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CTRI Number  CTRI/2021/11/037918 [Registered on: 10/11/2021] Trial Registered Prospectively
Last Modified On: 25/11/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of effectiveness of Fluoride containing paint and glue used during braces treatment in reducing and treating initial caries on teeth  
Scientific Title of Study   Comparison of effectiveness of Fluoride varnish and Fluoride releasing adhesives in prevention and management of multibracket induced white spot lesions: A Randomized Controlled Trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sanjay Miglani 
Designation  professor 
Affiliation  Faculty of Dentistry, Jamia Millia Islamia 
Address  faculty of dentistry jamia millia islamia
dept.of conservative dentistry
South
DELHI
110087
India 
Phone  9999208880  
Fax    
Email  smiglani@jmi.ac.in  
 
Details of Contact Person
Scientific Query  
Name  panchali batra 
Designation  professor 
Affiliation  Faculty of Dentistry, Jamia Millia Islamia 
Address  dept of orthodontics faculty of dentistry jamia millia islamia

South
DELHI
110025
India 
Phone    
Fax    
Email  pbatra@jmi.ac.in  
 
Details of Contact Person
Public Query  
Name  panchali batra 
Designation  professor 
Affiliation  Faculty of Dentistry, Jamia Millia Islamia 
Address  dept of orthodontics faculty of dentistry jamia millia islamia

South
DELHI
110025
India 
Phone    
Fax    
Email  pbatra@jmi.ac.in  
 
Source of Monetary or Material Support  
jamia millia islamia,jamia nagar,new delhi-25 
 
Primary Sponsor  
Name  ICMR 
Address  INDIAN COUNCIL OF MEDICAL RESEARCH V RAMALINGASWAMI BHAWAN ANSARI NAGAR NEW DELHI 110029 
Type of Sponsor  Government funding agency 
 
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 
drsanjay miglani  faculty of dentistry, jamia millia islamia  department of Orthodontics and department of Conservative dentistry, faculty of dentistry jamia millia islamia
South
DELHI 		 9999208880

smiglani@jmi.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JAMIA MILLIA ISLAMIA ETHICAL COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K026||Dental caries on smooth surface, (2) ICD-10 Condition: R52||Pain, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  fluoride adhesive  fluoride releasing adhesive will be used once for bonding brackets. 
Comparator Agent  fluoride varnish  fluoride containing varnish will be applied as a single coat every 6 weeks during orthodontic treatment 
 
Inclusion Criteria  
Age From  14.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  class I malocclusion with arch length tooth material discrepancy more than 6 mm 
 
ExclusionCriteria 
Details  patients with hypocalified teeth or dental flourosis
endocrine disorders,congenital anomalies 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the effectiveness of 2 modes of fluoride delivery agents (fluoride varnish and fluoride containing bonding agent) in preventing and reducing the size of lesions, if they developed during the fixed orthodontic treatment.
2. To compare the results of the 2 above mentioned fluoride delivery modes, with that of the control group.
3. To assess participant related outcomes, such as perception of WSLs and adverse effects due to the 2 agents.
 
Time in months
1-4 months
Training of research associate and enrollment of patients
5-30 months:Implementation of project
:rendering treatment to patients
31-36 months
Data Analysis and compilation of result

 
 
Secondary Outcome  
Outcome  TimePoints 
To assess participant related outcomes, such as perception of WSLs and adverse effects due to the 2 agents.  Time in months 1-4 5-30 months 31-36 months
Training of research associate and enrollment of patients
Implementation of project
:rendering treatment to patients

Data Analysis and compilation of result
 
 
Target Sample Size   Total Sample Size="210"
Sample Size from India="210" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="210" 
Phase of Trial   N/A 
Date of First Enrollment (India)   29/11/2021 
Date of Study Completion (India) 25/11/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   none 
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 - All of the individual participant data collected during the trial, after de-identification.

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

  3. Who will be able to view these files?
    Response - Anyone

  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 - Proposals should be directed to [arishaizhar@gmail.com].

  6. For how long will this data be available start date provided 27-12-2022 and end date provided 27-12-2023?
    Response - Immediately following publication. No end date.

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

Dental Caries is the most common chronic disease worldwide. WSLs(White Spot Lesion) represent the first clinical observation of the progression of dental caries.4,5,6It has been found that the prevalence of WSL can rise from 32% before treatment to74% after treatment with fixed Orthodontic braces.Fluoride which is an important agent in preventing dental caries,14 has been used in various forms to prevent and treat WSLs.

However, according to the Cochrane review in 2013, only one study has been judged to be at low risk of bias and no study has evaluated patient related outcomes with the use of flourides. The flaws in the previous studies were: qualitative methods of diagnosis of WSls, inappropriate long term follow-up, non standardization of control group and limited number of patients enrolled.Also, focus should be in developing strategies that are independent of patient compliance. Hence further adequately powered double blind RCTS are required to find the best means of preventing WSLs.

 
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