| CTRI Number |
CTRI/2024/04/065247 [Registered on: 05/04/2024] Trial Registered Prospectively |
| Last Modified On: |
04/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Oral health education using traffic light color coded visual technique among deaf children |
|
Scientific Title of Study
|
Effectiveness of a novel “Visual Orientation through Integrated Color-coding and Enhancement†technique (VOICE) in improving the Oral hygiene status among adolescents with Hearing and Speech-Impairment: A Double-Blind 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 David Coutinho |
| Designation |
Senior lecturer |
| Affiliation |
KAHERs KLE VK institute of dental sciences |
| Address |
Department number 2, Public Health Dentistry, Ground floor,
KAHERs KLE Vishwanath Katti Institute of Dental Sciences, JNMC
campus, Nehru Nagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9850647732 |
| Fax |
|
| Email |
coutinho.david8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr David Coutinho |
| Designation |
Senior lecturer |
| Affiliation |
KAHERs KLE VK institute of dental sciences |
| Address |
Department number 2, Public Health Dentistry, Ground floor,
KAHERs KLE Vishwanath Katti Institute of Dental Sciences, JNMC
campus, Nehru Nagar, Belagavi
KARNATAKA
590010
India |
| Phone |
9850647732 |
| Fax |
|
| Email |
coutinho.david8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr David Coutinho |
| Designation |
Senior lecturer |
| Affiliation |
KAHERs KLE VK institute of dental sciences |
| Address |
Department number 2, Public Health Dentistry, Ground floor,
KAHERs KLE Vishwanath Katti Institute of Dental Sciences, JNMC
campus, Nehru Nagar, Belagavi
KARNATAKA
590010
India |
| Phone |
9850647732 |
| Fax |
|
| Email |
coutinho.david8@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department number 2, Public Health Dentistry, Ground floor,
KAHERs KLE Vishwanath Katti Institute of Dental Sciences, JNMC
campus, Nehru Nagar, Belagavi 590010, Karnataka, India
Belgaum
KARNATAKA
590010
India |
|
|
Primary Sponsor
|
| Name |
Dr David Coutinho |
| Address |
Department number 2, Public Health Dentistry, Ground floor,
KAHERs KLE Vishwanath Katti Institute of Dental Sciences, JNMC
campus, Nehru Nagar, Belagavi |
| 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 David Coutinho |
Government school for deaf children |
Azam nagar, Belagavi
Belgaum
KARNATAKA |
9850647732
coutinho.david8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Government school for deaf children |
No Objection Certificate |
| Institutional Research and ethics committee KLE VKIDS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K051||Chronic gingivitis, (2) ICD-10 Condition: H913||Deaf nonspeaking, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Indian Sign
Language |
Oral health education will be delivered
using conventional Indian sign
language by the investigator. It
will be demonstrated in front of
school experts for smooth
delivery oral health education.
Frequency: At Baseline, 7th day, 1 month and 3 months |
| Intervention |
Novel Visual traffic light Colour coded oral health education technique |
Oral health education will be delivered with a help of a visual traffic light colour coded board and enhanced by use of visual aids by the investigator with the assistance of school expert.
Frequency: At Baseline, 7th day, 1 month and 3 months |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
All children in the age group of 12 – 15 years having hearing loss of
70 dB or greater (severe hearing loss) with speech
impairment. All the index teeth should have completely
erupted.
|
|
| ExclusionCriteria |
| Details |
Children with mild or moderate hearing loss.
Children with underlying systemic disease and/or other special
health care needs conditions.
Children on medications.
Uncooperative children.
Parents and children not agreeing to give consent and assent. |
|
|
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 |
| Gingival index, Plaque index |
At Baseline and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Knowledge and practices of Oral health |
At baseline and end of 3 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
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/04/2024 |
| 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
|
Hearing and Speech-Impaired Adolescents commonly struggle with
maintaining oral health, which can result in an increased
risk of oral health problems. Existing oral health education methods have
demonstrated limited success in motivating behavior change among this
age group. Thus, there is a pressing need to explore innovative
approaches that effectively engage and motivate Hearing and
Speech-Impaired Adolescents to improve their oral health. The
study aims to address this need by evaluating the impact of a novel traffic light colour coded technique assisted with visual aids on enhancing oral health among Hearing and Speech-Impaired Adolescents |