| CTRI Number |
CTRI/2024/06/069055 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
10/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative study about stability and failure in patients wearing two different types of retainer appliance after orthodontic treatment. |
|
Scientific Title of Study
|
Assessing retainer failure occurrence and stability in fixed lingual bonded retainer received post orthodontic patients with and without removable vacuum formed retainer– A pilot 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 |
KURUNJI KUMARAN N |
| Designation |
Professor and Head of the department |
| Affiliation |
government dental college cuddalore district |
| Address |
Department of Orthodontics & dentofacial orthopedics,Annamalai nagar, chidambaram, tamilnadu
Cuddalore
TAMIL NADU
608002
India |
| Phone |
9865835965 |
| Fax |
|
| Email |
drkurinchi@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
KURUNJI KUMARAN N |
| Designation |
Professor and Head of the department |
| Affiliation |
government dental college cuddalore district |
| Address |
Department of orthodontic & dentofacial orthopedics, Annamalai nagar, chidambaram, tamilnadu
Cuddalore
TAMIL NADU
608002
India |
| Phone |
9865835965 |
| Fax |
|
| Email |
drkurinchi@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
KURUNJI KUMARAN N |
| Designation |
Professor and Head of the department |
| Affiliation |
government dental college cuddalore district |
| Address |
Department of orthodontic & dentofacial orthopedics, Annamalai nagar, chidambaram, tamilnadu
Cuddalore
TAMIL NADU
608002
India |
| Phone |
9865835965 |
| Fax |
|
| Email |
drkurinchi@yahoo.com |
|
|
Source of Monetary or Material Support
|
| KURUNJI KUMARAN N
Professor & HOD
Department of Orthodontics Cuddalore government dental college, Chidambaram Tamilnadu 608002 |
|
|
Primary Sponsor
|
| Name |
KURUNJI KUMARAN N |
| Address |
Professor & HOD
Department of Orthodontics
government dental college cuddalore, Chidambaram Tamilnadu 608002 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| DrKURUNJI KUMARAN N |
Government dental college cuddalore district |
Department of Orthodontics & dentofacial orthopedics, Annamalai nagar, chidambaram tamilnadu 6
Cuddalore
TAMIL NADU |
9865835965
drkurinchi@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 Muthiah 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 |
Conventional retention |
Fixed lingual bonded retainer. Total duration 6 months |
| Intervention |
Dual retention |
Removable vacuum formed retainer in addition to fixed lingual bonded retainer. Total duration 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Both male and female subjects with in the age group of 18 to 30 yrs who had completed a course of fixed appliance therapy (involving both dental arches) with correction of dental malocclusion.
Subjects who had maintained good oral hygiene throughout treatment.
Subjects who had full and normal complement of teeth in the upper and lower anterior segments before starting orthodontic treatment.
Teeth within the anterior segments to be a regular size and shape and not restored or endodontically treated.
Subjects who have not underwent periodontal therapy except orthodontic adjunctive minor periodontal procedures before, during or at the end of orthodontic treatment. |
|
| ExclusionCriteria |
| Details |
Subjects with any general medical health problems which may influence gingival health such as diabetes mellitus, epilepsy, etc or physical / mental disability.
Subjects underwent rapid maxillary expansion or surgically assisted rapid maxillary expansion.
Subjects with cleft palate or severe facial deformities.
Subjects with severe skeletal malocclusion for which orthognathic surgical correction was carried out. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Retainer failure occurrence
Post orthodontic stability
|
T1(day of retainer delivery) and T2 (end of 6 months).
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Periodontal health
Patient perception
|
T1(day of retainer delivery) and T2 (end of 6 months). |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/07/2024 |
| Date of Study Completion (India) |
08/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Correction of dental malocclusion needs orthodontic intervention. Usually,
a comprehensive orthodontic treatment extends up to 24 to 30 months. Retainers
are given to patients to preserve the outcome of orthodontic treatment. Among
several types of retainers either fixed lingual bonded retainer or removable
vacuum formed retainer are commonly used. Fixed retainers are prone for bond
failure whereas removable vacuum formed retainers are patient compliance
dependent. To overcome this, the concept of hybrid/dual retention, in which the
use of removable vacuum formed retainer in addition to fixed lingual bonded
retainer has also been practiced. The
proponents of this hybrid method claims that it may serve the retention purpose
superior than single retainer, in situations wherein a fixed retainer fails and
patient not identify it earlier would be reporting to orthodontist only after
occurrence of notable relapse. In such situation, if the patient had been provided
with a removal vacuum formed retainer to be worn during night time over the
fixed retainer, it will act as an additional safety mechanism and the patient
will be in safe zone and relapse may not occur until the fixed retainer is
repaired or replaced. However, till date there is no scientific evidence to support
this. With our acquired knowledge from
English literature no previous studies have compared this, hence the goal of
the present study is to conduct a pilot RCT to assess retainer failure
occurrence, post orthodontic stability periodontal health and patient
perception in fixed lingual bonded retainer received post orthodontic patients
with and without removable vacuum formed retainer, over a period of 6 months. |