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CTRI Number  CTRI/2026/01/100132 [Registered on: 01/01/2026] Trial Registered Prospectively
Last Modified On: 27/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Main outcome of this study is to Evaluate The Effectiveness Of Tongue Repositioning Appliances in participants who position the tongue in forward position. 
Scientific Title of Study   To Evaluate The Efficacy Of Tongue Crib vs Tongue Tamers In Repositioned Tongue In Simple/ Complex Tongue Thrusters. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SIMMI ARORA 
Designation  MDS 2nd Year Student 
Affiliation  Subharti Dental College Meerut Uttar Pradesh 
Address  Room no 7, 2nd floor, Department Of Orthodontics and Dentofacial Orthopaedics, Subharti Dental College and Hospital , Meerut , Uttar Pradesh

Meerut
UTTAR PRADESH
250005
India 
Phone  08851216379  
Fax    
Email  simmiarora412@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  dr PRADEEP RAGHAV 
Designation  PROFFESSOR AND HEAD OF DEPT OF ORTHODONTICS 
Affiliation  Subharti Dental College Meerut Uttar Pradesh 
Address  Room no 7, 2nd floor, Department Of Orthodontics and Dentofacial Orthopaedics, Subharti Dental College and Hospital , Meerut , Uttar Pradesh

Meerut
UTTAR PRADESH
250005
India 
Phone  9837175914  
Fax    
Email  drpradeepraghav@gmail.com  
 
Details of Contact Person
Public Query
 
Name  SIMMI ARORA 
Designation  MDS 2nd Year Student 
Affiliation  Subharti Dental College Meerut Uttar Pradesh 
Address  Room no 7, 2nd floor, Department Of Orthodontics and Dentofacial Orthopaedics, Subharti Dental College and Hospital , Meerut , Uttar Pradesh


UTTAR PRADESH
250005
India 
Phone  08851216379  
Fax    
Email  simmiarora412@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Simmi Arora 
Address  Room no 7, Department of Orthodontics and Dentofacial Orthopaedics ,Subharti Dental College and Hospital, Meerut , Uttar Pradesh, 250005 
Type of Sponsor  Other [Subharti dental college and hospital] 
 
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 SIMMI ARORA  Subharti Dental College and Hospital  Room no 7 (2nd floor) Department Of Orthodontics and Dentofacial Orthopaedics, Subharti Dental College and Hospital, Meerut, Uttar Pradesh, Pin Code- 250005.
Meerut
UTTAR PRADESH 
08851216379

simmiarora412@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
University Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z848||Family history of other specifiedconditions,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  To Evaluate The Efficacy Of Tongue Crib vs Tongue Tamers In Repositioned Tongue In Simple/ Complex Tongue Thrusters  The secondary outcome is to evaluate the position of tongue in tongue thrusters before and after giving tongue tamers for 6 months 
Intervention  To Evaluate The Efficacy Of Tongue Crib vs Tongue Tamers In Repositioned Tongue In Simple/ Complex Tongue Thrusters  A total sample of 20 patients will be selected from the OPD in the Department Of Orthodontics And Dentofacial Orthopaedics, Subharti Dental College, meerut 250005 1. The primary outcome is to evaluate the position of tongue in tongue thrusters before and after giving tongue crib appliance for 6 months.  
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  1.Patients having proclined / spaced upper anterior teeth.
2. Pateints with retroclined / proclined lower incisors.
3.Patients having difficulty in chewing and speaking.
4. Patients having a convex profile.
5.Fully erupted Maxillary and mandibular incisors.
6. Bilaterally symmetrical face.
 
 
ExclusionCriteria 
Details  1.Crowding wrt upper/ lower teeth.
2.Loss of permanent incisors.
3.Tooth agenesis
4.Mentally challenged patient.
5.Patients with any known systemic or endocrinological disorder.
6History of trauma and surgery involving tongue.
7Patients undergone previous orthodontic treatment.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To see whether the tongue cribs or tongue tamers can effectively reposition the tongue in tongue thrusting patients within 6months  To see whether the tongue cribs or tongue tamers can effectively reposition the tongue in tongue thrusting patients within 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   15/01/2026 
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="0"
Months="6"
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  

Summary of the Study:

This study, titled "To evaluate the efficacy of tongue crib vs tongue tamers in repositioned tongue in simple/complex tongue thrusters," is a randomized clinical trial conducted at the Department of Orthodontics and Dentofacial Orthopaedics, Subharti Dental College, Meerut. Tongue thrusting is a habitual forward movement of the tongue between the teeth during swallowing or speech, often contributing to malocclusions such as open bites, increased overjet, and improper dental arch development. The aim of this study is to compare the effectiveness of two habit-breaking appliances—tongue cribs and tongue tamers—in repositioning the tongue in patients with simple or complex tongue thrusting habits.

Twenty patients exhibiting tongue thrusting behaviors will be selected based on specific inclusion criteria, such as proclined anterior teeth or having spacing between the teeth. Pre- and post-treatment CBCT scans will be performed to evaluate tongue position, with barium sulphate used as a contrast agent for better visualization. Tongue cribs, made from stainless steel wire, will be fixed to the molars, while tongue tamers will be bonded to the palatal and lingual surfaces of anterior teeth. After six months of appliance therapy, changes in tongue position will be assessed.

The study aims to compare whether tongue cribs or tongue tamers are more effective in repositioning the tongue, which can aid in preventing or correcting related orthodontic issues. Statistical analysis will be used to evaluate the differences in outcomes. The results are expected to provide valuable insights into appliance-based management of tongue thrust and improve treatment strategies in orthodontics.

 
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