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

Hearing Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05099146
• Other study ID #: DowMDS
• Status: Completed
• Phase: N/A
• Start date: October 5, 2019
• Est. completion date: January 2, 2020

Study information

• Verified date: November 2021
• Source: Dow University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2, 2020
• Est. primary completion date: December 5, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Hearing Loss

Intervention

Behavioral:
• pictures
pictures with brushing technique demonstrated technique for proper brushing
• video
video of brushing technique demonstrated technique for proper brushing
• control
oral hygiene instructions provided

Locations

Country	Name	City	State
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	change of dental plaque status	Assessed by plaque index, Change of plaque score From high to low levels after1 month	one month
Secondary	Change in oral hygiene status	Assessed by oral hygiene index, Change of Oral hygiene scores From high to low levels after 1 month	one month