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CTRI Number  CTRI/2024/10/075587 [Registered on: 21/10/2024] Trial Registered Prospectively
Last Modified On: 12/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of treatment results of functional appliances versus tooth extraction in patients  
Scientific Title of Study   Comparison of treatment outcomes of functional appliances versus extraction protocol in Skeletal Class II division 1 malocclusion patients: A prospective 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  Dr Vipul Kumar Sharma  
Designation  Professor  
Affiliation  Banaras Hindu University 
Address  Room no.3, Floor no.2, Department of Orthodontics and Dentofacial Orthopaedics, Faculty of Dental Sciences, Institute of Medical Sciences, Banaras Hindu University, Lanka, Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  9389460640  
Fax    
Email  vipulk.sharma1@bhu.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Vipul Kumar Sharma  
Designation  Professor  
Affiliation  Banaras Hindu University 
Address  Room no.3, Floor no.2, Department of Orthodontics and Dentofacial Orthopaedics, Faculty of Dental Sciences, Institute of Medical Sciences, Banaras Hindu University, Lanka, Varanasi


UTTAR PRADESH
221005
India 
Phone  9389460640  
Fax    
Email  vipulk.sharma1@bhu.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Sharvari Mairal 
Designation  Junior Resident  
Affiliation  Banaras Hindu University 
Address  Room no.3, Floor no.2, Department of Orthodontics and Dentofacial Orthopaedics, Faculty of Dental Sciences, Institute of Medical Sciences, Banaras Hindu University, Lanka, Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  9975483090  
Fax    
Email  sharvari35@gmail.com  
 
Source of Monetary or Material Support  
Banaras Hindu University, Varanasi, Uttar Pradesh, India -221005 
 
Primary Sponsor  
Name  Dr. Sharvari Mairal 
Address  Room no.3, Floor no.2, Department of Orthodontics and Dentofacial Orthopaedics, Faculty of Dental Sciences, Institute of Medical Sciences, Banaras Hindu University, Lanka, Varanasi-221005 
Type of Sponsor  Other [Self] 
 
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 Sharvari Mairal  Faculty of Dental Sciences  Room no.3, Floor no.2, Department of Orthodontics and Dentofacial Orthopaedics, Faculty of Dental Sciences, Institute of Medical Sciences, Banaras Hindu University, Lanka, Varanasi-221005
Varanasi
UTTAR PRADESH 		 9975483090

sharvari35@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Institute of Medical Sciences, Banaras Hindu University  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 
Intervention  Forsus Fatigue Resistant Device  After levelling and alignment, Forsus Fatigue Resistant device installed in Skeletal Class II div 1 patients till desired position of mandible is achieved. Total treatment duration is 12 months.  
Comparator Agent  Maxillary first premolar extraction bilaterally  After levelling and alignment, maxillary first premolar extraction bilaterally till complete retraction of anterior segment. Total treatment duration of 12 months  
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  21.00 Year(s)
Gender  Both 
Details  Skeletal Class II division 1 malocclusion
Angle’s Class II molar relationship
Both male and female patients
Minimal or no crowding in the mandibular arch and maxillary arch
Overjet [7-10mm]
No extracted or missing permanent teeth
• Post-pubertal phase of skeletal development CVMI (5 and 6)
• No medical history or systemic disease that could affect normal growth of the body or jaws
• No presence of any craniofacial syndrome
• No previous orthodontic treatment
 
 
ExclusionCriteria 
Details  Malocclusion other than Class II div 1 malocclusion
Previous orthodontic treatment
Patients having any Systemic disease or craniofacial syndromes
Temporomandibular dysfunction
Extracted or missing permanent tooth/teeth
Any facial asymmetry
• Presence of any parafunctional habits
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the skeletal, dentoalveolar and soft tissue changes in Class II division 1 patients undergoing maxillary premolar extractions and Forsus Fatigue Resistant device  At baseline, after 4 months, after 10 months  
 
Secondary Outcome  
Outcome  TimePoints 
Effectivity of Forsus Fatigue-Resistant device  After 6 months of installation 
 
Target Sample Size   Total Sample Size="26"
Sample Size from India="26" 
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   Phase 3 
Date of First Enrollment (India)   31/10/2024 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   This study is a prospective clinical trial conducted at Orthodontics and Dentofacial Orthopedics, Faculty of Dental Sciences, IMS, BHU, Varanasi, India where young adult patients of Class II division 1 malocclusion will be allocated into two groups: Group 1 where upper first premolars will be extracted as a treatment protocol and Group 2 where a Forsus Fatigue Resistant device will be the choice of treatment. The primary outcome is to evaluate the skeletal, dentoalveolar and soft tissue changes in Class II division 1 patients undergoing maxillary premolar extractions and Forsus Fatigue Resistant device. The secondary outcome is to assess the effectivity of Forsus Fatigue-resistant device. 

Patients of both the groups will undergo diagnostic evaluation accompanied by study models, radiographs and facial photographs. Pre-adjusted edgewise brackets will be bonded in patients of both the groups. Levelling and alignment will be done using NiTi wires and progressing upto stainless steel wires. First premolar extraction will be done in Group 1 followed by retraction of the anterior segment. In Group 2, Forsus Fatigue Resistant device will be installed till the desired position of mandible is achieved. Pre-treatment and post-treatment lateral cephalogram will be traced and skeletal, dentoalveolar and soft tissue parameters will be drawn, measured and compared within both the groups.
 
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