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CTRI Number  CTRI/2024/08/072924 [Registered on: 22/08/2024] Trial Registered Prospectively
Last Modified On: 14/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of two different fixed functional appliances which are used for madibular advancement 
Scientific Title of Study   Comparison of dentoskeletal changes in skeletal class ii with angles class ii division 1 cases using fixed functional appliances Forsus fatigue resistant device and mandibular Advansync 2 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pravinkumar Marure 
Designation  Professor  
Affiliation  Maharashtra Institute of Dental Sciences, Dental college, Latur 
Address  Department of Orthodontics and Dentofacial Orthopaedics, Maharashtra Institute of Dental Sciences, Dental college, Latur

Latur
MAHARASHTRA
413512
India 
Phone  9404366634  
Fax    
Email  drpravinkumar08@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nikhil Mukhedkar 
Designation  Post graduate student 
Affiliation  Maharashtra Institute of Dental Sciences, Dental college, Latur 
Address  Department of Orthodontics and Dentofacial Orthopaedics, Maharashtra Institute of Dental Sciences, Dental college, Latur

Latur
MAHARASHTRA
413512
India 
Phone  8605753777  
Fax    
Email  mukhedkarnikhil99@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Nikhil Mukhedkar 
Designation  Post graduate student 
Affiliation  Maharashtra Institute of Dental Sciences, Dental college, Latur 
Address  Department of Orthodontics and Dentofacial Orthopaedics, Maharashtra Institute of Dental Sciences, Dental college, Latur

Latur
MAHARASHTRA
413512
India 
Phone  8605753777  
Fax    
Email  mukhedkarnikhil99@gmail.com  
 
Source of Monetary or Material Support  
Maharashtra Institute of Dental Science Dental College Latur,Maharashtra,India 413512 
 
Primary Sponsor  
Name  MIDSR Dental College Latur 
Address  Department of Orthodontics and Dentofacial Orthopaedics, Maharashtra Institute of Dental Sciences, Dental college, Latur, Maharashtra, India,413512 
Type of Sponsor  Other [Private dental college] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nikhil Mukhedkar  Maharashtra Institute of Dental science and research dental college, latur  Department of Orthodontics and Dentofacial Orthopedics
Latur
MAHARASHTRA 		 8605753777

mukhedkarnikhil99@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethical Committee MIDSR DC Latur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  AdvanSyncâ„¢2  The AdvanSyncâ„¢2 Class II corrector is gadget with fixed functionality. it is based on the original Herbst appliance, it is considerably more compact, easier to use, install, and remove, and—most importantly can be integrated with full arch fixed appliances all through.  
Intervention  The Forsusâ„¢ Fatigue Resistant Device  The Forsusâ„¢ Fatigue Resistant Device is a fixed Class II appliance. It is a three-piece, semi-rigid telescoping system with a super elastic nickel-titanium coil spring. 
 
Inclusion Criteria  
Age From  11.00 Year(s)
Age To  17.00 Year(s)
Gender  Both 
Details  Patients with skeletal class II and Angle’s dental class II division 1 occlusion with minimum or no crowding with cervical vertebral maturity index more than 4 and skeletal maturity index more than 6 and overjet more than 4 mm 
 
ExclusionCriteria 
Details  1. Angles Class II div 2 or class III skeletal malocclusion
2. Congenitally missing teeth
3. Impacted teeth
4. Malformed and retained deciduous teeth
5. Periodontally compromised patients
6. Medically compromised patients
7. Patients with temporomandibular disorders 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the dentoskeletal changes observed in skeletal class II
with Angle’s class II division 1 malocclusion patients treated with fixed
functional appliances like Forsus TM fatigue resistant appliance and
Advansync TM2 		 14 months 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the relationship of maxilla with cranial base in skeletal
class II with Angle’s class II division 1 malocclusion patients treated
with fixed functional appliances like Forsus TM fatigue resistant
appliance & Advansync TM2 		 14 months 
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
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)   31/08/2024 
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="1"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
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 study titled "Comparison of Dentoskeletal Changes in Skeletal Class II with Angle’s Class II Division 1 Cases Using Fixed Functional Appliances: Forsusâ„¢ Fatigue Resistant Device and Mandibular AdvanSyncâ„¢2" aims to compare the effectiveness of two fixed functional appliances in treating Class II malocclusion, which affects a significant portion of the population. The Forsusâ„¢ and AdvanSyncâ„¢2 appliances, known for their hybrid and rigid designs respectively, are evaluated for their impact on dentoskeletal changes in patients. The research focuses on determining whether there are significant differences in treatment outcomes between the two devices and if gender influences these outcomes. Previous studies have shown that these appliances can induce substantial skeletal and dental adjustments, although their specific effects vary. This study intends to provide a comprehensive comparison to enhance treatment strategies for Class II malocclusion, addressing the gaps in existing data. 
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