| CTRI Number |
CTRI/2025/11/096750 [Registered on: 03/11/2025] Trial Registered Prospectively |
| Last Modified On: |
31/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
How counselling the childs parent help in improving overall oral health of child patient after doing all dental procedure under deep sleep controlled by medication. |
|
Scientific Title of Study
|
Consequence of motivational interviewing on oral health status of children after receiving full mouth dental rehabilitation under general anaesthesia. |
| 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 Sherin A |
| Designation |
Pg Student |
| Affiliation |
Karpaga Vinayaga Institute Of Dental Sciences |
| Address |
karpaga vinayaga institute of dental sciences, palaynoor post madhuranthagam kancheepuram district Room No:8,Department of Pedodontics , 4th floor .
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
8124420360 |
| Fax |
|
| Email |
sherinarul0104@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahesh Kumar P |
| Designation |
Head Of The Department |
| Affiliation |
karpaga Vinayaga Institute Of Dental Sciences |
| Address |
karpaga vinayaga institute of dental sciences,palaynoor post madhuranthagam kancheepuram district Room No:8,Department of Pedodontics , 4th floor .
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
9841397411 |
| Fax |
|
| Email |
maheshp1972@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sherin A |
| Designation |
Pg Student |
| Affiliation |
karpaga Vinayaga Institute Of Dental Sciences |
| Address |
karpaga vinayaga institute of dental sciences,palaynoor post madhuranthagam kancheepuram district Room No:8,Department of Pedodontics , 4th floor .
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
8124420360 |
| Fax |
|
| Email |
sherinarul0104@gmail.com |
|
|
Source of Monetary or Material Support
|
| karpaga vinayaga institute of dental sciences,Room No:8,Department of pedodontics ,4th floor,palayanoor post madhuranthagam,kancheepuram district,603308 |
|
|
Primary Sponsor
|
| Name |
Dr Sherin A |
| Address |
Karpaga Vinayaga Institute Of Dental Sciences,palaynoor post madhuranthagam kancheepuram district Room No:8,Department of Pedodontics , 4th floor . |
| Type of Sponsor |
Other [other(self)] |
|
|
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 Sherin A |
Karpaga Vinayaga Institute of Dental Sciences |
Room No:8,Department of Pedodontics,4th floor,kancheepuram district,palayanoor post ,madhuranthagam
Kancheepuram
TAMIL NADU |
8124420360
sherinarul0104@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instutional Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
pamphlet and verbal instruction on oral hygiene |
control group will be assessed for oral health status of patient , quality of life and parent knowledge towards oral health by Motivational Interviewing to their parents after full mouth dental rehabilitation under general anaesthesia by use of pamphlet as well as verbal instruction about oral hygiene.These parameters will be assessed before full mouth dental rehabilitation,3rd month and 6th month time interval. |
| Intervention |
Motivational Interviewing |
intervention group will be assessed for oral health status of patient , quality of life and parent knowledge towards oral health by Motivational Interviewing to their parents after full mouth dental rehabilitation under general anaesthesia by use of audiovisual aids,pamphlet about oral hygiene as well as verbal instruction .These parameters will be assessed before full mouth dental rehabilitation , 3rd month and 6th month time interval. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
1.healthy patient aged between 3-6years.
2.patient with early childhood caries and rampant caries.
3.parent with minimum education qualification (SSLC) or above.
4.ASA classification I and II. |
|
| ExclusionCriteria |
| Details |
1.patient or guardian who are not willing to participate in this study.
2.complete missing of anterior teeth .
3.ASA classification III and IV.
4.patient with special health care needs |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| parent receiving motivational interviewing ,verbal instruction,pamphlet will maintain good oral health for their children. |
3month ,6month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| parent receiving motivational interviewing ,verbal instruction,pamphlet will have better quality of life when compared to control group. |
3month ,6month |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/12/2025 |
| 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="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
|
The total particpants is 24 out of which 12 in each group is divided by simple randomization and who are willing to participate and with ASA classification I and II .Group I is control group without motivational interviewing and group II is intervention group with motivational interviewing .control group will be assessed for oral health status of patient quality of life and parents knowledge towards oral health by verbal instruction as well as they will be recieving pamphlet regarding oral hygiene instruction whereas intervention group wil be assessed for oral health status quality of life and parents knowledge on oral health by giving motivational interviewing to their parents use of audiovisual aids verbal instruction and pamphlet will be given which contain oral hygiene instructions Then three parameters that is oral health status of the child patient quality of life and parents knowledge towards oral health will be assessed with appropriate tools such as oral health index , quality of life questionnaire by pediatric oral health related quality of life by preschool version and parents knowledge about oral health byasendhen et al . then the values will be recorded for above mentioned parameters at before full mouth dental rehabailitation at baseline then at 3rd month and 6th month interval period. |