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CTRI Number  CTRI/2025/12/099314 [Registered on: 17/12/2025] Trial Registered Prospectively
Last Modified On: 16/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   CAD CAM Designed Jigs for Precision Bonding of Fixed Retainers in Orthodontics 
Scientific Title of Study   A Prospective Clinical Trial evaluating a CAD-CAM Fabricated Jig for Precision bonding of fixed Retainers assessing the Breakage Rate and Alignment Stability: A 6- Month Follow up Syudy 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  MUSKAN CHANDUKA 
Designation  Postgraduate Student 
Affiliation  Saveetha Dental College 
Address  Clinic 27, Department of Orthodontics, Saveetha Dental College, Poonamallee High Road, Chennai

Chennai
TAMIL NADU
600077
India 
Phone  7437924646  
Fax    
Email  muskan.chanduka098@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Ashwin Mathew George 
Designation  Professor 
Affiliation  Saveetha Dental College 
Address  Clinic 27, Department of Orthodontics, Saveetha Dental College, Poonamallee High Road, Chennai

Chennai
TAMIL NADU
600077
India 
Phone  9840032771  
Fax    
Email  ashwin.george10@gmail.com  
 
Details of Contact Person
Public Query  
Name  Aravind Kumar Subramanian 
Designation  Professor 
Affiliation  Saveetha Dental College 
Address  Clinic 27, Department of Orthodontics, Saveetha Dental College, Poonamallee High Road, Chennai

Chennai
TAMIL NADU
600077
India 
Phone  9841299939  
Fax    
Email  dr.aravind.s@gmail.com  
 
Source of Monetary or Material Support  
Clinic 27, Department of Orthodontics, Saveetha Dental College 
 
Primary Sponsor  
Name  Sunil Kumar Chanduka 
Address  Balabhadra Lane, Labanikhia Chawk, Puri-752001, Odisha 
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 MUSKAN CHANDUKA  Saveetha Dental College  Clinic 27, Department of Orthodontics,Saveetha Dental College, Poonamallee High Road
Chennai
TAMIL NADU 		 7437924646

muskan.chanduka098@gmail.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: K089||Disorder of teeth and supporting structures, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  CAD CAM fabricated jig   Use of a custom designed CAD CAM jig for accurate positioning and bonding of fixed retainers after orthodontic treatment. Follow up is done for 6 months. 
Comparator Agent  Conventional Direct bonding Technique  Bonding of fixed retainers using standard direct technique without using any jig or guided system. Follow up is done for 6 months. 
 
Inclusion Criteria  
Age From  14.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  1. Completed fixed appliance orthodontic treatment with satisfactory correction of malocclusion
2. Anterior teeth of adequate size and shape for bonded retainer placement
3. No missing anterior teeth in upper or lower arch
4. In good systemic health
5. willing and able to comply with the trial protocol
6. Provided written informed consent 
 
ExclusionCriteria 
Details  1. Presence of cleft palate or severe facial deformities
2. Nickel Allergy
3. Poor periodontal health at the pre debond appointment
4. Gross or uncontrolled caries
5. Need for prosthodontic treatment in the upper or lower arch post treatment
6. Lower incisor extraction cases 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Breakage rate of fixed retainers  Baseline, 1 month, 3 months, 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Gingival index  Baseline, 1 month, 3 months, 6 months 
Plaque Index  Baseline, 1 month, 3 months, 6 months 
Irregularity index  Baseline, 1 month, 3 months, 6 months 
Arch width changes  Baseline, 1 month, 3 months, 6 months 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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 3 
Date of First Enrollment (India)   27/12/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  27/12/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - 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 - 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 [muskan.chanduka098@gmail.com].

  6. For how long will this data be available start date provided 28-07-2025 and end date provided 30-04-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - No
Brief Summary   This prospective clinical trial aims to evaluate the effectiveness of a novel CAD-CAM fabricated jig for precision bonding of fixed retainers. The study will compare the jig assisted bonding technique with conventional direct bonding in terms of retainer breakage rate, alignment stability, periodontal health and arch width changes over a 6 month follow up period. A total of two groups will be assessed with clinical measurements recorded at baseline, 1 month, 3 months and 6 months follow up to determine efficacy and safety. The goal is to improve the precision, efficiency and long term success of fixed retainer placement in post orthodontic patients. 
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