| CTRI Number |
CTRI/2025/08/093936 [Registered on: 29/08/2025] Trial Registered Prospectively |
| Last Modified On: |
28/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Which Retainer Works Better After Braces? A Comparison of 3D-Printed and Traditional Types |
|
Scientific Title of Study
|
COMPARATIVE ASSESSMENT OF FAILURE RATE AND PERIODONTAL STATUS BETWEEN CAD/CAM GENERATED METAL FIXED LINGUAL BONDED RETAINER AND CONVENTIONAL FIXED LINGUAL BONDED RETAINER: A PROSPECTIVE RANDOMIZED CONTROLLED TRIAL |
| 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 SHARANJI S V |
| Designation |
MDS |
| Affiliation |
Indira Gandhi Institute of Dental Sciences |
| Address |
Department of Orthodontics and Dentofacial Orthopedics
Indira Gandhi Institute of Dental Sciences
Sri Balaji Vidyapeeth
Pillaiyarkuppam
Pondicherry
PONDICHERRY
607402
India |
| Phone |
8220584165 |
| Fax |
|
| Email |
sharanji0202@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DRPAVITHRANAND A |
| Designation |
Professor and Head |
| Affiliation |
Indira Gandhi Institute of Dental Sciences |
| Address |
Department of Orthodontics
Indira Gandhi Institute of Dental Sciences
SBV Pondicherry Campus Pillaiyarkuppam
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9443183590 |
| Fax |
|
| Email |
pavithranandammayappan@igids.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
DRPAVITHRANAND A |
| Designation |
Professor and Head |
| Affiliation |
Indira Gandhi Institute of Dental Sciences |
| Address |
Department of Orthodontics
Indira Gandhi Institute of Dental Sciences
SBV Pondicherry Campus Pillaiyarkuppam
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9443183590 |
| Fax |
|
| Email |
pavithranandammayappan@igids.ac.in |
|
|
Source of Monetary or Material Support
|
| Indira Gandhi Institute of Dental Sciences
SBV Campus, Pillaiyarkuppam 607402
Pondicherry |
|
|
Primary Sponsor
|
| Name |
DR SHARANJI S V |
| Address |
I MDS Department of Orthodontics and Dentofacial Orthopedics |
| Type of Sponsor |
Research institution 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 Sharanji S V |
Indira Gandhi Institute of Dental Sciences |
Department of Orthodontics and Dentofacial Orthopedics
5th floor
Indira Gandhi Institute of Dental Sciences
Sri Balaji Vidyapeeth
Pondicherry
PONDICHERRY |
8220584165
sharanji0202@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Indira Gandhi Institute of Dental Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M264||Malocclusion, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CAD/CAM generated metal fixed lingual bonded retainer |
The retainer will be made through laser sintered CAD/CAM generated stainless steel fixed bonded retainer will be fabricated and delivered |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Age group above 16 years
Completion of treatment with full fixed appliance with optimal overjet and overbite and
Occlusions According to the six keys of Andrews
Good general and oral health
Patients treated by both extraction and non extraction protocols
|
|
| ExclusionCriteria |
| Details |
Treatment involving extraction of anterior teeth
Conditions contraindicating fixed retainers
Craniofacial or severe asymmetry syndromes
Periodontally compromised patients
Dental restorations or missing teeth on the anterior area
Nickel allergy
Smoking
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Assessing the failure rate
2. Assessing the relapse rate
|
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of Periodontal status |
|
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
16/09/2025 |
| 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="1"
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 - NO
|
|
Brief Summary
|
Title of the Study:
Comparative Assessment of Failure Rate and Periodontal Status Between CAD/CAM Generated Metal Fixed Lingual Bonded Retainer and Conventional Fixed Lingual Bonded Retainer: A Prospective Randomized Controlled Trial Brief Summary:
This is a prospective randomized controlled trial conducted at the Department of Orthodontics and Dentofacial Orthopedics, Indira Gandhi Institute of Dental Sciences (IGIDS), Puducherry. The study aims to compare the clinical performance and periodontal outcomes of CAD/CAM-generated metal fixed lingual bonded retainers versus conventional fixed lingual bonded retainers in post-orthodontic patients. A total of 50 participants, aged above 16 years and having completed fixed appliance orthodontic treatment, will be randomly assigned into two groups: The CAD/CAM retainers will be fabricated using 3D scanning and laser sintering technology, while conventional retainers will be manually formed using stainless steel wires. Both will be bonded using the indirect technique. Double blinding (patient and assessor) is maintained. The study excludes patients with periodontal disease, anterior extractions, craniofacial anomalies, or nickel allergies. The study protocol includes all ethical considerations, informed consent/assent in both English and Tamil, and necessary quality control measures. Primary outcomes include the failure rate of the retainers and the relapse rate assessed through inter-canine width and Little’s irregularity index. Secondary outcomes include evaluation of periodontal status using gingival index, calculus index, periodontal index, and bleeding on probing at baseline and during follow-up visits at 1, 3, and 6 months. The study utilizes double blinding (participant and assessor) and block randomization. Ethical clearance has been obtained from the Institutional Ethics Committee, and informed consent will be acquired from all participants. The total study duration is one year, and the trial is self-funded. The findings are expected to inform clinical protocols and enhance long-term orthodontic retention strategies while maintaining periodontal health. |