| CTRI Number |
CTRI/2024/03/064898 [Registered on: 28/03/2024] Trial Registered Prospectively |
| Last Modified On: |
25/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Dentistry
Other (Specify) [Retainers] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparative evaluation of two types of appliance used to hold the tooth in position after braces treatment |
|
Scientific Title of Study
|
Comparative evaluation of post treatment stability during orthodontic retention using lingual
bonded retainers versus lingual bonded retainers coupled with thermoformed retainers – A
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 |
Meenakshi J |
| Designation |
Postgraduate student - MDS Orthodontics |
| Affiliation |
Chettinad Dental College and Research Institute |
| Address |
Room no:9,
Fourth floor,
Department of Orthodontics and Dentofacial Orthopaedics, Chettinad health city, Rajiv Gandhi Salai,Kelambakkam,Kanchipuram district,Chennai,Tamilnadu-603103
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9789671651 |
| Fax |
|
| Email |
meenakshijawaharlal5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prema Arasu |
| Designation |
Associate Professor |
| Affiliation |
Chettinad Dental College and Research Institute |
| Address |
Room no:9,
Fourth floor,
Department of Orthodontics and Dentofacial Orthopaedics,
Chettinad health city, Rajiv Gandhi Salai,Kelambakkam,Kanchipuram district,Chennai,Tamilnadu-603103
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9789671651 |
| Fax |
|
| Email |
prema.arasu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prema Arasu |
| Designation |
Associate Professor |
| Affiliation |
Chettinad Dental College and Research Institute |
| Address |
Room no:9,
Fourth floor,
Department of Orthodontics and Dentofacial Orthopaedics, Chettinad health city, Rajiv Gandhi Salai,Kelambakkam,Kanchipuram district,Chennai,Tamilnadu-603103
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9789671651 |
| Fax |
|
| Email |
prema.arasu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chettinad Dental College and Research Institute, Kelambakkam,TamilNadu |
|
|
Primary Sponsor
|
| Name |
Chettinad Dental College and Research Institute |
| Address |
Chettinad Dental College and Research Institute, Rajiv gandhi salai,kelambakkam,Chennai-603103 |
| 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 |
| Meenakshi J |
Chettinad Dental College and Research Institute |
Room no:9,
Fourth floor,
Department of Orthodontics and Dentofacial Orthopaedics, Chettinad Dental College and Research Institute, Kelambakkam, chennai
Kancheepuram
TAMIL NADU |
9789671651
meenakshijawaharlal5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee for Student research (CARE IHEC -I) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K039||Disease of hard tissues of teeth,unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bonded Lingual retainers coupled with thermoformed retainers |
After completion of orthodontic treatment patients are given orthodontic fixed lingual retainers along with thermoformed (clear) retainers immediately and will be followed up after 6 months |
| Comparator Agent |
Lingual bonded retainers |
After completion of orthodontic treatment patients are given lingual bonded retainers immediately and will be followed up after 6 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Patients who have undergone orthodontic treatment without any systemic complications and bone disorders |
|
| ExclusionCriteria |
| Details |
Patients with extracted or congenitally missing anterior teeth, periodontally compromised patients, patients with cleftlip and palate |
|
|
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 |
| Post treatment tooth movements during orthodontic retention |
0,6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of wire syndrome (twist effect, x effect) along with patient Satisfaction and acceptance |
0,6 months |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
11/04/2024 |
| 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="0"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - Data will be shared upon request
- For how long will this data be available start date provided 01-05-2025 and end date provided 08-03-2035?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
In this Randomised parallel study, patients recruited depending on the inclusion and exclusion criteria are assigned under two groups, Group-A patients with lingual bondd retainers only; Group-B patients with lingual bonded retainer in combination with thermoformed retainers. Study models and intraoral photographs and scans are to be obtained at the day of retainer insertion(T0) and after 6 months(T1). And the intraoral scans obtained at T0 and T1 are superimposed to look into unwanted tooth movements. |