| 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
|
|
|
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
|
|
|
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
|
|
|
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. |