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CTRI Number  CTRI/2024/02/063179 [Registered on: 27/02/2024] Trial Registered Prospectively
Last Modified On: 24/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Digital Dental Diet Diary 
Scientific Title of Study   Assessment of compliance and validity of digital application based diet diary with suggestive local food habits for prevention of dental caries in children. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Priyanka Agrawal  
Designation  Post Graduate  
Affiliation  Dr. D.Y. Patil Dental College and Hospital, Pune 
Address  A-502, Crosswinds Baner road, Baner Pune- 411045
Department of Pediatric Dentistry Second floor, Dr.D.Y.Patil dental hospital, near YCM hospital Sant tukaram nagar, pimpri, Pune-18
Pune
MAHARASHTRA
411045
India 
Phone  7387981365  
Fax    
Email  doctorpa899@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Nilesh Rathi 
Designation  Professor and Head of the department 
Affiliation  Dr. D.Y. Patil Dental College and Hospital, Pune 
Address  The head of the department cubicle, Second floor, Department of Pediatric Dentistry, Dr. D.Y.Patil Dental Hospital, Pimpri, Pune-18
Rathi Dental Clinic, Baner road, Baner-45
Pune
MAHARASHTRA
411018
India 
Phone  9960100010  
Fax    
Email  nilesh.rathi@dpu.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Priyanka Agrawal  
Designation  Post Graduate  
Affiliation  Dr. D.Y. Patil Dental College and Hospital, Pune 
Address  A-502, Crosswinds Baner road, Baner Pune- 411045
The head of the department cubicle, Second floor, Department of Pediatric Dentistry, Dr. D.Y.Patil Dental Hospital, Pimpri, Pune-18
Pune
MAHARASHTRA
411045
India 
Phone  7387981365  
Fax    
Email  doctorpa899@gmail.com  
 
Source of Monetary or Material Support  
Dr. D.Y. Patil Dental College and Hospital, Pimpri, Pune-18 
 
Primary Sponsor  
Name  Dr Priyanka Agrawal  
Address  A-502, crosswinds Baner road, Baner Pune-411045 
Type of Sponsor  Other [Post Graduate, Department of Pediatric dentistry, self funded] 
 
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 Priyanka Agrawal  Dr. D.Y. Patil dental college and hospital, pune  Department number 8, Department of pediatric and preventive dentistry, Second floor, Dr. D.Y. Patil dental hospital, Sant tukaram nagar, Pimpri
Pune
MAHARASHTRA 
7387981365

doctorpa899@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
DR.D.Y.PATIL VIDYAPEETH, PUNE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Patients having dental caries 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1 Children age 6-12 years of age​
2 Children with informed parental consent​
3 Parents preparedness to participate in the study​
4 Parents with digital device 
 
ExclusionCriteria 
Details  1.Children without provision for smartphone
2.Children without parental consent 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To create a digital application with validated content.​  2 months  
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the usability and compliance of digital diet diary​  1 months  
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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   N/A 
Date of First Enrollment (India)   25/03/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  25/03/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
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 - 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 -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

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

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [doctorpa899@gmail.com].

  6. For how long will this data be available start date provided 15-02-2024 and end date provided 15-02-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Aim- The aim of the study is to create a digital application based diet diary which helps in record maintenance of diet and suggests healthier sugar substitutes. The secondary aim of the study is to conduct a clinician trial to check the digital application’s validity and usability  in 6-12 year old children. 

BackgroundDietary intake of an individual has a direct correlation with the dental and oral health. For this reason, diet diaries have been recommended as a dietary assessment tool that enables the tailoring of effective dietary advice for individual patients in dental practiceHowever, despite the recognized merits of diet diaries as dietary assessment and self-monitoring tools in the general literature, an early search of literature revealed that very little empirical work had been devoted to this topic in the dental context. Mobile applications have been developed to monitor health, including diet. Diet apps aim to reduce and resolve common limitations associated with the conventional pen and paper dietary assessment methodsHowever, few studies report the validity of these apps for use in regular practiceHence, there is a need for a new app which can overcome these drawbacks. ‘Sugar smart’  is a unique smartphone  dietary assessment app that is being developed which uses artificial intelligence and permits real-time editing of food journals and makes recording and management of diet easier for the patients.

Methodology- 100 children age 6-12 reporting to the department of Pediatric dentistry will be selected and their parents will be introduced to the digital application. They will be asked to use the application for 1 week. After that, on follow-up 2 questionnaire will be provided to the parents to asses their feedback. 
 
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