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

Primary Purpose

Hearing Loss

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
pictures
video
control
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 Loss

Eligibility Criteria

12 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ida Rieu College For Blind And Deaf

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

pictorial

video

control

Arm Description

brushing technique taught by using pictures

brushing technique taught by showing video

only oral hygiene instructions provided

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 13, 2021
Last Updated
November 8, 2021
Sponsor
Dow University of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05099146
Brief Title
Impact of Oral Health Education on Oral Hygiene Status of Deaf Children
Official Title
Impact of Oral Health Educational Interventions on Oral Hygiene Status of Deaf Children - A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
October 5, 2019 (Actual)
Primary Completion Date
December 5, 2019 (Actual)
Study Completion Date
January 2, 2020 (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
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.
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pictorial
Arm Type
Experimental
Arm Description
brushing technique taught by using pictures
Arm Title
video
Arm Type
Experimental
Arm Description
brushing technique taught by showing video
Arm Title
control
Arm Type
Experimental
Arm Description
only oral hygiene instructions provided
Intervention Type
Behavioral
Intervention Name(s)
pictures
Intervention Description
pictures with brushing technique demonstrated technique for proper brushing
Intervention Type
Behavioral
Intervention Name(s)
video
Intervention Description
video of brushing technique demonstrated technique for proper brushing
Intervention Type
Behavioral
Intervention Name(s)
control
Intervention Description
oral hygiene instructions provided
Primary Outcome Measure Information:
Title
change of dental plaque status
Description
Assessed by plaque index, Change of plaque score From high to low levels after1 month
Time Frame
one month
Secondary Outcome Measure Information:
Title
Change in oral hygiene status
Description
Assessed by oral hygiene index, Change of Oral hygiene scores From high to low levels after 1 month
Time Frame
one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MARIA MOIN, MDS
Organizational Affiliation
DOW UNIVERSITY OF HEALTH SCINCES
Official's Role
Principal Investigator
Facility Information:
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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Impact of Oral Health Education on Oral Hygiene Status of Deaf Children

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