| 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
|
|
|
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
|
|
|
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. |