Immediate And Sustained Treatment Response Of Commercially Available BioMin F, Colgate Sensitive Pro-Relief And Sensodyne Rapid Action Dentifrices In Dentin Hypersensitivity - "A Randomized Clinical Trial"
Phase: PHASE3
Conditions: Dentin Hypersensitivity
Sponsor: Dow University of Health Sciences

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.