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CompletedNCT05099146Updated Nov 10, 2021

Impact of Oral Health Education on Oral Hygiene Status of Deaf Children

An interventional study of pictures and video in Hearing Loss, sponsored by Dow University of Health Sciences. Completed at 1 site in Pakistan. Open to participants aged 12 Years to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-10.

Sponsored by Dow University of Health Sciences · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 1 year 11 months after the study started (first participant enrolled Oct 2019, registered Sep 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
12 Years to 16 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Hearing Loss

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03

In context

Hearing Loss

1,092 studies on the registry are indexed under Hearing Loss; 235 are open to participants now.

This study's enrollment of 60 is above the median of 40 across 764 interventional studies indexed under Hearing Loss.

Browse Hearing Loss studies →

Lead sponsor

Dow University of Health Sciences is the lead sponsor of 170 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Conditions requiring antibiotic pre-medication prior to dental examination
  • Children with extensive dental calculus
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    pictorial

    brushing technique taught by using pictures

    Behavioral: pictures

  • Experimental
    video

    brushing technique taught by showing video

    Behavioral: video

  • Experimental
    control

    only oral hygiene instructions provided

    Behavioral: control

Interventions

  • Behavioralpictures

    pictures with brushing technique demonstrated technique for proper brushing

  • Behavioralvideo

    video of brushing technique demonstrated technique for proper brushing

  • Behavioralcontrol

    oral hygiene instructions provided

06

What researchers measure

Primary outcomes

  1. change of dental plaque status

    Assessed by plaque index, Change of plaque score From high to low levels after1 month

    Time frame: one month

Secondary outcomes

  1. Change in oral hygiene status

    Assessed by oral hygiene index, Change of Oral hygiene scores From high to low levels after 1 month

    Time frame: one month

07

Study locations

1 site
  • Ida Rieu College For Blind And Deaf
    Karachi, Sindh 77440, Pakistan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 10, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05099146
Lead sponsor
Dow University of Health Sciences
Responsible party
Maria Moin (Principal Investigator, Dow University of Health Sciences) — Principal investigator
First posted
Oct 29, 2021
Start date
Oct 5, 2019
Primary completion
Dec 5, 2019
Completion
Jan 2, 2020
Last update
Nov 10, 2021

Study contacts

MARIA MOIN, MDS
principal investigator · DOW UNIVERSITY OF HEALTH SCINCES

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

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