| CTRI Number |
CTRI/2022/03/041449 [Registered on: 29/03/2022] Trial Registered Prospectively |
| Last Modified On: |
25/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
to find method of tooth brushing among children who cannot speak and hear and are studying in schools at south coorg |
|
Scientific Title of Study
|
Assessment of oral hygiene status and brushing practices among institutionalized speech and hearing impaired children at South Coorg. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Niveditha M |
| Designation |
post graduate |
| Affiliation |
coorg institute of dental sciences |
| Address |
door no 492, 16th cross, A1 block vijayanagar 3rd stage, Mysore
kk campus, maggula village, Virajpet, kodagu , Karnataka 571218
Kodagu
KARNATAKA
570017
India |
| Phone |
08904470238 |
| Fax |
|
| Email |
niveditha.mohan15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Niveditha M |
| Designation |
post graduate |
| Affiliation |
coorg institute of dental sciences |
| Address |
492, 16th cross, A1 block vijayanagar 3rd stage, Mysore
department of pediatric dentistry, room no 8
kk campus, maggula village, virajpet, kodagu, karnataka
Kodagu
KARNATAKA
570017
India |
| Phone |
08904470238 |
| Fax |
|
| Email |
nivediha.nohan15@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr B M Shanthala |
| Designation |
professor and head of the department of pediatric and preventive dentistry |
| Affiliation |
coorg institute of dental sciences |
| Address |
department of pediatric and preventive dentistry
room no 8
coorg institute if dental sciences kk campus maggula village
virajpet kodagu district karnataka
department of pediatric and preventive dentistry
room no 8
coorg institute if dental sciences kk campus maggula village
virajpet kodagu district
karnataka
Kodagu
KARNATAKA
571218
India |
| Phone |
9901452918 |
| Fax |
|
| Email |
shanthalapedo@cids.edu.in |
|
|
Source of Monetary or Material Support
|
| coorg institute of dental sciences |
|
|
Primary Sponsor
|
| Name |
coorg institute of dental sciences |
| Address |
coorg institute of dental sciences kk campus maggula village 571218
virajpet |
| Type of Sponsor |
Other [private dental college] |
|
|
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 |
| DrNiveditha M |
coorg institute of dental sciences |
coorg institute of dental sciences
virajpet 571218
Kodagu
KARNATAKA |
8904470238
niveditha.mohan15@gail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional review board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F01-F99||Mental, Behavioral and Neurodevelopmental disorders, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Speech and hearing impaired children with consent of the institution will be included in this study. |
|
| ExclusionCriteria |
| Details |
Speech and hearing impaired children not interested in participating in the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
evaluation of the oral hygiene status and Assessment of brushing practises of the institutionalized speech and hearing impaired children at South Coorg
|
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| preventive strategy for advanced brushing techniques beneficial for deaf and dumb population |
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
04/04/2022 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Assessment and medical attention is required evaluate and improvise the quality of life of disabled children. Prevalence of deaf and dumb children in India is 10.8 and 6.8 in urban and rural areas respectively. limitations in communication might be the primary cause of deaf and dumb children oral neglect. People with disabilities deserve the same opportunity of health care as that of the normal healthy individuals. when diagnosing oral health status of the target population, health professionals should ensure that the child’s caregivers have demonstrated an understanding of the condition, its consequences and the recommended treatment, Thus assessment of oral hygiene status of deaf and dumb children and their brushing practices needs to be done, to come up with a preventive strategy. A descriptive cross sectional study will be conducted among institutionalized deaf and dumb children of age group 6 to 13 years, to evaluate the oral hygiene status. Research will be carried out at the institution with the consent from authorities. A questionnaire will be made with the guidance of subject experts and it will be validated by clinical psychologist. Study will contain 2 parts, recording oral hygiene status of students and assessing the brushing practices of the children using a questionnaire. Collected data will be statistically analysed and results will be published. |