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CTRI Number  CTRI/2025/10/096039 [Registered on: 14/10/2025] Trial Registered Prospectively
Last Modified On: 14/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Dentistry 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Study on a special tooth primer to prevent enamel damage in patients undergoing braces treatment 
Scientific Title of Study   Evaluation Of Efficacy Of Sr doped BAG Nanoparticle-Incorporated Orthodontic Primer 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Amritha Nehru 
Designation  Post graduate student 
Affiliation  Saveetha Dental College and Hospital 
Address  Clinic 27, department of orthodontics and dentofacial orthopaedics, Saveetha Dental College, 162 Poonamallee High Road, Velappanchavadi, Chennai

Chennai
TAMIL NADU
600077
India 
Phone  9976655446  
Fax    
Email  152308001.sdc@saveetha.com  
 
Details of Contact Person
Scientific Query  
Name  Navaneethan R 
Designation  Professor and Clinical Head of the Department Department department 
Affiliation  Saveetha Dental College and Hospital 
Address  clinic 27, Department of orthodontics, , Saveetha Dental College, 162 Poonamallee High Road, Velappanchavadi, Chennai

Chennai
TAMIL NADU
600077
India 
Phone  9662787531  
Fax    
Email  navaneethanramasamy@saveetha.com  
 
Details of Contact Person
Public Query  
Name  Amritha Nehru 
Designation  Post graduate student 
Affiliation  Saveetha Dental College and Hospital 
Address  Department of Orthodontics, Clinic 27, Saveetha Dental College, 162 Poonamallee High Road, Velappanchavadi, Chennai

Chennai
TAMIL NADU
600077
India 
Phone  9976655446  
Fax    
Email  152308001.sdc@saveetha.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Amritha Nehru 
Address  162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077 
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 
Dr Amritha Nehru  Saveetha Dental College and Hospital  Clinic 27, Department of orthodontics and Dentofacial Orthopedics,162,Poonamallee High Road, Velappanchavadi, Chennai
Chennai
TAMIL NADU 		 09976655446

152308001.sdc@saveetha.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human 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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  non Sr-BAG primer   After etching the teeth, the commercially available primer (Transbond) will be applied to the tooth surface and light-cured according to the manufacturer’s instructions prior to bracket bonding with composite.  
Intervention  Strontium-Doped Bioactive Glass Nanoparticle(Sr-BAG)Incorporated Orthodontic Primer  After etching the teeth, the Sr-doped Bioactive Glass (Sr-BAG) nanoparticle-incorporated primer will be applied to the tooth surface and light-cured according to manufacturer’s instructions prior to bracket bonding with composite. The duration will be for 6 months. 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  Patients who will be undergoing fixed orthodontic therapy, Patients with a full set of permanent maxillary anterior teeth,
patients who were caries-free and with healthy periodontal tissue were included 
 
ExclusionCriteria 
Details  patients with
fluorosed teeth or restoration on facial surface of upper anterior teeth 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
to compare the changes in amount of enamel demineralization around orthodontic brackets.  immediately after bonding (T0), 1 month after bonding (T1),
6 months after bonding (T2) 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
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   N/A 
Date of First Enrollment (India)   31/10/2025 
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)   Not Applicable 
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 - 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 - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [amrithanehru02@gmail.com].

  6. For how long will this data be available start date provided 05-06-2026 and end date provided 05-06-2031?
    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   A double blinded randomized controlled clinical trial with a split-mouth design investigating the efficacy of strontium-doped bioactive glass (Sr-BAG) nanoparticle-incorporated orthodontic primer in the management of white spot lesions in patients with fixed orthodontic therapy. The study will include 22 participants, each receiving the Sr-BAG and control primers on contralateral sides of the mouth (a split-mouth design), making it a total sample size of 44 (intervention group n=22, control group n=22). Outcome measures included comparison of the Sr-BAG primer and the control primer (Transbond) in terms of the incidence of white spot lesions (WSLs) or the degree of demineralization, assessed using a DIAGNOdent pen at three different time points during the clinical trial. 
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