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CTRI Number  CTRI/2024/04/066352 [Registered on: 26/04/2024] Trial Registered Prospectively
Last Modified On: 25/04/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of three desensitizing agents in management of dentinal hypersensitivity in adults experiencing pain due to hypersensitivity- an in-vivo study 
Scientific Title of Study   Comparison of three desensitizing agents in reduction of dentinal hypersensitivity an in vivo study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Thanima Chandran 
Designation  PG Student 
Affiliation  DR.RAJESH RAMDASJI KAMBE DENTAL COLLEGE AND HOSPITAL 
Address  Department of Conservative dentistry and Endodontics Dr. Rajesh Ramdasji Kambe dental college and hospital, Akola Kanheri sarap, Akola
Department of Conservative dentistry and Endodontics Dr. Rajesh Ramdasji Kambe dental college and hospital, Akola Kanheri sarap, Akola
Akola
MAHARASHTRA
444001
India 
Phone  07559417823  
Fax    
Email  thanima1221@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Thanima Chandran 
Designation  PG Student  
Affiliation  DR.RAJESH RAMDASJI KAMBE DENTAL COLLEGE  
Address  MDS Department of Conservative dentistry and Endodontics Dr. Rajesh Ramdasji Kambe dental college and hospital, Akola Kanheri sarap, Akola
MDS Department of Conservative dentistry and Endodontics Dr. Rajesh Ramdasji Kambe dental college and hospital, Akola Kanheri sarap, Akola
Akola
MAHARASHTRA
444001
India 
Phone  07559417823  
Fax    
Email  thanima1221@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR.MANOJ LIKHITKAR 
Designation  Head of the Department of Conservative dentistry and Endodontics 
Affiliation  DR.RAJESH RAMDASJI KAMBE DENTAL COLLEGE  
Address  Department of Conservative dentistry and Endodontics Dr. Rajesh Ramdasji Kambe dental college and hospital, Akola Kanheri sarap, Akola AKOLA
Department of Conservative dentistry and Endodontics Dr. Rajesh Ramdasji Kambe dental college and hospital, Akola Kanheri sarap, Akola
Akola
MAHARASHTRA
444001
India 
Phone  9920666031  
Fax    
Email  manojlikhitkar22@gmail.com  
 
Source of Monetary or Material Support  
Adults exhibibiting dentinal hypersensitivity in atleast three teeth and who falls under the inclusion criteria  
 
Primary Sponsor  
Name  Thanima Chandran 
Address  Dr. Rajesh Ramdasji Kambe dental college and hospital Akola 444001 
Type of Sponsor  Other [Self] 
 
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 
Thanima Chandran  Dr. Rajesh Ramdasji Kambe dental college and hospital  Department of Conservative Dentistry and Endodontics
Akola
MAHARASHTRA 
7559417823

thanima1221@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr. Rajesh Ramdasji Kambe dental college and hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K038||Other specified diseases of hard tissues of teeth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  comparative clinical evaluation on patients with dentinal hypersensitivty   three months 
Comparator Agent  desensitizing agents (D/Sense Crystal, Fluorprotector vivampuole,Single Bond Universal dentin bonding agent)  three months 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1) Patients who had a maximum of two non-adjacent teeth with no cervical caries.
2)Patients with good oral hygiene.
3)Patients with complete general health.
4) Patients who agreed to participate in this 3-month study.
 
 
ExclusionCriteria 
Details  1)Patients who had systemic diseases and/or psychologic disorders, or previous hospitalization and females who are pregnant.
2) Teeth with caries, cracks, or fracture at their cervical margin.
3) Teeth with extensive or faulty restorations, prostheses, or orthodontic appliances.
4) Substance abusers and patients taking analgesics and/or anti-inflammatory drugs.
5)Patients with a history of using desensitizing agents.
6) Patients who had allergy to materials used in the study.
7) Patients who did not consent to participation.
8) Patients who did not attend the follow-up.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
considering thedropout rate of 10 percent the sample size will be 78 and outcome is to comapre and evaluate the efficacy of densitizing agent in reduction of dentinal hypersensitivity.  IMMEDIATE, 1 WEEK,1 MONTH ,3 MONTHS 
 
Secondary Outcome  
Outcome  TimePoints 
to clinically evaluate the reduction of dentinal hypersensitivity and evaluation of prognosis of the treatment   2 months, 3 months. 
 
Target Sample Size   Total Sample Size="78"
Sample Size from India="78" 
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)   06/05/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  06/05/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Other (Terminated) 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [thanima1221@gmail.com].

  6. For how long will this data be available start date provided 04-12-2024 and end date provided 04-12-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Aim: The aim of this in vivo study was to compare the efficacy of three desensitizing agents in reducing dentinal hypersensitivity. The investigation focused on assessing the immediate and lasting effects of the three agents on alleviating discomfort associated with dentinal hypersensitivity.

Methods: A randomized controlled trial was conducted on a cohort of patients presenting with dentinal hypersensitivity. In this study, a total of 25 patients with at least three teeth exhibiting dentin hypersensitivity (78 teeth in total) were assessed. Three groups were randomly assigned to receive different treatments for the teeth: Group 1 received D/Sense Crystal treatment, Group 2 received Fluorprotector vivampuole therapy, and Group 3 received Single Bond Universal dentin bonding agent. Using a visual analogue scale (VAS), dentin hypersensitivity levels were measured based on the patients’ reactions to touch, air blast, and cold water stimuli. Before and after treatment, at particular intervals (one, seven, fourteen, sixty, and ninety days), pain levels were noted.

 Results: Initially, the baseline sensitivity measurements were similar across the three groups (Group-1: 9.2 ± 0.35, Group-2: 8.8 ± 0.46, Group-3: 8.9 ± 0.39) with a non-significant p-value of 0.15. However, significant differences in sensitivity reduction were observed immediately after treatment, with Group-3 exhibiting the most substantial decrease (5.3 ± 0.43) and Group-2 showing a moderate reduction (6.5 ± 0.45) with a p-value of 0.03. Over the 1-week, 1-month, and 3-month follow-ups, although differences persisted, they were not statistically significant (p-values of 0.09, 0.12, and 0.45, respectively). This study underscores the variable impacts of the dental agents on sensitivity reduction, emphasizing the need to consider both short-term and long-term effects when assessing dental treatments.

Conclusion: To summarize, this clinical trial successfully showcased a considerable reduction in dentin hypersensitivity (DH) across all three groups, with no reported side effects. After a single direct topical treatment, the Single Bond Universal dentin bonding agent administration resulted in an initial decrease in DH. Notably, at the 3-month follow-up, comparable DH scores were observed among all three groups.

 
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