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CTRI Number  CTRI/2025/06/089398 [Registered on: 24/06/2025] Trial Registered Prospectively
Last Modified On: 18/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Correction of abnormal tongue position using exercises and Removable appliances in children 
Scientific Title of Study   Comparative Effectiveness of Orofacial Myofunctional Therapy (OMT) with and without Removable Habit Breaking Appliances in pediatric patients with low tongue posture: A Randomized Control 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  Anoop Das P M 
Designation  Post graduate student 
Affiliation  Annoor Dental College and Hospital 
Address  Dr Anoop Das P M PG Student Department of Pediatric and Preventive Dentistry , Annoor Dental College and Hospital ,Perumattom , Muvattupuzha

Ernakulam
KERALA
686673
India 
Phone  9048403741  
Fax    
Email  dranoopdaspm@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Krishna Kumar R 
Designation  Professor 
Affiliation  Annoor Dental College and Hospital 
Address  Dr Krishna Kumar R Professor Department of Pediatric and Preventive Dentistry , Annoor Dental College and Hospital ,Perumattom , Muvattupuzha

Ernakulam
KERALA
686673
India 
Phone  9539796205  
Fax    
Email  drkrishnapedo@gmail.com  
 
Details of Contact Person
Public Query  
Name  John Joseph Methippara 
Designation  Professor 
Affiliation  Annoor Dental College and Hospital 
Address  Dr John Joseph Methippara Professor Department of Pediatric and Preventive Dentistry , Annoor Dental College and Hospital ,Perumattom , Muvattupuzha

Ernakulam
KERALA
686673
India 
Phone  9400947462  
Fax    
Email  johnjosephmethippara@gmail.com  
 
Source of Monetary or Material Support  
Annoor Dental College and Hospital, Muvattupuzha 
 
Primary Sponsor  
Name  Dr Anoop Das P M 
Address  Anoop Das P.M PG student Department of Pediatric and Preventive Dentistry, Perumattom , Muvattupuzha  
Type of Sponsor  Other [NIL] 
 
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 Anoop Das P M  Annoor Dental College and Hospital  Department of Pediatric and Preventive Dentistry Perumattom, Muvattupuzha
Ernakulam
KERALA 		 9048403741

dranoopdaspm@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Annoor Institutional Human Ethics Committee  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  Exercises  6 months of exerices will advice 
Intervention  Removable Habit Breaking Appliances  6 months of treatment will be done 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Children with the minimum distance between the dorsum of the tongue and palate equal or greater than 3mm in lateral cephalogram 
 
ExclusionCriteria 
Details  Children with tongue tie
Tongue range of motion less than 50% in TRMR scale
Medically compromised children
Differently abled children  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Distance between the dorsum of the tongue and palate will be measured in mm from lateral
ceph and the outcome measurement will be used to evaluate the change in tongue posture in four
groups 		 baseline and after 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Proclination of upper anterior teeth from both pre treatment and post treatment will be measured in
degrees 		 baseline and after 6 months  
Transpalatal width will be measured in mm from both pretreatment and posttreatment analysis  baseline and after 6 months 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   07/07/2025 
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="2"
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   Tongue is primarily a muscular organ that fills the functional area of mouth, It plays an active role in process like sucking, chewing, swallowing and speech production. Orofacial myofunctional disorder are characterized by inappropriate muscle function and incorrect habits involving tongue lips and jaw. One common manifestation of OMDs is low tongue posture, often associated with open mouth posture and incorrect swallowing pattern. Orofacial myofunctional therapy has been shown to improve swallowing pattern, reduce relapse after orthodontic treatments and enhance overall orofacial functions. The effectiveness of OMT can be influenced by additional interventions such as removable habit breaking appliances which are sometimes used  to support  the retraining process by providing mechanical assistance to correct tongue posture and other oral habits. 
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