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CTRI Number  CTRI/2025/11/098117 [Registered on: 26/11/2025] Trial Registered Prospectively
Last Modified On: 26/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Dentistry 
Study Design  Single Arm Study 
Public Title of Study   Effectiveness of Training Auxiliary Nurse Midwives on Early caries Risk Assessment in Children aged 1 to 3 years in Goa, India. 
Scientific Title of Study   Early Caries Risk Assessment in Toddlers : A Quasi-Experimental Study to Evaluate the Effectiveness of Capacity Building for Auxiliary Nurse Midwives’ in Goa, India 
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 Kunal Madne 
Designation  Student (Master of Dental Surgey) 
Affiliation  Goa Dental College and Hospital 
Address  Room no 8 Department of Public Health Dentistry Goa Dental college and Hospital, Bambolim, Goa
Room no 8 Department of Public Health Dentistry Goa Dental college and Hospital, Bambolim, Goa
North Goa
GOA
403202
India 
Phone  7095545009  
Fax    
Email  kunalmadne1998@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ridhima Gaunkar 
Designation  Professor 
Affiliation  Goa Dental College and Hospital  
Address  Room no. 8 Public Health Dentistry Goa Dental College and Hospital Babolim, Goa.

North Goa
GOA
403202
India 
Phone  9326469134  
Fax    
Email  drbirmani@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Akshatha Gadiyar 
Designation  Assistant Professor 
Affiliation  Goa Dental College and Hospital 
Address  Room no. 8 Public Health Dentistry Goa Dental College and Hospital Babolim, Goa.

North Goa
GOA
403202
India 
Phone  9740541867  
Fax    
Email  aksgadiyar@gmail.com  
 
Source of Monetary or Material Support  
Institute of Nursing Education Bambolim, Goa, India Pin code: 403202 
 
Primary Sponsor  
Name  Dr. Kunal M (Self sponsored) 
Address  Dr. Kunal madne Room no. F116, Boys Hostel Goa Dental college and Hospital, Bambolim Goa 
Type of Sponsor  Other [Self Sponsored] 
 
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 Kunal Madne  Institute of Nursing Education  Room no: 3 Multipurpose hall Institute of Nursing Education Bambolim, Goa. PIN: 403202
North Goa
GOA 
7095545009

kunalmadne1998@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Goa Dental College and Hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Prevention of Early Childhood caries 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  25.00 Year(s)
Gender  Female 
Details  ANMs enrolled in the course at INE 
 
ExclusionCriteria 
Details  1. ANMs who are not willing to provide informed consent.
2. ANMs who are absent on the days of training.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Improvement in Knowledge and Attitudes (KA)
2. Diagnostic accuracy of ANMs’ Assessments compared with a Dentist (Gold Standard)
 
1. Baseline and after two days
2. 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
1. Feasibility of Integration of Caries Risk assessment into routine at Immunization center.
2. Potential for early intervention. 
6 months 
 
Target Sample Size   Total Sample Size="65"
Sample Size from India="65" 
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)   14/12/2025 
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="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  

Early Childhood Caries remains one of the most prevalent chronic diseases among children, largely preventable through early identification of risk factors. Auxiliary Nurse midwives, who have close contact with mothers and children during immunization can play a vital role in the early detection and prevention of dental caries. However, limited training opportunities restrict their ability to assess and counsel families effectively.

Objectives:

1)    To train ANMs in caries risk assessment using the CAMBRA 123 tool through a structured educational intervention.

2)    To evaluate and compare the pre- and post-training knowledge and attitudes of ANMs regarding early childhood caries risk assessment.

3)    To assess the diagnostic accuracy of ANM-performed caries risk assessments compared to a Dentist (gold standard), by calculating sensitivity, specificity and Inter-examiner reliability.

4)    To determine the feasibility and identify common operational challenges of integrating caries risk assessment into routine immunization visits conducted by ANMs in primary health settings

Methodology

This quasi-experimental study aims to evaluate the effectiveness of a structured training program on caries risk assessment tool (CAMBRA 123) for Auxiliary Nurse Midwives. The study will be conducted in two Phases, Phase 1 will be conducted in the Institute of Nursing Education Bambolim, Goa. Participants will undergo pre- and post-training evaluation using a validated questionnaire assessing knowledge, attitudes regarding caries risk assessment. Following the training, in the second phase ANMs will assess the caries risk of Toddlers visiting immunization centers with their mothers. Their assessments will be compared with those made by a dentist (gold standard) who is blinded to the ANMs results to evaluate the Reliability and Feasibility of ANMs performing such assessments in routine practice. Data will be analysed using SPSS software version 26.0,  Descriptive statistics, Kappa statistics for Reliability and Intraclass correlation will be used to assess agreement between ANM and Dentist.

 
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