| CTRI Number |
CTRI/2017/03/008153 [Registered on: 20/03/2017] Trial Registered Retrospectively |
| Last Modified On: |
18/03/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
assess the effectiveness of braille and audio tactile performance method on oral health of visually impaired children |
|
Scientific Title of Study
|
To assess oral health related quality of life of visually impaired students and the effectiveness of braille and audio tactile performance (ATP) aid in improving their oral hygiene status – An Interventional Study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Soumya Muraleedharan |
| Designation |
Post graduate student |
| Affiliation |
YENEPOYA UNNIVERSITY |
| Address |
YYenepoya Dental College Yenepoya University Deralakatte University Road Mangalore Karnataka
Dakshina Kannada
KARNATAKA
575018
India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
|
| Fax |
|
| Email |
dr.soumyamuraleedharan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ganesh Shenoy Panchmal |
| Designation |
Professor and Head of the Department |
| Affiliation |
Yenepoya University |
| Address |
Yenepoya Dental College Yenepoya University Deralakatte University Road Mangalore Karnataka
Dakshina Kannada
KARNATAKA
575018
India
Yenepoya Dental College Yenepoya University Deralakatte University Road Mangalore Karnataka
Dakshina Kannada
KARNATAKA
575018
India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9343565557 |
| Fax |
|
| Email |
panchmal45@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ganesh Shenoy Panchmal |
| Designation |
Professor and Head of the Department |
| Affiliation |
Yenepoya University |
| Address |
Yenepoya Dental College Yenepoya University Deralakatte University Road Mangalore Karnataka
Dakshina Kannada
KARNATAKA
575018
India
YENEPOYA DENTAL COLLEGE
DEPT OF PUBLIC HEALTH DENTISTRY
UNNIVERSITY ROAD
DERLAKKATE MANGALORE
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9343565557 |
| Fax |
|
| Email |
panchmal45@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Soumya Muraleedharan |
| Address |
Yenepoya Dental College Yenepoya University Deralakatte, Mangalore, Karnataka - 575018 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 |
| Mr Moideenkutty A |
BLIND SCHOOL |
1) Roman Catherine Lobo School for Blind, Bejai, Mangalore
2) Calicut Higher Secondary School for the Handicapped, Kolathara, Calicut
3) Blind School Vallikkapatta, Kootillangadi, Malappuram
4) Ma’din School for Blind, Swalath Nagar, Malappuram
5) Kerala Blind School, Aluva, Kochi
Malappuram
KERALA |
04832738343
info@mahdinonline.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| YENEPOYA UNIVERSITY ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
VISUALLY IMPAIRED |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
AUDIO TACTILE PERFORMANCE AID |
Oral health education will be given using audio tactile performance aid. |
| Intervention |
HEALTH EDUCATION IN BRAILLE |
Oral health education will be given using braille
|
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Visually impaired subjects of 8- 18 years of age who havevisual acuity of less than 3/60 m.
Visually impaired subjects for whom informed consent is given by parents were included in the study..
|
|
| ExclusionCriteria |
| Details |
Subjects with any other additional disability or syndrome. |
|
|
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 Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Oral Health Related Quality of Life |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Oral hygiene status |
at baseline and at the end of nine months |
|
|
Target Sample Size
|
Total Sample Size="220"
Sample Size from India="220"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/10/2016 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This
study aims to assess the oral health related quality of life of visually
impaired students and effectiveness of braille and audio tactile performance aids
in improving their oral hygiene status. This study will be conducted for a
period of nine months in five blind schools located in Mangalore, Calicut,
Malapurram and Kochi comprising a total of 260 visually impaired students. The
oral health related quality of life will be assessed by questionnaire printed
in braille. Oral health status will be assessed by clinical examination and
will be recorded using oral hygiene index- simplified OHI-S 1964 and
a comparison will be done on effectiveness of two different oral health
education aids in improving the oral health status of visually impaired students.
Only few studies have
been conducted and found in the literature to evaluate the effectiveness of
different oral health education aids in visually impaired children. This necessitates
the present study to determine the oral health related quality of life of
visually impaired children and to evaluate the effectiveness of two different
health education aids (Education in Braille language and Audio Tactile
Performance aid) in improving their oral hygiene status. |