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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06089564
Other study ID # DowUHS 1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 11, 2023
Est. completion date July 25, 2023

Study information

Verified date October 2023
Source Dow University of Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date July 25, 2023
Est. primary completion date July 23, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 7 Years to 20 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Skit video, Pictorial, Sign language
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.

Locations

Country Name City State
Pakistan ABSA School and college for deaf Karachi Sindh
Pakistan Ida Rieu College For Blind And Deaf Karachi Sindh

Sponsors (1)

Lead Sponsor Collaborator
Dow University of Health Sciences

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Plaque Index Decrease in mean dental plaque scores from baseline to after intervention one month
Primary Gingival Index Decrease in mean gingival scores from baseline to after intervention one month
Secondary Oral Hygiene Index Decrease in mean OHI scores from baseline to after intervention One month
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