| CTRI Number |
CTRI/2025/12/098407 [Registered on: 03/12/2025] Trial Registered Prospectively |
| Last Modified On: |
03/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
To find the appropriate wear duration of each aligner to be worn by patient undergoing wires and braces treatment with aligners for crooked teeth |
|
Scientific Title of Study
|
To Compare and evaluate the mechanical properties of different aligner materials : 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 |
Dr Varun Goyal |
| Designation |
Phd scholar |
| Affiliation |
MM College of dental sciences and Research |
| Address |
Department of Orthodontics,MM College of Dental Sciences and research,MM University(Deemed to be University), Ambala, Mullana, Haryana
Ambala
HARYANA
133207
India |
| Phone |
07838683317 |
| Fax |
|
| Email |
varungoyal29@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepankar Bhatnagar |
| Designation |
Professor and Head |
| Affiliation |
MM College of dental sciences and Research |
| Address |
Department of Orthodontics,MMCDSR,MM University(Deemed to be University), Ambala, Mullana, Haryana
Ambala
HARYANA
133207
India |
| Phone |
8847245115 |
| Fax |
|
| Email |
hod.orthodontics@mmumullana.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Varun Goyal |
| Designation |
Phd scholar |
| Affiliation |
MM College of dental sciences and Research |
| Address |
Department of Orthodontics,MMCDSR,MM University(Deemed to be University), Ambala, Mullana, Haryana
Ambala
HARYANA
133207
India |
| Phone |
07838683317 |
| Fax |
|
| Email |
varungoyal29@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Varun Goyal, Phd Scholar, Department of Orthodontics,MMCDSR,MM University(Deemed to be University), Ambala, Mullana, Haryana Pin 133207 |
|
|
Primary Sponsor
|
| Name |
Dr Varun Goyal |
| Address |
Phd Scholar, Department of Orthodontics,MM College of Dental Sciences and Research,MM University(Deemed to be University), Ambala, Mullana, Haryana |
| Type of Sponsor |
Other [Individual] |
|
|
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 Varun Goyal |
MM College of dental sciences and research |
Department of orthodontics and Dentofacial Orthopedics, MMCDSR Mullana, Ambala
Ambala
HARYANA |
07838683317
varungoyal29@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, MMIMSR, Mullana |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K038||Other specified diseases of hard tissues of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
taking used aligners back from patient and studying their mechanical properties |
studying three different mechanical properties of three different aligner material and comparing them at 0, 7 and 14 days. total duration of such intervention will be 21 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1)Patient with good oral hygiene.
2)Patient with mild to moderate malocclusion.
3)Patient with good compliance to wear aligners at least 20-22 hours per day.
|
|
| ExclusionCriteria |
| Details |
1)Patient with poor oral hygiene.
2)Patient with a habit of smoking, tobacco chewing or bruxism.
3)other food habit which could alter the aligner material properties.
4)Distorted aligners.
• Patient with Esophageal reflux as it may affect the property of the material.
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| change in mechanical properties of aligner materials at 3 different points of time |
Baseline i.e 0 days, 7 days and 14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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)
|
15/12/2025 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Aligners will be given to patient undergoing orthodontic treatment and after use these aligners will be collected after use by the patient. then the mechanical properties of these aligner material will be compared to see the ideal time of wear of aligners and the degradation of mechanical properties of aligners |