| CTRI Number |
CTRI/2025/02/081129 [Registered on: 21/02/2025] Trial Registered Prospectively |
| Last Modified On: |
18/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study on the effects of orthodontic treatment done with or without friction mechanics for moving the front teeth back using 3-D radiograph. |
|
Scientific Title of Study
|
Effectiveness of friction and frictionless mechanics during en-masse retraction of anterior teeth using CBCT—a randomized clinical 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 |
Dr Shalini D |
| Designation |
Junior Resident |
| Affiliation |
Centre for Dental Education and Research |
| Address |
4th floor Division of Orthodontics and Dentofacial Deformities
CDER, AIIMS, Block D2, Ansari Nagar East, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
8760434135 |
| Fax |
|
| Email |
shalinid2804@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prabhat Kumar Chaudhari |
| Designation |
Additional Professor |
| Affiliation |
Centre for Dental Education and Research |
| Address |
Room No 407, 4th floor, Division of Orthodontics and Dentofacial
Deformities, CDER, AIIMS Block D2, Ansari Nagar East New Delhi
New Delhi
DELHI
110029
India |
| Phone |
8375044325 |
| Fax |
|
| Email |
dr.prabhatkc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shalini D |
| Designation |
Junior Resident |
| Affiliation |
Centre for Dental Education and Research |
| Address |
4th floor Division of Orthodontics and Dentofacial Deformities
CDER, AIIMS, Block D2, Ansari Nagar East, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
8760434135 |
| Fax |
|
| Email |
shalinid2804@gmail.com |
|
|
Source of Monetary or Material Support
|
| Division of Orthodontics and Dentofacial Deformities, 4th floor, Centre for
Dental Education and Research, AIIMS, New Delhi-110029 |
|
|
Primary Sponsor
|
| Name |
Shalini D |
| Address |
4th floor, Division of Orthodontics and Dentofacial Deformities, CDER, AIIMS Block D2, Ansari Nagar East New Delhi. |
| 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 |
| SHALINI D |
Centre for Dental Education and Research |
4th floor - Division of
Orthodontics and
Dentofacial
Deformities Block D2
Ansari Nagar East
New Delhi - 110029
New Delhi
DELHI |
8760434135
shalinid2804@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE FOR POST GRADUATE RESEARCH AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Friction mechanics |
En-masse retraction will be
done by NiTi closed coil spring
which delivers 150 gm of force
per side. |
| Comparator Agent |
Frictionless mechanics |
En-masse retraction will be
done by T-loops fabricated
using 0.019 × 0.025-inch
titanium-molybdenum alloy
(TMA) wire, which deliver 200
gram of force per side |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1. Angle Class I malocclusion with bimaxillary dentoalveolar
protrusion requiring four first premolars extraction and maximum
anchorage.2. Patients with a full set of permanent dentitions (except
third molars) and adequate oral hygiene.3. Patients with minimal
crowding |
|
| ExclusionCriteria |
| Details |
1.Patients with systemic diseases, craniofacial syndromes and
conditions that interfere with tooth movement.
2. Previous orthodontic treatment.
3. Severe crowding.
4. Extracted or missing permanent teeth (except for third molars)
5. Grossly decayed tooth (except for first premolars) |
|
|
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 |
Individual tooth movement of six anterior teeth
in the maxillary arch and mandibular arch using
CBCT.
|
Before and after En-masse retraction of anterior
teeth |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Root resorption of six anterior teeth in the
maxillary and mandibular arch. |
Before and after En-masse retraction of anterior
teeth |
Duration of en-masse retraction of anterior teeth
in the maxillary and mandibular arch |
Before and after En-masse retraction of anterior
teeth. |
Patient-reported outcomes, including pain
assessment and patient satisfaction towards
treatment procedure |
Before and after En-masse retraction of anterior
teeth. |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
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)
|
10/03/2025 |
| 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 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
|
The bimaxillary protrusion is a dentofacial condition in which the upper and lower incisors are proclined and protruded with increased lip procumbence. The extraction of first premolars and the retraction of anterior teeth into the extraction space are commonly employed treatments for bimaxillary protrusion cases. There are two different mechanics for the retraction of anterior teeth into extraction spaces: friction and frictionless mechanics. The purpose of this study is to evaluate the treatment effects of friction and frictionless mechanics during en masse retraction which includes evaluating three-dimensional tooth movement and root resorption in CBCT, duration of en masse retraction, and patient-related outcomes during orthodontic treatment |