| CTRI Number |
CTRI/2023/07/055195 [Registered on: 13/07/2023] Trial Registered Prospectively |
| Last Modified On: |
12/07/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Evaluation of removable clear tooth moving plastic braces and traditional fixed metallic braces for the treatment of misaligned teeth |
|
Scientific Title of Study
|
3D-printed aligners as a state-of-the-art smile designing appliance for its integration in Indian public hospitals |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prabhat Kumar Chaudhari |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi. |
| Address |
Division of Orthodontics and Dentofacial Deformities, Centre for Dental Education and Research, All India Institute of Medical Sciences, New Delhi.
South
DELHI
110029
India |
| Phone |
8375044325 |
| Fax |
|
| Email |
dr.prabhatkc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prabhat Kumar Chaudhari |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi. |
| Address |
Division of Orthodontics and Dentofacial Deformities, Centre for Dental Education and Research, All India Institute of Medical Sciences, New Delhi.
South
DELHI
110029
India |
| Phone |
8375044325 |
| Fax |
|
| Email |
dr.prabhatkc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prabhat Kumar Chaudhari |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi. |
| Address |
Division of Orthodontics and Dentofacial Deformities, Centre for Dental Education and Research, All India Institute of Medical Sciences, New Delhi.
South
DELHI
110029
India |
| Phone |
8375044325 |
| Fax |
|
| Email |
dr.prabhatkc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Division of Orthodontics and Dentofacial Deformities, Centre for Dental Education and Research, All India Institute of medical Sciences, New Delhi. |
| Science and Engineering Research Board |
|
|
Primary Sponsor
|
| Name |
Science and Engineering Research Board |
| Address |
3rd & 4th Floor, Block II,
Technology Bhawan,
New Mehrauli Road
New Delhi - 110016 |
| Type of Sponsor |
Government funding agency |
|
|
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 Prabhat Kumar Chaudhari |
All India Institute of Medical Sciences, New Delhi |
4th Floor, Division of Orthodontics and Dentofacial Deformities, Centre for Dental Education and Research,
All India Institute of Medical Sciences,
New Delhi, India.
South
DELHI |
8375044325
dr.prabhatkc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, All India Institute of Medical Sciences |
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 |
| Intervention |
Direct 3D-printed aligners |
The patients will be treated using direct 3D-printed aligners (removable appliance) manufactured using biocompatible resin (2 years). |
| Comparator Agent |
Labial fixed orthodontic appliances |
The patients will be treated using the MBT preadjusted fixed appliances (2 years). |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
24.00 Year(s) |
| Gender |
Both |
| Details |
Patients having mild to moderate malocclusion
Patients having a complete set of permanent dentition
Patients having no requirement of extraction
Patients having no requirement of distallization
Completion of treatment using clear aligners alone. |
|
| ExclusionCriteria |
| Details |
Patients having crowding or spacing more than 6mm
Patients having severe antero-posterior/ transverse/ vertical skeletal dysplasia
Patients having severely rotated of teeth
Patients with multiple edentulous spaces, root stumps
Patients with compromised periodontium and poor oral hygiene Patients with centric relation and centric occlusion discrepancies
Patients with prosthetic dental implants
Patients with retained deciduous teeth |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the treatment outcome between direct 3D-printed aligners & conventional fixed orthodontic appliance as assessed by American Board of Orthodontics Discrepancy Index & Objective Grading system. |
Pre-treatment
Post-treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the amount of time taken for the completion of treatment (duration) to compare the relative efficiency of the 3D printed aligners & conventional fixed orthodontic appliances |
Pre-treatment
Post-treatment |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
20/07/2023 |
| 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="2"
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 is a non-randomized prospective controlled clinical study comparing the effectiveness and duration of orthodontic treatment with direct 3D-printed clear aligners and traditional fixed labial orthodontic appliances in 20 patients with mild-to-moderate malocclusion. The primary outcome measure will be the assessment of treatment outcome using dental models, panoramic, and cephalometric radiographs. The secondary outcome will be the determination of time taken to complete the orthodontic treatment with the respective modality. |