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CTRI Number  CTRI/2025/03/081666 [Registered on: 05/03/2025] Trial Registered Prospectively
Last Modified On: 04/06/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Diagnostic
Screening
Dentistry
Other (Specify) [Educational]  
Study Design  Other 
Public Title of Study   Comparative evaluation of Diet o gram mobile app versus Diet diary in determining the diet pattern in relation with the status of untreated dental caries in children. 
Scientific Title of Study   Comparative evaluation of Diet o gram vs Diet diary in determining the status of untreated dental caries in children:: An educational intervantion study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aalla Anjali Keerthana 
Designation  Post graduate student 
Affiliation  Narayana dental college and hospital 
Address  Department of Paediatric and preventive dentistry, Division- 7, Room number-7, Narayana Dental College and hospital, Chinthareddypalem, Nellore, 524003.

Nellore
ANDHRA PRADESH
524003
India 
Phone  7997001815  
Fax    
Email  anjalikeerthana95@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Sivakumar Nuvvula 
Designation  Professor and head 
Affiliation  Narayana dental college and hospital 
Address  Department of Paediatric and preventive dentistry, Division- 7, Room number-7, Narayana Dental College and hospital, Chinthareddypalem, Nellore, 524003.

Nellore
ANDHRA PRADESH
524003
India 
Phone  9441624429  
Fax    
Email  dentist4kids@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr. K V Sai Kiran 
Designation  Senior lecturer 
Affiliation  Narayana dental college and hospital 
Address  Department of Paediatric and preventive dentistry, Division- 7, Room number-7, Narayana Dental College and hospital, Chinthareddypalem, Nellore, 524003.

Nellore
ANDHRA PRADESH
524003
India 
Phone  8125774535  
Fax    
Email  saikiran4u@gmail.com  
 
Source of Monetary or Material Support  
Department of Paediatric and preventive dentistry, Division- 7, Room number-7, Narayana Dental College and hospital, Chinthareddy palem, Nellore, 524003. 
 
Primary Sponsor  
Name  Dr Aalla Anjali Keerthana 
Address  Department of Paediatric and preventive dentistry, Division- 7, Room number-7, Narayana Dental College and hospital, Chinthareddypalem, Nellore, 524003. 
Type of Sponsor  Other [self] 
 
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 A Anjali keerthana  MPHS vengalrao nagar  NBT Street,Vengalrao nagar, Podalkur road, Nellore-4, Andhra pradesh
Nellore
ANDHRA PRADESH 
7997001815

anjalikeerthana95@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional ethical commitee Narayana dental college and hospital  Approved 
Institutional ethical commitee Narayana dental college and hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Untreated dental caries 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  DIET CHART  Diet chart used to fill the daily diet details of a week from baseline 
Intervention  DIET O GRAM APP  Diet o gram app used for day to day diet registration upto a week from baseline 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1.Children in the age range of 6-12 years.
2.Children and parents who are willing to participate in the study.
3. Parents using smartphones .
4.Children with untreated carious tooth.
5.ICDAS II scores 0,1,2 are included. 
 
ExclusionCriteria 
Details  1. Children with special health care needs
2. Children who are not willing to participate in the study 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
number of new caries teeth will be assesed using DMFT in relation with diet pattern  1st week and after 12 months 
 
Secondary Outcome  
Outcome  TimePoints 
Comparison of which diet recording assessment, i.e, diet o gram versus the diet diary is best in recording the diet patterns effectively & have to determine thus the correlation of diet & newly formed dental caries lesions   12 months 
 
Target Sample Size   Total Sample Size="788"
Sample Size from India="788" 
Final Enrollment numbers achieved (Total)= "800"
Final Enrollment numbers achieved (India)="800" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   17/03/2025 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

Dental caries is a multifactorial disease with diet being one of the contributing factors. Frequent consumption of easily fermentable carbohydrates is a prerequisite for the development of caries. Hence, dental caries is directly related to diet, as it is dependent on the presence of sugars. Thus, a detailed dietary assessment is seen as an appropriate intervention for dental teams, for patients identified to be at high risk of dental caries. Several tools, such as 24-h dietary recall (retrospective) and diet-diaries (prospective), have been recommended for dietary assessment in dental practice. However, low adherence is found to be a recognized downside of their use in dental settings. Hence a need for the development of more appropriate tool for dietary assessment that is patient-centered and compatible with modern lifestyles is necessary to know the incidence of dental caries like a mobile app in relation with the dietary patterns. Frequency of diet has huge impact on dental caries. Hence there is need to collect 24 hour diet chart for 7 days to know the child’s type of diet and  frequency. Hence there is need to know the impact of dietogram app and diary diary and to know influence on the untreated dental caries.

This study aims to analyze the performance of Diet o gram app versus diet diary for determining a child’s diet pattern and to know the correlation of diet on the status of untreated  dental caries by calculating the newly formed carious lesions.

It is an observational study with educational intervention carried out in schools of Nellore district. Informed consent was obtained from the parents of children who will be participating in study.

788 children in the age range of 6 -12 years will participate in this study. After recruitment, untreated dental caries is scored based on ICDAS II criteria at baseline. The participants will be divided into two groups by using a simple randomization technique. The group 1 utilizes the diet o gram app, while Group 2 utilizes a diet diary. Later, instructions will be given to the respective group on how to record the data in a mobile application and diet diary for one week.  Based on the baseline data, a presentation on oral health is given to all the children as well as to the parents, outlining the significance of diet and how it affects the development of dental caries individually using a pamphlet to the group using diet diary and with AV aids to the group using diet o gram app. Based on the baseline data the diet assessment will be carried out using the formula Dental health diet score = [Food score + Nutrient score – Sweet score] in the mobile app. Subsequently, all the children will receive specific instructions on how to improve and maintain good healthy diet patterns based on their scores every month for a year. After a year the status of untreated dental caries  is assessed again using ICDAS II criteria and compared  between two individual groups.


 
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