Clinical trial NCT04249336
Conditions: Dentin Hypersensitivity
Keywords: Dentine hypersensitivity Dentine Sensitivity Oral dentifrices Bio-active glasses
Sponsor: Dow University of Health Sciences
Start date: 2019-09-27; Completion date: 2021-01-16
Enrollment: 140 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This will be multi-centered, triple blinded, randomized, four parallel treatments assigned study to compare clinical efficacy of commercially available dentifrices with placebo for immediate and sustained relief from Dentin Hypersensitivity after short term use.

Condition or disease: Dentin hypersensitivity Intervention/Treatment: Product 1; Fluoro-Calcium-Phospho-silicate based BioMin F Product 2; Pro-Argin formula based Colgate Sensitive Pro-Relief Product 3; Strontium Acetate based Sensodyne Rapid Action Product 4; Sodium Fluoride based Colgate Total

Detailed description:
It is a randomized controlled clinical trial with non invasive topical intervention in 140 adult patients of 18 to 60 years age, that will be selected randomly after screening and diagnosis of dentin hypersensitivity, in dental Out Patient Department of Periodontology. Written informed consent will be obtained. Participants will be allocated randomly into four equal study arms for parallel treatment assignment with dentifrices named BioMin F, Colgate Sensitive Pro-Relief Trade Mark,Sensodyne rapid action Trade Mark and Colgate Total Trade Mark dentifrices. Colgate total Trade Mark dentifrices does not claim pain relief in Dentin Hypersensitivity. Interim efficacy will be assessed immediately after topical application on sensitive teeth, in one minute, after 5 minutes, on day three and week 4 respectively. Dentin hypersensitivity will be tested with mechanical stimulus, evaporative air blast stimulus and water jet stimulus. It will be measured on Visual Analogue Scale and Schiff cold air sensitivity scale (SCASS). Statistical analysis will be done using ANOVA in Statistical Package for Social Sciences software 21.

Arms: arm 1: Participants will be instructed to dose a dry toothbrush with a full strip of dentifrices and to brush teeth for 1 minute twice daily. arm 2: Participants will be instructed to dose a dry toothbrush with a full strip of dentifrices and to brush teeth for 1 minute twice daily. arm 3: Participants will be instructed to dose a dry toothbrush with a full strip of dentifrices and to brush teeth for 1 minute twice daily. arm 4: Participants will be instructed to dose a dry toothbrush with a full strip of dentifrices and to brush teeth for 1 minute twice daily.
Interventions: intervention 1: Fluoro-Calcium-Phospho-Silicate based dentifrices intervention 2: 8% Arginine based dentifrices intervention 3: 8% Strontium Acetate intervention 4: Sodium Fluoride
Intervention descriptions: intervention 1: Bio-Active glass based formulation intervention 2: Tubular occluding formulation intervention 3: Tubular occluding formulation intervention 4: No claim of relieving Dentin Hypersensitivity

Protocol documents:
Prot_SAP_000.pdf: 
Title of The Study 
CLINICAL EFFICACY OF BIOMIN F, COLGATE SENSITIVE PRO-RELIEF AND 
SENSODYNE RAPID ACTION DENTIFRICES IN DENTIN HYPERSENSITIVITY 
 
 
 
 
September 7, 2019 
NCT04249336 


Background:  
Dentin hypersensitivity (DH) was a clinical condition with acute pain of short duration that adversely 
influenced the patient’s daily life. Clinical management of DH had been a challenging issue for 
practitioners with different treatment modalities. Numerous over the counter (OTC) and in-office 
desensitization formulations including Potassium, Fluorides, Arginine, Strontium, Bi-Fluorides, And 
Casein Phosphopeptide–Amorphous Calcium Phosphate (CPP-ACP) and Bioactive Glasses (BAGs) had 
been advocated clinically and claimed commercially for immediate and sustained treatment of DH 
without definitive outcome. Prime focus of treatment options was now trending towards utilization of 
the remineralization potential of dentinal tubules for occluding exposed tubular endings. Currently no 
gold standard treatment modality and product for DH is available worldwide. Clinical testing was 
essentially required to substantiate the claims of different OTC products, to seek out permanent 
management of DH without industrial influences. The potential impact of DH on the patient’s daily life 
by altering dietary habits, speaking, and its impact on social status needed to be ascertained.  
Objective:  
The aim of the study was to compare three different formulations of OTC dentifrices; these are 8% 
Arginine, 8% Strontium acetate, and fluoro-calcium-phospho-silicate (FCPS) BAGs to measure their 
clinical efficacy for immediate and sustained reduction in the pain of DH.  
Methods:  
This study was a randomized, controlled clinical trial with four equal treatment arms. 140 healthy 
individuals of more than 18 years of age were included in the study. They had at least two sensitive 
teeth anterior to molars and were selected from clinically diagnosed patients of DH after written 
informed consent. Parallel treatments were assigned for sensitive teeth with four OTC dentifrices. 


Dentifrices having flouro-calcium-phospho-silicate formulation were provided in experimental group, 
having 8% Arginine formulations were provided in active comparator 1, having 8% Strontium Acetate 
formulation were provided in active comparator 2 and having Sodium Fluoride (NaF) formulation were 
provided in placebo comparator. DH was tested with Air blast/Evaporative stimulus, Mechanical 
stimulus, and Water jet stimulus. Change in the pain response was measured over time by Visual 
Analogue Scale (VAS) and Schiff Cold Air sensitivity (SCHIFF) Scale with five minutes gap between 
applications of each stimulus for internal reliability. Interim efficacies were assessed in one minute after 
topical application on sensitive teeth, in five minutes after application, on third day, and four weeks 
respectively. Dentin Hypersensitivity Experience Questionnaire (DHEQ) was administered before and 
after treatments.  
Statistical Analysis:  
The software used for data analysis was SPSS version 16. Baseline characteristics and DH scores were 
assessed in terms of mean, standard deviation and mean difference within the treatment group and 
between the treatment groups at different time points to compare the baseline scores with the 
measures taken immediately after treatment, on day – 3, in week – 4. Statistical analysis was done 
independently for air blast stimulus associated DH, mechanical stimulus associated DH, and water jet 
stimulus associated DH. Baseline characteristics were observed by comparing means statistics for the 
age, gender and baseline DH score on SCHIFF scale and VAS by groups. Paired sample t-test was 
performed to compute mean scores of each follow up respective to baseline. Percent change from 
baseline was assessed Within the treatment group by using ANOVA for each group. Statistical 
significance of percent change for baseline versus follow ups was assessed by paired sample t-test with 
level of significance 0.05. Between treatment groups comparison was done by performing ANOVA to 
compare different treatments at different follow ups and reported as percent difference between 


groups at Level of significance 0.05. Adjustment for multiple comparisons was done by Tukey HSD with 
level of significance 0.05. For Mechanical and Water jet stimulus responses pre-application and post-
application responses were assed in subjects enrolled for the 6- week clinical trial. Those who did not 
respond at baseline were considered in missing values.  
 
 

ICF_001.pdf: 
 
CLINICAL EFFICACY OF BIOMIN 
F, COLGATE SENSITIVE PRO-
RELIEF AND SENSODYNE RAPID 
ACTION DENTIFRICES IN DENTIN 
HYPERSENSITIVITY 
 
 
 
 
SEPTEMBER 7, 2019 
NCT04249336 
 


CONSENT FORM  
MR. No. _____________ Patient name; ____________________  
Age; _______________ Contact number; __________________  
Address ________________________________________________  
 I understand that Dr _____________________will use her/his best knowledge, skills and training 
expertise in my dental examination and treatment of suddenly arising severe pain of short duration 
in my teeth. I have been fully explained regarding my disease named dentine hypersensitivity, its 
causes and treatment procedure with potential benefits as  
• Dentine hypersensitivity is a sharp pain of short duration in the teeth due to cold and usually hot 
drink or food intake. It can be initiated by touch and air blow and vanishes when exposure is 
removed.  
• It occurs by tubular opening in the tooth structure due to either aggressive tooth brushing or 
wrong tooth brushing technique or excessive use of acidic and carbonated food and drinks.  
• I have been informed to refrain from these factors and assured that it can be treated by blocking 
the openings of tubules with the help of medicinal components present in the toothpaste.  
• The Proposed treatment plan is intended to stop severe pain immediately after application of 
provided tooth paste as well as to prevent the pain arising in future.  
• No discomfort is anticipated by application of provided toothpaste.  
• I understand that further alternative treatment may be needed later if clinical test of tooth paste 
doesn’t provide intended treatment response.  
• Method of proper tooth brushing with the provided tooth paste, brushing time and duration have 
been explained to me properly.  


• My treatment will be done free of cost.  
• It is my responsibility to schedule regular dental checkups and follow the instructions of my 
doctor regarding treatment method for required treatment response.  
 Treatment record of the patients will be used for research purpose and for university examination. 
I do not have any objection on proposed treatment plan and on sharing my treatment records with 
my doctor for this purpose.  
  
  
  
  
___________________  
Patient’s signature