| CTRI Number |
CTRI/2025/04/084873 [Registered on: 16/04/2025] Trial Registered Prospectively |
| Last Modified On: |
11/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive Screening Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Helping Kids Eat Healthier: Comparing an AI Diet App with Traditional Counseling |
|
Scientific Title of Study
|
Development of Artificial intelligence assisted mobile application for diet counseling and comparing its efficacy with manual approach in children aged 3 -6 years – Randomized control Trial |
| Trial Acronym |
- |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Neeraja R |
| Designation |
Professor |
| Affiliation |
M R Ambedkar Dental College and Hospital |
| Address |
Department of Pediatric and Preventive Dentistry
Room no 7
M R Ambedkar Dental College and Hospital, 1/36, Cline Rd, Balaji Layout, Cooke Town, Bengaluru, Karnataka 560005, India
Bangalore KARNATAKA 560005 India |
| Phone |
8197919680 |
| Fax |
|
| Email |
drneeru.r@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Neeraja R |
| Designation |
Professor |
| Affiliation |
M R Ambedkar Dental College and Hospital |
| Address |
Department of Pediatric and Preventive Dentistry
Room no 7
M R Ambedkar Dental College and Hospital, 1/36, Cline Rd, Balaji Layout, Cooke Town, Bengaluru, Karnataka 560005, India
Bangalore KARNATAKA 560005 India |
| Phone |
8197919680 |
| Fax |
|
| Email |
drneeru.r@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Neeraja R |
| Designation |
Professor |
| Affiliation |
M R Ambedkar Dental College and Hospital |
| Address |
Department of Pediatric and Preventive Dentistry
Room no 7
M R Ambedkar Dental College and Hospital, 1/36, Cline Rd, Balaji Layout, Cooke Town, Bengaluru, Karnataka 560005, India
Bangalore KARNATAKA 560005 India |
| Phone |
8197919680 |
| Fax |
|
| Email |
drneeru.r@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharathi Vidyapeeth Dental College and Hospital,Satara Road, Katraj - Ambegaon BK Rd, Dhankawadi, Pune, Maharashtra 411043, India |
| M R Ambedkar Dental College and Hospital, 1/36, Cline Rd, Balaji Layout, Cooke Town, Bengaluru, Karnataka 560005, India |
|
|
Primary Sponsor
|
| Name |
Dr Neeraja R |
| Address |
M R Ambedkar Dental College and Hospital, 1/36, Cline Rd, Balaji Layout, Cooke Town, Bengaluru, Karnataka 560005, India |
| Type of Sponsor |
Other [Investigator initiated trial] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Neeraja R |
Bharathi Vidyapeeth Dental College and Hospital |
Department of Pediatric and Preventive Dentistry,
Bharathi Vidyapeeth Dental College and Hospital, Sector , Pune – Satara Road, Katraj - Ambegaon BK Rd, Dhankawadi, Pune, Maharashtra 411043, India Pune MAHARASHTRA |
918197919680
drneeru.r@gmail.com |
| Dr Neeraja R |
M R Ambedkar Dental College & Hospital |
Department of Pediatric and Preventive Dentistry, Room no 7, M R Ambedkar Dental College & Hospital, 1, 36, Cline Rd, Balaji Layout, Cooke Town, Bengaluru, Karnataka 560005, India Bangalore KARNATAKA |
8197919680
drneeru.r@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee BVDU DCH Pune |
Approved |
| Institutional Ethics Commitee M R Ambedkar Dental College and Hospital Bengaluru |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Dental caries prevention |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Diet chart - Manual method of assessment |
Diet counseling and Dental caries prevention for 3 months |
| Intervention |
Tiny Tracks - Artificial intelligence assisted mobile application |
Diet counselling and Dental caries prevention for 3 months |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
1. Children aged 3-6 years
2. Children with dmft greater than or equal to 4
3. Parents of children willing to participate
4. Mothers who are educated house wives
5. Children of nuclear family
6. Mothers with android phone |
|
| ExclusionCriteria |
| Details |
1. Children requiring pulp therapy
2. Medically compromised patients
3. Patients with systemic disorders
4. Uncooperative patients
5. Patients with oral pathological conditions.
6. Mentally retarded patients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in dietary habits and nutritional intake. |
At 2 weeks, 4 weeks, 6 weeks and 24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a) Adherence to diet recommendation & user satisfaction
b) Reduction in dental caries. |
a) At 24 weeks
b) At 24 weeks
|
|
|
Target Sample Size
|
Total Sample Size="140" Sample Size from India="140"
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 1 |
|
Date of First Enrollment (India)
|
01/06/2025 |
| 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 Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - Proposals should be directed to (email ID to be provided drneeru.r@gmail.com )
- For how long will this data be available start date provided 01-06-2027 and end date provided 01-06-2035?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Phase -1 Artificial Intelligence assisted mobile application for diet counselling will be developed with the help of AI department, R.V Engineering College, Bangalore. The application will be a comprehensive tool that enables patients to track their dietary habits, receive personalized dental hygiene advice, and engage in real time conversations with an AI model to address their dental health queries The source of data to develop the app will be 500 filled diet charts, Diet counselling instructions and frequently asked questions. The app will have the main page with child details to be filled followed by diet diary with the timings and the food score. Once this is done the next option of diet counselling pops up. The diet counselling by AI and manual method will include the following steps: 1. The sugary food in the diet chart will be circled and the suggestions for personalized replacements will be provided. 2. The following instructions will be provided to the parents. - Ensure children consume a balanced diet that includes all food groups fruits, vegetables, whole grains, lean proteins, and dairy at appropriate portions.
- Provide appropriate portion sizes of food to prevent overeating, which can lead to childhood obesity.
- Encourage diverse food preferences, avoid excessive sugar, and establish regular meal times, discourage skipping meals (especially breakfast), and limit snacking to healthy options like fruits or nuts.
- Encourage adequate water intake throughout the day and limit sugary drinks like soda and juice. Water and milk are preferred choices.
- Discourage constant drinking from a bottle and putting the child to bed with a bottle which contains milk.
- Limit Sugar and Processed Foods: Advise limiting consumption of sugary snacks, sodas, and highly processed foods, which contribute to poor health outcomes.
- Restricting the consumption of sugary drinks to 120 ml (4 oz) per day. Teach children to eat slowly, recognize hunger and fullness cues, and avoid mindless eating in front of screens (TV, tablets).
- Emphasize the role of parents and caregivers in setting examples for healthy eating.
- Shared family meals foster healthy eating habits.
- Address any food allergies or intolerances (e.g., lactose, gluten) and ensure proper nutritional substitutes are provided.
- Recommend supplements only when necessary, such as vitamin D in infancy, or iron in cases of anemia, under healthcare supervision.
- Avoid labelling foods as "bad" or "good" to prevent disordered eating behaviors; promote a balanced and positive approach to eating.
- Non-cariogenic or low-cariogenic snacks must be available at home and provided in school lunchboxes, e.g., dairy products such as cheese, plain milk, fibrous food (vegetables, fruit a) and nuts.
- Replace sugar with alternatives such as: Raw Honey/Forest Honey. It is one of the oldest known natural sweeteners, sourced directly from the honeycomb. Date Sugar. Dates have long been used as a natural sweetener in a variety of dishes, including traditional sweets. Coconut Sugar. Jaggery. Organic Brown Sugar.
- Ensure the child brushes twice with fluoridated paste and in circular motion. These steps will be fed into the AI application; By clicking on the query option button, they can have a real time interaction with the application and clarify their doubts.
Phase -2 Children aged 3-6 years reporting to department of Pediatric and Preventive Dentistry, M R Ambedkar Dental College and Hospital, Bangalore, Karnataka will be screened and 140 children fulfilling the inclusion and exclusion criteria will be selected. The procedure of restorations and oral prophylaxis will be carried out in all the subjects and randomly divided using computer generated random allocation sequence into two groups of Group -A and Group -B of 70 each.
Level 1: Parents of Group A patients will be given an AI based android application to install in their phone and will have to update the daily diet the child consumes for duration of 2 weeks, after which the diet score will be calculated by the software and the information will be retrieved by the blinded observer 1and the patient must report to the department for recording of baseline values of S. mutans count, pH of saliva and Oral Hygiene, Gingival and Plaque indices which will be recorded by a blinded observer 2. Following this, diet counselling will be accomplished by the AI application. The diet counselling option will be open tom the patient for a period of 2 weeks and the patient can listen to it how many ever times he wants. In Group-B, the diet diary will be given to the parents to fill the daily diet the child consumes for duration of 2 weeks, after which the diary will be handed back to the blinded observer 3 to calculate the score and the baseline values will be recorded by the blinded observer 2 and diet counselling will be given by the dentist. The handouts of the diet counselling instructions will be given for the parent to carry it home and read it how many ever times he wants.
Level 2: After the diet counselling both the following which the diet score is assessed and diet counselling is reinforced in both the groups.
Level 3: Both the groups will have to record the daily diet of the child for next 2 weeks and the results will be analyzed and compared.
Level 4: After 6 months after provision of diet counselling both the groups will be assessed for all the parameters along with clinically checking for white spot lesion development. The unstimulated saliva sample will be assessed for salivary pH and S. mutans count at baseline, 1month after diet counselling and 6 months by a blinded observer. The oral hygiene status in primary dentition will be determined using simplified Oral hygiene Index by Miglani 9 and in mixed dentition by simplified Oral hygiene index, Gingival index by Loe and Silness10,11 and Turesky -Gilmore -Glickman modification of the Quigley -Hein Plaque Index 12,13,14 at Level 1, Level 2 and Level 3 and Level 4. At Level 4 along with the other parameters the development of new white spot lesions will be assessed.15 The diet score, salivary Ph and S. mutans counts and the indices of Group A and Group B will be compared to check the effectiveness of diet counselling by both the methods. The awareness of parents regarding the association between diet and dental caries before and after the diet counselling will be checked with a questionnaire. |