| CTRI Number |
CTRI/2025/09/094530 [Registered on: 10/09/2025] Trial Registered Prospectively |
| Last Modified On: |
09/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study on how Brief Action Planning can improve the oral health of adolescents |
|
Scientific Title of Study
|
Effect of Brief Action Planning intervention on oral health behaviours of adolescents A randomised controlled study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sindhuja Arunachalam |
| Designation |
Junior Resident |
| Affiliation |
King George Medical University |
| Address |
Department of Paediatric and Preventive Dentistry, Ki g George Medical University Lucknow
Lucknow
UTTAR PRADESH
226013
India |
| Phone |
07548890272 |
| Fax |
|
| Email |
sunarun71@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Richa Khanna |
| Designation |
Professor |
| Affiliation |
King George Medical University |
| Address |
Department of Paediatric and Preventive Dentistry King George medical University Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
09936038511 |
| Fax |
|
| Email |
richa.bahal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajeev Kumar Singh |
| Designation |
Professor and Hod |
| Affiliation |
King George Medical University |
| Address |
Department of Paediatric and Preventive Dentistry Ki g George Medical University Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9450849528 |
| Fax |
|
| Email |
rajeevkumarsingh@kgmcindia.edu |
|
|
Source of Monetary or Material Support
|
| King George Medical University Lucknow Pincode 226003 Uttarpradesh India |
|
|
Primary Sponsor
|
| Name |
King George Medical University |
| Address |
Shahmina road Chowk Lucknow |
| 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 Sindhuja A |
King George Medical University |
Department of Paediatric and Preventive Dentistry Faculty of dental sciences
Lucknow
UTTAR PRADESH |
7548890272
sunarun71@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| King Georges Medical University, Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A00-B99||Certain infectious and parasitic diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional health education ‘Information (IO)’ |
All participants in this group shall be given a standard format of oral hygiene instructions in verbal and written forms in colourful pamphlets regarding the frequency and duration of toothbrushing, brushing techniques and dietary habits which will be for about 15 to 20 minutes |
| Intervention |
MI- BAP counselling approach |
The participants in the intervention group (Group II) shall be given a 15 to 20 minute MI-BAP counselling where the participants shall be motivated to set a goal to improve his or her oral health related behaviours, frame an action plan and execute it. The targeted behaviours include: frequency of tooth brushing, duration of tooth brushing, consumption of free sugars. The 15 to 20 minute counselling will be given in the baseline, 1 month , 3 months follow up periods also |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1 Adolescents in the age group of 10 to 14 years.
2 Adolescents whose sugar consumption score is more than equal to 10
3 Adolescents whose Silness and Loe plaque scores between 1 and 2
4 Adolescents who have a moderate to high likelihood of caries development as determined using ICCMS International Caries Classification and management system
4 Adolescents who are able to read, write and understand in English or Hindi
5 Adolescents who are not diagnosed with behavioural disorders assessed using Child Behaviour Checklist |
|
| ExclusionCriteria |
| Details |
1 Adolescents with any systemic conditions impacting oral health.
2 Adolescents who are un cooperative to OHRBS due to any reason.
3 Adolescents with any diagnosable psychiatric disorder.
• Adolescents with any intellectual disability in clinical assessment.
|
|
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Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Caries increment as assessed by
1 number of new carious lesions,
2 number of progressed lesions,
3 change in number of active/inactive lesions
|
Baseline, 1 month, 3 months, 6 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in plaque score |
Baseline, 1 month, 3 months, 6 months |
| Change in sweet score |
Baseline, 1 month, 3 months, 6 months |
| Oral health confidence score |
6 months |
| Correlation of caries increment plaque scores with sweet scores Oral health confidence scores & self reported OHRB |
6 months |
|
|
Target Sample Size
|
Total Sample Size="122"
Sample Size from India="122"
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)
|
04/10/2025 |
| 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="1"
Months="0"
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
|
This randomized controlled study will assess the effectiveness of Motivational Interviewing with Brief Action Planning MI BAP versus conventional health education in improving oral health behaviours of adolescents aged 10 14 years The primary outcomes include sustained toothbrushing behaviour caries increment plaque score sweet score and oral health confidence Secondary outcomes involve correlations between dietary behaviours caries activity and plaque accumulation Eligibility adolescents aged 10 14 years with moderate high caries risk plaque scores 1 2 sugar score greater than and equal to 10 able to read and write English or Hindi and without systemic or psychiatric disorders Conclusion MI BAP offers a structured patient centred approach with minimal risk and potential long term behavioural benefits
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