| CTRI Number |
CTRI/2024/02/062483 [Registered on: 09/02/2024] Trial Registered Prospectively |
| Last Modified On: |
29/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of sugar board on sugar intake and oral health |
|
Scientific Title of Study
|
Impact of sugar board on sugar intake and oral hygiene practices among 12-15-year-old school children: A Randomized Controlled Trial |
| 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 Yuvarani K P |
| Designation |
Postgraduate student |
| Affiliation |
KAHERS KLE VK Institute of dental sciences |
| Address |
Department number 2, Public Health Dentistry, Ground floor,
KAHER’s KLE Vishwanath Katti Institute of Dental Sciences, JNMC campus, Nehru Nagar, Belagavi 590010, Karnataka, India
Belgaum
KARNATAKA
590010
India |
| Phone |
07639270619 |
| Fax |
|
| Email |
yuvasrikpyk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Laxmi kabra |
| Designation |
Lecturer |
| Affiliation |
KAHERS KLE VK Institute of dental sciences |
| Address |
Department number 2, Public Health Dentistry, Ground floor,
KAHER’s KLE Vishwanath Katti Institute of Dental Sciences, JNMC
campus, Nehru Nagar, Belagavi 590010, Karnataka, India
Belgaum
KARNATAKA
590010
India |
| Phone |
9743870216 |
| Fax |
|
| Email |
drlaxmikabra@kledental-bgm.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Laxmi kabra |
| Designation |
Lecturer |
| Affiliation |
KAHERS KLE VK Institute of dental sciences |
| Address |
Department number 2, Public Health Dentistry, Ground floor,
KAHER’s KLE Vishwanath Katti Institute of Dental Sciences, JNMC
campus, Nehru Nagar, Belagavi 590010, Karnataka, India
Belgaum
KARNATAKA
590010
India |
| Phone |
9743870216 |
| Fax |
|
| Email |
drlaxmikabra@kledental-bgm.edu.in |
|
|
Source of Monetary or Material Support
|
| Department of Public Health Dentistry, KAHER’s KLE Vishwanath Katti Institute of Dental
Sciences, JNMC campus, Nehru Nagar, Belagavi-590010, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Dr Yuvarani K P |
| Address |
Department of Public Health Dentistry, KAHER’s KLE Vishwanath Katti Institute of Dental
Sciences, JNMC campus, Nehru Nagar, Belagavi-590010, Karnataka, India |
| Type of Sponsor |
Other [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 Yuvarani K P |
KLES International school,belagavi |
Class VII to IX, Section A, Third floor,
KLES International school,
No 40, Kuvempu nagar,
Belagavi-590010
Belgaum
KARNATAKA |
7639270619
yuvasrikpyk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Research and Ethics Committee KLE VKIDS |
Approved |
| Private school children |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K051||Chronic gingivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional oral health education |
Conventional Oral health education will be given in front of school experts for smooth delivery oral health education.
Frequency: At Baseline, 1
month and 3 months. Total
Duration: 3 months.
|
| Intervention |
Sugar board with visual reinforcement |
This approach will utilize a sugar board depicting various concentration of sugar in various snacks and beverages and also includes about beneficial oral hygiene and dietary practices. This sugar board is also used as pamphlets in the form of stickers which will be stickled on to any books of the study participants as an enhancement tool for periodic reinforcement to promote good oral hygiene practices. The sugar Board and the pamphlets will be designed by the graphic designer.
Visual reinforcement will be carried out on the baseline, 1st month and 2nd months and final data will be collected at the end of three month.
Duration: 3 months.
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
Participants in the age group of 12-15 years who are ready to give consent for taking part in the study |
|
| ExclusionCriteria |
| Details |
Participants who are not willing to participate in the study
Those who are unable to cope with the oral examination procedure. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in dietary practices
Oral hygiene index-simplified,plaque index |
Baseline and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in toothbrushing efficacy |
Baseline and 3 months |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
14/02/2024 |
| 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="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 - NO
|
|
Brief Summary
|
Childhood obesity and dental caries pose significant health challenges
among adolescents aged 12-15, with excessive sugar intake being a major
contributing factor. To reduce the risk of unhealthy weight gain and tooth decay, the World Health
Organization (WHO) recommends reducing the intake of free sugars to below 10
energy percent at all stages of life. Despite ongoing educational efforts, modifying dietary
behavior in this age group remains challenging. This study addresses this gap
by introducing a novel intervention, the "sugar board," designed to visually
represent sugar content in common snacks and beverages to raise awareness and
encourage healthier choices. Using a Randomized Controlled Trial (RCT) design,
we aim to rigorously assess the impact of the sugar board on sugar intake and
oral hygiene practices. By evaluating the effectiveness of this innovative
approach, this study aims to contribute insights that could inform future
public health strategies, ultimately promoting better overall health and
reducing the prevalence of obesity, dental caries and other health related consequences
among 12-15-year-old school children. |