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Effectiveness of Skit Video to Improve Oral Hygiene Status of Children With Hearing Impairment

Primary Purpose

Hearing Impaired Children

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Skit video, Pictorial, Sign language
Sponsored by
Dow University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hearing Impaired Children

Eligibility Criteria

7 Years - 20 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • ABSA School and college for deaf
  • Ida Rieu College For Blind And Deaf

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Skit video

Pictorial

Signed Language

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Plaque Index
Decrease in mean dental plaque scores from baseline to after intervention
Gingival Index
Decrease in mean gingival scores from baseline to after intervention

Secondary Outcome Measures

Oral Hygiene Index
Decrease in mean OHI scores from baseline to after intervention

Full Information

First Posted
September 19, 2023
Last Updated
October 13, 2023
Sponsor
Dow University of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT06089564
Brief Title
Effectiveness of Skit Video to Improve Oral Hygiene Status of Children With Hearing Impairment
Official Title
Enhancing Oral Hygiene in Children With Hearing Impairment: The Impact of Skit Video Interventions - A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
April 11, 2023 (Actual)
Primary Completion Date
July 23, 2023 (Actual)
Study Completion Date
July 25, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dow University of Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Impaired Children

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Skit video
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Pictorial
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Signed Language
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Skit video, Pictorial, Sign language
Intervention Description
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.
Primary Outcome Measure Information:
Title
Plaque Index
Description
Decrease in mean dental plaque scores from baseline to after intervention
Time Frame
one month
Title
Gingival Index
Description
Decrease in mean gingival scores from baseline to after intervention
Time Frame
one month
Secondary Outcome Measure Information:
Title
Oral Hygiene Index
Description
Decrease in mean OHI scores from baseline to after intervention
Time Frame
One month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Moin, MDS
Organizational Affiliation
Bahria University Dental College
Official's Role
Principal Investigator
Facility Information:
Facility Name
ABSA School and college for deaf
City
Karachi
State/Province
Sindh
ZIP/Postal Code
22770
Country
Pakistan
Facility Name
Ida Rieu College For Blind And Deaf
City
Karachi
State/Province
Sindh
ZIP/Postal Code
77440
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

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Effectiveness of Skit Video to Improve Oral Hygiene Status of Children With Hearing Impairment

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