- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05099146
Impact of Oral Health Education on Oral Hygiene Status of Deaf Children
Impact of Oral Health Educational Interventions on Oral Hygiene Status of Deaf Children - A Randomized Controlled Trial
Objective: To compare the impact of pictorial and video demonstration oral health educational interventions on oral hygiene status of children aged 12-16 years with hearing impairment.
Methods: This randomized controlled trial spanned over the period of three months was conducted in purposively selected three schools of deaf children of Karachi. Baseline dental examination was performed to assess the dental plaque and gingival status of study participants. Dental plaque and gingival status of the participants was assessed by employing the World Health Organization recommended Plaque Index and Gingival Index. The 60 children were than randomly allocated into three interventional groups, pictorial, video and control, 20 in each group. The children were examined again after one month of oral health education provision by single examiner. Tooth brushes were provided to students at the time of baseline examination to use for one month. Collected data was subjected to statistical analysis and described in terms of Mean and Standard Deviation, mixed model ANNOVA was applied to see the difference between the mean plaque and gingival scores of three groups after one month. The p-value of <0.05 was considered as statistically significant at the 95% confidence interval.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background: Health education, conventionally and appropriately, one of the foundation of preventive dentistry, has over the years involved in significant investments of time, power, human resources and funds. Children with impaired hearing have difficulties in speaking and communication and so learning process would be longer and even more challenging than the other children without such disabilities.
Objective: To compare the impact of pictorial and video demonstration oral health educational interventions on oral hygiene status of children aged 12-16 years with hearing impairment.
Methods: This randomized controlled trial spanned over the period of three months was conducted in purposively selected three schools of deaf children of Karachi. Baseline dental examination was performed to assess the dental plaque and gingival status of study participants. Dental plaque and gingival status of the participants was assessed by employing the World Health Organization recommended Plaque Index and Gingival Index. The 60 children were than randomly allocated into three interventional groups, pictorial, video and control, 20 in each group. The children were examined again after one month of oral health education provision by single examiner. Tooth brushes were provided to students at the time of baseline examination to use for one month. Collected data was subjected to statistical analysis and described in terms of Mean and Standard Deviation, mixed model ANNOVA was applied to see the difference between the mean plaque and gingival scores of three groups after one month. The p-value of <0.05 was considered as statistically significant at the 95% confidence interval.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Sindh
-
Karachi, Sindh, Pakistan, 77440
- Ida Rieu College For Blind And Deaf
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Children with hearing impairment
- Children with age of 12-16 years
- Children with no systemic disease
- Children with Plaque adhering to the free gingival margin, more than one third and more than two thirds of tooth surface
- Children with mild, moderate and severe gingivitis
- Agreement on written accent
- Agreement to comply with study visits and procedure
Exclusion Criteria:
- Conditions requiring antibiotic pre-medication prior to dental examination
- Children with extensive dental calculus
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: pictorial
brushing technique taught by using pictures
|
pictures with brushing technique demonstrated technique for proper brushing
|
Experimental: video
brushing technique taught by showing video
|
video of brushing technique demonstrated technique for proper brushing
|
Experimental: control
only oral hygiene instructions provided
|
oral hygiene instructions provided
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change of dental plaque status
Time Frame: one month
|
Assessed by plaque index, Change of plaque score From high to low levels after1 month
|
one month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in oral hygiene status
Time Frame: one month
|
Assessed by oral hygiene index, Change of Oral hygiene scores From high to low levels after 1 month
|
one month
|
Collaborators and Investigators
Investigators
- Principal Investigator: MARIA MOIN, MDS, DOW UNIVERSITY OF HEALTH SCINCES
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DowMDS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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