| 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
|
|
|
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
|
|
|
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
- 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 - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [doctorpa899@gmail.com].
- 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.
- 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. Background- Dietary 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 practice. However, 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 methods. However, few studies report the validity of these apps for use in regular practice. Hence, 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. |