| CTRI Number |
CTRI/2025/08/093665 [Registered on: 26/08/2025] Trial Registered Prospectively |
| Last Modified On: |
26/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The study is about which type of material plastic or metal retains the teeth straighter and breaks less frequently after the braces are removed. |
|
Scientific Title of Study
|
Comparative Evaluation of Occlusal Stability and Retainer Failure between CAD-CAM Fabricated Poly-Ether-Ether Ketone [PEEK] and Multistranded SS Bonded Retainer: A Randomised Clinical 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 |
Padmapriya S |
| Designation |
Post Graduate Student |
| Affiliation |
Government Dental college and Hospital Cuddalore (erstwhile Rajah Muthiyah Dental College) |
| Address |
Department of Orthodontics and Dentofacial Orthopaedics
Government Dental college and Hospital Cuddalore (erstwhile Rajah Muthiyah Dental College)
Annamalai University
Chidambaram
Cuddalore
Cuddalore
TAMIL NADU
608002
India |
| Phone |
8838137352 |
| Fax |
|
| Email |
priyasundararajan0912@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
N Kurunji Kumaran |
| Designation |
Professor and Head |
| Affiliation |
Government Dental college and Hospital Cuddalore (erstwhile Rajah Muthiyah Dental College) |
| Address |
Department of Orthodontics and Dentofacial Orthopaedics
Government Dental college and Hospital Cuddalore (erstwhile Rajah Muthiyah Dental College)
Annamalai University
Chidambaram
Cuddalore
TAMIL NADU
608002
India |
| Phone |
9865835965 |
| Fax |
|
| Email |
dr.kurinchi@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
N Kurunji Kumaran |
| Designation |
Professor and Head |
| Affiliation |
Government Dental college and Hospital Cuddalore (erstwhile Rajah Muthiyah Dental College) |
| Address |
Department of Orthodontics and Dentofacial Orthopaedics
Government Dental college and Hospital Cuddalore (erstwhile Rajah Muthiyah Dental College)
Annamalai University
Chidambaram
Cuddalore
TAMIL NADU
608002
India |
| Phone |
9865835965 |
| Fax |
|
| Email |
dr.kurinchi@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Government Dental College And Hospital Cuddalore Erstwhile Rajah Muthiyah Dental College Annamalai University Chidambaram Tamil Nadu
608002 |
|
|
Primary Sponsor
|
| Name |
Padmapriya S |
| Address |
Department of Orthodontics and Dentofacial Orthopaedics,
Government Dental College and Hospital, Cudddalore (erstwhile Rajah Muthiyah Dental College)
Annamalai University
Chidambaram
Cuddalore
608002
|
| Type of Sponsor |
Other [Self Funding] |
|
|
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 N Kurunji Kumaran |
Government Dental College and Hospital |
Department Of Orthodontics and Dentofacial Orthopaedics
First Floor
Room no 101
Government Dental College and Hospital
Cuddalore
TAMIL NADU
Cuddalore
TAMIL NADU |
9865835965
dr.kurinchi@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Medical College And Hospital Cuddalore District Erstwhile Rajah Muthiyah Medical College Institutional Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Multistranded SS retainer |
Adapted and bonded to the lingual surface of the mandibular anterior teeth. |
| Intervention |
PEEK retainer |
Fabricated and bonded to the lingual surface of the mandibular anterior teeth |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
28.00 Year(s) |
| Gender |
Both |
| Details |
Subjects who finished fixed orthodontic treatment and are ready to go into retention phase
Age group 15-28 years
Any type of malocclusion before treatment
Treated with non-extraction approaches in mandibular arch
Little Irregularity Index score of 0-0.5mm after completion of treatment
Patient with sound periodontal condition
Patient with capability of maintaining good oral hygiene
|
|
| ExclusionCriteria |
| Details |
Relapse and Reorthodontic treatment cases
Discontinued or incomplete fixed orthodontic treatment cases
H/O of systemic mental illness or any other syndrome
Missing anteriors either congenitally or extracted in mandibular arch
Persistent Parafunctional habits
Patients treated with adjuvant surgical procedures like circumferential supracrestal fibrotomy or frenectomy in mandibular arch
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
occlusal stability
retainer failure |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
occlusal measurements such as overjet, overbite, arch width and arch length
periodontal characteristics such as plaque index, calculus index, gingival index, bleeding index and periodontal index
Microbial characteristics of Streptococcus Mutans, Lactobacilli |
1 year |
|
|
Target Sample Size
|
Total Sample Size="58"
Sample Size from India="58"
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 4 |
|
Date of First Enrollment (India)
|
15/09/2025 |
| 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="0"
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
|
This Study is a randomized parallel group trial, this study evaluate the occlusal stability and retainer failure between Cad Cam fabricated Polyether Ether Ketone and Multistranded SS bonded retainer after completion of orthodontic treatment. The primary outcome is to assess and compare the Occlusal stability Retainer failure between PEEK retainer and multistranded SS bonded retainer. The secondary outcome is to assess and compare the occlusal measurements such as overjet, overbite arch width and arch length. Followed by periodontal health status and microbial characteristics of Streptococcus mutans Lactobacilli between PEEK retainer and multistranded SS bonded retainer |