CTRI Number |
CTRI/2021/01/030399 [Registered on: 12/01/2021] Trial Registered Prospectively |
Last Modified On: |
08/10/2023 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Dentistry |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Treatment of growing individuals with small lower jaw using appropriate fixed functional appliances.
|
Scientific Title of Study
|
Comparative evaluation of clinical efficacy of two fixed functional appliances for treating skeletal class II malocclusion : A randomised controlled trial |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Vishvaroop |
Designation |
Assistant Professor |
Affiliation |
Armed Forces Medical College, Pune |
Address |
Department of Dental Surgery & Oral Health Sciences, Division of Orthodontics & Dentofacial Orthopedics,
Armed Forces Medical College,Pune
Pune MAHARASHTRA 411040 India |
Phone |
9596957766 |
Fax |
|
Email |
vrnagpal_1008@yahoo.co.in |
|
Details of Contact Person Scientific Query
|
Name |
Vishvaroop |
Designation |
Assistant Professor |
Affiliation |
Armed Forces Medical College, Pune |
Address |
Department of Dental Surgery & Oral Health Sciences, Division of Orthodontics & Dentofacial Orthopedics,
Armed Forces Medical College,Pune
Pune MAHARASHTRA 411040 India |
Phone |
9596957766 |
Fax |
|
Email |
vrnagpal_1008@yahoo.co.in |
|
Details of Contact Person Public Query
|
Name |
Vishvaroop |
Designation |
Assistant Professor |
Affiliation |
Armed Forces Medical College, Pune |
Address |
Department of Dental Surgery & Oral Health Sciences, Division of Orthodontics & Dentofacial Orthopedics,
Armed Forces Medical College,Pune
Pune MAHARASHTRA 411040 India |
Phone |
9596957766 |
Fax |
|
Email |
vrnagpal_1008@yahoo.co.in |
|
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
|
Name |
Address |
Office of DGDS |
L Block Integrated HQ, Ministry of Defence
New Delhi |
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 2 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Lt Col Vishvaroop |
Armed Forces Medical College |
First Floor, Div of Orthodontics & Dentofacial Orthopedics, Department of Dental Surgery & Oral Health Sciences, Armed Forces Medical College. Pune MAHARASHTRA |
9596957766
vrnagpal_1008@yahoo.co.in |
Lt Col D C Chaudhary |
Army Dental Centre Research and Referral |
Second Floor,Department of Orthodontics,Army Dental Centre Research and Referral,
Army Hospital New Delhi DELHI |
8826217840
drdinesh2424@yahoo.co.in |
|
Details of Ethics Committee
|
No of Ethics Committees= 2 |
Name of Committee |
Approval Status |
Institutional Ethical Committee, ADC R&R,Delhi Cantt |
Approved |
Institutional Ethical Committee, AFMC, Pune |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
AdvanSync2 Appliance |
AdvanSync2 appliance will be inserted in the initial appointments, as alignment of teeth will be carried out simultaneously. |
Comparator Agent |
FORSUS FRD appliance |
Fixed Functional Appliance will
be given after alignment of
upper lower arches after six to
eight months or till the time
correction is achieved |
|
Inclusion Criteria
|
Age From |
12.00 Year(s) |
Age To |
16.00 Year(s) |
Gender |
Both |
Details |
1. Cases of Class II malocclusion (ANB>4 degrees)
2. Molar relation class II/Half cusp class II
3. Overjet > 4mm
4. Positive Visual Treatment Objective
5. CVMI stage III-VI
6. No missing or supernumerary teeth
7. Patients giving written consent to participate in the study
8. No h/o previous orthodontic treatment/trauma to jawbones
|
|
ExclusionCriteria |
Details |
1.Negative VTO
2.History of previous orthodontic treatment
3.Systemic diseases affecting bone metabolism
4.Patients with neuromuscular disorders & TMJ problems
5.Insufficient teeth/periodontal status to support the appliance
|
|
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 chairside time taken for appliance insertion and removal between the study groups.
c) Patient comfort and operator convenience.
d) Frequency of breakage of appliance and bracket debonding.
|
After completion of treatment |
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="30" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
15/01/2021 |
Date of Study Completion (India) |
31/07/2023 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="3" Months="1" Days="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
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)
|
Fixed functional appliances are used for correction of skeletal Class II malocclusion with retrognathic mandible in growing patients. In patients who report after the pubertal growth spurt or during late stages of puberty with minimal growth left, fixed functional appliances are a treatment of choice. They are often called "non-complaint Class II correctors" as they require minimum patient co-operation unlike removable appliances. The Forsus FRD (3M Unitek Corp., Monrovia, Calif) is one of the most commonly used fixed functional appliance for correction of class II malocclusion. But it is often associated with limitations like frequent breakage of canine brackets and soft tissue lacerations. It is available in various sizes, hence a large inventory must be maintained and chairside time is increased as correct size for individual patient needs to be selected. The AdvanSync 2 is the latest addition to the orthodontist’s armamentarium. It comprises of several modifications in the original AdvanSync appliance to deliver latest, simple and efficient Class II correction. A bonus that came out of this new smaller design of this appliance was the ability to bracket every tooth anterior to this appliance that has allowed orthopaedic correction along with simultaneous orthodontic correction resulting in reduced treatment time by almost 06 months in correction of malocclusion. Apart from few case reports there is no published study which compares the AdvanSync2 appliance with FORSUS FRD appliance. Thus, the purpose of this pilot study is to evaluate clinical efficacy of AdvanSync2 appliance in the treatment of skeletal class II malocclusion and compare with FORSUS FRD. The null hypothesis is that there is no significant difference in treatment effects between Forsus and AvanSync2. |