- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06089564
Effectiveness of Skit Video to Improve Oral Hygiene Status of Children With Hearing Impairment
October 13, 2023 updated by: Maria Moin, Dow University of Health Sciences
Enhancing Oral Hygiene in Children With Hearing Impairment: The Impact of Skit Video Interventions - A Randomized Controlled Trial
Introduction: Oral health is considered as a vital component of overall health and its importance in children may not be disregarded.
In children with hearing impairment, communication barriers may hamper their understanding of oral hygiene practices, making them particularly vulnerable to dental problems.
Objective: The objective of this study was to compare effectiveness of skit video, pictorial and sign language interventions to improve oral hygiene status of children with hearing impairment.
Methods: Sixty children were completed the study and allocated randomly into each group with twenty children as follows: group A: Skit video, group B: Pictorial, and group C: Sign language.
Mean gingival and OHI scores were recorded before and after implementation of interventions.
Oral hygiene habits, oral hygiene and gingival index scores were recorded by structured questionnaire.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Sindh
-
Karachi, Sindh, Pakistan, 77440
- Ida Rieu College For Blind And Deaf
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Karachi, Sindh, Pakistan, 22770
- ABSA School and college for deaf
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Children with hearing impairment and total hearing loss at birth
- Aged 7 to 20 years for both genders,
- Minimum of 20 teeth in the oral cavity
- Children with mild, moderate, and severe gingivitis
Exclusion Criteria:
- Children with dental plaque covered more than two-thirds of their tooth surface, had a plaque score of >1.0
- Children with fair to poor oral hygiene
- Children who had previously participated in any activity or programme promoting oral health within the previous six months
- Children with mild to moderate hearing loss
- Children taking long-term antibiotics
- Children who had used mouthwash within the previous three months
- Children with any known systemic diseases
- Presence of extensive dental calculus
- Uncooperative children
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Skit video
The video was shown to children lasting for 5 minutes.
It was about oral habits, good and bad food.
Video was also showed brushing technique.
|
Three oral health educational intervention groups, group A (skit video), group B (pictorial) and group C (sign language) by using Sequentially Numbered Sealed Opaque Envelopes (SNOSE).
Children picked a sealed envelope randomly and assigned to oral health education intervention group A, B and C. Participants in group A were assigned a skit video method of oral hygiene intervention and shown 5 minute video on what to eat and how to brush their teeth.
The video included that what is good and bad for teeth, and how to brush which includes method, time and duration of tooth brushing.
Participants assigned to group B and C was provided same instructions for tooth brushing and eating habits in the form of pictures and sign language respectively.
The children of Group A received instructions in the form of laminated cards and asked to take with them at home.
Participants in group C were received instructions in sign language in the presence of teacher.
|
|
Active Comparator: Pictorial
The pictures related to brushing technique and oral health advices such as good and bad habits was provided in the form of laminated cards.
The children has taken those cards along with them.
|
Three oral health educational intervention groups, group A (skit video), group B (pictorial) and group C (sign language) by using Sequentially Numbered Sealed Opaque Envelopes (SNOSE).
Children picked a sealed envelope randomly and assigned to oral health education intervention group A, B and C. Participants in group A were assigned a skit video method of oral hygiene intervention and shown 5 minute video on what to eat and how to brush their teeth.
The video included that what is good and bad for teeth, and how to brush which includes method, time and duration of tooth brushing.
Participants assigned to group B and C was provided same instructions for tooth brushing and eating habits in the form of pictures and sign language respectively.
The children of Group A received instructions in the form of laminated cards and asked to take with them at home.
Participants in group C were received instructions in sign language in the presence of teacher.
|
|
No Intervention: Signed Language
The oral health education related to oral habits, good and bad food was delivered via sign language with the help of children sign language teacher.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Plaque Index
Time Frame: one month
|
Decrease in mean dental plaque scores from baseline to after intervention
|
one month
|
|
Gingival Index
Time Frame: one month
|
Decrease in mean gingival scores from baseline to after intervention
|
one month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Oral Hygiene Index
Time Frame: One month
|
Decrease in mean OHI scores from baseline to after intervention
|
One month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Maria Moin, MDS, Bahria University Dental College
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 11, 2023
Primary Completion (Actual)
July 23, 2023
Study Completion (Actual)
July 25, 2023
Study Registration Dates
First Submitted
September 19, 2023
First Submitted That Met QC Criteria
October 13, 2023
First Posted (Actual)
October 18, 2023
Study Record Updates
Last Update Posted (Actual)
October 18, 2023
Last Update Submitted That Met QC Criteria
October 13, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DowUHS 1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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