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CTRI Number  CTRI/2025/02/080691 [Registered on: 17/02/2025] Trial Registered Prospectively
Last Modified On: 16/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   An assessment of post-operative pain after applying varnish based on resin-modified glass ionomers and varnish based on ormocer as a treatment for dentinal hypersensitivity 
Scientific Title of Study   A Randomised Control Trial For Evaluation Of Post-Operative Pain Following Application Of Resin Modified Glass Ionomer-based Varnish And Ormocer-based Varnish As A Treatment For Dentinal Hypersensitivity  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sunayana Bidave 
Designation  Post Graduate 
Affiliation  VSPM Dental College and Research Centre Nagpur 
Address  311 Department of conservative dentistry and endodontics

Nagpur
MAHARASHTRA
440003
India 
Phone  9405389193  
Fax    
Email  sbidave155@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vandana Kokane 
Designation  Guide 
Affiliation  VSPM Dental College and Research Centre Nagpur 
Address  311 Department of conservative dentistry and endodontics

Nagpur
MAHARASHTRA
440003
India 
Phone  9405389193  
Fax    
Email  vandanakokane30@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sunayana Bidave 
Designation  Post Graduate 
Affiliation  VSPM Dental College and Research Centre Nagpur 
Address  311 Department of conservative dentistry and endodontics

Nagpur
MAHARASHTRA
440003
India 
Phone  9405389193  
Fax    
Email  sbidave155@gmail.com  
 
Source of Monetary or Material Support  
311 Department of conservative dentistry and endodontics. VSPM Dental College and Hospital Nagpur 
 
Primary Sponsor  
Name  Sunayana Bidave 
Address  Flat no 404, Divya Prayag Apartment Wanjari Nagar, Nagpur, Maharashtra 440003 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Dr Vandana Kokane  VSPM Dental college and Research centre ,Nagpur 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sunayana Bidave   Vspm Dental College and Research Centre,Nagpur  311 Department of conservative dentistry and endodontics
Nagpur
MAHARASHTRA 		 9405389193

sbidave155@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
VSPM Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Minimum two teeth per patient in two different quadrants of the mouth and a visual analog pain scale value of ≥2 will be preferred 
Patients  (1) ICD-10 Condition: K031||Abrasion of teeth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Ormocer based varnish   Applied on cervical defects of teeth according to manufacturers instructions. 
Intervention  Resin modified glass ionomer based varnish   Applied on cervical defects of teeth according to manufactures instructions. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Minimum two teeth per patient in two different quadrants of the mouth and a visual analog pain scale value of ≥2 will be preferred 
 
ExclusionCriteria 
Details  Patients who have used desensitizing toothpaste in the last 3 months
Patients with fractured or cracked teeth
Patients receiving periodontal therapy
Patients with uncontrolled systemic diseases where oral hygiene is compromised
Patients with chronic users of anti-inflammatory and analgesic drugs 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Intervening the effects between two varnish in reducing dentinal hypersensitivity  Baseline, 1 week  
 
Secondary Outcome  
Outcome  TimePoints 
Intervening the effect between two varnish in reducing dentinal hypersensitivity  1 month 
 
Target Sample Size   Total Sample Size="11"
Sample Size from India="11" 
Final Enrollment numbers achieved (Total)= "11"
Final Enrollment numbers achieved (India)="11" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   27/02/2025 
Date of Study Completion (India) 20/01/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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

  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 - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  NOT APPLICABLE

  6. For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
    Response - Beginning 3 months and ending 5 years following article publication.

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

Primary Hypothesis: There is a significant difference between the post-operative pain following application of Resin- modified Glass Ionomer-based Varnish And Ormocer-based Varnish as a treatment for Dentinal Hypersensitivity. 

Null Hypothesis: There is no significant difference between the post-operative pain following application of Resin- modified Glass Ionomer-based Varnish And Ormocer-based Varnish as a treatment for Dentinal Hypersensitivity.

Double blinding will be done because the patient and the evaluator do not know the type of intervention being used. Then patients fulfilling the inclusion criteria will be recruited for this study. The treatment and the study design will be  explained to the qualifying patients, and informed consent will be obtained from the voluntary patients who were willing to participate in the study. Eleven patients with cervical defects  and having dentinal hypersensitivity reporting to OPD of Department of Conservative Dentistry and Endodontics under age group of 18-50 years will be selected for this study. Each selected patient had minimum two cavities in different  quadrants. A Visual Analog Scale(VAS) will be used to record the pre-operative sensitivity levels using air blast and cold test (ethyl chloride spray). Sequential randomisation will be done and patients were assigned into two experimental groups. (Group A:Resin- modified Glass Ionomer-based Varnish Group B: Ormocer-based Varnish).The application of varnish will be done according to manufacture’s instructions.The sensitivity score will be recorded using the pre-operative protocol immediately after application of experimental varnishes.The patient was recalled after 1 week and 1 month and similar protocol will be followed to evaluate postoperative dentinal hypersensitivity using VAS scale.

 
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