| CTRI Number |
CTRI/2025/03/083483 [Registered on: 26/03/2025] Trial Registered Prospectively |
| Last Modified On: |
26/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
To evaluate the skeletal, dental and soft tissue changes in skeletal class II patient using Twin block appliance |
|
Scientific Title of Study
|
Comparative evaluation of the effects of Twin Block appliance therapy in skeletal Class II malocclusion patients with horizontal and vertical growth patterns: A 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 |
Vishal Gupta |
| Designation |
Resident |
| Affiliation |
Army Dental Centre , Research and Referral |
| Address |
Dept of Orthodontics and Dentofacial Orthopaedics, Army Dental Centre, Research and Referral, Dhaula Kuan, Delhi Cantt, New Delhi
South
DELHI
110010
India |
| Phone |
7302421553 |
| Fax |
|
| Email |
vishalgupta1994p@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Brig Sukhbir Singh Chopra |
| Designation |
HOD |
| Affiliation |
Army Dental Centre , Research and Referral |
| Address |
Dept of Orthodontics and Dentofacial Orthopaedics, Army Dental Centre, Research and Referral, Dhaula Kuan, Delhi Cantt, New Delhi
South
DELHI
110010
India |
| Phone |
9402707591 |
| Fax |
|
| Email |
drsschopra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Brig Sukhbir Singh Chopra |
| Designation |
HOD |
| Affiliation |
Army Dental Centre , Research and Referral |
| Address |
Dept of Orthodontics and Dentofacial Orthopaedics, Army Dental Centre, Research and Referral, Dhaula Kuan, Delhi Cantt, New Delhi
South
DELHI
110010
India |
| Phone |
9402707591 |
| Fax |
|
| Email |
drsschopra@gmail.com |
|
|
Source of Monetary or Material Support
|
| Army Dental Centre Research and Referral, New Delhi
South Delhi
110010
India |
|
|
Primary Sponsor
|
| Name |
Army Dental Centre Research and Referral |
| Address |
Army Dental Centre Research and Referral, Dhaula Kuan, Delhi Cantt, New Delhi
South Delhi
110010
India |
| Type of Sponsor |
Research institution |
|
|
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 Vishal gupta |
Army Dental Centre , Research and Referral |
Dept of Orthodontics and Dentofacial Orthopaedics, Army Dental Centre, Research and Referral, Dhaula Kuan, Delhi Cantt, New Delhi
New Delhi
DELHI |
07302421553
vishalgupta1994p@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Army Dental Centre , Research and Referral |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Skeletal Class II malocclusion |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Correction of Class II malocclusion by Twin Block Therapy |
Comparative evaluation of the effects of Twin Block appliance therapy in skeletal Class II malocclusion patients with horizontal growth patterns along with IGF-1serum level
Lateral cephalograms will be taken at T0- Pretreatment
T1- At Pterygoid response
T2- Postfunctional treatment |
| Comparator Agent |
Correction of Class II malocclusion using Twin Block Therapy |
Comparative evaluation of the effects of Twin Block appliance therapy in skeletal Class II malocclusion patients with vertical growth patterns along with IGF-1serum level Lateral cephalograms will be taken at T0- Pretreatment T1- At Pterygoid response T2- Postfunctional treatment |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient with mandibular deficiency as a cause of skeletal class II with ANB of greater than 4 degree
2. Molar class II relationship bilaterally
3. Overjet greater than 4 mm
4. Positive visual treatment objective
5. Cervical vertebrae maturity index stage 3 to 5
6. minimal crowding of less than 3 mm |
|
| ExclusionCriteria |
| Details |
1. History of previous orthodontic treatment
2. Trauma to jaw bones
3. systemic diseases involving jaw bones
4. Patient with neuromuscular disorder or TMJ pathology
4. Syndromic cases including patients with cleft lip and cleft palate
5. Facial asymmetry of jaws |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Skeletal, Dental, Soft tissue changes produced by Twin block appliance in class II malocclusion patients with horizontal and vertical grower |
T0- Pretreatment - 0 month
T1- At Pterygoid response - 3 months
T2- Post functional- 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the change in serum IGF-1 level |
T0- Pretreatment- 0 weeks
T1- At pterygoid response- 3 months
T2- Post functional treatment- 6 months |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
07/04/2025 |
| 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="9"
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
|
Functional jaw orthopaedics are important in orthodontics to module mandibular growth deficiency in skeletal class II malocclusion patients. Twin block is most commonly used appliance due to ease of fabrication and patient compliance. This study is to find out skeletal, dental and soft tissue effects in horizontal and vertical grower patients treated with Twin block appliance for skeletal class II malocclusion. And to find out that ,does IGF-1 serum level are elevated or not during growth modulation |