| 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
|
|
|
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
|
|
|
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. |