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Completed

NCT Number: NCT05099146

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

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.

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Key information

Age range

12 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ida Rieu College For Blind And Deaf

Karachi, Sindh, 77440, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pictures

Behavioral

pictures with brushing technique demonstrated technique for proper brushing

Video

Behavioral

video of brushing technique demonstrated technique for proper brushing

Control

Behavioral

oral hygiene instructions provided

Primary outcomes

  1. change of dental plaque status

    Time frame: one month

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

Secondary outcomes

  1. Change in oral hygiene status

    Time frame: one month

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

Sponsors and collaborators

Lead sponsor

Dow University of Health Sciences

Other

Registry information

Official study title

Impact of Oral Health Educational Interventions on Oral Hygiene Status of Deaf Children - A Randomized Controlled Trial

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Oct 29, 2021
Registry last updated
Nov 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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