| CTRI Number |
CTRI/2018/10/015977 [Registered on: 10/10/2018] Trial Registered Prospectively |
| Last Modified On: |
05/10/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Assessment of oral health needs and to make a oral health education braille tool for blind children |
|
Scientific Title of Study
|
Assessment of Oral Health Status and treatment needs in visually impaired children and to develop a new Braille tool for Oral health education - A Randomised Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Saraswathy |
| Designation |
Post Graduate |
| Affiliation |
Tamilnadu Government Dental College and Hospital |
| Address |
No:18/8,
3rd street, Periyar Nagar, Thorapadi,
NO.4 Public Health Dentistry Dept.
NO.2,frazer bridge road park town,Chennai -600003
Chennai
TAMIL NADU
632002
India |
| Phone |
9962013227 |
| Fax |
|
| Email |
prabusaras@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M B Aswath Narayanan |
| Designation |
professor and head |
| Affiliation |
Tamilnadu Government Dental College and Hospital |
| Address |
room no:4, department of public health dentistry,
tamilnadu government dental college and hospital,chennai
Chennai
TAMIL NADU
600003
India |
| Phone |
|
| Fax |
|
| Email |
mban1965@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M B Aswath Narayanan |
| Designation |
professor and head |
| Affiliation |
Tamilnadu Government Dental College and Hospital |
| Address |
room no:4, department of public health dentistry,
tamilnadu government dental college and hospital,chennai
Chennai
TAMIL NADU
600003
India |
| Phone |
|
| Fax |
|
| Email |
mban1965@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
GSaraswathy |
| Address |
NO.4,Public Health Dentistry.
N0.2,Frazer Bridge Road,Park Town,Chennai -600003 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Mrs Jacquilne |
Government Blind School |
n0 : 4 trunk road poonamalle high road
karaiyanchavadi
chennai 600056
Chennai
TAMIL NADU |
9445089599
govtblindschoolpovai@gmail.com |
| Mr Govindkrishnan |
Nethrodaya self help organisation for visually impaired children |
47/1 nolambur phase II Mogappair west
chennai
Tamilnadu 600007
Chennai
TAMIL NADU |
9382896636
nethrodaya@gmail.com |
| John savier |
St.Louis Institute for Blind |
No: 25
canal bank road
near old cancer hospital
gandhinagar
adyar
chennai 600020
Chennai
TAMIL NADU |
044-24910886
stlouisadyar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tamil Nadu Government Dental college and Hospital |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H540||Blindness, both eyes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Braille tool for visually impaired children |
Braille is a language and an important media for reading and writing for visually impaired children. It helps them to perceive and visualize the world via touch and understand.It consists of Oral hygiene instructions and knowledge about oral diseases for improving the oral health status of the visually impaired children |
| Comparator Agent |
Tooth models and audio aids |
Audio aids used in education to help visually impaired to understand and grasp the matter.It consists of Oral hygiene instructions and knowledge about oral diseases for improving the oral health status of the visually impaired children |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
20.00 Year(s) |
| Gender |
Both |
| Details |
Participants aged 13-20 years with both congenital and acquired blindness |
|
| ExclusionCriteria |
| Details |
Children with systemic disease were excluded |
|
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Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Oral hygiene index,Plaque index and dental caries experience index [DMFT] |
At the end of first month, Oral hygiene index,Plaque index and dental caries experience index [DMFT] Same outcomes will be measured after third month to compare the effectiveness of the Braille tool |
|
|
Secondary Outcome
|
|
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Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
16/10/2018 |
| 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
|
none yet and will be submitted after the completion of study |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Background of study: According to WHO [2009], it has been estimated that globally 314 million people are visually impaired and 45 million of them are blind. The Census 2011 shows that, in India 20.42 lakhs children aged 0-6 years are disabled among them 30% has difficulty in seeing.The prevalence of blindness in the Country ranges from 14 per 1000 to 3 per 1000 population. In Tamil Nadu, the prevalence of blindness is 4 per 1000 population. Oral health of children with special health care needs has been one of grey areas in the field of paediatric dentistry. Children with special health care needs present unique challenges for both paediatric and general dentists in order to provide them access to the oral health care system by establishing a treatment plan for those with unique medical, behavioural and dental needs and maintaining oral health over the lifetime. Models, audiotapes, magnifying aids, large print materials, raised label markers; Braille scripts, bold scripts, etc. can be used as instructional aids. Positive reinforcement of the information provided is a very important factor in building a strong foundation, especially in the case of visually impaired children. Braille is the language and an important media for reading and writing for the visually impaired. It helps them perceive & visualize the world via touch and also to understand & assert a certain meaning to a word. Audio aids are being used in education to help the visually impaired to understand and grasp the matter. Need for study: In recent years, there have been an increasing number of studies concerning the dental health of general population. However, very little attention has been paid to the dental health of the physically handicapped population, who actually deserve special care and attention in this field. It is needless to say that due to their physical handicap these group of population cannot be expected to maintain proper oral hygiene and dental health for want of proper education. Materials and methods: It is a randomised controlled trial shall be conducted among visually impaired children, in Chennai. Children who were congenitally and acquired blind were going to be included. Children with underlying systemic disease and/or other handicapping conditions were going to be excluded. Informed consent shall be taken from parents and respective authorities of school. Base line scores using OHI-S ,Plaque score,DMFT indexes shall be taken first and oral prophylaxis shall be done to make the score 0. Braille tool shall be given to test group. Audio aids and tooth models will be given to control group. Then review shall be done after 1 and 3 months shall be done to check the effectiveness of Braille tool for visually impaired children.
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