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CTRI Number  CTRI/2018/03/012748 [Registered on: 22/03/2018] Trial Registered Retrospectively
Last Modified On: 14/03/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   This study is to find the chewing capability and biting ability in patients treated for correction of small lower jaw with two bite blocks named Twin Block inside the mouth. 
Scientific Title of Study   Evaluation of masticatory efficiency and functional occlusal contacts in Class II patients treated with Twin Block functional appliance. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anand Lukose 
Designation  Post Graduate Student 
Affiliation  Institute of Dental Studies and Technologies 
Address  IDST Dental College, Kadarabad, Modinagar, NH58 Delhi Meerut Road, Department of orthodontics and orthopedics, First floor, Room no 4
Modinagar, Rjchopla, Nivadi road, Street no 4, House no 33 NH58 Delhi Meerut Road,
Ghaziabad
UTTAR PRADESH
201201
India 
Phone  9045252169  
Fax    
Email  anandlukose606@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Saurabh Sonar 
Designation  Professor 
Affiliation  Institute of Dental Studies and Technologies 
Address  IDST Dental College, Kadarabad, Modinagar, NH58 Delhi Meerut Road, Department of orthodontics and orthopedics, First floor, Room no 4
Malviya Nagar,#H-13/7, First floor, Near main bus terminal Delhi
Ghaziabad
UTTAR PRADESH
201201
India 
Phone  9810327188  
Fax  01232224958  
Email  drsaurabhsonar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Anand Lukose 
Designation  Post Graduate Student 
Affiliation  Institute of Dental Studies and Technologies 
Address  IDST Dental College, Kadarabad, Modinagar, NH58 Delhi Meerut Road, Department of orthodontics and orthopedics, First floor, Room no 4
Modinagar, Rjchopla, Nivadi road, Street no 4, House no 33 NH58 Delhi Meerut Road,
Ghaziabad
UTTAR PRADESH
201201
India 
Phone  90452169  
Fax    
Email  anandlukose606@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Anand Lukose 
Address  IDST Dental college Modinager up 201201 
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 
Anand Lukose   IDST Dental college   IDST Dental college, Modinagar 201201, NH58 Delhi Meerut Road, Department of orthodontics and dentofacial orthopedics, First floor, Room no 4
Ghaziabad
UTTAR PRADESH 		 9045252169
01232224958
anandlukose606@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethical committee of IDST Dental college  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Class II malocclusion,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Evaluation of masticatory efficiency and functional occlusal contacts in class II patients treated with Twin-Block functional appliance  Masticatory efficiency was checked using spectrophometer and occlusal contacts were recorded by using T-Scan. 
Comparator Agent  none  none 
 
Inclusion Criteria  
Age From  11.00 Year(s)
Age To  14.00 Year(s)
Gender  Both 
Details  Patients with Skeletal Class II malocclusion due to retrognathic mandible.
Patients under CVMI Stage 4.
Moderately proclined upper labial segment.
No proclination of the lower labial segment.
No history of previous orthodontic treatment.
Patients having sound peridontal condition.
 
 
ExclusionCriteria 
Details  Patients having facial muscular problems.
Patients having dysosteosis.
Patients with systemic diseases.
Patients with syndromic mal occlusion. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Evaluation of masticatory efficiency in class II patients treated with twin-block functional appliance.  T0 - At the time of appliance delivery to the patient.
T1 - One month after initiating twin-block.
T2 - At the end of three months of treatment.
T3 - At the end of six months of treatment.
 
 
Secondary Outcome  
Outcome  TimePoints 
Evaluation of occlusal contacts in class II patients treated with twin-block functional appliance.  T0 - At the time of appliance delivery to the patient.
T1 - One month after initiating twin-block.
T2 - At the end of three months of treatment.
T3 - At the end of six months of treatment.
 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
Final Enrollment numbers achieved (Total)= "10"
Final Enrollment numbers achieved (India)="10" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/11/2015 
Date of Study Completion (India) 04/04/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="5" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NOt published 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   The study was an evaluation of masticatory efficiency and functional occlusal contacts in Class II patients treated with Twin-block functional appliance. The results of the study showed that masticatory efficiency and occlusal contacts of Class II cases  treated with Twin-Block functional appliance is the better treatment option than any other method. At the early treatment phase masticatory efficiency and occlusal contact may reduce as a result of change in occlusal scheme but gradually  occlusal trimming of Twin block  increase the masticatory efficiency and occlusal contact, This change in masticatory efficiency is not statically significant thus treatment with Twin-Block functional appliance therapy did not hamper the normal nutritional requirement of the patients, so we can expect the normal growth and development of the patients during  Twin-Block functional appliance therapy. 
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