| CTRI Number |
CTRI/2025/09/094361 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
06/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to see how ASHA (Acrredited social health activists) which are community health workers can help improve oral health of people in community visited by them using a new oral health education toolkit compared to simple verbal oral health education |
|
Scientific Title of Study
|
Effectiveness of ASHA worker - led intervention on oral health using Novel oral health education toolkit with Conventional method of oral health education among Adult beneficiaries: A Randomised controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MEHAK JAIN |
| Designation |
Post graduate Student |
| Affiliation |
Maulana Azad Institute of Dental Sciences |
| Address |
Department of Public Health Dentistry, Maulana Azad Institute of
Dental Sciences, Bahadur Shah Zafar Marg, New Delhi
Central
DELHI
110002
India |
| Phone |
9205637177 |
| Fax |
|
| Email |
mehakjn2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vikrant Mohanty |
| Designation |
Professor(SAG) and Head of Department of Public health Dentistry |
| Affiliation |
Maulana Azad Institute of Dental Sciences |
| Address |
Department of Public Health Dentistry, Maulana Azad Institute of
Dental Sciences, Bahadur Shah Zafar Marg, New Delhi
Central
DELHI
110002
India |
| Phone |
9654700983 |
| Fax |
|
| Email |
vikrantmohanty@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
MEHAK JAIN |
| Designation |
Post graduate Student |
| Affiliation |
Maulana Azad Institute of Dental Sciences |
| Address |
Department of Public Health Dentistry, Maulana Azad Institute of
Dental Sciences, Bahadur Shah Zafar Marg, New Delhi
Central
DELHI
110002
India |
| Phone |
9205637177 |
| Fax |
|
| Email |
mehakjn2@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Institute of Dental Sciences, Mirdard Marg, Bahadur Shah Zafar Marg, LNJP Colony, New Delhi, Delhi, 110002,India |
|
|
Primary Sponsor
|
| Name |
Mehak Jain |
| Address |
Department of Public Health Dentistry, Maulana Azad Institute of
Dental Sciences, Bahadur Shah Zafar Marg, New Delhi 110002 |
| Type of Sponsor |
Other [Self] |
|
|
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 Mehak Jain |
Maulana Azad Institute Of Dental Sciences |
Room no-401,Floor no-4,Phase -2, Department of Public Health Dentistry, Mirdard marg Bahadur Shah Zafar Marg, New Delhi-110002
Central
DELHI |
9205637177
mehakjn2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Maulana Azad Institute of Dental Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Dental examination or Oral health education (preventive) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional oral health presentation |
The presentation will be Based on principles of- Training Manual for Oral care for ASHA at Ayushman Bharat-Health and Wellness Centres, Ministry of Health and Family Welfare and Training Manual on Oral Health Promotion for Health workers by National Oral Health Program, Ministry of Health and Family Welfare, Government of India.
The presentation will include the following components like
Parts of mouth, Risk factors of common oral diseases like tooth decay, gum diseases, etc, Clinical signs and symptoms of common oral diseases like tooth decay, gum diseases, etc.
o Preventive and Promotive strategies for common oral diseases like tooth decay, Gum diseases, etc,Role of ASHA Worker in Prevention of common Oral Diseases,Summary,etc.
|
| Intervention |
Novel Oral Health Education Toolkit for ASHA Workers
|
The toolkit will be made involving flipcharts, videos, basic examination tools, etc which will be more illustrative and comprehensive compared to the conventional method of presentation. All materials are age-appropriate, culturally sensitive, and written in simple, easily understandable language for the target population. The toolkit will be developed according to the principles of the two manuals: Training Manual for Oral care for ASHA at Ayushman Bharat-Health and Wellness Centres, Ministry of Health and Family Welfare
and Training Manual on Oral Health Promotion for Health workers by National Oral Health Program, Ministry of Health and Family Welfare, Government of India .The toolkit will include the following components-Torch, Wooden spatulas, Toothbrush and Toothbrushing demonstration Model, Oral health education Flipchart in Hindi, Short videos on oral health and disease prevention for smart phones in Hindi.
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
ASHA Workers not trained on oral health and disease prevention since last 2 years
Beneficiaries present at the day of baseline clinical examination. |
|
| ExclusionCriteria |
| Details |
Beneficiaries with known history of any other systemic diseases
/comorbidities.
ASHA worker included in any other trial for oral health education training. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in plaque, gingival and dental caries status in adult beneficiaries |
Baseline and at the end of one month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in Knowledge, Attitude and Practices of ASHA Workers and Adult beneficiaries |
Baseline, immediate post training and at the end of one month |
|
|
Target Sample Size
|
Total Sample Size="330"
Sample Size from India="330"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
20/10/2025 |
| 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="4"
Days="10" |
|
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
|
The study is a two arm, Parallel time series randomised controlled community trial comparing effectiveness of a Novel Oral health education toolkit for ASHA Workers with Conventional method of oral health education in improving their oral health related knowledge by training them in Delhi government dispensaries and evaluating its impact by checking oral health related knowledge, attitude and practices and some components of oral health condition among adult Beneficiaries covered by those ASHA Worker. The Primary Outcomes include changes in plaque, gingival and dental caries status in adult beneficiaries. The Secondary Outcomes include Improvement in Knowledge, Attitude and Practices of ASHA Workers and Adult beneficiaries.
|