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CTRI Number  CTRI/2025/04/084400 [Registered on: 08/04/2025] Trial Registered Prospectively
Last Modified On: 21/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Dentistry 
Study Design  Randomized, Crossover Trial 
Public Title of Study   A Study Comparing the Effects of Fixed and Removable Retainers on Long-Term Treatment Stability and Gingival Health 
Scientific Title of Study   COMPARATIVE EVALUATION OF FIXED AND REMOVABLE RETAINERS ON TREATMENT STABILITY AND PERIODONTAL HEALTH: A PROSPECTIVE OBSERVATIONAL 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  Dr Yugarshi Kaul 
Designation  POST GRADUATE STUDENT 
Affiliation  ITS Dental College Hospital and Research Centre 
Address  Room number 10, Department of Orthodontics and Dentofacial Orthopedics ITS Dental College Hospital and Research Centre, 47 Knowledge Park III Greater Noida

Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  9123320499  
Fax    
Email  23kaulyugarshi@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Amrita Puri 
Designation  Professor 
Affiliation  ITS Dental College Hospital and Research Centre 
Address  Room number 10, Department of Orthodontics and Dentofacial Orthopedics ITS Dental College Hospital and Research Centre, 47 Knowledge Park III Greater Noida

Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  9899216233  
Fax    
Email  amritapuri@its.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Yugarshi Kaul 
Designation  POST GRADUATE STUDENT 
Affiliation  ITS Dental College Hospital and Research Centre 
Address  Room number 10, Department of Orthodontics and Dentofacial Orthopedics ITS Dental College Hospital and Research Centre, 47 Knowledge Park III Greater Noida

Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  9123320499  
Fax    
Email  23kaulyugarshi@gmail.com  
 
Source of Monetary or Material Support  
ITS DENTAL COLLEGE HOSPITAL AND RESEARCH CENTRE GREATER NOIDA 
 
Primary Sponsor  
Name  ORTHOPEDICS ITS DENTAL COLLEGE HOSPITAL AND RESEARCH CENTRE  
Address  ROOM NUMBER 10, DEPARTMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPEDICS ITS DENTAL COLLEGE HOSPITAL AND RESEARCH CENTRE 47, KNOWLEDGE PARK-III GREATER NOIDA  
Type of Sponsor  Other [Research Institute and Hospital] 
 
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 Yugarshi Kaul  ITS Dental College Hospital and Research Centre  Room number 10, Department of Orthodontics & Dentofacial Orthopedics, ITS Dental College Hospital and Research Centre, 47, Knowledge Park-III Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH 
9123320499

23kaulyugarshi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ITS Dental College Hospital and Research Centre Institutional Ethics 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  Beggs Wraparound Retainer  Beggs Wraparound Retainer will be given to patients after completion of fixed orthodontic treatment. 
Comparator Agent  Bonded Lingual Retainer  Bonded Lingual Retainer will be given to patients after completion of fixed orthodontic treatment. 
Comparator Agent  Vacuum Formed Retainer  Vacuum Formed Retainer will be given to patients after completion of fixed orthodontic treatment. 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  22.00 Year(s)
Gender  Both 
Details  1.Prospective observational trial on patients in the age group of 15-22 years who have completed fixed orthodontic treatment with Pre- Molar extraction cases.
2.Patients having permanent dentition

 
 
ExclusionCriteria 
Details  1.Hypomineralized teeth
2.Patients with any syndromes or craniofacial deformity.
3.Pre existing gingival or periodontal disease
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Treatment stability, Periodontal health  Baseline, 3 months and 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
none  none 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   01/05/2025 
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="2"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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 - NO
Brief Summary  

Retention is a critical phase in orthodontic treatment, essential for maintaining the treatment stability of the results achieved by fixed orthodontic treatment. Massive efforts have been carried out to find the best strategies to retain the teeth in their new position after orthodontic treatment and to avoid relapse. Different retention treatments have also been analyzed with respect to tooth stability and periodontal health. The retention phase may last a year or longer, making the use of retainers particularly important during the first year after the orthodontic treatment. Retainers can be fixed or removable. Each kind has advantages and disadvantages. Fixed retainers are effective and do not need the patient’s cooperation, but they have been criticized for their potential to compromise the periodontal status, due to the accumulation of plaque and calculus on the retainer. Thus, removable retainers have become more common for a number of reasons, including lower costs, better esthetics, and less time consumed in the laboratory, and they can be removed from the mouth and cleaned by the patient. Current thinking is to hold the corrections achieved with a retainer because the exact cause of relapse is not known. The etiology of post-treatment relapse is multifactorial and subject to individual variations. As a result, it is impossible to guarantee absolute post-treatment stability.

 
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