| 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
|
|
|
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
|
|
|
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. |