FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/07/069789 [Registered on: 01/07/2024] Trial Registered Prospectively
Last Modified On: 28/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Single Arm Study 
Public Title of Study   Changes in tongue position and airway volumes after twin block appliance therapy. 
Scientific Title of Study   Evaluation of Tongue Posture and Airway volumes following Twin Block Appliance Therapy in Growing skeletal class II patients- An Experimental Study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SAKSHI JAIN 
Designation  Junior resident 
Affiliation  Government Dental College and Hospital,Nagpur 
Address  104, Department of Orthodontics, Government Dental College and Hospita,Nagpur, Medical square, Nagpur

Nagpur
MAHARASHTRA
440003
India 
Phone  7218524733  
Fax    
Email  jainsakshi224.sj@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jyoti Manchanda 
Designation  Associate professor 
Affiliation  Government dental college and hospital nagpur 
Address  104, Department of Orthodontics, Government Dental College and Hospita,Nagpur, Medical square, Nagpur

Nagpur
MAHARASHTRA
440003
India 
Phone  9423188175  
Fax    
Email  drjyotimadaan@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Jyoti Manchanda 
Designation  Associate professor 
Affiliation  Government dental college and hospital nagpur 
Address  104, Department of Orthodontics, Government Dental College and Hospita,Nagpur, Medical square, Nagpur

Nagpur
MAHARASHTRA
440003
India 
Phone  9423188175  
Fax    
Email  drjyotimadaan@yahoo.com  
 
Source of Monetary or Material Support  
Department of Orthodontics & Dentofacial Orthopaedics, Government Dental College and Hospital Nagpur, Medical College Premises, Medical Square, Nagpur, Maharashtra 440003 
 
Primary Sponsor  
Name  Dr. Sakshi Jain 
Address  104, department of orthodontics and dentofacial orthopedics, government dental college and hospital, Nagpur. 
Type of Sponsor  Other [Self funded] 
 
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 SAKSHI JAIN  Government Dental College and Hospital, Nagpur  104, Department of Orthodontics, Government Dental College and Hospita,Nagpur, Medical square, Nagpur
Nagpur
MAHARASHTRA 
7218524733

jainsakshi224.sj@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITEE GDC & H, NAGPUR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K149||Disease of tongue, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Twin block therapy  An informed consent will be taken from all patients parents or legal guardians, who agree to take part in study. Patients will be instructed to wear twin block for 24 hours. Pre-treatment records – 1. Case history 2. Clinical examination 3. Study models 4. Lateral cephalograms 5. Orthopantomogram (OPG) 6. Intraoral and extraoral photographs 7. IOPA for MP3 8. CBCT Appliance fabrication- Twin block appliance will be fabricated according to the steps mentioned below and then delivered to patients. Steps in Twin Block appliance fabrication- 1. Bite registration 2. Determining vertical dimension 3. Appliance designing and construction 4. Appliance delivery 5. Recall and reactivation of twin block Post-treatment records- Post-treatment records will be taken after achieving Class I molar relationship and post treatment records will be same as that of pre-treatment records  
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  14.00 Year(s)
Gender  Both 
Details  Clinically:
No previous history of any orthodontic treatment.
Each subject with a full cusp class II or end-on molar relationship bilaterally with convex facial profile.
The overjet should be more than 4 mm.
Positive visual treatment objective (VTO)
Radiographically:
ANB angle more than 4 degrees with favourable growth pattern.
Subjects who are at accelerated phase of pubertal growth spurt (CVMI stage-3), MP3-FG and MP3- G stage.
 
 
ExclusionCriteria 
Details  Syndromic cases.
Patients with following disorders –
A) Disorders of Bone metabolism.
B) Hepatobiliary disorders.
C) Systemic Inflammatory diseases.
Patients with compromised oral hygiene.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Changes in tongue posture & airway volumes  Baseline, 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in airway volumes  Baseline, 6 months 
 
Target Sample Size   Total Sample Size="22"
Sample Size from India="22" 
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/ Phase 4 
Date of First Enrollment (India)   21/07/2024 
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 Applicable 
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  

          Myofunctional appliances are valuable tools in the armamentarium of orthodontics for the correction of altered form and function. Their mode of action on different sites of orofacial skeleton can control and modify the growth of mandible. Skeletal class II malocclusion being a prevalent condition can be corrected by these functional appliances in growing patients. Among these appliances Twin Block is the choice of appliance due to its versatility.

   The tongue is the most active muscular structure of the oropharyngeal system and is directly influenced by any modification in the dentoskeletal environment. After skeletal discrepancy is corrected, the tongue adapts within the altered position of the dental arches and can enhance post-functional stability.

         The tongue is a muscular organ that may be posteriorly positioned in a retrognathic mandible. With the use of a functional appliance such as Twin Block, posture of tongue can be improved, resulting in increased dimensions of the airways.

To our knowledge, there is limited literature evidence regarding changes in the posture of tongue after functional appliance therapy.  Most of the studies are retrospective studies with two-dimensional imaging modality, which is not reliable due to magnification errors. There is no prospective study demonstrating the changes in tongue posture, using a three-dimensional (3D) imaging modality. Hence this study is designed to evaluate changes in tongue posture and airway volumes after twin block appliance therapy in growing skeletal class II patients using Cone Beam Computed Tomography.


 
Close