| CTRI Number |
CTRI/2024/11/076154 [Registered on: 01/11/2024] Trial Registered Prospectively |
| Last Modified On: |
01/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Jaw Growth in Class II Patients Using Two Different Dental Devices: Twin Block vs. AdvanSyncâ„¢ 2 |
|
Scientific Title of Study
|
Evaluation of Volumetric Changes in the Mandible After Treatment with Twin Block and Mandibular AdvanSyncâ„¢ 2 Appliance in Skeletal Class II Patients: 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 |
Jaspreet Singh |
| Designation |
Junior Resident |
| Affiliation |
Post Graduate Institute of Medical Science |
| Address |
Room No 208 Department of Orthodontics and dentofacial orthopedics, 1st Floor, Oral health science center, Post graduate institute of medical research and education, sector 12, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9818643130 |
| Fax |
|
| Email |
dr.jas.official@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Satinder Pal Singh |
| Designation |
Professor, Head of Department |
| Affiliation |
Post Graduate Institute of Medical Science |
| Address |
1st Floor, Oral health science center, Post graduate institute of medical research and education, sector 12, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9818643130 |
| Fax |
|
| Email |
drspsingh_chd@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Jaspreet Singh |
| Designation |
Junior Resident |
| Affiliation |
Post Graduate Institute of Medical Science |
| Address |
Room No 208, 1st Floor, Department of Orthodontics and dentofacial orthopedics, Oral health science center, Post graduate institute of medical research and education, sector 12, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9818643130 |
| Fax |
|
| Email |
dr.jas.official@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institue of Medical Research and Education, Sector 12 , Chandigarh |
|
|
Primary Sponsor
|
| Name |
Postgraduate Institute of Medical Education and Research PGIMER Chandigarh |
| Address |
Sector 12, Chandigarh 160012 |
| Type of Sponsor |
Government medical 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 Jaspreet Singh |
Postgraduate Institute of Medical Education and Research |
Room No 208 Department of Orthodontics and dentofacial orthopedics, 1st Floor, Oral health science center, Post graduate institute of medical research and education, sector 12, Chandigarh
Chandigarh
CHANDIGARH |
9818643130
dr.jas.official@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Postgraduate Institute of Medical Education and Research, Chandigarh Institutional Ethics Committee (Intramural) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M260||Major anomalies of jaw size, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Mandibular AdvanSync 2 Appliacne |
The Mandibular AdvanSync 2 is a pre-fabricated, fixed functional appliance. It is commonly used to correct skeletal Class II malocclusion by advancing the lower jaw (mandible). Unlike removable appliances, the AdvanSync 2 is fixed and remains in place for a certain period to encourage continuous jaw advancement. It is designed to correct Class II discrepancies by stimulating mandibular growth in growing patients. |
| Intervention |
Twin Block Appliance |
The Twin Block Appliance is a functional appliance used in orthodontics for the treatment of Class II malocclusions (where the lower jaw is set back relative to the upper jaw). It is custom-made for each patient, typically constructed as described by Clark, using heat-cured acrylic. This appliance works by guiding the lower jaw forward through continuous wearing, thereby correcting the bite and encouraging forward growth of the mandible in growing patients. |
|
|
Inclusion Criteria
|
| Age From |
11.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
• Growing Class II patients due to retrognathic mandible (Twin block and Mandibular AdvanSync™ 2 Appliance).
• Overjet ≥ 5 mm
• Presence of a Class II Skeletal pattern with an ANB angle ≥ 5 degrees.
• Good oral hygiene maintenance and no active periodontal disease.
• Patients in stage 3 or 4 cervical vertebrae maturation indicators (CVMI).
• Patients with FMA less than 28 degrees.
• Age group – 11 to 15 years
|
|
| ExclusionCriteria |
| Details |
• Patients exhibiting craniofacial syndromes or cleft lip and palate.
• Patients with systemic disorders such as thyroid, parathyroid, or renal and liver diseases that affects bone and growth.
• Patients with TMJ diseases.
• Patients with previous history of orthodontic treatment.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Volumetric changes in mandible |
before the start of treatment and 6 months after the start of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Ramus length, mandibular body length, effective mandibular length |
before the start of treatment and 6 months after the start of treatment |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
12/11/2024 |
| 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 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
|
The primary purpose of the protocol titled "Evaluation of Volumetric Changes in the Mandible After Treatment with Twin Block and Mandibular AdvanSyncâ„¢ 2 Appliance in Skeletal Class II Patients: A Randomized Clinical Trial" is to evaluate and compare the volumetric changes in the mandible six months after treatment using the Twin Block and Mandibular AdvanSyncâ„¢ 2 appliances in growing Skeletal Class II patients. The hypothesis being tested is that there is no significant difference in the change of mandibular volume between the two treatment groups (Twin Block and Mandibular AdvanSyncâ„¢ 2) |