Impact of Oral Health Education on Oral Hygiene Status of Deaf Children
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 5, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 2, 2020
CompletedFirst Submitted
Initial submission to the registry
September 13, 2021
CompletedFirst Posted
Study publicly available on registry
October 29, 2021
CompletedNovember 10, 2021
November 1, 2021
2 months
September 13, 2021
November 8, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
change of dental plaque status
Assessed by plaque index, Change of plaque score From high to low levels after1 month
one month
Secondary Outcomes (1)
Change in oral hygiene status
one month
Study Arms (3)
pictorial
EXPERIMENTALbrushing technique taught by using pictures
video
EXPERIMENTALbrushing technique taught by showing video
control
EXPERIMENTALonly oral hygiene instructions provided
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Conditions requiring antibiotic pre-medication prior to dental examination
- Children with extensive dental calculus
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ida Rieu College For Blind And Deaf
Karachi, Sindh, 77440, Pakistan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
MARIA MOIN, MDS
DOW UNIVERSITY OF HEALTH SCINCES
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 13, 2021
First Posted
October 29, 2021
Study Start
October 5, 2019
Primary Completion
December 5, 2019
Study Completion
January 2, 2020
Last Updated
November 10, 2021
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will not share