Exploratory Study on Effect of Whitening Agent With Emulsion Gel in Xerostomic Population
Phase: NA
Conditions: Xerostomia
Sponsor: Tufts University

Confidential 
 
 
 
 
 
 
 
 
Exploratory Study on Effect of Whitening Agent with Emulsion Gel in 
Xerostomic Population 
___________________________________________________________ 
 
 
 
Principal Investigator:   Mabi Singh, DMD, MS 
 
Co-Investigators:  
Athena Papas, DMD, PhD 
 
 
 
 
 
Study Coordinators: 
 
 
 
 
Elizabeth Tzavaras , AS, CDA, CCRP 
 
 
 
 
Joseph Cimmino, BS, CCRP 
 
 
 
 
Tiffany Bairos, RDH 
Ann-Marie Billig 
 
 
Study Location: 
 
Tufts University School of Dental Medicine 
One Kneeland Street  
Boston, MA 02111 
 
Sponsor:        
 
Procter & Gamble               
    
 
 
 
Protocol Version Date:  4/14/2023 
 
 

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Mabi Singh, DMD, MS 
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I) Introduction 
A) Aim/Hypothesis/Objective 
Objectives: 
• Primary aim: To see a reduction in the self-reported subjective perception of dryness in 
the oral cavity.    
• Secondary aims: To measure self-reported sensitivity of the teeth, self-reported 
perception of teeth whiteness, and objective measurement of improvement of saliva 
production. 
 
 
II) Background and Rationale 
Xerostomia, is a subjective sensation of dryness of the mouth, which may have a significant 
effect in a persons quality of life. The sensation of dryness of the mouth may be caused by 
autoimmune diseases which attack the saliva producing glands irreversibly e.g., salivary glands, 
or the sensation of dryness could be caused by therapeutic radiation, which can destroy the 
salivary glands at the genetic level and impede their functions. Additionally, there are more than 
700 medications including antihypertensives, anti-anxiety agents, psychiatric remedies, and 
antihistamines that can effect neural transmission.  Neural transmission is when the neuro 
transmission is hindered reversibly leading to the salivary hypofunction that results in dry mouth. 
It is estimated that 12-47% of the elderly and 10-19.3% in their early 30's suffer from dry mouth 
(6)(7). In a study, it was found that the prevalence of xerostomia was 10.0% (with no apparent 
gender difference) among 32-year-olds and was significantly higher among those taking 
antidepressants (odds ratio =4.7) (5). At risk groups may present much higher (60+%) rates of 
xerostomia. A systemic literature review suggests a prevalence of 27 –32% of the medicated 
population suffer from xerostomia as a side effect (7). 
Saliva, the bulk fluid of the oral cavity is very important in maintaining the functions and 
balance in the oral cavity including candidiasis and enamel erosion prevention. In past studies, 
residual mucosal fluid levels were seen to vary in different oral cavity sites from an average of 
70–100 μm (2)(3). In addition, the vault of the hard palate has much less mucosal fluid thickness 
than the floor of the mouth. Over the moisture layer is the lipid layer and reduction or loss of this 

Exploratory Study on Effect of Whitening Agent with Emulsion Gel in Xerostomic Population  
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moisture layer can contribute to the subjective perception of the dryness in the mouth. An 
addition of the lipid layer will also increase lubrication in the oral cavity.   
Unstimulated salivary flow in dry mouth patients has shown an increased clinical oral dryness 
score and mucosal wetness is at a significantly reduced rate (p<0.05) when compared with 
healthy subjects (4). 
Historically, various products containing methylcellulose, water, oily emulsions etc., have 
been used to alleviate the subjective sensation of dryness in the oral cavity in the forms of rinse, 
gel, ointment and paste.  However, the alleviation of the dry mouth symptoms has been varied. 
This study will investigate a semi solid cohesive gel (referred to as Whitening Gel) that has 
the primary marketed purpose of teeth whitening. We theorize that the whitening gel’s retention 
in the oral cavity is longer than rinse forms and this is likely to promote the flow of saliva by 
stimulating taste buds which could alleviate the sensation of dryness in the oral cavity. 
 The study product contains an inert hydrophobic phase in an amount from 30% to 98%, 
preferably from 40% to 90% by weight of the composition. It also contains an emulsifying system 
in an amount from 1% to 10%, preferably from 3% to 7% by weight of the composition. 
P&G’s whitening gel emulsifying system is comprised of at least one surfactant having an 
hydrophilic-lipophilic balance (HLB) <10, preferably comprised between 3 and 7, and at least one 
surfactant with HLB>10, preferably comprised between 12 and 16.  
The optimal duration and frequency of application for whitening is up to 4 times a day. For 
the purpose of this study, the whitening gel will set on the subject’s teeth for 5 minutes during 
each use.  
The product being used is a commercially available product, known as “Crest Whitening 
Emulsions”, will be used as the investigative product. There will be no active control group. This 
is not the first time P&G whitening gel will be used in humans.  We do believe this is the first 
study investigating dry mouth sensation from using a whitening gel. 
 
III) Research Plan 
A) Experimental Design 
 

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This will be a single center, two visit study investigating the effectiveness of dryness in the 
oral cavity, whiteness of teeth, and teeth sensitivity after one week’s use of whitening 
agent. 
 
B) Sample Size and Statistical Analysis 
 
Sample size  
This is a single site study. All study-related procedures will take place at TUSDM. Based on 
our preliminary data from a previous study, we anticipate 25 subjects will be needed to 
achieve the necessary statistical power required to observe expected differences in relief 
of dryness in the oral cavity. Because we anticipate the potential of many screen failures 
due to the VAS scale and saliva production requirements outlined in the 
exclusion/inclusion criteria section, we will screen/enroll a total of 100 subjects to 
conservatively account for potential dropouts or screening failures.   
 
 
Statistical analysis 
The subjects will be asked to complete one questionnaire each visit. Completing the first 
part before the application of the study product, and completing the second part after 
the application of the study product, as directed on the questionnaire. The self-reported 
scores from the visual analogue scales (VAS) will be considered on the first and final 
visit. The salivary flow before and after the application of the product, Pre & Post-
Product Use Dry Mouth & Sensitivity Questionnaire before and after the product 
application will be compared using a student -t test method. The same method will be 
used to make comparisons of these gathered data points between the first and final 
visits.    
 
Randomization 
This will be an open label study; thus no randomization plan is necessary. 
 
Blinding  
There will be no blinding for this study. 
 
C) Products 

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The investigational product to be used in this study is manufactured by P&G and called, “Crest 
Whitening Emulsions”. The amount of each dose should be enough to cover the entire tip of the 
whitening wand, approximately ½ a tsp. The use of the study product in this study will be for 
what they are approved for. Per the manufacturer’s instructions, study subjects will be asked to 
apply the study product up to 4 times a day. 
 
Procter and Gamble will be supplying the study product gel to the study team. IDS will not be 
involved in this study.  
 
 
The investigative product to be used in this study is a hydrophobic emulsion containing agent (a 
teeth whitening gel with emulsification gel). It contains: 
Petrolatum, Water, Hydrogen Peroxide, Flavor, Sucralose, Sorbitan Palmitate 
 
 
D) Subject Characteristics 
1) Inclusion Criteria 
− At least 18 years of age. 
− The inability to produce more than < 0.18mL/min of unstimulated saliva. 
− Score of 5 or more on question 1 of the VAS dry mouth scale (How severe 
is your dryness right now?), evaluated in the Pre-Product Use Dry Mouth 
& Sensitivity Questionnaire . 
− Evidence of currently taking Xerostomia-inducing medication such as, 
antihypertensives, anti-anxiety agents, psychiatric remedies, 
antihistamines. 
− Subject not currently using any teeth whitening or desensitizing products 
that contain potassium nitrate such as Sensodyne or Pronamel. 
− Subject willing to comply with the study regimen and products. 
 
2) Exclusion Criteria 
− Subjects who are currently pregnant (self-reported). 
− Subjects able to produce more than 0.18mL/min of unstimulated saliva  

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− Subjects that have ever received therapeutic radiation in the head and 
neck area. 
− Subjects with a diagnosis of conditions that would affect salivary flow 
such as Sjogren’s Syndrome. 
− Subjects with a condition the investigator believes not suitable for the 
study such as autoimmune diseases that impact salivary flow. 
− Subjects that currently use whitening toothpaste, desensitizing 
toothpaste, or any other products causing similar results. 
− Subjects currently participating in any other research studies. 
− Subject unable to provide consent (ex. Cognitively impaired adults). 
− Non-English speaking  
 
3) Subject Withdrawal/Termination Criteria 
− Subjects who do not comply with the study procedures, such as use of 
teeth whitening products, may be withdrawn from the study. 
− The study team may terminate subjects if they no longer fulfill inclusion 
criteria, if an exclusion criterion is met, or if they do not show up for 
scheduled study visits.   
− Subjects who experience an unanticipated adverse drug effect will be 
withdrawn from the study. 
− Subjects unable to complete the study procedures due to a medical 
condition such as dry mouth and sensitivity conditions that result in the 
inability to capture meaningful data during the study procedures.  
− Subjects may choose to withdraw from the study at any time.  
 
Subjects may remain patients of TUSDM if they decide to withdraw from the 
study or are withdrawn by the study team.   
 
If during the course of their participation in the study, a subject chooses to 
withdraw or is withdrawn by the research team, any data that has been 

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collected will not be included in the analysis and the subject will be asked to 
return any leftover whitening gel and the diary. The subject is able to keep the 
toothpaste and toothbrush. 
 
Subjects will not be able to partially withdrawal from study intervention and 
just be involved with continued data collection. 
 
The Principal Investigator will determine whether subjects (either withdrawn 
subjects or subjects completing the study) are in need of additional treatment 
and/or follow-up observation as a result of participation in this trial and will refer 
them to their primary care provider for further care. Subjects and/or their 
insurance will be responsible for the cost of any standard of care follow-up visits 
or additional treatment that is not part of this study. 
 
4) Vulnerable Populations 
Transgender subjects will be recruited as part of this study. All subjects will be asked 
on the Medical/Dental History Form to identify their sex, to which they will answer 
however they choose. They will not be sought out or targeted for participation and 
will not be discriminated against as a result of their sexual orientation/gender 
identity. The subjects will not be asked to disclose if they are transgender or not on 
the Medical/Dental History Form. 
 
Cognitively impaired adults and pregnant adults will not be enrolled in this study. 
There would be no direct benefits to these specific vulnerable populations by 
enrolling them. Pregnancy will be determined through self-reporting. 
 
 
Non-English speakers will be excluded from the study because the study team does 
not have validated questionnaires developed in multiple languages. The study team 
also does not have the resources to translate the take home diary or manufacturer’s 

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instructions. In addition, the visual demonstration of the application of the study 
product will not be able to be effectively translated using the Interpreter Machine 
available at TUSDM. There are no physical translators available at TUSDM to assist in 
translating the visual demonstration. There are no direct benefits to this population 
by participating in this study. 
 
 
E) Assessment 
1) Risk 
 
The standard risk associated with teeth whitening products   include causing gum 
irritation, gum or teeth bleaching, teeth sensitivity, and irritation of the oral mucosa 
(cheeks, lips, tongue).  In addition, there is a risk of irritation or whitening from contact 
with skin from using this study product. Subjects may also feel discomfort when they 
abstain eating or drinking before the study visit. 
 
There is the risk of loss of confidentiality to the subject by participating in this study.  
This risk will be kept to a minimum by following procedures listed under 
confidentiality section. 
 
2) Benefits 
 
There is no direct medical benefit to the subject for participation in this study. 
However, the results of the study will help better understand whether the application 
of hydrophobic emulsion containing agents have a beneficial effect in alleviating 
subjective sensation of mouth dryness along with teeth whitening in a Xerostomic 
population. The results of this study will help in understanding the contributing factors 
that alleviate dry mouth and increase esthetics through whitening of teeth. 
 
3) Alternatives 
Patients may choose not to participate in the study and to receive the standard of 
care treatment for dry mouth at TUSDM at normal clinic fees. 

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F) Study Procedures 
 
Visit 1 (1-1.5 hours) Screening/ Baseline (Day 0) 
1. Subject will be called 1-2 days before their appointment to confirm that in order 
to participate, they must: 
a. Not consume alcohol for 24 hours prior to their visit. 
b. Not brush their teeth for 1.5 hours prior to their visit. 
c. Not have had anything to eat or drink (including chewing gum or eating 
candy) for 1.5 hours prior to their visit). Water is acceptable to drink up to 
1 hour prior to the study visit. 
d. Not smoke 1.5 hours prior to their visit. 
2. The subjects will be asked to read the informed consent form (ICF). Subjects will 
be given ample time to have any questions answered. If a subject decides to 
participate, he or she will be asked to sign the ICF. A copy of the ICF will be given 
to the subject. 
3. Subject will be asked to complete demographic information and a medical history. 
4. An oral exam, including evaluation of oral cavity, soft and hard tissues, will be 
completed following standard of care procedures in US dentistry using a mouth 
mirror and dental explorer. 
5. Subject medications with potential side effects being dry mouth will be verified 
using the Physician’s Reference Desk. 
6. Saliva Collection 1 (pre-product application): Saliva will be collected by asking 
subjects to do nothing but drool into a pre-weighed vial for 5 minutes (referred to 
as the Drooling Method). The post collection weight will be subtracted from the 
pre-weight to determine the flow rate. The saliva samples will be discarded after 
they are weighed. 
7.  A paper questionnaire will be given to subject to complete before application of 
study product and after application of study product. Questionnaire includes 
Visual Analogue Scale (VAS) questionnaire on dry mouth, quantity of saliva, and 
perceived sensitivity of teeth. 

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8. Inclusion/exclusion criteria will be evaluated and eligibility for the study will be 
determined. 
9. Demonstration and application of study product:  
a.  A visual and oral demonstration of application of the whitening gel will be 
performed by a study team member. The script for the demonstration will 
be the one provided in the information packet in each study product box 
so the subject can bring the instructions home. The study team member 
will mimic the necessary steps to properly apply the gel, without using the 
product. The study team member will then have the subject complete the 
steps while applying the gel to their own teeth. Subjects will then be asked 
to sit for 5 minutes to let the gel set on their teeth.  
10. Saliva Collection 2 (post-product application): Saliva will be collected using the 
same Drooling Method as Saliva Collection 1.  The saliva samples will be discarded 
after they are weighed. 
11. Photographs of subject teeth will be taken by a standard dental camera. The 
photos will only contain subject teeth and oral cavity with no subject identifiers 
visible. In addition to the ICF, the subjects will be asked to sign a photo release 
form. If the subject does not wish to sign this form, their photographs will not be 
taken. Those who do not consent to having their photos taken will be tracked in 
the enrollment log. Photographs will be taken pre-application of the study product 
at visit 1. 
12. Distribution of study product and diary: One box of study whitening gel product,  
(0.88Oz) toothpaste, and a toothbrush will be dispensed by study team members. 
This is to ensure all participants are using the exact same dental products during 
the trial period.  The subjects will be asked to not use any other oral tools or 
products during the trial period aside from the ones distributed by the study team 
at Visit 1. A diary will also be dispensed for the record keeping of the application 
of the products. A study team member will again verbally tell the participant the 
instructions that are provided with the study product and that per the 

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instructions, they can apply the product up to 4 times per day until their next study 
visit. The same script from step 9.a. will be used. 
13. Gift card will be distributed upon successful completion of visit. 
 
Visit 2 (1-1.5 hours) Final Visit - 7 ∓ 2 days after visit 1 
 
1. Subject will be called 1-2 days before their appointment to confirm that in order 
to participate, they must: 
a. Not consume alcohol for 24 hours prior to their visit. 
b. Not brush their teeth for 1.5 hours prior to their visit. 
c. Not have had anything to eat or drink (including chewing gum or eating 
candy) for 1.5 hours prior to their visit). Water is acceptable to drink up to 
1 hour prior to the study visit. 
d. Not smoke 1.5 hours prior to their visit. 
2. Medical history will be reviewed, and any changes will be noted. Any changes to 
medications will also be reviewed and noted. 
3. Eligibility and subject withdrawal criteria will be reviewed to ensure the subject 
still qualifies for the study. 
4. Subject medications with potential side effects being dry mouth will be verified 
using the Physician’s Reference Desk. Subjects will be asked to confirm that they 
have taken their medications as prescribed since Visit 1. 
5. An oral exam, including evaluation of oral cavity, soft and hard tissues, will be 
completed following standard of care procedures in US dentistry using a mouth 
mirror and dental explorer.  
6. Saliva Collection 1 (pre-product application): Saliva will be collected using the 
drooling method for 5 minutes into a pre-weighed vial. The post collection weight 
will be subtracted from the pre-weight to determine the flow rate. The saliva 
samples will be discarded after they are weighed. 
 
7. The paper questionnaire will be given to subject to complete before application 
of study product and after application of study product. The questionnaire 

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includes the Visual Analogue Scale (VAS) questionnaire on dry mouth, quantity of 
saliva, and perceived sensitivity of teeth.  
8. Application of study product: A study team member will ask the subjects to apply 
the gel to their teeth. Subjects will then be asked to sit for 5 minutes to allow the 
gel to set on their teeth.  
9. Saliva Collection 2 (post-product application): Saliva will be collected using the 
same drooling method as Saliva Collection 1. The saliva samples will be discarded 
after they are weighed. 
 
10. Photographs of subject teeth will be taken by a standard dental camera. The 
photos will only contain subject teeth and oral cavity with no subject identifiers 
visible. Photographs will be taken post-application of the study product at visit 2.  
11. The study diary and any leftover whitening gel product will be collected. 
12. Gift card will be distributed upon successful completion of visit. 
 
 
 
 
Screening/ Baseline Visit 
Day 0 
Visit 2 
Day 7 (±2 days) 
Informed Consent Form 
x 
 
Demographics  
x 
 
Collect and/or Review Medical History  
x 
x 
Review eligibility and withdrawal criteria 
 
x 
Confirmation of Xerogenic Medications  
x 
 
Pre-Product Use Dry Mouth & Sensitivity 
Questionnaire  
x 
x 
Post-Product Use Dry Mouth & Sensitivity 
Questionnaire 
x 
x 
Unstimulated Salivary Test 
x 
x 
Oral Exam  
x 
x 
Evaluate eligibility criteria 
x 
 
Oral Photographs 
X (Pre-Application) 
X (Post-Application) 
Demonstration of Product Use 
x 
 
Product Usage 
x 
x 
 
 
 

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Post Product Use Unstimulated Salivary Test 
x 
x 
Product Distribution or Collection 
x 
x 
Adverse Event Reporting (if applicable) 
x 
x 
Stipend 
x 
x 
 
 
G) Subject Safety  
1) Adverse Event Reporting 
Adverse Events 
An adverse event is any untoward or unfavorable medical occurrence in a human 
subject, including any abnormal physical exam or laboratory finding, symptom, or 
disease, temporally associated with a subject’s participation in the research.  
 
Adverse events will be recorded in source documents and on case report forms. All 
adverse events and non-serious situations will be recorded, monitored, and reported 
to the IRB at time of continuing review or at the study’s termination if this occurs 
before the study’s next continuing review.  
 
Serious Adverse Events  
A serious adverse event is one that results in death, or is life-threatening, or results in 
hospitalization or prolongation of existing hospitalization, or results in a persistent or 
significant disability/incapacitation, or results in a congenital anomaly/birth defect, or 
may jeopardize the subject’s health and may require medical or surgical intervention 
to prevent one of the other outcomes listed above. 
 
Serious adverse events will be recorded in source documents and on case report 
forms. Serious Adverse Events that meet the criteria of an unanticipated problem will 
be reported to the IRB within 5 business days following the Reportable New 
Information Policy. Serious Adverse Events not meeting the criteria for an 
unanticipated problem will be reported to the IRB at time of continuing review or at 
the study’s termination if this occurs before the study’s next continuing review. 

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Unanticipated Problems 
An unanticipated problem is an incident, experience, or outcome that meets all of the 
following criteria: 1) The nature, severity, or frequency is unexpected for the subject 
population or research activities as described in the current IRB approved protocol, 
supporting documents, and the ICF(s); 2) it is related or possibly related to 
participation in the research; 3) it suggests the research may place the subject or 
others at a greater risk of harm then was previously recognized. 
 
Unanticipated problems will be recorded in source documents and on case report 
forms. Unanticipated problems will be reported to the IRB within 5 business days after 
the PI/study team becomes aware of the problem. A Reportable New Information 
Form will be submitted to the IRB no later than 5 business days after the PI/study 
team becomes aware of the problem. 
 
Unanticipated Adverse Device Effects (UADEs)  
Unanticipated adverse device effect means any serious adverse 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 (including a 
supplementary plan or application), or any other unanticipated serious problem 
associated with a device that relates to the rights, safety, or welfare of subjects.  
 
UADEs will be documented in source documents and on case report forms as to onset, 
severity, duration, management, outcome and relatedness to the test device. UADEs 
will be reported to the IRB within 5 business days after learning of the effect. 
 
H) Subject Participation 
 
1) Screening 

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The PI/CO-I (Dr. Mabi Singh and Dr. Athena Papas) will conduct screening 
examinations to identify subjects who meet the inclusion / exclusion criteria for 
enrollment into the study. 
 
2) Informed Consent 
 
The PI or his representative will introduce the study.  Consenting will take place in a 
private clinic room at on the 14th floor of Tufts University School of Dental Medicine 
(TUSDM) and the patient will be given as much time as they need to consider 
participation or have any questions answered by the PI. The participant will be invited 
to include or exclude any associates (e.g., loved ones) in the consent process.  
 
Patients will be asked to read the consent form and be given ample opportunity to 
have their questions answered.  To avoid coercion, the consenting investigator will 
read through the copy of the consent form with the participant section by section, 
making sure the participant understands each section and has an opportunity to ask 
questions.  If at any time the participant indicates they are not interested in 
participation, the meeting will end.   
 
If after going through the consent form, the participant indicates they would like to 
discuss the study with associates or think about participating, then the meeting will 
be ended, and the participant will be asked to contact the study when they make their 
decision. If the participant contacts the study in the future for participation, they will 
be invited back to the clinic, and if informed consent is given at that time, study 
activities will begin then. 
 
If the participant indicates they may be interested in participating after going through 
the consent form with the investigator, and the investigator determines the 
participant has the capacity to provide informed consent, the participant will be asked 
to provide informed consent at that time. Written consent will be obtained following 

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“SOP: Written Documentation of Consent (HRP-091)” and we will follow the “SOP: 
Informed Consent Process for Research (HRP-090).” Patients will certify their 
willingness to participate in the study by signing and dating the IRB approved informed 
consent document.  The subject will be given a copy of the consent form.    
 
If any new finding requires any change to the informed consent form, the subject will 
be reconsented. 
 
 
 
Study Location: 
Tufts University School of Dental Medicine 
 
3) Personnel 
 
All study personnel will be GCP and CITI certified and trained on all their roles, 
responsibilities, and study procedures. 
 
I. 
Ongoing communication with the IRB and sponsor– The PI 
II. 
Subject Recruitment – The PI or his representative 
III. 
Obtaining Informed Consent – The PI, Co-I, or a study coordinator, who is CITI 
and GCP trained, will obtain informed consent.   
a. The PI or CO-I will be available to answer any medical questions the 
subject may have. 
IV. 
Conducting inclusion/exclusion evaluation – the PI or CO-I 
V. 
Saliva collection, questionnaire dissemination, product use demonstration 
and dissemination – The PI or his representative 
VI. 
Maintaining participant’s research records – The PI  
VII. 
Monitoring and reporting of adverse events – The PI 
 
 
4) Payment for Participation 
 
(a) Compensation 

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Subjects will be given a $75 Target gift card upon successful completion of each study 
visit. In total, subjects will receive $150 for their full participation in the study, as long 
as they attend both visits and are not withdrawn. Subjects that withdraw before either 
study visit is completed will not be provided a parking voucher.  Subjects who fail to 
meet the inclusion criteria of the study will receive a $25 Target gift card. 
 
(b) Transportation 
− Travel reimbursement and transportation costs.   
Subjects will be provided a parking voucher to accommodate their parking 
needs at TUSDM at the successful completion of each study visit. 
 
(c) Costs and Insurance 
 
Neither the subject, nor their insurance company, will be billed for any 
study procedures.  
 
5) Study Results 
Subjects will not receive information regarding the results of the study. 
 
A final report and results will be transferred to the sponsor when requested. Individual 
data will not be transferred. The study team will consult with Tufts 
University Technology Transfer to determine whether an agreement is needed to permit 
the transfer of data/specimens, and an agreement (e.g., contract, Clinical Trial 
Agreement, Collaboration Agreement, Data Use Agreement (DUA), or Material Transfer 
Agreement (MTA)) has been or will be established that will cover any transfer of 
data/specimens, and the agreement will be executed prior to any transfer.   
 
Study records will be retained for the timeframe described in the record retention policy of the 
“SOP – Records Retention Timeframe – Investigators”. The study team will follow the 
“Confidentiality  and Data Security Guidelines for Electronic Research Data” for electronic data. 
 
6) Confidentiality 

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To ensure confidentiality of subject information, each subject enrolled in the study 
will be assigned a unique alphanumeric code. Subjects’ paper files will be kept in a 
secure, locked cabinet in a secure room (TUSDM 742 or 1418) when the files are not 
being reviewed. Coded items will be kept in a separate locked drawer in 742 or 1418 
from those with identifiers. The information will only be shared between the 
researchers on this study team. All HIPAA requirements will be followed. All 
electronic files will be kept on a password protected Tufts-encrypted computer in a 
secure, locked office.  
No information or samples collected as part of this study will be used or distributed 
for future research studies.  
 
 
(a) Coding 
Each subject will be assigned a subject identification number. Alphanumeric 
identification numbers will be assigned sequentially. This will be accessible by 
study personnel only.  
 
The study team will maintain a confidential list of the subjects separate from the 
consent forms, which will serve as a means of linking the subject ID number to the 
study records. This key between subject ID number and identifiable information 
will be kept in password protected document in Tufts BOX. The gift card receipt 
documents and parking vouchers, which have both subject ID and identifiers on 
them, will also be kept in a password protected Tufts Box Folder and/or in a locked 
cabinet in 742 or 1418 separate from coded subject files. All data used in analysis 
and reports will be used without identifiable reference to the subjects; only 
Subject ID will be used. Only the research team will have access to the key code 
for the subject ID numbers, study files, and data. No identifiable photographs will 
be recorded as part of this study. Genetic information will not be collected from 
the subjects for the purpose of this study.   The study data entry and study 
management systems used by Tufts University School of Dental Medicine research 

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staff will be secured and password protected. At the end of the study, all study 
databases will be archived at the Tufts University School of Dental Medicine. 
 
(b) Access 
Only study personnel will have access to data.  Investigators will permit 
monitoring, audits, and regulatory inspections and will provide direct access to 
study related documentation. The study sponsor will not have access to any 
identifiable data. 
 
8) Data Safety Monitoring Plan: 
Study personnel will monitor this trial for all safety related issues to determine 
whether an unreasonable risk to subjects develops. Quality control measures include 
routine inspection of case report forms, source documents, data tabulations, and 
tracking of adverse events. 
 
9) New Findings: 
The subject will be informed of any significant new findings discovered during the course of this 
study that might influence the subject’s continuation and participation in the study.  Subjects will 
be told at a study appointment or via telephone of new findings during the study. If new findings 
require revisions to the ICF, the subject will be re-consented. 
 
I) Record Retention 
1) Study Records 
The Principal Investigator will maintain all study records and documents during 
the study period.  All paper files and documents will be kept in a locked file cabinet, 
within a locked room, 742.  For electronic records, the study team will use Tufts 
BOX, which is HIPAA compliant, and data would only be accessible to study team 
members. 
  
2) Long Term Retention 
 
All study records will be kept for a minimum of 7 years after the study has ended as 
described in the record retention policy of the “SOP – Records Retention Timeframe 

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– Investigators”. All research records will be kept at Tufts University School of Dental 
Medicine, de-identified, and in a locked cabinet in office 742 for a minimum of two 
years after the study close. At the end of the two years, the research material can be 
sent to Iron Mountain for the remainder of the seven years.  The study team will 
follow the “Confidentiality  and Data Security Guidelines for Electronic Research 
Data” for electronic data. 
 
K) Reporting 
Unanticipated problems, adverse events, and RNI will be reported per the Tufts MC/TUHS 
IRB Reportable New Information Policy.  
The IRB will be notified of any deviations from the protocol in cases of medical 
emergencies when the change is necessary to eliminate an apparent immediate hazard 
to the subject.  
Progress reports on the investigation shall be submitted to the IRB at regular intervals, 
but in no event less often than yearly, e.g., at continuing review. 
 
L) Protocol Deviations 
No protocol changes or deviations will be made without prior agreement by the IRB and 
study sponsor unless implemented to prevent an immediate hazard to subjects.  All other 
protocol changes or deviations will be made by a formal amendment subject to IRB 
approval.  All such changes or deviations will be reported to the IRB and sponsor as they 
occur and included in the final study report. 
M) Study Termination 
This study may be terminated for the following reasons:  
Discovery of unforeseen risk that could jeopardize the dental/physical well-being 
of subjects. 
Enrollment or recall rates that are not likely to produce sufficient data for 
evaluation of safety and efficacy. 
Non-compliance with the clinical investigational plan, the Investigator 

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Agreement, applicable FDA regulations or conditions of approval imposed by the 
reviewing IRB. 
Withdrawal of IRB approval.  
In the event of study termination, the Principal Investigator will determine whether 
subjects are in need of additional treatment and/or follow-up observation as a result of 
participation in this trial. 
 
N) Subject Recruitment/Advertising 
Paper flyers will be posted throughout TUSDM and Oral Medicine Clinic. Permission is not 
required for these posting locations. Flyers will remain posted until enrollment goals are 
met. Subjects will be recruited through responding to posted study advertisements.  
These posted advertisements will be visible to faculty, staff, students, and patients. 
Investigators may also inform clinic patients about the study.  
All of the forms of recruitment will be submitted for IRB approval prior to use.  
A phone screening script and voicemail script will be used for recruitment. When an 
interested subject responds to the recruitment material, they will be informed of the 
general purpose of the study, procedures that will take place, and study time 
commitment. The study coordinator will conduct a brief screening via phone to 
determine eligibility. During this screening call, the coordinator will collect subject name, 
telephone number, email address, and mailing address for future correspondence.  
Patients coming into the Oral Medicine Clinic for regularly scheduled visits will also be 
recruited. AxiUm maintains a computerized database of patient information of the Tufts 
Dental School.  Potential subjects will be identified and prescreened from the Oral 
Medicine Clinic patient list containing the ICD 10 code number # code R68.2, which is the 
diagnosis code for xerostomia. These patients will be recruited using the same phone 
script outlined above. In the event the subject does not answer the phone, a voicemail 
script will be used. Up to 3 attempts will be made to contact potential subjects. 

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Screen failure data will be retained by PI in a screening log using Subject ID #. Identifiable 
information will not be recorded in the screening log and study sponsor will not have 
access to it. 
 
O) References/Bibliography 
1.  Apperley, O., Medlicott, N., Rich, A., Hanning, S. and Huckabee, M.L. (2017), A clinical 
trial of a novel emulsion for potential use as a saliva substitute in patients with 
radiation‐induced xerostomia. J Oral Rehabil, 44: 889-895. 
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2. Collins LM, Dawes C. The surface area of the adult human mouth and thickness of the 
salivary film covering the teeth and oral mucosa. J Dent Res. 1987 Aug;66(8):1300-2. 
3. Pramanik R, Osailan SM, Challacombe SJ, Urquhart D, Proctor GB. Protein and mucin 
retention on oral mucosal surfaces in dry mouth patients. Eur J Oral Sci. 2010 
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4. Samira Osailan, Rashida Pramanik, Soha Shirodaria, Stephen J Challacombe, Gordon 
Burgess Proctor. Investigating the relationship between hyposalivation and mucosal 
wetness. Oral Diseases, Wiley, 2010, 17 (1), pp.109. ff10.1111/j.1601-
0825.2010.01715.xff. ffhal-00599898f 
5. Murray Thomson W, Poulton R, Mark Broadbent J, Al-Kubaisy S. Xerostomia and 
medications among 32-year-olds. Acta Odontol Scand. 2006;64(4):249-254. 
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