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CTRI Number  CTRI/2025/07/090759 [Registered on: 11/07/2025] Trial Registered Prospectively
Last Modified On: 29/04/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry
Behavioral
Other (Specify) [Educational]  
Study Design  Single Arm Study 
Public Title of Study   Oral health education through Anganwadis 
Scientific Title of Study   Impact of an education training package to Anganwadi workers for improving oral health knowledge among mother-child dyads in Kerala, 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 Venkitachalam Ramanarayanan 
Designation  Reader 
Affiliation  Amrita School of Dentistry, Amrita Vishwa Vidyapeetham 
Address  Room No 6, Department of Public Health Dentistry, Amrita School of Dentistry, AIMS, Ponekkara P.O., Kochi, Kerala, India

Ernakulam
KERALA
682041
India 
Phone  9895741775  
Fax    
Email  venkitr2006@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Chandrashekar Janakiram 
Designation  Prof and Head 
Affiliation  Amrita School of Dentistry, Amrita Vishwa Vidyapeetham 
Address  Room No 6, Department of Public Health Dentistry, Amrita School of Dentistry, AIMS, Ponekkara P.O., Kochi, Kerala, India

Ernakulam
KERALA
682041
India 
Phone  9481789572  
Fax    
Email  sekarcandra@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vineetha Karuveettil 
Designation  Additional Reader 
Affiliation  Amrita School of Dentistry, Amrita Vishwa Vidyapeetham 
Address  Room No 6, Department of Public Health Dentistry, Amrita School of Dentistry, AIMS, Ponekkara P.O., Kochi, Kerala, India

Ernakulam
KERALA
682041
India 
Phone  8289959380  
Fax    
Email  kvineetha2016@gmail.com  
 
Source of Monetary or Material Support  
Infrastructural support - Amrita School of Dentistry, AIMS, Ponekkara P.O., Kochi, Kerala, India  
Monetary - Borrow Foundation, United Kingdom 
 
Primary Sponsor  
Name  The Borrow Foundation  
Address  Padnell Grange, Cowplain, Hampshire PO8 8ED, United Kingdom 
Type of Sponsor  Other [The Borrow Foundation is a UK based charity organisation:Charity No.1060308] 
 
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 Venkitachalam Ramanarayanan  Amrita School of Dentistry  Room No 6, Department of Public Health Dentistry, AIMS, Ponekkara P.O., Kochi 682041
Ernakulam
KERALA 
9895741775

venkitr2006@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee of Amrita School of Medicine  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K025||Dental caries on pit and fissure surface,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not Applicable  Not Applicable 
Intervention  Oral health education training package to mother-child dyads through Anganwadi workers in Corporation of Cochin, Kerala   Training of Anganwadi workers will be done based on the training manual on oral health promotion for health workers developed by Centre for Dental Education and Research, AIIMS. This is the official training manual of National Oral Health Program by Ministry of Health and Family welfare, Government of India. The manual aims at enhancing the understanding of frontline workers on oral health, their abilities to communicate regarding this with families and promote behaviours that are conducive to good oral health, following a life course approach starting from the pregnant women to neonates, children, adults, family, geriatric individuals and special groups. It would also help in management of a few dental emergencies like trauma to teeth. Intervention (training) will be provided for 1 day and refresher session will be organized if requested by Anganwadi teachers.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  -Oral health training will be provided to the Anganwadi teachers in the selected Anganwadi centres.
- Trained Anganwadi teachers conduct oral health education sessions for the beneficiaries, such as Children in the age group of 3 to 6 years and their mothers who belong to the respective Anganwadi centre.  
 
ExclusionCriteria 
Details  Anganwadi teachers not willing to be a part of the study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Acceptability: Number of Anganwadi centres initially accepting to participate in the training.

Coverage: Determined by calculating the reach of the program, represented as the number of Anganwadi centres implementing the training package.

Adoption: Number of trained Anganwadi workers delivered oral health education to the mothers in a month.

Fidelity: Number of Anganwadi workers adopted the training module as original described in manual.
 
6 months 
 
Secondary Outcome  
Outcome  TimePoints 
- Current oral hygiene practices, facilitators and barriers to implement oral health education training package among Anganwadi workers, parents and other key stakeholders.

 
6 months 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   15/07/2025 
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)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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  

Anganwadi workers (AWW) are community-based health workers, under the Integrated Child Development Scheme (ICDS) of the Government of India, trained to provide services at the grassroots level. Anganwadi workers are primarily women, and they are selected from the local community. In India, Anganwadi workers, predominantly local women serving as community-based health workers, play a crucial role in delivering maternal and child healthcare services. Oral health promotion has been shown to be effective when implemented early in life. The National Oral Health Program is being piloted in many states in India, and the use of grassroot workers for oral health promotion has been envisaged. While this approach seems very promising, a comprehensive assessment of the project in terms of implementation, logistics, and outcomes is lacking. In a country as diverse as India, understanding and adapting to local contexts are important. To address this gap, a project aims to empower Anganwadi workers with comprehensive oral health training, with a specific focus on maternal and child oral health due to its significance in early childhood development. An implementation research project is planned to implement an oral health care program through Anganwadi workers, targeting pregnant women, young mothers, and children attending Anganwadi centers. Utilizing a training manual developed as part of the National Oral Health Program (NOHP), 100 Anganwadi workers will deliver oral health education to the beneficiaries (mothers and children). Training sessions for Anganwadi workers will be conducted by dentists affiliated with the district health services (DHS). The study aims to assess the coverage, acceptability, adoption, and fidelity of the oral health training program. Additionally, it will evaluate the improvement in knowledge regarding oral health among the beneficiaries. Employing a mixed-method approach, the evaluation will encompass surveys, in-depth interviews, and focus group discussions. The project is led by Amrita School of Dentistry and conducted through Amrita Urban Health Centre in Kerala, India, benefiting approximately 6,000 children and their mothers directly and around 20,000 family members indirectly.

 
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