Back to resultsEffect of Dental Educational Program on Oral Hygiene Status Among Institutionalized Deaf Children
Primary Purpose
Hearing Loss
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
educational programm
no educational program
Sponsored by
About this trial
This is an interventional prevention trial for Hearing Loss
Eligibility Criteria
Inclusion Criteria:
- Children aged from 6-12 years with mixed dentition.
- Institutionalized Deaf children in Cairo, Egypt.
Exclusion Criteria:
- Children above the age of 12 years and below the age of 6 years
- Patient un able to give informed consent
- Patient suffering from any other type of disability such as (mental retardation, physically and mentally handicapped, .etc.)
- Medically compromised patient
- Patient who were absent in the day of examination
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
educational programm
no educational programm
Arm Description
Oral health education will be done for children and their care givers about various diseases affecting the oral cavity, the effects of bad oral hygiene and tooth decay, importance of tooth brushing, and correct methods of tooth brushing. Three follow up examination is assessed after one week, three weeks and six weeks using questionnaire for evaluation of participant satisfaction about oral health and using OHIS index for evaluating the effect of the dental educational program on the oral health status of deaf children.
without educational program Three follow up examination is assessed after one week, three weeks and six weeks using questionnaire for evaluation of participant satisfaction about oral health and using OHIS index for evaluating the effect of the dental educational program on the oral health status of deaf children.
Outcomes
Primary Outcome Measures
patient satisfaction
this outcome will be assessed via questionnaire
Secondary Outcome Measures
oral hygiene index simplified
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03030014
Brief Title
Effect of Dental Educational Program on Oral Hygiene Status Among Institutionalized Deaf Children
Official Title
Effect of Dental Educational Program on Oral Hygiene Status Among Institutionalized Deaf Children. A Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 2017 (Anticipated)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
June 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
assess the effect of dental educational program on oral hygiene among institutionalized hearing impaired and mute children in Cairo, Egypt.
Detailed Description
Evaluate participants satisfaction regarding the dental educational program(learning teeth brushing technique)
Measure the oral hygiene index simplified to the participants at a different follow up periods for assessing the effect of the dental educational program on oral hygiene.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
238 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
educational programm
Arm Type
Experimental
Arm Description
Oral health education will be done for children and their care givers about various diseases affecting the oral cavity, the effects of bad oral hygiene and tooth decay, importance of tooth brushing, and correct methods of tooth brushing.
Three follow up examination is assessed after one week, three weeks and six weeks using questionnaire for evaluation of participant satisfaction about oral health and using OHIS index for evaluating the effect of the dental educational program on the oral health status of deaf children.
Arm Title
no educational programm
Arm Type
Placebo Comparator
Arm Description
without educational program Three follow up examination is assessed after one week, three weeks and six weeks using questionnaire for evaluation of participant satisfaction about oral health and using OHIS index for evaluating the effect of the dental educational program on the oral health status of deaf children.
Intervention Type
Behavioral
Intervention Name(s)
educational programm
Intervention Description
Oral health education will be done for children and their care givers about various diseases affecting the oral cavity, the effects of bad oral hygiene and tooth decay, importance of tooth brushing, and correct methods of tooth brushing.Three follow up examination is assessed after one week, three weeks and six weeks using questionnaire for evaluation of participant satisfaction about oral health and using OHIS index for evaluating the effect of the dental educational program on the oral health status of deaf children.
Intervention Type
Other
Intervention Name(s)
no educational program
Intervention Description
without oral health education will be done for children and their care givers about various diseases affecting the oral cavity, the effects of bad oral hygiene and tooth decay, importance of tooth brushing, and correct methods of tooth brushing.Three follow up examination is assessed after one week, three weeks and six weeks using questionnaire for evaluation of participant satisfaction about oral health and using OHIS index for evaluating the effect of the dental educational program on the oral health status of deaf children.
Primary Outcome Measure Information:
Title
patient satisfaction
Description
this outcome will be assessed via questionnaire
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
oral hygiene index simplified
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Children aged from 6-12 years with mixed dentition.
Institutionalized Deaf children in Cairo, Egypt.
Exclusion Criteria:
Children above the age of 12 years and below the age of 6 years
Patient un able to give informed consent
Patient suffering from any other type of disability such as (mental retardation, physically and mentally handicapped, .etc.)
Medically compromised patient
Patient who were absent in the day of examination
12. IPD Sharing Statement
Learn more about this trial
Effect of Dental Educational Program on Oral Hygiene Status Among Institutionalized Deaf Children
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