| CTRI Number |
CTRI/2025/07/091251 [Registered on: 21/07/2025] Trial Registered Prospectively |
| Last Modified On: |
16/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Development of a Web-Based Application with Telephonic Support to Help Change Diet and Reduce dental caries in children aged 5-14 years – A Controlled Study |
|
Scientific Title of Study
|
An interactive Web based application augmented by Telereinforcement
for dietary modification to reduce caries activity"
|
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ahana Sharma |
| Designation |
Post graduate student |
| Affiliation |
Santosh Dental College |
| Address |
Department of Pediatric and Preventive Dentistry Santosh Dental College Santosh deemed to be university K Block House no K 64 Sector 12 Pratap Vihar Ghaziabad Uttar Pradesh India
Ghaziabad
UTTAR PRADESH
201009
India |
| Phone |
08802004154 |
| Fax |
|
| Email |
ahanas0206@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Natasha Gambhir |
| Designation |
Professor and Assistant Dean |
| Affiliation |
Santosh Dental College |
| Address |
Department of Pediatric and Preventive Dentistry Santosh Dental College Santosh deemed to be university K Block House no K 64 Sector 12 Pratap Vihar Ghaziabad Uttar Pradesh India
Ghaziabad
UTTAR PRADESH
201009
India |
| Phone |
9871966965 |
| Fax |
|
| Email |
tash_aa@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Natasha Gambhir |
| Designation |
Professor and Assistant Dean |
| Affiliation |
Santosh Dental College |
| Address |
Department of Pediatric and Preventive Dentistry Santosh Dental College Santosh deemed to be university K Block House no K 64 Sector 12 Pratap Vihar Ghaziabad Uttar Pradesh India
UTTAR PRADESH
201009
India |
| Phone |
9871966965 |
| Fax |
|
| Email |
tash_aa@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Research institution |
|
|
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 Ahana sharma |
Santosh Deemed to be university |
Department of pediatric and preventive dentistry, santosh dental college, santosh deemed to be university, sector 12, pratap vihar, Ghaziabad, Uttar Pradesh, 201009
Ghaziabad
UTTAR PRADESH |
8802004154
ahanas0206@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics commitee, Santosh deemed to be university |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Dietary Counselling |
High caries risk group with Conventional Dietary Counselling (n=40) |
| Intervention |
Web Based Application |
High caries risk group with dietary counselling & the web-application intervention group (n=40) for 6 months |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1) High caries risk patient
2) Cooperative child |
|
| ExclusionCriteria |
| Details |
1) Medically compromised children.
2) No cooperation from child
3) Allergic patients
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Development of an AI tool to help asses an individuals sugar consumption on daily basis and in turn provide solutions along with dietary substitutes.
|
The web based application intervention will be given at the second appointment after 5 days and then further follow-ups will be taken after 21 days and 3 months.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
31/07/2025 |
| 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="6"
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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- 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 [ahanas0206@gmail.com].
- For how long will this data be available start date provided 31-07-2025 and end date provided 26-07-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Dental caries is a common, preventable disease caused by the demineralization of tooth structures due to acid produced by bacteria fermenting dietary sugars. Its high prevalence, especially in children from low- and middle-income countries, is linked to poor dietary habits and high sugar consumption. A key approach to prevention involves limiting sugar intake and improving oral hygiene. This study introduces a web-based digital tool designed to help users assess and reduce their sugar consumption, offering personalized dietary recommendations. The study, conducted in the Department of Pediatric and Preventive Dentistry at Santosh Dental College, will evaluate the tool’s effectiveness by monitoring salivary levels of Streptococcus mutans, Lactobacillus, and pH. Eighty high-caries-risk children aged 5–14 will be divided into two groups—one receiving only conventional counselling and the other using the web-based tool. This innovative approach aims to empower users, improve dietary behavior, and promote preventive oral health using digital technology. |