| CTRI Number |
CTRI/2025/09/094847 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
01/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of clinical effectiveness between 3D-printed and thermoformed retainers in post orthodontic patients. |
|
Scientific Title of Study
|
Comparison of clinical effectiveness between 3 Dimensional printed and thermoformed retainers: A randomized clinical trial
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aliya jamal |
| Designation |
junior resident |
| Affiliation |
CDER AIIMS NEW DELHI |
| Address |
room no 413 4th floor Division of orthodontics and dentofacial deformities CDER AIIMS NEW DELHI
New Delhi
DELHI
110029
India |
| Phone |
9718096475 |
| Fax |
|
| Email |
aliyajamal495@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rajiv B |
| Designation |
Assistant professor |
| Affiliation |
CDER AIIMS NEW DELHI |
| Address |
room no 406B 4th floor Division of orthodontics and dentofacial deformities CDER AIIMS NEW DELHI
New Delhi
DELHI
110029
India |
| Phone |
9871191530 |
| Fax |
|
| Email |
drrajivmds@aiims.edu |
|
Details of Contact Person
Public Query
|
| Name |
Rajiv B |
| Designation |
Assistant professor |
| Affiliation |
CDER AIIMS NEW DELHI |
| Address |
room no 406B 4th floor Division of orthodontics and dentofacial deformities CDER AIIMS NEW DELHI
New Delhi
DELHI
110029
India |
| Phone |
9871191530 |
| Fax |
|
| Email |
drrajivmds@aiims.edu |
|
|
Source of Monetary or Material Support
|
| Division of orthodontics and dentofacial deformities CDER AIIMS NEW DELHI,110029
INDIA |
|
|
Primary Sponsor
|
| Name |
Aliya jamal |
| Address |
room no 413 4th floor division of orthodontics and dentofacial deformities CDER AIIMS NEW DELHI,110029
INDIA |
| 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 |
| Dr Aliya jamal |
AIIMS |
Room no 413 4th floor Division of orthodontics and dentofacial deformities CDER AIIMS NEW DELHI,110029
INDIA
New Delhi
DELHI |
9718096475
aliyajamal495@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Aiims institutional 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, (2) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
3D printed retainer |
After debonding alginate impression will be taken to obtain study model of the dental arches or intra oral scanning will be done at T (0).The test group will receive a 3D printed orthodontic retainer fabricated using Dental LT clear 2 material |
| Comparator Agent |
Thermoformed retainer
|
After debonding, impression will be taken, pressure formed retainer will be fabricated, trimmed, and delivered to the patient within 1 day after debonding
|
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient who have completed fixed orthodontic treatment with all 1st premolar extraction with good alignment and levelling.
2. Patient aged between 14-30 years
3. Patient willing to comply with retainer wear and follow up appointments.
4. No history of allergies or sensitivities to the material used in either retainer type.
5. Patient with no remaining active growth phase.
|
|
| ExclusionCriteria |
| Details |
1. Patient with systemic diseases, craniofacial syndromes and condition interfere with tooth movement.
2. Previous orthognathic surgery.
3. Patient with poor oral hygiene or unwillingness to maintain oral hygiene.
4. Patient unwilling or unable to attend follow up visits.
5. Patient with bruxism habit which may damage retainer.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of tooth stability between 3D printed and thermoformed retainer at 0, 1, 3, 6 months of post treatment |
T0 Baseline
T1 After 1 month
T2 After 3 months
T3 After 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of patient satisfaction and retainer survival (breakage/distortion) between 3D printed and thermoformed retainer |
T0 Baseline
T1 After 1 month
T2 After 3 months
T3 After 6 months |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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 3 |
|
Date of First Enrollment (India)
|
01/12/2025 |
| 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
|
This is a randomized controlled trial using a parallel group study design to compare the effectiveness between 3D printed retainer and thermoformed retainer in post orthodontic patients. Primary objective of my study is to assess and compare the tooth stability between 3D printed and thermoformed retainer over 6 months period. The secondary objective of my study is to compare patient satisfaction and retainer breakage or distortion. • •
|