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CTRI Number  CTRI/2021/07/035044 [Registered on: 22/07/2021] Trial Registered Prospectively
Last Modified On: 27/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Single Arm Study 
Public Title of Study   Treatment of Class III malocclusion using Modified Fixed Reverse Twin-Block Therapy 
Scientific Title of Study   Treatment of Class III malocclusion using Modified Fixed Reverse Twin-Block Therapy - A prospective Cephalometric and Magnetic Resonance Imaging Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Harpreet Singh 
Designation  Associate Professor 
Affiliation  Department of Orthodontics and Dentofacial Orthopedics, ESIC Dental College & Hospital  
Address  Sector 15 Rohini New Delhi

North West
DELHI
110092
India 
Phone  9871269907  
Fax    
Email  drhpreet_mamc04@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Harpreet Singh 
Designation  Associate Professor 
Affiliation  Department of Orthodontics and Dentofacial Orthopedics, ESIC Dental College & Hospital  
Address  Sector 15 Rohini New Delhi

North West
DELHI
110092
India 
Phone  9871269907  
Fax    
Email  drhpreet_mamc04@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Harpreet Singh 
Designation  Associate Professor 
Affiliation  Department of Orthodontics and Dentofacial Orthopedics, ESIC Dental College & Hospital  
Address  Sector 15 Rohini New Delhi

North West
DELHI
110092
India 
Phone  9871269907  
Fax    
Email  drhpreet_mamc04@yahoo.co.in  
 
Source of Monetary or Material Support  
ESIC Dental College Hospital 
 
Primary Sponsor  
Name  ESIC Dental College Hospital 
Address  Sector 15 Rohini Delhi 
Type of Sponsor  Government medical 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 Harpreet Singh  Department of Orthodontics and Dentofacial Orthopedics, ESIC Dental College and Hospital  Hall-C, Department of Orthodontics and Dentofacial Orthopedics, ESIC Dental College & Hospital
North West
DELHI 		 9871269907

drhpreet_mamc04@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee ESIC Dental College & Hospital  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  Modified Reverse Twin Block  Pick-up impressions shall be made with molar bands in-situ and working models will be obtained with molar bands in place. Construction Bite registration will be done at maximal mandibular retruded contact position with posterior vertical clearance of 5 mm, and the prepared casts will be mounted on hinge articulator. In accordance with the recommendations of Clark5, bite blocks shall be inclined at 40-70° to the occlusal plane in reverse configuration achieved by placing the upper block (covering the upper premolars) anteriorly and enabling the lower block (covering the lower molars) to occlude behind it. The upper assembly shall include bite blocks anchored on modified palatal arch which will be soldered onto the molar bands. The lower assembly will consist of modified lingual arch onto which bite block will be anchored. The entire wire framework shall be fabricated with 19-gauge hard round stainless-steel wire. 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  14.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  (i) Age from 14 years upto18 years,
(ii) Established Angle Class III malocclusion with an anterior crossbite involving three
to four incisors in Intercuspal position (ICP),
(iii) Ability to achieve edge-edge incisor relationship in Retruded contact position (RCP) with no pain or discomfort in TMJ
(iv) Minimal dental decompensation of the maxillary and mandibular incisors.
(v)-4ÌŠ< ANB < 0ÌŠ
(vi) Normodivergent to mild hyperdivergent growth pattern
(vii) Concave facial profile
(viii) Minimal or no crowding in the maxillary and mandibular arches
(ix) Full complement of permanent teeth (third molars excluded)
(x) Transition to Maturation phase of growth based on Cervical Vertebrae Maturity Indicators (CVMI) assessment
 
 
ExclusionCriteria 
Details  (i) Class III malocclusion not amenable to functional correction
(ii) Presence of true laterognathism or any syndromic craniofacial deformity such as cleft
lip and/or palate or any systemic disease that could affect normal growth of the body
and/or the jaws.
(iii) Claustrophobia and unwillingness to participate in the study
(iv) Patients exhibiting allergy/delayed hypersensitivity to methylmethacrylate resins
(v) Patients with associated severe TMJ symptoms and any other systemic problems
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
evaluate the effectiveness of modified fixed RTB as a functional treatment modality for Class III correction during adolescence.
 		 6-9 months 
 
Secondary Outcome  
Outcome  TimePoints 
1) To assess dentoalveolar, skeletal and soft tissue effects of modified fixed RTB therapy for Class III correction during adolescence.
2) To compare temporomandibular joint adaptation changes especially disk-condyle-fossa relationship following treatment of Class III malocclusion using modified fixed RTB and fixed appliances.
 		 18 months 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
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)   23/07/2021 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   Not Yet Done 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Inspite of lower prevalence rate of Class III malocclusion compared to Class I and Class II in global and Indian population, Class III jaw relationships often present a unique therapeutic challenge  due to complex interplay between environmental and innate factors involved  in the genesis of these malocclusions. By utilization of Cephalometric Radiography and Magnetic Resonance Imaging (MRI), this clinical study proposes to assess dentoalveolar, skeletal and soft-tissue effects including adaptive TMJ mechanisms (alterations within the condyle-glenoid fossa complex and the positional changes of the glenoid fossa in the cranium) in Class III adolescents treated with modified fixed RTB therapy accompanied by fixed appliances. This would help formulate more satisfying treatment plans while taking into consideration the concerns and expectations of the patients. 
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