| CTRI Number |
CTRI/2020/05/025077 [Registered on: 08/05/2020] Trial Registered Prospectively |
| Last Modified On: |
07/10/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Efficacy of oral health education among deaf and dumb children ( verbal and sign language based)- An interventional study |
|
Scientific Title of Study
|
Effectiveness of verbal based and non-verbal based oral health education on self perceived oral health status and oral hygiene among children with hearing and expressive language disorder - 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 |
Aarthy c s |
| Designation |
Post graduate student |
| Affiliation |
Ragas Dental College & Hospital |
| Address |
532 school south street
krishnapuram
kadayanallur
Department of Public Health Dentistry.
Tirunelveli
TAMIL NADU
627759
India |
| Phone |
7418216834 |
| Fax |
|
| Email |
aarthycharms@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr PDMadan kumar |
| Designation |
Head of the Department |
| Affiliation |
Ragas Dental College & Hospital |
| Address |
Department of Public Health Dentistry
Ragas Dental College and Hospital.
Department of Public Health Dentistry
Chennai
TAMIL NADU
600119
India |
| Phone |
7418216834 |
| Fax |
|
| Email |
madankumar21@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Aarthy c s |
| Designation |
Post graduate student |
| Affiliation |
Ragas Dental College & Hospital |
| Address |
Department of Public Health Dentistry
Department of Public Health Dentistry
Tirunelveli
TAMIL NADU
627759
India |
| Phone |
7418216834 |
| Fax |
|
| Email |
aarthycharms@gmail.com |
|
|
Source of Monetary or Material Support
|
| St.Louis institute for deaf and blind school.Adayar |
|
|
Primary Sponsor
|
| Name |
Ragas Dental College and Hospital |
| Address |
2/102,SH 49,uthandi
chennai-600119 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| BotherJohn Xavier |
St.Louis blind and deaf and dumb school |
deaf and dumb children(Department)
No.5,canal road , Adyar
Chennai
TAMIL NADU |
044-24910886
aarthycharms@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ragas Dental College & Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H913||Deaf nonspeaking, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Oral health education |
30 children will be recruite from a tertiary care center , who were diagnosed with hearing and expressive language disorder .
For 15 children we will give to oral health education by sign language method .
For another 15 children we will give to oral health education by verbal based method.
Interventions(oral health education models). |
| Intervention |
oral health education. |
oral health education will give by using oral health education models to children. |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1. Children diagnosed with hearing impaired using pure-tone air-conduction hearing thresholds.
2. Children diagnosed with expressive language disorder by speech language therapist.
3. Children within the age group of 10-15 years
4. Children whose parents give consent to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1. Children with age below 10 years
2. Children whose parents did not give consent to participate in the study.
|
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
| Oral Health Status |
Base line, 3 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Plaque and Gingival index |
Base line, 3 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
11/05/2020 |
| 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="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
I have one publication regarding Association between developmental defects of enamel and Intellectual disability |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
30 children will be recruite from a tertiary care center , who were diagnosed with hearing and expressive language disorder .Base line assessment of oral health status will record using OHI-S(Johnc C Greene, 1964) and PLAQUE indices (Quignley Hein modification of Loe and Silness ,1970). Self perception about oral health will be assessed using a easy to use and low cost questionnaire along with demographic details( Walda Viana BrÃgido de Moura). NonVerbal ( Sign language provide by a trained speech therapist at the center) and verbal (using hearing aid) based oral health education will give to children. Post evaluation of self perception about oral health , OHIS and PLAQUE scores will record after 3 months. |