| CTRI Number |
CTRI/2025/09/095477 [Registered on: 30/09/2025] Trial Registered Prospectively |
| Last Modified On: |
29/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Evaluation of Soft-Tissue Changes with Structured Light Scanning after the Course of Twin Block Appliance Therapy- A 3-dimensional Prospective Study |
|
Scientific Title of Study
|
Evaluation of Soft-Tissue Changes with Structured Light Scanning after the Course of Twin Block Appliance Therapy- A 3-dimensional Prospective 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 Sejal Naikwadi |
| Designation |
Pg Student |
| Affiliation |
Government Dental College , Mumbai |
| Address |
206, Department of Orthodontics and Dentofacial Orthopaedics,Government Dental College and Hospital,Mumbai
Mumbai
MAHARASHTRA
400001
India |
| Phone |
08600677736 |
| Fax |
|
| Email |
sej99naik@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sejal Naikwadi |
| Designation |
Pg Student |
| Affiliation |
Government Dental College , Mumbai |
| Address |
206, Department of Orthodontics and Dentofacial Orthopaedics Government Dental College and Hospital,Mumbai
Mumbai
MAHARASHTRA
400001
India |
| Phone |
08600677736 |
| Fax |
|
| Email |
sej99naik@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sejal Naikwadi |
| Designation |
Pg Student |
| Affiliation |
Government Dental College , Mumbai |
| Address |
206, Department of Orthodontics and Dentofacial Orthopaedics, Government Dental College and Hospital,Mumbai
Mumbai
MAHARASHTRA
400001
India |
| Phone |
08600677736 |
| Fax |
|
| Email |
sej99naik@gmail.com |
|
|
Source of Monetary or Material Support
|
| 206 , Department of Orthodontics and Dentofacial Orthopaedics, Government Dental College and Hospital , Mumbai 400001 India
|
|
|
Primary Sponsor
|
| Name |
Dr Sejal Naikwadi |
| Address |
206 , Department of Orthodontics and Dentofacial Orthopaedics,Government Dental College and Hospital, Mumbai 400001 |
| Type of Sponsor |
Other [Government Dental College] |
|
|
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 Sejal Sandip Naikwadi |
Government Dental College |
206,Department of Orthodontics and Dentofacial Orthopaedics,Government Dental College and Hospital,
PD Mello Road , CST, Mumbai 400001
Mumbai
MAHARASHTRA |
08600677736
sej99naik@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Dental College and Hospital Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients with Class II Malocclusion and retrognathic mandible |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
twin block appliance |
The Twin Block appliance is a type of functional orthodontic appliance used mainly for the correction of skeletal Class II malocclusion caused by a retruded (backward-positioned) mandible. |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1) Skeletal Class II division 1 malocclusion with the normal maxilla and
mandibular retrognathia (ANB angle greater than 4°)
2) Dental bilateral (molar and canine) Class II relation and minimal or no
crowding in both arches.
3) Increased overjet at or greater than 6 mm.
4) Normal growth pattern or horizontal and have growth potential according to
cervical vertebra maturation indicators. (CVMI – Stage III- V). |
|
| ExclusionCriteria |
| Details |
1) History of orthodontic or orthopaedic treatment.
2) Presence of any craniofacial anomaly. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) To evaluate qualitative changes in soft tissue structure after completion of twin
block appliance therapy using superimposed coloured map images.
2) To evaluate quantitative changes in soft tissue structure after completion of twin
block appliance therapy using deviation analysis (calculate the deviation in landmarks
and regions for superimposed facial scan). |
Evaluate changes 7 months after the twin block appliance therapy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
3)To compare the linear & angular measurements taken on lateral cephalograph vs
3-D soft tissue images. |
Evaluate the changes 7 month after the twin block appliance therapy |
|
|
Target Sample Size
|
Total Sample Size="21"
Sample Size from India="21"
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)
|
22/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
22/10/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
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 prospective clinical study aims to evaluate qualitative and quantitative changes in facial soft tissues of skeletal Class II Division 1 patients following Twin Block Appliance therapy, using a structured light 3D scanner. Twenty-four patients aged 12–15 years with normal maxilla and retrognathic mandible will be included. Pre- and post-treatment records will consist of clinical examination, cephalograms, and 3D facial scans.
Structured light scanning will be used to capture high-resolution surface data for superimposition and deviation analysis, assessing linear, angular, and volumetric changes in defined facial regions and landmarks. Qualitative assessment will use color map superimpositions, and quantitative analysis will compare deviations across treatment phases. A secondary objective will compare 3D measurements with conventional lateral cephalometric data.
Statistical analysis will employ paired t-tests, ANOVA, or non-parametric equivalents, with significance set at p < 0.05. The study’s outcome is expected to provide precise documentation of soft tissue adaptations, improving understanding of treatment effects and supporting more accurate orthodontic planning for Class II malocclusion cases. |