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CTRI Number  CTRI/2020/03/023962 [Registered on: 13/03/2020] Trial Registered Prospectively
Last Modified On: 12/03/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   To check treatment effects in comparison with usage of lower jaw repositioning appliance with Digital sensor timer 
Scientific Title of Study   Assessment of treatment efficacy in relation to wear time of Twin Block with Electronic timing device 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR NIKITA RAVINDRA BAHETI 
Designation  Post graduate student 
Affiliation  Government Dental College and Hospital, Nagpur 
Address  101, PG section, Department of Orthodontics and Dentofacial Orthopaedics, Government dental college and hospital, Medical campus, Medical square, Nagpur
101, PG section, Department of Orthodontics and Dentofacial Orthopaedics, Government dental college and hospital, Medical campus, Medical square, Nagpur
Nagpur
MAHARASHTRA
440003
India 
Phone  9422712340  
Fax    
Email  nikita.baheti3@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR NIKITA RAVINDRA BAHETI 
Designation  Post graduate student 
Affiliation  Government Dental College and Hospital, Nagpur 
Address  101, PG section, Department of Orthodontics and Dentofacial Orthopaedics, Government dental college and hospital, Medical campus, Medical square, Nagpur
101, PG section, Department of Orthodontics and Dentofacial Orthopaedics, Government dental college and hospital, Medical campus, Medical square, Nagpur
Nagpur
MAHARASHTRA
440003
India 
Phone  9422712340  
Fax    
Email  nikita.baheti3@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR WASUNDHARA BHAD 
Designation  Professor and Head of Department 
Affiliation  Government Dental College and Hospital, Nagpur 
Address  HOD Chamber, Department of Orthodontics and Dentofacial Orthopaedics, Government dental college and hospital, Medical campus, Medical square, Nagpur
HOD Chamber, Department of Orthodontics and Dentofacial Orthopaedics, Government dental college and hospital, Medical campus, Medical square, Nagpur
Nagpur
MAHARASHTRA
440003
India 
Phone  9890227819  
Fax    
Email  wasundharabhad@gmail.com  
 
Source of Monetary or Material Support  
Department of Orthodontics and Dentofacial Orthopaedics, Government dental college and hospital, Medical campus, Medical square, Nagpur- 440003 
 
Primary Sponsor  
Name  Self Sponsor 
Address  Government Dental College and Hospital,Nagpur. Medical campus, medical square, Nagpur 440003 
Type of Sponsor  Other [Self Sponsor] 
 
Details of Secondary Sponsor  
Name  Address 
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 Nikita Ravindra Baheti  Government Dental College and Hospital, Nagpur  101 PG section, Department of orthodontics, Government Dental College and Hospital, medical college premises, medical square, Nagpur- 440003
Nagpur
MAHARASHTRA 
9422712340

nikita.baheti3@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee,GDCH, Nagpur  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  Twin Block appliance with Electronic timing device   Wear time of Twin Block appliance placed inside the oral cavity close to prescribed wear time by Clark. Frequency of checking time of wearing appliance in mouth is per month for total duration of six months. 
Intervention  Twin Block with Electronic timing device  Twin Block appliance placed inside the oral cavity is modified by placing electronic timing device within acrylic to assess wear time and wear time differs from prescribed wear time by Clark. Frequency of checking time of wearing appliance in mouth is per month for total duration of six months. 
 
Inclusion Criteria  
Age From  11.00 Year(s)
Age To  14.00 Year(s)
Gender  Both 
Details  Clinically:
1.No previous history of any orthodontic treatment.
2.Each subject with a full cusp class II or end-on molar relationship
bilaterally with convex facial profile.
3.The overjet should not be less than 5mm.
4.VTO improved with anterior positioning of mandible.
Radiographically:
1.ANB angle more than 4 degree with favorable functional analysis
and favorable growth pattern.
2.Subjects who are at accelerated phase of pubertal growth spurt
(CVMI stage-3, MP3-FG and MP3- G stage). 
 
ExclusionCriteria 
Details  1) Class I due to TSALD (Tooth Size Arch Length Discrepancy)
2) Excess Lower anterior face height
3) Proclined mandibular incisors.
4) Nasal stenosis due to structural problems.
5) Non-growing individuals
6) Syndromic cases 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The wear time affects/ does not affect treatment efficacy of twin block appliance  6 months after Twin Block appliance delivery 
 
Secondary Outcome  
Outcome  TimePoints 
The patient does/does not wear Twin Block appliance to recommended wear time  Monthly till 6 months 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   16/03/2020 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
Class II malocclusion is one of the most prevalent orthodontic conditions throughout the world, and these deformities are mainly treated by using functional appliances in growing patients. The most popular myofunctional appliance used for correction of class II malocclusion is the versatile removable twin block appliance in growing patients. Twin block is designed for full time wear to take the advantage of all functional forces applied to dentition.
The cooperation of children and adolescents plays a major role in achieving the desired treatment outcome with twin block appliance. Objective measurement of wear time has been demanded in orthodontics for a long time. In cases of failure or stagnating treatment it helps to find possible explanations. Studies show that patients sometimes are not very honest or unrealistic concerning their reported wear times.
Therefore, different devices have been introduced to measure the objective wear time of removable appliances. Most of these devices consist of a thermal microsensor that is embedded in the appliances.4 But in the country like India where most of the time environmental temperature is more than mouth temperature, these thermal sensors will give a false result. So, need to design a low cost electronic timing device suitable for application in removable acrylic orthodontic appliances. In this study, pretested electronic timing device which uses sensor with a switch function to record wear time will be used.
The aim of this study is to measure the wear time and to evaluate treatment efficacy in relation to wear time with twin block appliance.
 
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