subjects will be instructed 
to avoid discussing their assigned product with the evaluator. 
 
3.4 
Study Materials and Labeling 
 
3M™ Dry Mouth Moisturizing Spray formula is an oil-in-water emulsion. The oil 
phase provides comfort to the oral mucosa. The water phase is buffered at a neutral 
pH using a phosphate buffering system, and is sweetened with non-cariogenic sugars 
including xylitol, erythritol and sucralose. 3M Dry Mouth Moisturizing Spray will be 
applied to the oral mucosa as needed for the relief of dry mouth symptoms. 
Components are of food or compendial grade. The instructions for use are provided as 
Appendix B. 
 
• 
Treatment [A]: 3M™ Dry Mouth Moisturizing Spray 
• 
Treatment [B]: Control - Biotène® Moisturizing Mouth Spray 
• 
Treatment [C]: Control – Bottled water 

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3.4.1 Investigational Material Labeling 
3M will label, package and ship the study materials to the research facility. 
Each experimental material will be labeled with the following minimum 
information: 
 
For use in Study EM-11-050038 only 
3M Health Care, St. Paul, MN 55144-1000 
Identifying lot or control number 
Study Material name or code designation: 
Quantity of contents 
Expiration date: 
“Use as directed” 
Storage conditions: Store at room temperature. 
If you have questions, call 909-558-8069. 
3.4.2 Other Material Labeling 
Biotene® is a commercially available product. It will be over labeled with 
the following: 
 
For use in Study EM-11-050038 only 
3M Health Care, St. Paul, MN 55144-1000 
Identifying lot or control number 
Study Material name or code designation: 
Quantity of contents 
Expiration date: 
“Use as directed” 
Storage conditions: Store at room temperature. 
If you have questions, call 909-558-8069. 
 
Bottled water will be labeled with Sample C. 
 
3.5 
Study Duration 
 
The anticipated duration of this clinical study from enrollment of first subject to 
treatment of final subject is 3- to 6 months. 
 
Each participant’s time commitment to this research project will be 90 minutes at first 
visit (screening and enrollment/start of wash-in). On the 2nd visit (water only 
evaluation) an Oral Exam and Challacombe assessment will be completed prior to 
dosing. If the Challacombe score is 0, then the subject will not be enrolled, and the 
time commitment will be up to 90 minutes. If the Challacombe score is 1 or greater, 
subject will complete to the 5-hour water-only evaluation. On the 3rd visit (baseline 
period 1) the Challacombe assessment will be re-checked to ensure it is still ≥1. If 

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the subject still meets all the other inclusion/exclusion criteria, the subjects will be 
randomized into the treatment phase of the study. 
 
Enrolled subjects will be scheduled for 2 additional 5-hour visits and two 60-minute 
visits. There is also at least a 2-day wash-in period prior to any sample dosing and at 
least a 2-day wash-out period between 1st and 2nd study periods. Each individual 
subject will participate in the study for total time of up to 4 weeks. There is the 
possibility that a subject may develop a study related adverse event during 
participation. Should this happen, a detailed description of start date and other 
pertinent information will be recorded on an adverse event form and the subject’s 
continued participation in the study and treatment will be at the Investigator’s 
discretion. 
 
All subjects experiencing an adverse event will be followed until the adverse event is 
resolved. 
 
 
3.6 
Study Termination/Subject Discontinuation or Withdrawal/Subject Revocation 
of Authorization 
 
3.6.1 Study Termination 
3M or the Investigator has the right to terminate or suspend the study at any 
time for medical and/or administrative reasons. As far as possible, this should 
occur after mutual consultation. 
 
3.6.2 Subject Discontinuation 
The Investigator may discontinue individual subjects from the study at any 
time. Subjects may voluntarily withdraw from the study at any time. The 
Investigator will provide a written report on the appropriate CRF describing 
the date and reason for discontinuance. 
 
A subject who is discontinued or voluntarily withdraws will not be replaced. 

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3.6.3 Subject Revocation of Authorization to Use and Disclose PHI 
In order to implement a valid revocation of authorization, the subject or their 
representative must make the request in writing to the Loma Linda University 
School of Dentistry, Chan Shun Pavilion, CSP-A1010, 11175 Campus Street, 
Loma Linda, CA 92350, to the attention of the PI. The revocation cannot stop 
the use or disclosure of information that has been collected prior to the 
revocation, is needed to ensure complete and accurate study results, is 
required by law or government regulation (e.g., reporting adverse events, etc.). 
Revocation of an authorization may not be used to withhold normal medical 
care from the subject but will make the subject ineligible to receive the study 
treatment or care. 
 
3.7 
Investigational Material Accountability 
 
3M™ always requires Investigators to maintain accountability and adequate 
inventory security of the experimental material at all times. The Investigator or 
designee will: 
 
• 
Complete a Confirmation of Release and Receipt of Clinical Supplies form 
and maintain and account for inventory on the Investigational Material 
Disposition form. 
 
• 
Keep experimental materials in a secure storage area, accessible only to 
authorized individuals. 
 
• 
Dispense experimental material only to subjects properly enrolled into the 
study. 
 
• 
Return all unused experimental materials to 3M at the end of the study or 
dispose of as agreed upon. 
3.8 
Randomization and Blinding 
 
The cross-over order of treatments will be assigned using sealed randomization 
envelopes. Order assigned will be either A->B (AB) or B->A (BA). The Investigator 
or their designated staff member is responsible to assure that the study randomization 
is followed. Subjects randomized will have their data and records numbered with the 
assigned numbers 001 to 040. Study treatment materials will be labeled with the 
appropriate codes. The 3M study monitor must be notified within 24 hours of any 
emergency deviation from protocol related to randomization errors. 
 
3.9 
Source Data 

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Data will be written on data collection sheets and then entered into the electronic data 
capture (eDC) database by research staff, the paper is then considered source data. 
The data entry should occur within a week of collection and copies of the data sheets 
should be sent to sponsor. Subject will be keeping a diary, this is considered source 
data, and will be returned to the research staff and transferred to the sponsor for data 
entry within a week of the return of the diary to the research staff. Completed paper 
data collection sheets and eCRFs will be reviewed by the site monitor to ensure 
accuracy and consistency of subject data. Any discrepancies found during CRF 
review are to be clarified by the Investigator or designee. Investigator must keep 
physical CRFs in the study subject binder for a minimum of 2 years after completion 
of the study. 
 
3.10 Protocol Modifications 
 
3.10.1 
Protocol Amendments 
The party initiating an amendment must confirm it clearly in writing using the 
Amendment/Administrative Revision form. It must be signed and dated by 3M 
and, in the case of a significant amendment, the Investigator. A significant 
amendment means one that affects the safety, rights or welfare of subjects, the 
scope of the investigation or the scientific quality of the study. 
 
3M will notify the Investigator when a protocol amendment may be 
implemented. 
 
3.10.2 
Protocol Deviations 
A deviation is a departure from the protocol that will likely affect the safety, 
rights or welfare of subjects, the scope of the investigation or the scientific 
quality of the study. 
 
A protocol deviation is only for an individual subject. Protocol deviations are 
documented on a Protocol Deviation Form or appropriate CRF. 
 
Deviations that potentially affect 1) subject safety, rights or welfare, 2) data 
integrity or 3) compromise the statistical analysis of the study require immediate 
communication to 3M. The Investigator must contact the 3M study monitor 
within 24 hours of occurrence at the following phone number: 651-737-0263. 
 
A Protocol Deviation Form must be completed by the Investigator and include 
the type of deviation and a description of the circumstances surrounding the 
deviation. A copy is sent to the 3M study monitor within 24 hours of identifying 
the occurrence. 

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Deviations which are made to protect the life or physical well-being of a 
subject in an emergency must be reported to the IRB within 5 working 
days after 3M learns of the occurrence. 
 
The major protocol deviations include subjects missing the primary 
endpoint visit for one or both treatment periods, subjects not taking 
product for one or more days, and subjects taking excluded medications 
(any non-study assigned dry mouth alleviating products). 
 
3.11 Computerized Systems 
 
All statistical analyses will be conducted using SAS software. Clindex will be used for 
electronic capture of study data. Electronic study documents will be stored in ENOVIA. 
Any additional computerized systems used in the conduct of this study will be identified in 
the study report. 
 
4. Subject Selection 
4.1 
Subject Inclusion Criteria 
Screening – Start of Wash-In Visit 
• Subject who is ≥18 years of age and complains of dry mouth 
• Only 1 subject per household is allowed into study 
• Subject with a Challacombe scale score of 1 or higher 
• Subject agrees to refrain from eating spicy foods and foods containing garlic 
beginning 48-hours prior to all study visits 
• Subject agrees to eat a meal prior to all study visits that include sample evaluation 
in the clinic 
• Subject agrees to not eat, drink, chew tobacco, chew gum, smoke, brush or floss 
teeth for 2-hours prior to sample evaluation study visits 
• Subject agree to not use any oral care products and any type of breath mint or 
lozenges for 2-hours prior to sample evaluation study visits 
• Subject agrees to refrain from any food and liquid during the 5-hour study visits 
except for what is provided by the study research staff (e.g., water and treatments 
A and B during evaluation periods) 
• Subject agrees to only use those clinical oral care supplies provided during the 
entire study 
• Able to understand and willing to sign the Informed Consent Form 
Water Only Evaluation Visit 
• Subject has successfully completed a ≥ 2-day wash-in period 
• Subject has Challacombe scale score of 1 or higher 

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• Subject has refrained from eating spicy foods and foods containing garlic 
beginning 48-hours prior to the sample evaluation visits 
• Subject ate a meal prior to sample evaluation study visits 
• Subject has not eaten, drank, chewed tobacco, chewed gum, smoked, brushed or 
flossed teeth for 2-hours prior to sample evaluation study visits 
• Subject has not used any oral care products, any type of breath mint or lozenges 
for 2-hours prior to sample evaluation study visits 
• Subject agrees to refrain from any food and liquid during the 5-hour study visits 
except for what is provided by the study research staff (e.g., water and treatments 
A and B during evaluation periods) 
• Subject has used only those clinical oral care supplies provided during study 
Baseline Period 1/Randomization Visit 
• Subject has successfully completed a ≥ 2-day wash-in period 
• Subject has a Challacombe Scale score of 1 or higher 
• Subject has refrained from eating spicy foods and foods containing garlic 
beginning 48-hours prior to sample evaluation study visits 
• Subject ate a meal prior to sample evaluation study visits 
• Subject has not eaten, drank, chewed tobacco, chewed gum, smoked, brushed or 
flossed teeth for 2-hours prior to sample evaluation study visits 
• Subject has not used any oral care products and any type of breath mint or 
lozenges for 2-hours prior to sample evaluation study visits 
• Subject agrees to refrain from any food and liquid during the 5-hour study visits 
except for what is provided by the study research staff (e.g., water and treatments 
A and B during evaluation periods) 
• Subject has used only those clinical oral care supplies provided during study 
 
4.2 
Subject Exclusion Criteria for Start of Wash-In, Water Only Evaluation and 
Baseline Period 1 (Randomization Visit) 
• Subject has active mouth sores (e.g., cold sores, cuts, burns, canker sores) 
• Subject has a life-threatening pathological condition 
• Subject is participating in another clinical trial at the time of the study 
• Subject has profound marginal periodontal disease (purulent exudate, tooth 
mobility, and/or extensive alveolar bone loss) 
• Medical and oral conditions that, in the investigator’s judgment, may compromise 
the subject's safety or interfere with the conduct and outcome of the study 
• Difficult to be compliant with recalls, such as extensive travel commitments, lack 
of transportation etc. 
 
4.3 
Subject Consent 
The Principal Investigator or qualified Co-Investigators mentioned above are 
responsible for protecting patient confidentiality when discussing the study 

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details. The potential subject will have as much time to make a decision about 
participation in the study as they need to ensure that they understand everything 
within the consent document. The Investigator must ensure that written informed 
consent to participate in the investigation is obtained before including any 
individual as a subject in the investigation. Written informed consent will be 
obtained after the aims, methods, anticipated benefits, and potential hazards are 
explained and each subject’s questions have been answered. The Investigator 
must provide the prospective subject or their representative sufficient opportunity 
to consider whether or not to participate and minimize the possibility of coercion 
or undue influence. The process is designed to 1) give the subject all the 
information that they need, 2) ensure that the subject understands the information 
and 3) give the subject a chance to consider study participation. The process 
should permit the subject to ask questions and exchange information freely. 
 
Specifically, the Investigator is to explain to each subject all elements of informed 
consent as specified in 21 CFR 50.25. After the explanation, the subject or 
representative will voluntarily sign and date the consent form if they wish to 
participate in the study. A copy of the consent form must be provided to the 
subject. A signed and dated copy of the consent form must be maintained in the 
Investigator study documentation file at all times. Consent and study 
participation, with date, must be documented in the patient record/chart. 
 
Photographs will be taken of some of the subjects for non-diagnostic, publication 
and/or research development purposes. Of those subjects initially photographed, 
they will be followed throughout the study with photographs at each visit. For 
any extreme outcomes or outcome of interest to the investigator, subject 
photographs will be taken at any time throughout the study. 
 
4.4 
Subject Authorization for Use and Disclosure of Protected Health Information 
(PHI) 
The Investigator must ensure that written authorization for use and disclosure of 
protected health information is obtained before including any individual as a subject 
in the investigation. Written authorization for use and disclosure of protected health 
information is combined with the consent form (e.g., compound authorization) and 
must be obtained by the Investigator prior to including any individual as a subject in 
the investigation. 
 
Specifically, the Investigator is to explain to each subject all elements of 
authorization as specified in 45 CFR 164.508. After the explanation, the subject or 
representative must voluntarily sign and date the authorization form if they wish to 
participate in the study. A copy of the authorization form must be provided to the 
subject. A signed and dated copy of the authorization form must be maintained in the 

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Investigator study documentation file at all times and may be placed in the patient’s 
medical record. 
 
An authorization form may be combined with a consent form (e.g., compound 
authorization) if required by the IRB. All required elements for both informed 
consent and authorization must be included in a compound authorization. 
 
5. 
Treatment of Subjects 
 
5.1 
Treatment(s) to be Administered 
Visit 1 – Screening Visit/Start of Wash-In 
1. The subject signs the study consent form and authorization form. 
 
2. A study examiner will perform an oral exam and perform an assessment using 
the Challacombe-Scale to determine the severity level of dry mouth prior to 
any dosing. If the Challacombe score is 0, then the subject will not continue 
with study participation. If the Challacombe score is 1 or greater, subject will 
be enrolled. 
 
3. Participants will be qualified using the inclusion/exclusion criteria set forth in 
this protocol. 
 
4. Participant’s medical history will be collected and recorded. 
 
5. Subject will be instructed for how to perform at least a 2-day wash-in period. 
 
6. Subject will be given clinical study oral care supplies. 
 
7. The participant will be scheduled for a 5-hour appointment. 
 
Visit 2 - Water Only Evaluation Visit 
 
1. Confirm that subject still meets the inclusion/exclusion criteria set forth in this 
protocol. 
2. Confirm there were no changes to medications. 
 
3. A study examiner will perform an oral exam and perform an assessment using 
the Challacombe-Scale to determine the severity level of dry mouth prior to 
any dosing. If the Challacombe score is 0, then the subject will not continue 

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with study participation. If the Challacombe score is 1 or greater, subject will 
complete water-only evaluation. 
4. Subjects will not be allowed to eat or drink during the study visit except for 
when directed by study staff. 
 
5. Subjects will be asked to complete a Dry Mouth Inventory (DMI) 
questionnaire to understand their opinion on their severity of dry mouth prior 
to water evaluation. 
 
6. Subjects will be asked to complete a Visual Analog Scale (VAS) for mouth 
dryness for a baseline mouth dryness score prior to water evaluation. 
 
7. Subjects will drink 15 ml of water in their mouth and swallow the water. 
 
8. Subjects will be asked to answer 1 question regarding mouth dryness at 5-, 15- 
, 30-, 60-, 120-, and 240-minutes post single dose, using a Visual Analog 
Scale (VAS) assessment format and a Product Performance Attribute 
Question (PPAQ) format of none/no relief, not enough, some/good, very 
good, significant/excellent. 
 
9. Also, subjects will be asked to answer an additional PPAQ on the secondary 
endpoints at 5-, 15-, 30-, 60-, 120-, and 240-minutes post single dose using a 
format- poor, fair, good, very good, excellent. 
 
10. Subject will be instructed on restrictions during the study (e.g., no spicy foods, 
medicine, oral care products, gum, hard candy). 
11. Subject will be scheduled for Baseline Period 1 visit. Note: Subjects will 
continue with water only wash-in requirements and be randomized on 
treatment day. 
 
Visit 3 - Baseline Period 1 
 
1. Confirm that subject still meet the inclusion/exclusion criteria set forth in this 
protocol. 
 
2. Confirm there were no changes to medications. 
 
3. A study examiner will perform an oral exam and perform an assessment using 
the Challacombe-Scale to determine the severity level of dry mouth prior to 
any dosing. 

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4. Photographs may be taken of the subject’s mouth for publication and/or 
research development purposes, no diagnosis, treatment or decisions will be 
made from the photographs. 
 
5. A salivary flow test will be performed to determine if there is any 
hyposalivation. 
 
6. Subjects will be asked to complete a Visual Analog Scale (VAS) for mouth 
dryness for a baseline mouth dryness score prior to dosing. 
 
7. Sealed envelope is opened, and treatment order noted. 
8. Subjects will not be allowed to eat or drink during the study visit except for 
when directed by study staff. 
 
9. Subjects will self-administer 1-2 sprays into their mouth using the first sample 
assigned based on the randomization card. 
 
10. Subjects will be asked to answer 1 question regarding mouth dryness at 5-, 15- 
, 30-, 60-, 120-, and 240-minutes post single dose, using a Visual Analog 
Scale (VAS) assessment format and a PPAQ format of none/no relief, not 
enough, some/good, very good, significant/excellent. 
 
11. Also, subjects will be asked to answer an additional PPAQ on the secondary 
endpoints at 5-, 15-, 30-, 60-, 120-, and 240-minutes post single dose using a 
format- poor, fair, good, very good, excellent. 
 
12. The subjects will be given a subject diary and instructed to record frequency 
of use, number of sprays, and any side effects and/or adverse events they 
experience while using their assigned study product. 
 
13. Subjects will be instructed to use the product at home for 7 days. They will be 
scheduled to return to the clinic with their product container and subject diary. 
They will present for their follow-up appointment without having taken any of 
their sample product. 
 
14. Subject will be instructed on restrictions during the study regarding food, 
medicine, oral care products, gum, hard candy. 
 
15. Subjects will be instructed to use the product at home at least 1X/day. 
 
16. Subjects will be instructed to call the clinic if they experience any adverse 
events. 

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17. Subject will be scheduled for a 1-hour appointment on the 7th day of Baseline 
Period 1 treatment. 
 
Visit 4 - End of Treatment Period 1 
 
1. Subjects will not be allowed to eat or drink during their study visit except 
when directed by study staff. 
 
2. Confirm there were no changes to medications. 
 
3. Photographs may be taken of the subject’s mouth for publication and/or 
research development purposes. No diagnosis, treatment, or decisions will be 
made from the photographs. 
4. A study examiner will perform an oral exam and perform an assessment using 
the Challacombe-Scale to determine the severity level of dry mouth. 
5. Subject will be asked to complete questionnaire on product efficacy, usability 
and acceptability. 
 
6. Subjects will return the sample bottle, to the research staff who will record its 
weight. They will also return their completed diary to the clinic research staff. 
 
7. Subjects will be instructed on restrictions during the study regarding food, 
medicine, oral care products, gum, hard candy. 
 
8. Subjects will be instructed about the wash-out period and told to use only the 
oral care products supplied by the study staff for at least a 2-day wash-out 
period. Additional study-supplied oral products may be distributed if needed. 
 
9. Subjects will be scheduled to return in a minimum of 2-days for the period 2 
treatment. 
 
Visit 5-Baseline Period 2 
1. Confirm subject completed the 2-day wash-out period. 
 
2. Confirm there were no changes in medications. 
 
3. Subjects will not be allowed to eat or drink during the scheduled study visit 
except when directed by study staff. 

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4. Photographs may be taken of the subject’s mouth for publication and/or 
research development purposes. No diagnosis, treatment or decisions will be 
made from the photographs. 
 
5. Subjects will be asked to complete a Dry Mouth Inventory (DMI) 
questionnaire to document their opinion on their severity of dry mouth prior to 
any dosing. 
 
6. Subjects will be asked to complete a Visual Analog Scale (VAS) for mouth 
dryness for a baseline mouth dryness score prior to any dosing. 
 
7. A study examiner will perform an oral exam and perform an assessment using 
the Challacombe-Scale to determine the severity level of dry mouth prior to 
any dosing. 
8. Subjects will be placed into their Period 2 treatment group. 
 
9. Subjects will self-administer a 1 to 2 spray dose into their mouth of their 
assigned sample product. 
 
10. Subjects will be asked to answer 1 question regarding mouth dryness at 5-, 15- 
, 30-, 60-, 120-, and 240-minutes post single dose, using a Visual Analog 
Scale (VAS) assessment format and a Product Performance Attribute 
Question (PPAQ) format of none/no relief, not enough, some/good, very 
good, significant/excellent. 
 
11. Also, subjects will be asked to answer an additional PPAQ on the secondary 
endpoints at 5-, 15-, 30-, 60-, 120-, and 240-minutes post single dose using a 
format- poor, fair, good, very good, excellent. 
 
12. The subjects will be given a subject diary to record frequency of use, number 
of sprays, and any side effects and/or adverse events. 
 
13. Subjects will be instructed to use the product at home for 7 days and return to 
the clinic with the randomized sample and subject diaries on the 7th day prior 
to any doses of the randomized sample have been administered. 
 
14. Subject will be instructed on restrictions during the study regarding food, 
medicine, oral care products, gum, hard candy. 
 
15. Subjects will be instructed to use the product at home at least 1X/day. 

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16. Subjects will be instructed to call the clinic if they experience any adverse 
events. 
 
17. Subject will be scheduled for a 1-hour follow-up appointment on the 7th day 
of period 2 treatment. 
 
Visit 6-End of Treatment Period 2 
 
1. Subjects will not be allowed to eat or drink during the study visit except for 
when directed by study staff. 
 
2. Confirm there were no changes to medication. 
 
3. Photographs may be taken of the subject’s mouth for publication and/or 
research development purposes, no diagnosis, treatment or decisions will be 
made from the photographs. 
4. A study examiner will perform an oral exam and perform an assessment using 
the Challacombe-Scale to determine the severity level of dry mouth. 
5. Subjects will return the sample bottle, to the research staff who will record its 
weight. They will also return their completed diary to the clinic research staff. 
 
6. Subject will be asked to complete various questionnaire regarding product 
efficacy, usability, acceptability and preference. After these questionnaires 
are completed the subject has completed the study. 
 
7. No further follow-up will be required, unless an adverse event occurred. In the 
case of an AE, the subject should continue to be followed until the AE has 
resolved. 
 
See Appendix A for a table that summarizes the protocol procedures that will be 
performed at screening and for treatment. 
 
5.2 
Medication(s)/Treatment(s) Permitted 
Subjects will not be permitted to take new or change the dosing of medications at the 
time of randomization that will change their dry mouth conditions during the study. 
Otherwise, there will be no medication or treatment restrictions for the duration of the 
study. Subjects will be expected to only use dry mouth oral care relief and oral 
hygiene study products provided. In general, subjects will not be permitted to use 
non-study products that affect, exacerbate or alleviate their dry mouth symptoms 
other than the study products provided. 

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6. 
Assessment of Efficacy 
 
6.1 
Efficacy Parameters 
• Primary endpoint 
o Mouth dryness 
• Secondary endpoints 
o Feels comfortable in the mouth 
o Effectively lubricates the mouth 
o Soothing to the mouth 
o Effectively moistens the mouth 
• Acceptance questionnaire 
o Likeability of flavor and mouth feel 
o Helps with eating, chewing, swallowing and speech difficulties 
o Fights malodor 
o Helps freshen breath 
o Improves my quality of life 
• Usability questionnaire 
6.2 
Assessment Methods 
Oral Tissue Exam 
An oral tissue exam conducted by the study examiner will be completed at all visits to 
assess the soft palate, hard palate, oral mucosa, attached gingiva, tongue, sublingual 
and submandibular areas, salivary glands, tonsillar and pharyngeal areas, and teeth. 
Assessment responses will be given as Normal or Abnormal. 
 
Salivary Flow Testing 
Modified Schirmer tear strip Test (MST) - Testing with unstimulated saliva flow rate 
taken during the baseline period 1 visit (after wash-in and water only evaluation 
visits) to understand if the subject has hyposalivation and further characterize the 
study population. 
 
This is an objective assessment where subjects are asked not to eat, drink, chew 
tobacco, chew gum, smoke, brush or floss teeth for 2 hours prior to Baseline Period 1 
study visit. Test strips are placed on the floor of the mouth for 3-minutes to measure 
unstimulated flow rates. A calibrated paper that has an indicator that shows the 
amount of saliva present.5,6 
 
Challacombe Scale 
The Challacombe Scale will be conducted prior to any dosing at all visits. Subjects 
with a score of 0 will not be enrolled in the study. Subjects with a score of 1 or 
greater, will be enrolled. 

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This is an objective assessment to stratifying subjects into 3 groups representing their 
severity of dry mouth symptoms. A study examiner will conduct an oral exam and 
evaluate 10 symptoms. This scale works as an additive score of 1 to 10: 1 being the 
least and 10 being the most severe. Each symptom that is present is given a score of 
1. 
 
Dry Mouth Inventory 
Dry Mouth Inventory (DMI) will be conducted for each sample at the Water Only 
Evaluation visit and the Baseline Period 2 visit prior to any dosing. 
 
This assessment is to understand the subject’s opinion on their severity of dry mouth. 
Subjects will be asked to respond to 4 symptoms of dry mouth: 
1. No moisture in the mouth 
2. Lips sticking to the teeth 
3. Tongue sticking to the roof of mouth 
4. Throat dryness 
 
This is an accumulative total score on a 6-point scale: Disagree (0), Disagree a little 
(0), Strongly Disagree (0), Agree a little (1), Agree (2), Strongly Agree (3). 
 
Primary endpoint 
The primary endpoint is relief of dry mouth, it will be scored using the Visual Analog 
Scale (VAS) – 10 cm long where the subject will score their mouth dryness. The 
anchor points of the scale are 0 represents “normal” (i.e., no dry mouth symptoms), 
and 10 representing “the worst imaginable” dry mouth symptoms. 

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Use the VAS prior to dosing at the Water Only Evaluation visit and all remaining 
visits. 
 
The primary endpoint of relief of dry mouth, post dosing, will also be evaluated by 
using a 5-point ordinal scale where none/(no relief) (1), not enough (2), some/good 
(3), very good (4), significant/excellent (5) are used. 
 
This will be used after dosing on the Water Only Evaluation visit and Baseline 1 & 2 
visits. 
 
Secondary endpoints 
Secondary endpoints will be scored using a 5-point ordinal scale where Poor (1), Fair 
(2), Good (3), Very Good (4) and Excellent (5) are used. Secondary endpoints are the 
formulation: feel comfortable in the mouth, effectively lubricates the mouth, soothing 
to the mouth and effectively moistens the mouth. 
 
Use the 5-point ordinal scale to assess each sample at the Water Only Evaluation and 
sample evaluation visits after 1 dose at 5-minutes, 30-minutes, 60-minutes, 120- 
minutes, 240-minutes. 
 
Also used to assess secondary endpoints will be the Visual Analog Scale (VAS) – 10 
cm long where the subject will score their mouth dryness. The anchor points of the 
scale are 0 represents “normal” (ie, no dry mouth symptoms), and 10 representing 
“the worst imaginable” dry mouth symptoms 
 
It will be used at the Water Only Evaluation and Baseline 1 & 2 visits, after 1 dose at 
5-, 30-, 60-, 120-, 240-minutes. 
 
Weigh bottles 
Weights taken prior to any dosing at Baseline, Period 1 and 2, and after dosing at the 
End of Treatment for both Period 1 and Period 2 visits. 
 
Subject Diary 
To record subject’s product use, any side effects, and adverse events if applicable. 
 
Product Usability Questionnaires 
This questionnaire will be completed for each sample at End of Treatment Period 1 
and End of Treatment Period 2 visits. 
 
Product Acceptability Questionnaires 
This questionnaire will be completed for each sample at End of Treatment Period 1 
and End of Treatment Period 2 visits. 

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For description of analysis see section 8.2.1. 
 
7. 
Assessment of Safety 
 
7.1 
Safety Parameters 
The principal measures of safety will be the incidence of adverse events reported during 
the study. 
Only treatment-emergent adverse event will be reported. 
Examples of anticipated adverse events are: 
• Temporary and mild, mouth or tongue sensations such as: 
o Numbness 
o Burning sensation 
o Tingling sensations 
o Taste alteration 
• Superficial tissue sloughing on the inner surface of the cheeks, which is transient and 
painless. 
 
7.2 
Adverse Events 
The Investigator is responsible for identifying adverse events that occur to each 
subject throughout the study and follow-up period. An adverse event can occur at 
any time during the conduct of the study, in any phase of the study or after the study 
is completed. An adverse event can be identified by the Investigator or reported by 
the subject. 
 
Note: The Federal Privacy Rule (HIPAA) specifically permits the use and disclosure 
of protected health information “without written authorization of the individual” 
when used for public health activities such as reporting adverse events, tracking 
FDA-related products, enabling recalls, repairs, replacements, lookbacks, or 
conducting post-market surveillance [45 CFR 164.512]. This use and disclosure is 
subject to the minimum necessary standard, i.e. “the minimum necessary to 
accomplish the intended use, disclosure, or request” [45 CFR 164.502(b)(1)]. 
 
Definitions 
 
● Adverse event (AE) means any undesirable clinical occurrence in a subject 
whether or not it is considered to be device or drug related. 
 
● Device-related adverse event (i.e., adverse device effect) is an AE considered 
by the Investigator to have a reasonable likelihood of being associated with 
the experimental device. 

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Serious adverse event is an adverse event or suspected adverse reaction which, in the 
view of either the investigator or sponsor, results in any of the following outcomes: 
Death, a life-threatening adverse event, inpatient hospitalization or prolongation of 
existing hospitalization, a persistent or significant incapacity or substantial 
disruption of the ability to conduct normal life functions, or a congenital 
anomaly/birth defect. Important medical events that may not result in death, be life- 
threatening, or require hospitalization may be considered serious when, based upon 
appropriate medical judgment, they may jeopardize the patient or subject and may 
require medical or surgical intervention to prevent one of the outcomes listed in this 
definition. 
● Serious adverse device effect is a device effect that has a serious adverse 
effect on health or safety causing hospitalization or prolonged hospitalization, 
or is life threatening or causes death. 
 
● Unanticipated adverse device effect is any serious adverse device effect on 
health or safety or any life-threatening problem or death caused by, or 
associated with a device if that effect, problem or death was not previously 
identified in nature, severity or degree of incidence in the investigational plan 
or application, or any other unanticipated serious problem associated with a 
device that relates to rights, safety and welfare of subjects. 
 
7.3 
Recording and Reporting 
 
The Investigator records each material-related adverse event on an Adverse Device 
Effect Record. Documentation includes the description, severity, seriousness, date of 
onset and resolution, relationship to the experimental material, action taken and 
outcome. 
 
The Investigator must promptly report an adverse device effect to the 3M Clinical 
Research Associate. If the adverse device effect is also considered by the Investigator 
to be serious and/or unanticipated, the Investigator must report it to the IRB as soon 
as possible and within IRB requirements. 
 
A serious AE involving a non-3M commercialized product is reported to the 3M 
study monitor and IRB. 
 
If a subject has no adverse device effect during the study, the absence of such must be 
recorded on the CRF. 
 
8. Statistics 
 
8.1 
Data Sets Analyzed 

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The intent-to-treat (ITT) data set will be the primary efficacy data set and will 
include all subjects randomized in the study. Subjects will be analyzed in the 
group to which they were randomly assigned. Subjects with missing post-baseline 
VAS scores will be included in the ITT analysis using appropriate input data sets 
and multiple imputation method. 
 
A second per-protocol (PP) data set will be defined excluding any subjects with 
major deviations or lack of compliance with taking their treatments. 
The major protocol deviations that will lead to exclusion from the per protocol 
data set include subjects missing the primary endpoint for one or both treatment 
periods, subjects not taking product for >= 2 days, and subjects taking excluded 
dry mouth products. 
Deviations not captured above that will result in exclusion from the PP analysis 
will be defined and justified in a blinded fashion. In addition, documentation will 
be made of these data classification decisions prior to data lock. 
 
8.2 
Statistical Methods 
The primary endpoint will be the paired-difference in VAS scores between 
experimental and active control product after 15 minutes of the first dose on the 
first day of the treatment period. 
 
8.2.1 Efficacy Analyses 
Primary efficacy analysis will be a mixed effects model of the VAS scores with 
baseline VAS (prior to first dose) included as a covariate and treatment group, 
period, and order assigned as fixed effects in the model. In addition, subject 
(group) will be included as a random effect in the cross-over model. 
 
If the upper 95% confidence limit of the difference in VAS scores (experimental- 
control) is <= 1.5 then non-inferiority of the experimental product relative to the 
control product will be declared. Simultaneous testing of non-inferiority and 
superiority will be carried out without inflation of alpha error, maintaining a one- 
sided 0.025 significance level. 
 
Secondary efficacy analyses: 
To control the type 1 error rate, a fixed sequence of non-inferiority/superiority 
testing of the VAS dry mouth score differences will be conducted in the following 
order if the primary analysis at 15-minutes post first dose shows Treatment A is 
non-inferior/superior to the control Treatment B: 
VAS dry mouth efficacy results immediately after use (within 5 minutes) 
VAS dry mouth efficacy results 30 minutes after use 
VAS dry mouth efficacy results 60 minutes after use 
VAS dry mouth efficacy results 120 minutes after use 

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VAS dry mouth efficacy results 240 minutes after use at baseline or at start of 
treatment period (after first sample dose) 
 
A comparison of Treatment A against water will be carried out using a mixed 
effects model. The model of the VAS scores will have the baseline VAS (prior to 
first dose) and treatment group as fixed effects, and subject (group) will be 
included as a random effect in the model. 
 
The responses on dry mouth relief, lubricating effects, soothing effects, 
comforting effects, and moistening effect, will be analyzed using a signed rank 
test for each of the two treatment arms at each time point. P-values will be 
adjusted using the Holm method for repeat testing done over time (5, 30, 60, 120 
and 240 minutes) for families of hypotheses 
 
Area under the curve (AUC) will be computed for the VAS endpoint and will be 
analyzed using an ANOVA model with baseline values, treatment group, order 
(or sequence) and period as fixed effects, and subject (group) as the random 
effect. 
 
8.2.2 Safety Analyses 
All adverse events (AEs) occurring after initiation of study treatment (treatment 
emergent AEs) will be summarized by severity, relatedness, overall and treatment 
group. AEs occurring during the screening period will be summarized separately. 
All AEs will be classified using the MedDRA dictionary. 
 
All verbatim descriptions will be listed for all AEs, along with information 
regarding onset, duration, severity, relationship to treatment, and action taken. 
 
Serious adverse events will be summarized and presented according to nature, 
time to onset, duration, relationship to treatment and outcome. 
 
Fisher’s Exact tests will be carried out to compare each preferred term between 
treatment groups. Testing will be carried out at a two-sided alpha level of 0.05. 
 
8.3 
Sample Size Justification 
When the sample size in each group is 33, a paired t-test with a one-sided 
significance level of 0.01 will have 90% power to reject the null hypothesis that 
the test is inferior to the standard in favor of the alternative hypothesis that the 
treatment is non-inferior when the expected mean difference is 0.5, assuming that 
the non-inferiority margin is 1.5 and the standard deviation of the differences is 
1.5. The sample size goal is inflated to 40 to allow for an approximately 15% 
drop out rate. 

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References: Mouly et al. Drugs Aging 2007; 24(11) and Mouly et al Journal of 
Clin Psychopharmacology; 27(5) 2007. The former reference documented that 
the mouth dryness VAS responses at baseline and Day 14 end of study varied 
with standard deviations of 1.5, which is the basis for the non-inferiority margin 
of 1.5 chosen. In addition, standard deviations of VAS differences were 0.4 in the 
latter reference. 
 
8.4 
Interim Analyses Planned and Criteria for the Termination of the Study 
There are no interim analyses planned for this study. 
 
8.5 
Procedures for Accounting for Missing, Unused, and Spurious Data 
Missing efficacy data will not be imputed. Subjects lost to follow-up or 
discontinued will not be replaced. 
8.6 
Deviations to Statistical Plan 
Any deviation from the original statistical plan will be described and justified in 
the final report. 
 
9. 
Monitoring 
 
3M, as sponsor of this study, is responsible for ensuring the proper conduct of the study 
with regard to protocol adherence and validity of the data recorded on the CRFs. 3M 
Company uses a risk-based approach to study monitoring. Protocol compliance and source 
data review will be conducted periodically (e.g., at a minimum of annually) by the assigned 
CRA. The progress of the study will be monitored by: 
 
• Periodic on-site review 
• Review of CRFs and source documents (e.g., patient hospital records, clinical charts, 
progress/doctor’s notes, oral exam results) 
• Telephone and email communications as needed 
 
The Investigator will give the 3M study monitor direct access to source documents that 
support data on the CRFs and make available such records to authorized 3M, quality 
assurance, IRB, and regulatory personnel for inspection and/or copying. 
 
Note: The Federal Privacy rule (HIPAA) specifically permits the use and disclosure of 
protected health information “to a person subject to the jurisdiction of the Food and Drug 
Administration (FDA) [e.g., study sponsor] with respect to an FDA-related product or 
activity for which that person has responsibility, for the purpose of activities related to the 
quality, safety, or effectiveness of such FDA-regulated product or activity” [45 CFR 
164.512(b)(1)(iii)]. 
 
10. Quality Control and Quality Assurance 

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3M is responsible for implementing and maintaining quality assurance and quality control 
systems through written standard operating procedures (SOPs) to ensure that this study is 
conducted, and data are generated, documented and reported in compliance with the 
protocol, GCP and regulations cited in Section 1.5 of this protocol. Study monitoring is 
carried out to accomplish this. 
 
A qualified individual designated by 3M, to evaluate study conduct and compliance with 
the protocol, SOPs, GCP and regulatory requirements, will conduct an independent audit of 
study records. (see ICH GCP Guidance E6 Parts 5.1, 5.19) 
 
11. Ethics 
 
This study will be conducted in accordance with the principles that have their origin in the 
Declaration of Helsinki, 21 CFR 50 (Informed Consent) and 56 (IRBs). 
The study will start only after approval of the protocol and consent form by the IRB. The 
approval letter or notice must contain the IRB name and identification number, meeting 
date, and sufficient information to identify the protocol and informed consent by name and 
number that were reviewed. 3M, prior to study initiation, must receive a copy of the IRB 
approval letter. 
 
12. Data Handling and Record Keeping 
 
12.1 
Study Personnel 
 
Prior to study initiation, the Investigator must provide 3M with a signed 
investigator agreement (Statement of Investigator). The agreement 
contains pertinent investigator information (e.g., qualifications, 
experience, etc.) as well as the Investigator’s commitment to conduct the 
study according to the protocol and all applicable state and federal 
regulations. 
 
12.2 
Pre-Study Documentation Requirements 
Prior to study initiation, the Investigator must provide 3M with the following 
documents: 
 
• Signed Statement of Investigator 
• Signed protocol including any amendments in place prior to study 
initiation 
• Curriculum vitae for the Investigator and any co-investigators 
• IRB approved consent form. 
• HIPPA Authorization form 
• IRB study approval letter 

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• IRB name, location and chairperson 
• Financial Disclosure documents per 21 CFR 54 
• Signed research agreement 
 
12.3 
Completion of Case Report Forms 
 
3M intends to use electronic data capture (eDC) software for this study. Sites will 
be trained on the eDC software prior to study enrollment. Each site will be 
provided with a manual, including instructions on how to complete the CRFs and 
how to make CRF corrections. Data may be recorded onto data collection sheets 
(provided by 3M) prior to data entry or may be entered directly into the eDC 
system. Once the forms are completed, the monitor will review the CRFs to 
assure accuracy and completeness. The Investigator must review and sign the 
CRFs for each subject in a timely fashion following completion. 
 
12.4 
Final Report 
3M will prepare and submit a Sponsor Final Report to all reviewing IRBs within 6 
months after study completion or termination [see 21 CFR 812.150 (b)(7)]. 
 
12.5 
Records, Reports and Retention Requirements 
The Investigator will maintain study records for a minimum of 2 years 
following completion of the study. Records that must be maintained by 
the Investigator include, but are not restricted to: 
 
• Signed study protocol, amendments, deviations 
• IRB approval of protocol, consent form, authorization form* waiver of 
consent and/or authorization and amendments to any of these documents 
• Applications to the IRB 
• Signed consent and authorization forms 
• Case report forms 
• Adverse event reports 
• Correspondence relating to the study 
• Sponsor Final Report 
 
*Note: “IRBs are not required to review and approve Authorizations under the 
Privacy Rule. Likewise, IRBs are not required to approve stand-alone 
Authorizations (i.e. Authorizations that are not incorporated into the informed 
consent document)”. [Institutional Review Boards and the HIPAA Privacy Rule, 
NIH Publication Number 03-5428, August 2003.] However, IRBs may require 
approval of the Authorization form at their discretion. 

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13. Appendices 
 
13.1 
Appendix A - Study Schedule 
 
Screeni 
Water 
End of 
ng/Start 
Only 
End of 
Treatme 
Visit 
of 
Wash- 
Evaluati 
on 
Baseline 
Period 1 
Treatme 
nt 
Baseline 
Period 2 
nt 
Period 2 
In 
 
 
Period 1 
 
 
Subject Meets Inclusion/Exclusion Criteria 
X 
X 
X 
Subject Consented 
X 
Subject Authorization 
X 
Health History and Changes to Concomitant Medication 
X 
X 
X 
X 
X 
X 
Give directions for wash-in/out ≥ 2-day period with water only 
X 
X 
Distribute oral care supplies (initially or as needed for on-going 
study) 
X 
X 
Subject Scheduled for Next Visit; give appropriate directions 
X 
X 
X 
X 
X 
Subject Completed Wash-In ≥2-day period with Water Only 
X 
X 
Study Examiner Completes Oral Tissue Exam/Challacombe Scale 
X 
X 
X 
X 
X 
X 
Water Only Evaluation – subject swallows 15 ml of water 
X 
Subjects Randomized 
X 
Salivary Flow Testing 
X 
Photographs Taken (Selective) 
X 
X 
X 
X 
Subjects Complete Dry Mouth Inventory (DMI) prior to dosing 
X 
X 
Subjects Complete Visual Analog Scale for Mouth Dryness, prior 
to dosing 
X 
X 
X 
X 
X 
1-2 sprays of sample self -dosed by subject in clinic 
X 
X 
Subjects Completes Assessment for (post single dose): 
VAS Form 
PPAQ form 
Dry Mouth Relief 
X 
X 
X 
Subject Diary and take-home sample distributed, along with 
review of directions for take home use 
X 
X 
Subject Diary Collected 
X 
X 
Experimental Sample Spray Bottle Weighed 
X 
X 
Experimental Sample Spray Bottle Collected and Weighed 
X 
X 
Adverse Events Assessed 
X 
X 
X 
X 
X 
Usability and Sample Acceptance Questionnaires 
X 
X 
Preference Questionnaire, Study Discontinuation or Completion1 
X 
1to be completed at the final visit or at any time the subject is prematurely discontinued 
An unscheduled visit may occur at any time during the study that may require a spray bottle replacement, protocol deviation, adverse event, or 
oral examination forms to be filled out 

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Clinical and Non-Clinical: CLIN-INDEX-3M-SPON-US-11-050038 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
 
 
 
 
 
 
 
 
 
 
 

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Clinical and Non-Clinical: CLIN-INDEX-3M-SPON-US-11-050038 
 
 
 
 
 
 
 
 
 
 

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13.3 Appendix C – References 
 
1. Anderson G, Johansson G, Attstrom R, et al. Comparison of the effect of the linseed 
extract Salinum and methyl cellulose preparation on the symptoms of dry mouth. 
Gerodontology. 1995;12:12-17. 
2. Locker D. Xerostomia in older adults; a longitudinal study. Gerodontology. 1995;12:18- 
25. 
3. Fox PC. Management of dry mouth. Dent Clin North Am. 1997;41:863-875. 
4. Guijarro Guijarro B, Lopez Sanchez AF, Herandex Vallejo G. Treatment of xerostomia. 
A review. Med Oral. 2001;6:7-18. 
5. Fontana M, Zunt S, Eckert GJ, Zero D. A screening test for unstimulated salivary flow 
measurement. Operative Dentistry. 2005; 30(1):3-8. 
6. Zunt, S. Oral health care for cancer patients. Determining and managing salivary gland 
function in cancer patients: a fact sheet for dental professional. 2010.