Comparing Three Caries Prevention Products on Dentinal Hypersensitivity - A Pilot Study
Phase: NA
Conditions: Hypersensitivity
Sponsor: Tufts University

Confidential 
 
 
 
 
 
 
 
 
 
Comparing Three Caries Prevention Products on Dentinal 
Hypersensitivity – A Pilot Study 
___________________________________________________________ 
 
 
 
 
NCT02136576 
 
 
Protocol Version Date:  4/4/2017 
 
 

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I) Introduction 
A) Aim/Hypothesis/Objective 
The aim of this pilot research project is to compare the clinical effect on 
dentinal 
hypersensitivity 
of 
three 
products: 
Casein 
Phosphopeptide-
Amorphous Calcium Phosphate (CPP-ACP) paste with fluoride, 5000 Sodium 
Fluoride (NaF) dentifrice containing Tri-Calcium Phosphate (TCP), and a 
dentifrice containing Potassium Nitrate. 
 
The hypothesis of this study is that CPP-ACP with fluoride and 5000ppm NaF 
with TCP will exhibit a greater reduction in dentinal hypersensitivity compared 
to the control (dentifrice containing Potassium Nitrate). 
 
The results of this pilot study will validate or negate the need for a larger 
clinical study that may provide generalizable results for using caries-
prevention products with the additional benefit of minimizing dentinal 
hypersensitivity. 
 
II) Background and Rationale 
 
Dentinal hypersensitivity commonly occurs in patients with gingival recession, 
resulting from a reduced periodontium or in patients who have undergone non-
surgical and surgical periodontal therapy.1,2 When the gingiva recede, the root 
surfaces of the teeth are exposed.3 In addition, after a non-surgical or surgical 
periodontal procedure, the cementum of the root surface is removed as a result 
of scaling and root planing.  This leaves dentin exposed on the root surface with 
open dentinal tubules.  In addition, dentin is less mineralized than enamel and 
has a greater susceptibility to and a faster progression of root caries and 
dentinal hypersensitivity.4 Root caries commonly occurs in patients who have 
undergone periodontal therapy and extensive root caries often results in the 
extraction of the tooth.5 
 
Dental professionals often make a variety of recommendations to remedy dental 
hypersensitivity, including the application of fluoride varnishes, anti-
hypersensitivity toothpaste, gingival grafting procedures and various restorative 
procedures, aiming to occlude the dentinal tubules or desensitize the pulpal 
nerve endings.6,7 
 
Since the introduction of CAMBRA (CAries Management By Risk Assessment) in 
the Journal of the California Dental Association in 2007,8,9 the marketplace for 
anti-caries products has surged.  As a result, many approaches to the 
management of dental caries have been introduced and dental practitioners and 
sales representatives have promoted several anti-caries products.  In addition, 
the reduction or the abatement of the progression of dental caries (coronal, root 
and interproximal) as a result of a caries management program has been 
reported.10,11 Many caries management products have ingredients that include 
fluoride and calcium phosphate (Amorphous Calcium Phosphate-Casein 
Phosphopeptide (Recaldent ™),12 Tri-Calcium Phosphate ™ or Novamin ™).13  

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Moreover, encouraging clinical findings have been reported, including, but not 
limited to the reduction of white spot enamel lesions and dentinal 
hypersensitivity.14 
 
The topical application of “antihypersensitivity” materials is a common 
recommendation (least invasive of the “standard of care” recommendations) to 
diminish dentinal hypersensitivity and will serve to provide data for the research 
study.  The study will evaluate which of these products result in the greatest 
reduction of dentinal hypersensitivity. The application of the experimental 
products for the reduction of dentinal hypersensitivity is for research purposes.   
 
The methods used to test sensitivity in this study have been used in published 
studies.6,15,16 The VAS scale used in this study has also been used for tooth 
sensitivity studies.16,17 A 30% decrease in VAS score has been shown to be 
clinically meaningful.18,19  
 
This pilot study would investigate the ability of anti-caries products to reduce 
dentinal hypersensitivity when compared to a sensitivity-reducing dentifrice.  It 
would be a novel contribution to the dental community if a material that is 
proven to reduce tooth decay is also proven to reduce dentinal hypersensitivity.  
The results may potentially have a tremendous impact on the dental community 
because it may provide dental professionals a scientifically-supported approach 
to improve the comfort and quality of life of periodontal patients (patients who 
are treated for gum disease/ bone loss around teeth) and increase the lifespan 
of teeth that undergo periodontal treatment. 
 
III) Research Plan 
A) Experimental Design 
This pilot study utilizes a single center, blinded, IRB-approved, randomized, 
prospective, paralleled group design to compare the reduction of dentinal 
hypersensitivity using CPP-ACP with fluoride or 5000ppm NaF with TCP to 
potassium nitrate (control). 
 
B) Sample Size and Statistical Analysis 
Sample Size 
The primary analysis will be to compare the percent change in dentinal 
hypersensitivity between the 3 groups.  We assume that the control group may 
exhibit a modest improvement in dentinal hypersensitivity (~5%) whereas the 
two test groups should demonstrate a more significant improvement (~30%).  
Assuming a common standard deviation of 25%, we will have 58% power to 
detect a difference between the 3 groups using one way analysis of variance, 
with 10 subjects per group, and setting alpha to 0.05 (nQuery Advisor, Version 
7.0). Up to 13 subjects per group will be recruited, to allow for a more than 
20% dropout rate. 
 
The literature is varying on the amount of improvement possible with the products.  
Guidelines for sensitivity studies indicate that a main objective 

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should be to produce a clinically significant reduction in symptoms20.  With the use 
of VAS scores, a 30% decrease in VAS score has been shown to be clinically 
meaningful.18,19  For this study we anticipate a clinically meaningful decrease in 
sensitivity for the two test groups. 
 
 
Statistical Analysis 
Normality will be assessed using the Kolmogorov-Smirnov test.  If the 
assumptions of normality hold, then means and standard deviations will be 
reported and the relationship between treatment arm and percent change in 
dentinal hypersensitivity will be tested using one-way ANOVA.  If the 
assumptions of normality do not hold, then medians and interquartile ranges 
will be reported and relationships will be tested using the Kruskal-Wallis test.   
If the initial analyses are significant, then the post hoc pairwise comparisons 
will be made using either independent-sample t-tests or Mann-Whitney U-
tests.  When patients are lost to follow-up, their information will be excluded 
from the analyses.  
All p-values less than 0.05 will be considered statistically significant.  
Analyses will be performed using SAS, Version 9.2 (SAS Institute, Cary, NC).  
Randomization 
Each subject will be randomized to a treatment arm using a randomization 
website (www.random.org).  When subjects have multiple teeth eligible for the 
study, a separate randomization scheme (also from www.random.org) will be 
used to select that tooth. A printout of the randomization scheme will be used 
by the investigator distributing the products. 
 
Blinding  
Examiners collecting the sensitivity data will be blinded as to which group the 
subject is in.  An investigator who did not examine the subject will distribute 
the product.  
 
C) Products 
 
Group            Product 1 
Product 2  
Group I 
(Control) 
Sensodyne (Potassium 
Nitrate) manufactured by 
GalaxoSmithKline 
N/A 
Group II  
Crest Cavity Protection 
manufactured by Procter and 
Gamble 
MI Paste Plus (CPP-ACP with 
fluoride) manufactured by 
GC America 
Group III 
Clinpro 5000 (5000ppm NaF 
with TCP) manufactured by 
3M ESPE  
N/A 
 
 
 
Senosydne is FDA approved for decreasing tooth sensitivity.  It is approved for 
use as it is being used this study. 

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Clinpro 5000 has been FDA approved for the prevention or reduction of dental 
caries.  A reduction in dentinal hypersensitivity has been anecdotally 
documented in the literature. 
 
MI Paste Plus is FDA approved for the reduction of dentinal hypersensitivity. It 
is approved for use as it is being used this study. 
Crest Cavity Protection Toothpaste is FDA approved as an anticavity drug.   
 
Oral-B 35 soft manual toothbrush is FDA approved and being used as approved 
for this study. 
 
 
All products are being used according to manufacturer’s instructions. 
 
D) Subject Characteristics 
 
1) Inclusion Criteria 
− At least 18 years of age 
− Tooth with exposed root surface and/or exposed dentin 
− Tooth with a VAS score greater than or equal to 3 
− No adjacent tooth/teeth with sensitivity (as defined as greater 
than 2 on the VAS) 
 
2) Exclusion Criteria 
− Participation in another dental study that may alter the results of 
this study. 
− A medical condition that could interfere with reliable pain 
reporting (e.g., pain disorders) 
− Any chronic medical condition that requires the regular use of 
pain or anti-inflammatory medications 
− Used a desensitizing dentifrice within the preceding four weeks 
− Have received an antihypersensitivity treatment (varnish or 
precipitating solution) of the identified tooth within the preceding 
four weeks  
− Undergoing active orthodontic treatment. 
− Teeth with carious lesions, buccal vertical cracks in enamel, 
evidence of irreversible pulpitis (pain lasting more than five 
seconds after air stimulation)  
− Pregnant/ lactating patients (Clinpro5000 has 5000ppm fluoride 
and there is a risk of ingesting the product) 
− Patients with Milk Allergy (CPP-ACP is a dairy based product) 
− Patients on Kidney Dialysis (due to the free calcium in CPP-ACP, 
dialysis patients should be on a diet with limited calcium)  
3) Subject Withdrawal/Termination Criteria 
− Subjects will be withdrawn from the study if they report the use 
of other dental hygiene products, including but not limited to: 
toothpaste, rinses, fluoride varnishes 

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− Subjects will be withdrawn from the study if they undergo any 
phase I periodontal procedures, including a prophylaxis or scaling 
and root planing 
− Subjects would be withdrawn if they experience a negative side 
effect from any product used in the study.  
− The tooth being studied is extracted, damaged from trauma or 
receives endodontic therapy. 
− Subjects may participate in another research study at the same 
time, as long as it does not impact the results from this study.  
− Subjects who do not comply with the study procedures, such as 
not returning for visits, not using product as documented in diary, 
may be withdrawn from the study. 
− Subjects who become pregnant during the course of the study 
will be withdrawn. Subjects will be informed in the informed 
consent form to inform principal investigator or their designate if 
they become pregnant.  
− Subjects who decide to stop participating in the study will be 
withdrawn.    
 
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.  
 
E) Assessment 
1) Risk 
This study poses minimal risk to subjects as these are products that 
approved for use.   
 
With Clinpro5000, although the patient will be instructed not to ingest the 
product, ingestion may result in GI discomfort, nausea, vomiting, diarrhea, 
cramping and fluorosis in children.  Fluoride exposure should be monitored 
in pregnant and nursing women. Pregnant and lactating women and 
children will be excluded from this study. 
 
MI Paste Plus contains Recaldent (Amorphous Calcium Phosphate-Casein 
Phosphopeptide) which is a milk-derived product.  This product is 
contraindicated with patients who have a milk protein (Casein IgE) allergy 
(this product is safe for lactose-intolerant patients). Fluoride exposure 
should be monitored in pregnant and nursing women. Pregnant and 
lactating women and children will be excluded from this study. 
 
Sensodyne contains fluoride and should not be ingested in large doses, 
especially by children.  Fluoride exposure should be monitored in pregnant 
and nursing women. Pregnant and lactating women and children will be 
excluded from this study. 
 
There is no anticipated risk with the completion of subject diaries. 

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There is the risk of some discomfort/sensitivity during tooth sensitivity 
scoring. 
 
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. 
 
2) Benefits 
The subject may experience some decrease in tooth sensitivity. 
 
3) Alternatives 
The alternative for the patient is to not participate in this study. An 
alternative for the patient to receive alternative procedures (e.g., fluoride 
treatment, topical desensitizer, composite restoration, or gingival graft) for 
sensitivity at normal clinic fees.  
 
F) Study Procedures 
 
Visit 1: Screening Visit/ Baseline: 
The subjects will be instructed 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 instructed to sign the ICF. A 
copy of the ICF will be given to the subject. 
 
Subject will be asked to complete demographic information and a medical 
history. 
 
An oral exam, including evaluation of oral cavity and soft tissues, will be 
completed following standard of care procedures.  
 
All potential qualifying teeth will be evaluated for dentinal hypersensitivity and 
the one tooth with the most severe dentinal hypersensitivity (in response to 
air) will be selected for the study.  If two or more teeth have the same score, 
one will be randomly selected. 
 
Each subject will be evaluated for the severity of dentinal hypersensitivity 
utilizing the VAS Scale to determine the subject’s perception of pain.  Testing 
methods described by Brahmbhatt et al.6 will be utilized in this study. Testing 
is for research purposes.  
 
Air test: A 1 second blast of air from an air-water syringe that is set to 
45psi at a distance of 10mm will be applied to the tooth. Adjacent teeth 
will be protected with fingers or cotton rolls. The subject will classify the 
extent of the sensitivity on the VAS. If the discomfort becomes 
intolerable, the stimulus will be immediately removed.    
 

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Water test: The patient will be given a 5-minute rest between tests. 
Disposable, plastic syringes filled with water will be kept in an ice water 
bath until use. Then, cold water will be applied to tooth using a plastic 
syringe with a plastic tip. Three drops of water will be placed on the 
tooth16. Adjacent teeth will be protected with fingers or cotton rolls. The 
subject will classify the extent of the sensitivity on the VAS. If the 
discomfort becomes intolerable, the stimulus will be immediately 
removed.    
 
Schiff Test: The Schiff Sensitivity Scale21 will be utilized by the 
examiners to evaluate the response of the subjects to both the air and 
water test. This analog scale scores for the tooth as 0, 1, 2 or 3.  
 
0-Tooth/Subject does not respond to stimulus. 
1-Tooth/Subject responds to stimulus, but does not request 
discontinuation of stimulus. 
2-Tooth/Subject 
responds 
to 
stimulus 
and 
requests 
discontinuation or moves from stimulus. 
3-Tooth/Subject responds to stimulus, considers stimulus to be 
painful, and requests discontinuation of the stimulus 
 
 
If the subject qualifies for the study, they will be entered into randomization. 
 
Intraoral photographs of the study teeth will be taken. Photographs are for 
research purposes. Photographs will be taken at Visits 1 and 4.  Additional 
photographs may be taken to document any adverse reactions. 
 
After taking the data, the examiner will leave the operatory and another study 
team member will do the randomization.  In this way the examiner will be 
blinded as to which group the subject is a part of. 
 
Subject will be randomized to one of three groups: 
Group I: Control 
The control group will use Sensodyne toothpaste twice daily (2 minutes 
each time in the morning and the evening) during the duration of the 
study.  
 
Group II:  
Subjects will be instructed to brush twice daily (2 minutes each time in 
the morning and the evening) using Crest Cavity Protection toothpaste. 
They will be instructed to apply MI Paste Plus (CPP-ACP with fluoride) 
twice daily to the study teeth after brushing their teeth.  MI Paste Plus 
will be applied to the study teeth with a finger. 
 
 
 
Group III:   

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Subjects will be instructed to brush twice daily (2 minutes each time in 
the morning and the evening) using Clinpro 5000 (5000ppm NaF with 
TCP).  
 
The study team member will describe the proper use for the products and will 
review oral hygiene 
instructions.  Once the 
subject demonstrates 
understanding for the use of the products, the products and a handout for the 
use of the products will be distributed. A toothbrush and 2-minute timer will 
also be given to the subject.  The use of any other topical dental products 
(e.g., rinses, toothpastes, fluoride varnish) will be discontinued.  The subjects 
may use additional products (e.g., dental floss, interproximal devices) to 
remove plaque.  Subjects will be given a diary in which to track product usage. 
Diary is for research purposes.   
 
 
 
VAS 
0  
1  
2  
3  
4  
5  
6  
7  
8  
9  
10 
               No pain 
 
 
 
  
 
 
 
 
          Worst pain imaginable 
 
 
 
Visit 2 (2 weeks +/- 2 days after Visit 1):   
A study team member who did not examine the subject at the initial visit will 
ask the subject for any changes in the medical or dental history. The study 
team member will also discuss patient compliance, adverse events, review and 
collect the patient’s diary, hand out a new patient diary, and answer any 
questions that the subject has regarding the products and dispense additional 
products, if necessary.  
 
Eligibility and subject withdrawal criteria will be reviewed to ensure the 
subject still qualifies for the study.  
 
The same examiner from the initial visit will then conduct the oral exam and 
collect the sensitivity data (if necessary, another examiner may see the 
subject, however, this will be avoided if possible).   
 
An oral exam, including evaluation of oral cavity and soft tissues, will be 
completed following standard of care procedures. 
 
The same sensitivity tests will be done as at Visit 1. Tests are for 
research purposes. 
 
Visit 3 (4 weeks +/- 2 days after Visit 1):   
A study team member who did not exam the subject at the initial visit will ask 
the subject for any changes in the medical or dental history. The study team 
member will also discuss patient compliance, adverse events, review and 

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collect the patient’s diary, hand out a new patient diary, answer any questions 
that the subject has regarding the products.  
 
Eligibility and subject withdrawal criteria will be reviewed to ensure the 
subject still qualifies for the study.  
 
The same examiner from the initial visit will then conduct the oral exam and 
collect the sensitivity data (if necessary, another examiner may see the 
subject, however, this will be avoided if possible).   
 
An oral exam, including evaluation of oral cavity and soft tissues, will be 
completed following standard of care procedures. 
 
The same sensitivity tests will be done as at Visit 1. Tests are for 
research purposes. 
 
Visit 4 (8 weeks +/- 1 week after Visit 1):   
A study team member who did not exam the subject at the initial visit will ask 
the subject for any changes in the medical or dental history. The study team 
member will also discuss patient compliance, adverse events, review and 
collect the patient’s diary, answer any questions that the subject has regarding 
the products.  
 
Eligibility and subject withdrawal criteria will be reviewed to ensure the 
subject still qualifies for the study.  
 
The same examiner from the initial visit will then conduct the oral exam and 
collect the sensitivity data (if necessary, another examiner may see the 
subject, however, this will be avoided if possible).   
 
An oral exam, including evaluation of oral cavity and soft tissues, will be 
completed following standard of care procedures. 
 
The same sensitivity tests will be done as at Visit 1. Tests are for 
research purposes. 
 
Intraoral photographs will be taken of the study teeth. Photographs are for 
research purposes. 
 
All products may be kept by the subject at the end of the study. 
 
 
 
 
 
Subject timeline 

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                        Appointment 
 
 
Procedures 
Visit 1 
Screening/ 
Baseline 
 
Visit 2 
(Treatment 
Day 14) 
Visit 3 
(Treatment 
Week 4) 
Visit 4 
(Treatment 
Week 8) 
Informed Consent 
X 
 
 
 
Demographics 
X 
 
 
X 
Medical/Dental History 
X 
X 
X 
X 
Evaluate Eligibility and 
Subject Withdrawal Criteria  
X 
X 
X 
X 
Oral Examination 
X 
X 
X 
X 
Subject VAS Score (Air/Cold 
Water) 
X 
X 
X 
X 
Examiner Schiff Sensitivity 
Scale 
X 
X 
X 
X 
Digital Intraoral Photographs 
X 
 
 
X 
Assignment into Study Group 
X 
 
 
 
Adverse Event Assessment 
 
X 
X 
X 
Handout Diary 
X 
X 
X 
 
Collect Diary 
 
X 
X 
X 
Stipend 
X 
X 
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.  
 
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 will be reported to the IRB 
within 15 business days. 
 
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 

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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. 
 
H) Subject Participation 
 
1) Screening 
The study co-investigators will conduct screening examinations to identify 
subjects who meet the inclusion / exclusion criteria for enrollment into the 
study.  
 
2) Informed Consent 
An investigator or study coordinator (who is GCP and CITI trained) will 
introduce the study.  Patients will be asked to read the consent form and 
given ample opportunity to have their questions answered.  An investigator 
will assess the patient’s competency to provide consent by discussing the 
study with the patient and ensuring that they understand the study. 
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. 
 
Non-English speaking subjects will not be enrolled in the study because 
study staff at this time are not certified, prepared, or trained to translate 
or communicate in any language other than English. The study budget does 
not allow for the payment of translation services at this time. 
 
3) Study Location 
Tufts University School of Dental Medicine 
 
4) Personnel 
Responsible for ongoing communication with the IRB – PI 
 
Obtaining informed consent – PI, Co-Is, and study coordinator (who is GCP 
and CITI trained)  
 
Maintaining study records – PI  
 
Sensitivity testing and oral exam – PI and Co-Is 
 

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Product distribution and instructions, answering any questions that the 
subject has regarding the products. – Study coordinator (with instruction 
from PI/Co-I who has not treated subject). 
 
Reviewing and collecting the patient’s diary, handing out diaries - PI, study 
coordinator/team member 
 
Intraoral photographs – PI, Co-Is 
 
Gift card distribution – PI, study coordinator/team member 
 
5) Payment for Participation 
(a) Compensation 
The subject will be given up to $100 in gift cards.  $25 upon completion 
of visit 1, $25 upon completion of visit 2, $25 upon completion of visit 
3, $25 upon completion of visit 4. 
 
(b) Transportation 
No reimbursement will be given for transportation or parking 
 
(c) Payment and Insurance 
There will be no fees associated with the study procedures.  Neither the 
subject, nor their insurance company, will be billed for any study 
procedures. 
 
6) Study Results 
If interested, a copy of the published paper will be mailed to interested 
study participants. A log will be kept of the participants who are 
interested in receiving study results. 
 
7) Confidentiality 
(i) To ensure confidentiality of subject information, each subject 
enrolled in the study will be assigned a unique alphanumeric code. 
Subjects’ files will be kept in a secure, locked cabinet in a secure 
room (DHS-1418) when the files are not reviewed. The information 
will only be shared between the researchers. All HIPAA requirements 
will be followed. All electronic files will be kept on a password 
protected computer in a secure, locked office. 
 
(a) Coding 
(i) Each will be assigned a subject identification number.  Alphanumeric 
identification numbers will be assigned sequentially. The full subject 
identification number will consist of the three letters from the 
subject’s initials and their enrollment number.  This will be accessible 
by study personnel only. 
 
(b) Access / Data Safety Monitoring Board 

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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. 
 
10) 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 
 
11) 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) Collaboration 
N/A 
 
J) Record Retention 
1) Study Records 
The 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 (DHS-212).  Electronic records will be 
kept on a password protected computer and only be accessible to study 
personnel. 
 
2) Long Term Retention 
The investigator will maintain all study records following completion or 
termination of this study in accordance to state law and institutional policy 
(at least 7 years after study is completed or terminated). 
 
K) Reporting 
1) Final Report 
Unanticipated problems and adverse events will be reported per the Tufts 
MC/TUHS IRB Unanticipated Problem and Adverse Event Reporting 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. 
 
 

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L) Protocol Deviations 
No protocol changes or deviations will be made without prior agreement by the 
IRB 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 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 
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, Tufts University School of 
Medicine and Tufts University School of Nutrition Science and Policy. 
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.  The same language from the approved flyers 
may be posted on the TUSDM website and screen in the lobby. 
Investigators may also verbally inform clinic patients, faculty members who 
oversee students in the clinic, and post-graduate residents about the study.  
Investigators may send messages to colleagues via axiUm or inform colleagues 
verbally, asking for their help in recruiting eligible subjects.  
An email that alerts the TUSDM community to ongoing studies may include 
information on this study for recruiting purposes.  
Advertisements/information regarding the study may be posted on Facebook 
and/or Craigslist. 
All of the forms of recruitment will be submitted to the IRB for approval prior 
to use.  
A screening interview/questionnaire or screening script will be used for 
recruitment. Screen failure data will be retained by PI. Screening ID number 

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and demographic information will be recorded.  Identifiable information will 
not be recorded in the screening log. 
 
O) References/Bibliography 
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Containing Calcium Sodium Phosphosilicate to a Dentifrice Containing 
Potassium Nitrate and to a Placebo on Dentinal Hypersensitivity:  A 
Randomized Clinical Trial.  J Periodontol.  2010; 81(8):  1167-1173. 
2) Yilmaz, HG., Kurtulmus-Yilmaz, S., Cengiz, E.,  Long-Term Effect of Diode 
Laser Irradiation Compared to Socium Fluoride Varnish in the Treatment 
of Dentine Hypersensitivity in Periodontal Maintenance Patients:  A 
Randomized Controlled Clinical Study.  Photomedicine and Laser Surgery.  
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3) West, NX.  Dentine hypersensitivity:  preventive and therapeutic 
approaches to treatment.  Periodontology 2000.  2008; 48:  31-41. 
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double blind controlled trial comparing three treatment modalities for 
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7) Orsini, G., et al.  A double-blind randomized-controlled trial comparing the 
desentizing efficacy of a new dentifrice containing 
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nitrate dentifrice.  J Clin Periodontol.  2010; 37: 510-517. 
8) Journal of the California Dental Association, October 2007 (entire journal) 
9) Journal of the California Dental Association, November 2007 (entire journal) 
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treatment of dentin hypersensitivity. Adv Med Sci. 2006;51: 40–42. 
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A Clinical Study Comparing Three Caries Prevention Products on Dentinal Hypersensitivity 
 
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containing dentifrice for the relief of dentinal hypersensitivity.  Indian 
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16) Holland, GR., Narhi, MN., Addy, M., Gangarosa, L., Orchardson, R.  
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19) Raymond, WJ., Ostelo, JG., Deyo, RA., Stratford,P., Waddell, G., Croft, P., 
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