| CTRI Number |
CTRI/2026/02/102957 [Registered on: 04/02/2026] Trial Registered Prospectively |
| Last Modified On: |
02/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Influence of Tongue Thrusting on Occlusal Bite Force in Children Aged 6-12 Years: An Observational Study |
|
Scientific Title of Study
|
Influence of Tongue Thrusting on Occlusal Bite Force in Children Aged 6–12 Years: An Observational 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 |
Dr Akanksha Akhatkar |
| Designation |
Post Graduate Student |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Pediatric and Preventive Dentistry, Third Floor (303), Sharad Pawar Dental College, Sawangi
Wardha
MAHARASHTRA
442001
India |
| Phone |
8378815623 |
| Fax |
|
| Email |
akankshaakhatkar8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrNilima Thosar |
| Designation |
Professor and Head |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Pediatric and Preventive Dentistry, Third Floor (303), Sharad Pawar Dental College, Sawangi
Wardha
MAHARASHTRA
442001
India |
| Phone |
9284522620 |
| Fax |
|
| Email |
drnthosar@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrNilima Thosar |
| Designation |
Professor and Head |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Pediatric and Preventive Dentistry, Third Floor (303), Sharad Pawar Dental College, Sawangi
MAHARASHTRA
442001
India |
| Phone |
9284522620 |
| Fax |
|
| Email |
drnthosar@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research, Sawangi Meghe Wardha, Maharashtra, India 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Sawangi Meghe Wardha, Maharashtra, India 442001 |
| Type of Sponsor |
Private medical college |
|
|
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 Akanksha Akhatkar |
Sharad Pawar Dental College |
Department of Pediatric and Preventive Dentistry, Third Floor (303), Sharad Pawar Dental College, Sawangi
Wardha
MAHARASHTRA |
8378815623
akankshaakhatkar8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Datta Meghe Institute of Higher Education and Research, Wardha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Children aged 6–12 years.
2. Children with mixed dentition stage (eruption of first permanent molars and presence
of primary teeth).
3. Systemically healthy children with no neuromuscular disorders.
4. Children with clinically diagnosed tongue thrusting habit (study group).
5. Children without tongue thrusting habit (control group).
6. Children with no history of orthodontic or myofunctional therapy.
7. Parental/guardian consent obtained for participation in the study. |
|
| ExclusionCriteria |
| Details |
1. Children with a history of orthodontic or orthognathic treatment.
2. Children with craniofacial anomalies such as cleft lip and palate.
3. Children with neuromuscular or developmental disorders affecting swallowing or
muscle function.
4. Children with acute or chronic temporomandibular joint disorders.
5. Children with missing or grossly carious permanent first molars affecting occlusal
contact.
6. Children who will not provide informed consent. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Children with tongue thrusting habit will exhibit a reduced occlusal bite force compared to those without the habit. |
Assessment will be done after 1 week after diagnosis |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
15/03/2026 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 thrusting is a common oral habit in children and may affect muscle function and bite force. This study is planned to evaluate the influence of tongue thrusting on occlusal bite force in children aged 6–12 years. Tongue thrusting will be assessed clinically, and maximum occlusal bite force will be recorded using a bite force measuring device under standardized conditions. The data will be statistically analyzed to compare bite force between the two groups. It is expected that children with tongue thrusting habit will show reduced occlusal bite force compared to children without the habit. |