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

Sponsor
Dow University of Health Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT05099146
Collaborator
(none)
60
1
3
2.9
20.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: pictures
  • Behavioral: video
  • Behavioral: control
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Impact of Oral Health Educational Interventions on Oral Hygiene Status of Deaf Children - A Randomized Controlled Trial
Actual Study Start Date :
Oct 5, 2019
Actual Primary Completion Date :
Dec 5, 2019
Actual Study Completion Date :
Jan 2, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: pictorial

brushing technique taught by using pictures

Behavioral: pictures
pictures with brushing technique demonstrated technique for proper brushing

Experimental: video

brushing technique taught by showing video

Behavioral: video
video of brushing technique demonstrated technique for proper brushing

Experimental: control

only oral hygiene instructions provided

Behavioral: control
oral hygiene instructions provided

Outcome Measures

Primary Outcome Measures

  1. change of dental plaque status [one month]

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

Secondary Outcome Measures

  1. Change in oral hygiene status [one month]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years to 16 Years
Sexes Eligible for Study:
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:
  • Conditions requiring antibiotic pre-medication prior to dental examination

  • Children with extensive dental calculus

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ida Rieu College For Blind And Deaf Karachi Sindh Pakistan 77440

Sponsors and Collaborators

  • Dow University of Health Sciences

Investigators

  • Principal Investigator: MARIA MOIN, MDS, DOW UNIVERSITY OF HEALTH SCINCES

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Maria Moin, Principal Investigator, Dow University of Health Sciences
ClinicalTrials.gov Identifier:
NCT05099146
Other Study ID Numbers:
  • DowMDS
First Posted:
Oct 29, 2021
Last Update Posted:
Nov 10, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 10, 2021