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CTRI Number  CTRI/2025/11/097494 [Registered on: 17/11/2025] Trial Registered Prospectively
Last Modified On: 15/11/2025
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of change talk therapy to parents over multiple sessions on taking care of their childrens teeth and extent of tooth decay in young children with cavities. 
Scientific Title of Study   Impact of multi-session parental motivational interviewing on parental self-efficacy in oral health care practices and dental caries experience in children with early childhood caries 
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 Suprabha BS 
Designation  Professor 
Affiliation  Manipal College of Dental Sciences Mangalore Karnataka 
Address  Department of Pediatric and Preventive Dentistry, Manipal College of Dental Sciences Mangalore, Light House Hill Road, Hampankatta, Mangaluru

Dakshina Kannada
KARNATAKA
575001
India 
Phone  09480655538  
Fax    
Email  suprabha.bhat@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Suprabha BS 
Designation  Professor 
Affiliation  Manipal College of Dental Sciences Mangalore Karnataka 
Address  Department of Pediatric and Preventive Dentistry, Manipal College of Dental Sciences Mangalore, Light House Hill Road, Hampankatta, Mangaluru

Dakshina Kannada
KARNATAKA
575001
India 
Phone  09480655538  
Fax    
Email  suprabha.bhat@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Suprabha BS 
Designation  Professor 
Affiliation  Manipal College of Dental Sciences Mangalore Karnataka 
Address  Department of Pediatric and Preventive Dentistry, Manipal College of Dental Sciences Mangalore, Light House Hill Road, Hampankatta, Mangaluru

Dakshina Kannada
KARNATAKA
575001
India 
Phone  09480655538  
Fax    
Email  suprabha.bhat@manipal.edu  
 
Source of Monetary or Material Support  
ICMR (INVESTIGATOR-INITIATED RESEARCH PROPOSALS FOR SMALL EXTRAMURAL GRANTS-approved with comments) Indian Council of Medical Research (ICMR), V. Ramalingaswami Bhawan, P.O. Box No. 4911, Ansari Nagar, New Delhi - 110029, India.  
 
Primary Sponsor  
Name  Manipal College of Dental Sciences Mangalore 
Address  Room no. 6, Department of Pediatric and Preventive Dentistry, Manipal College of Dental Sciences Mangalore, Light house hill road, Hampankatta, Mangalore, Karnataka, India-575001 
Type of Sponsor  Other [Dental College] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Suprabha BS  Manipal College of Dental Sciences Mangalore  Room no.6, Department of Pediatric and Preventive Dentistry, Manipal College of Dental Sciences Mangalore, Light House Hill Road, Hampankatta, Mangalore-575001
Dakshina Kannada
KARNATAKA 		 09480655538

suprabha.bhat@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Manipal College of Dental Sciences, Mangalore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K029||Dental caries, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Dental Health Education  Parents of children with ECC will be educated about the oral health care practices for their children by providing oral and written information. 
Intervention  Motivational Interviewing  Parents of children with ECC will undergo three sessions corresponding to pre-contemplative, contemplative, and preparation stages of motivational interviewing, followed by practice stage session of motivational interviewing at 3-months on oral health care practices for their children 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  6.00 Year(s)
Gender  Both 
Details  Children with ECC (at least one decayed tooth, based on the dmft criteria of World Health Organization according to American Academy of Pediatric Dentistry)  
 
ExclusionCriteria 
Details  Children with systemic diseases, mental or developmental abnormalities. 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Parental Self-efficacy  6-months and 12-months 
 
Secondary Outcome  
Outcome  TimePoints 
dmft and dmfs  6-months and 12-months 
 
Target Sample Size   Total Sample Size="128"
Sample Size from India="128" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   08/06/2026 
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="4"
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  

Objectives:

Stage 1

To study the differences in parental perceptions of self-efficacy about oral health care practices of their children with and without early childhood caries.

To check the reliability and validity of  parental oral health self-efficacy questionnaire

Stage 2

To study the association of parental self-efficacy in oral health care practices with early childhood caries experience of their children and their oral health care practices.

Stage 3

To study the effectiveness of multi-session motivational interviewing of parents on parental self-efficacy in their children’s oral health care practices and dental caries experience of their children with early childhood caries in comparison with conventional dental education method by oral and written instructions, over a 12-month follow-up.

Methodology:

Stage 1: Developing the questionnaire

Objective 1: To study the differences in parental perceptions on self-efficacy about oral health care practices of their children with and without early childhood caries

Study design: Descriptive qualitative study

Study duration: 6 months

Focus group discussions will be conducted until data saturation is obtained. All sessions will be audio recorded. Each session will be approximately 45 minutes, with 6 participants in each group.

Outcome

Differences in parental self-efficacy on oral health practices and the existing oral health care practices among children with and without ECC. 

Self-efficacy indicators for oral health care practices among children with ECC, that will help in developing a questionnaire tool.

Objective 2

To check the reliability and validity of parental oral health self-efficacy questionnaire

For the pilot testing of the questionnaire, 500 parents of preschool children from preschools of Mangalore Taluk, based on convenience sampling and fulfilling the inclusion and exclusion criteria will be selected.

Subject experts will evaluate the questionnaire for face validity and content validity. After pre-testing the questionnaire for cognition by parents, pilot testing will be conducted to assess the construct validity. Reliability will be tested after translating to local (Kannada) language.

Stage 2: CASE-CONTROL STUDY

Objective: To study the association of parental self-efficacy in oral health care practices with early childhood caries experience of their children and their oral health care practices.

Study design:  Case-control (Parents of children with and without ECC)

Study duration: 6 months

Sampling (target population): Parents of the children with and without ECC from Anganwadis and preschools at Mangalore taluk, Dakshina Kannada district, Karnataka, using two stage simple cluster random sampling technique.

The questionnaire on self-efficacy that was derived based on the qualitative study outcomes and undergone validity and reliability testing  will be used for the case-control study. A questionnaire on oral health care practices, including home oral hygiene routines, sugar consumption in the child’s diet, and patterns of dental care utilization through dental clinic visits, will be administered to parents.

Chi-square tests and multiple logistic regression will be used to analyze the data and compare between cases and controls.

Stage 3: Randomized Controlled study with Motivational Interviewing Intervention

Objective

To study the effectiveness of multi-session motivational interviewing of parents on parental self-efficacy in their children’s oral health care practices and dental caries experience of their children with early childhood caries in comparison with conventional dental education method by oral and written instructions.

Study design: Randomized controlled trial

Sampling: Two stage simple cluster random sampling method will be used in a similar manner as the case control study. The sample will consist of parent-child dyads with ECC only (cases only). Parents of children with ECC who participated in the phase 1 study will be selected using the lottery method, from each cluster. Each preschool/Anganwadi will be clusters

Study duration: 18 months

Randomization: The parents will be randomly allocated into two groups using block randomization technique with allocation concealment

Group1: Motivational interviewing (MI)

Group 2: Conventional dental health education (DHE) (positive control)

Group 1 (MI Group): A brief one-to-one MI will be conducted for each parent individually by a trained pediatric dentist. The duration of each session will be approximately 20 minutes, with three sessions (Pre-contemplative, contemplative, and preparation stages) conducted at 15-day intervals. The oral health practices will be reviewed at 3-month follow-up (practice stage).

Group 2 (DHE group): The parents will be provided with oral and written information about the importance of primary teeth, the decay process, and oral health practices such as oral hygiene, dietary sugars, and regular dental visits for their child using an educational booklet and study models to demonstrate tooth brushing.

Outcomes: Parents will be followed up at 6 and 12 months after the last stage of intervention and assessed for parental self-efficacy and oral health practices of their children using the same questionnaire as in the Phase 1 case-control study.

Examination: Children will be examined for dental caries experience at 6 and 12-month follow-up using dmft and dmfs index, plaque index and ICDAS II caries scoring system.

Repeated Measures of ANOVA, Chi-square tests and multivariate regression analysis will be used to compare parental self-efficacy, dental caries experience and oral health care practices of their children between the groups over time.

 
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