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CTRI Number  CTRI/2025/03/083422 [Registered on: 25/03/2025] Trial Registered Prospectively
Last Modified On: 12/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect Of Two Tooth Pastes On Decreasing Sensitivity : A 6 Months Study 
Scientific Title of Study   Longevity Of Desensitizing Efficacy Of Dentifrices Containing Fluoro Calcium Phosphosilicate And Calcium Sodium Phosphosilicate: A 6 Months Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sahithi Pamidimukkala 
Designation  Senior Lecturer 
Affiliation  GITAM Dental College and Hospital Gandhinagar Campus, Rushikonda, Visakhapatnam, Andhra Pradesh 530045 
Address  GITAM Dental College and Hospital Gandhinagar Campus, Rushikonda, Visakhapatnam, Andhra Pradesh 530045

Visakhapatnam
ANDHRA PRADESH
530045
India 
Phone  9573182186  
Fax    
Email  spamidim@gitam.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Sahithi Pamidimukkala 
Designation  Senior Lecturer 
Affiliation  GITAM Dental College and Hospital Gandhinagar Campus, Rushikonda, Visakhapatnam, Andhra Pradesh 530045 
Address  GITAM Dental College and Hospital Gandhinagar Campus, Rushikonda, Visakhapatnam, Andhra Pradesh 530045

Visakhapatnam
ANDHRA PRADESH
530045
India 
Phone  9573182186  
Fax    
Email  spamidim@gitam.edu  
 
Details of Contact Person
Public Query  
Name  Dr Sahithi Pamidimukkala 
Designation  Senior Lecturer 
Affiliation  GITAM Dental College and Hospital Gandhinagar Campus, Rushikonda, Visakhapatnam, Andhra Pradesh 530045 
Address  GITAM Dental College and Hospital Gandhinagar Campus, Rushikonda, Visakhapatnam, Andhra Pradesh 530045

Visakhapatnam
ANDHRA PRADESH
530045
India 
Phone  9573182186  
Fax    
Email  spamidim@gitam.edu  
 
Source of Monetary or Material Support  
self sponsor 
 
Primary Sponsor  
Name  GITAM Dental College and Hospital 
Address  GITAM Dental College and Hospital Gandhinagar Campus, Rushikonda, Visakhapatnam, Andhra Pradesh 530045 
Type of Sponsor  Other [Private Dental College and Hospital] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sahithi Pamidimukkala  Gitam dental college and hospital  Conservative Dentistry and Endodontics Department, Room number - 4.
Visakhapatnam
ANDHRA PRADESH 		 9573182186

spamidim@gitam.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
GITAM DENTAL COLLEGE AND HOSPITAL  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Dentinal hypersensitivity 
Patients  (1) ICD-10 Condition: K038||Other specified diseases of hard tissues of teeth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  To assess decrease in sensitivity rates of calcium sodium phosphosilicate  To compare decrease in sensitivity rates of calcium sodium phosphosilicate at 21 days (3 weeks), at 3 months (13 weeks) and 6 months (26 weeks) from baseline values 
Intervention  To assess decrease in sensitivity rates of fluoro calcium phosphosilicate  To compare decrease in sensitivity rates of fluoro calcium phosphosilicate at 21 days (3 weeks), at 3 months (13 weeks) and 6 months (26 weeks) from baseline values 
Intervention  To compare the longevity of desensitizing efficacy of fluoro calcium phosphosilicate and calcium sodium phosphosilicate  To assess the decrease and effectiveness of desensitising ability of fluoro calcium phosphosilicate and calcium sodium phosphosilicate 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1)Patient with VAS score of more than or equal to 4 to subjective, tactile and thermal sensitivity in at least two teeth at the qualifying visit were considered eligible for the study.
2) Patients with complaint of sensitivity to stimuli like cold, sweet, sour.
3) Teeth with enamel loss and cementum loss. 
 
ExclusionCriteria 
Details  1) Patients with age below 30 years and above 65 years.
2) Subjects with a history of allergy to any of the drugs or chemicals used in the study.
3) Patients with lingering pain.
4) On-going orthodontic treatment with fixed appliances.
5) Presence of any large or defective restorations, cracked enamel or caries on the hypersensitive tooth.
6) Dental pathology causing pain similar to dentin hypersensitivity.
7) Patients who are using analgesic, steroid therapy and anti-inflammatory medication.
8) Patients who had undergone periodontal surgery within last three months. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Decrease in sensitivity levels from baseline  Decrease in sensitivity levels at baseline, at 3 weeks, at 13 weeks, at 26 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
maintenance of decreased sensitivity levels  after 21 days, at 3 months, at 6 months 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   07/04/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
The study duration will be 6 months (26 weeks), in which sensitivity scores will be measured at baseline, at 21 days (3 weeks), at 3 months (13 weeks) and 6 months (26 weeks).
Each participant will be given respective dentifrice along with a soft-bristled toothbrush and will be instructed to apply dentifrice in an amount equal to about half the length of the bristle head and will also be instructed to brush for 2 min and no more than a total of 2 times/day. Participants will be directed to refrain from any other dentifrice or mouth rinse during the study. Participants will be recalled at 21 days, 3 months, and 6 months to record the VAS scores for subjective, tactile and thermal sensitivity. Sensitivity will be measured using a 10 cm VAS score, with the score of 0 being a no-pain response and a score of 10 being extreme pain or discomfort. The data will be subjected to statistical analysis.
 
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