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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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
  1. 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).

  2. What additional supporting information will be shared?
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  Proposals should be directed to (email ID to be provided drneeru.r@gmail.com )

  6. 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.

  7. 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.
 
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