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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  
Status 
Not Applicable 
 
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.
 
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