Clinical trial NCT05099146: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Lead sponsor: Dow University of Health Sciences
Sponsor class: OTHER
First posted: 2021-10-29
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: change of dental plaque status
timeFrame: one month
Secondary outcomes:
measure: Change in oral hygiene status
timeFrame: one month
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Ida Rieu College For Blind And Deaf
state: Sindh
Study officials:
affiliation: DOW UNIVERSITY OF HEALTH SCINCES
name: MARIA MOIN, MDS
role: PRINCIPAL_INVESTIGATOR
References: