| CTRI Number |
CTRI/2025/04/083759 [Registered on: 01/04/2025] Trial Registered Prospectively |
| Last Modified On: |
31/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to determine whether there is any change in attention deficit hyperactivity disorder like symptoms following treatment for mouth breathing habit in children of age group 7-12 years |
|
Scientific Title of Study
|
Effect of dental treatment for mouth breathing habit on attention deficit
hyperactivity disorder like symptoms among 7-12 years old children |
| 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 Arya S Kumar |
| Designation |
Senior Resident |
| Affiliation |
Government Dental College |
| Address |
Department of Pediatric and Preventive Dentistry, Government Dental college, Thrissur.
Thrissur
KERALA
680596
India |
| Phone |
9895790268 |
| Fax |
|
| Email |
aryaasok29@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arya S Kumar |
| Designation |
Senior Resident ( Faculty ) |
| Affiliation |
Government Dental College |
| Address |
Department of Pediatric and Preventive Dentistry, Government Dental college, Thrissur, India.
Thrissur
KERALA
680596
India |
| Phone |
9895790268 |
| Fax |
|
| Email |
aryaasok29@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arya S Kumar |
| Designation |
Senior Resident |
| Affiliation |
Government Dental College |
| Address |
Department of Pediatric and Preventive Dentistry, Government Dental college, Thrissur.
Thrissur
KERALA
680596
India |
| Phone |
9895790268 |
| Fax |
|
| Email |
aryaasok29@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Dental College, Thrissur, Kerala, India. Pin 680596 |
|
|
Primary Sponsor
|
| Name |
Dr Arya S Kumar |
| Address |
Department Of Pediatric Dentistry, Government Dental College, Thrissur, Kerala, India. Pin 680596 |
| Type of Sponsor |
Government 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 Arya S Kumar |
Government Dental College hospital Thrissur |
Department Of Pediatric Dentistry, Government Dental College Thrissur.
Thrissur
KERALA |
9895790268
-
aryaasok29@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Government Dental College, Thrissur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, (2) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Oral Screen |
Used to correct mouth breathing habit |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children of age group 7 – 12 years with mouth breathing attending OPD of the
Department of Pediatric and Preventive Dentistry, Govt. Dental College,
Thrissu |
|
| ExclusionCriteria |
| Details |
Children who are previously diagnosed as Attention Deficit Hyperactivity Disorder patients. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine the change in the Attention Defecit Hyperactivity Disorder like symptoms before and after dental treatment for
mouth breathing habit with oral screen and myofunctional exercises among 7-12 years old
children.
|
9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine the effect of dental treatment with oral screen and myofunctional exercises
on dental and facial features of children with mouth breathing habit. |
9 months |
|
|
Target Sample Size
|
Total Sample Size="21"
Sample Size from India="21"
Final Enrollment numbers achieved (Total)= "21"
Final Enrollment numbers achieved (India)="21" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/04/2025 |
| Date of Study Completion (India) |
03/02/2026 |
| Date of First Enrollment (Global) |
15/04/2025 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
This is a quasi experimental study where children with ADHD like features and mouth breathing habit will be given oral screen appliance. After the treatment with oral screen the same group of children will be assessed for any change in ADHD like features. Hence aim of the study is to check if there is any reduction in ADHD like features following treatment with oral screen appliance. |