| 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
|
|
|
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
|
|
|
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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