| CTRI Number |
CTRI/2023/05/053166 [Registered on: 26/05/2023] Trial Registered Prospectively |
| Last Modified On: |
21/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation of outcome for splint supported Forsus FRD Vs Twin block appliance |
|
Scientific Title of Study
|
Evaluation of treatment efficacy of splint-supported Forsus Fatigue Resistant Device vs Twin block in skeletal Class II growing subjects. A randomised clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Surg Cdr Saugat Ray |
| Designation |
Reader and Instructor |
| Affiliation |
Armed Forces Medical College |
| Address |
Department of Dental Surgery and Oral Health Sciences
Armed Forces Medical College
Wanowrie
Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
9057443123 |
| Fax |
|
| Email |
saugatray80@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Surg Cdr Saugat Ray |
| Designation |
Reader and Instructor |
| Affiliation |
AFMC |
| Address |
Department of Dental Surgery and OHS
AFMC
Wanowrie
Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
9057443123 |
| Fax |
|
| Email |
saugatray80@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Surg Cdr Saugat Ray |
| Designation |
Reader and Instructor |
| Affiliation |
AFMC |
| Address |
Department of Dental Surgery and OHS
AFMC
Wanowrie
Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
9057443123 |
| Fax |
|
| Email |
saugatray80@gmail.com |
|
|
Source of Monetary or Material Support
|
| Armed Forces Medical Research Committee, Director General Armed Forces Medical Services,
M Block, Ministry of Defence, New Delhi 01 |
|
|
Primary Sponsor
|
| Name |
Director General Armed Forces Medical Services |
| Address |
M Block Integrated HQ
Ministry of Defence
New Delhi |
| 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 |
| Surg Cdr Saugat Ray |
Armed Forces Medical College |
Department of Dental Surgery and Oral Health Sciences
Armed Forces Medical College
Wanowrie
Pune
Pune
MAHARASHTRA |
9057443123
saugatray80@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, AFMC, Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M262||Anomalies of dental arch relationship, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Splint supported FFRD |
The functional appliance will be given and the outcome will be checked and compared after 6 moths or achievement of the desired mandibular advancement. Total duration of intervention will be approximately 8-10 months for each patient. |
| Comparator Agent |
Twin block appliance |
The functional appliance will be given and the outcome will be checked and compared after 6 moths or achievement of the desired mandibular advancement. Total duration of intervention will be approximately 8-10 months for each patient. |
|
|
Inclusion Criteria
|
| Age From |
11.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1. Cases of skeletal Class II malocclusion (ANB> 4 degrees)
2. Class II or Half cusp Class II molar relation
3. Positive visual treatment objective
4. CVMI stage III
5. No missing or supernumerary teeth
6. Patients giving written consent to participate in the study
7. No h/o previous orthodontic treatment
|
|
| ExclusionCriteria |
| Details |
1. Those refusing for written consent to participate in the study
2. Negative visual treatment objective
3. History of previous orthodontic treatment
4. Systemic diseases affecting bone metabolism
5. Patients with neuromuscular disorder & TMJ problems
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Correction of Skeletal Class II malocclusion |
After completion of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a) To compare treatment duration between the study groups
b) To compare patient comfort and operator convenience
c) To compare frequency of breakage of appliance
|
After completion of treatment |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/06/2023 |
| Date of Study Completion (India) |
31/05/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Subjects found suitable in the pre determined inclusion criteria for the study shall be explained the scope of the study and a written consent shall be obtained. Pre-treatment records (T1) in the form of photographs (extraoral & intraoral), radiographs i.e., OPG, Lateral cephalogram, and dental models for maxillary and mandibular arch shall be recorded. For splint-supported FFRD group a customized splint will be fabricated on the mandibular arch and FFRD shall be installed using upper molar band and splint in lower canine region. Standard Twin block shall be given to another group. On achieving satisfactory profile improvement /correction in overjet /molar relation, post functional treatment records (T2) in the form of photographs (extraoral & intraoral), radiographs i.e., OPG, Lateral cephalogram, dental models for maxillary and mandibular arch shall be obtained. Pre-treatment and post functional treatment lateral Cephalogram shall be analyzed using various cephalometric values to ascertain the corrections achieved. Corrections achieved will be quantified and will be grouped as skeletal, dental & soft tissue changes. In addition, the treatment duration for the study groups shall be recorded, the patient comfort & operator convenience along with frequency of breakage of appliance (if any) shall be noted. |