- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05112224
A Model-based Health Education Program to Improve Oral Health in School Going Children
Effectiveness of a Health Education Program Using Health Belief Model to Improve Oral Health in School Going Children
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Oral health problems especially dental carries are common in school children and education programs may help to prevent these conditions. The aim of current study was to investigate how an education program based on health belief model (HBM) may improve oral health status of the elementary school children.
One hundred twelve 6-12 year children along with one of their parents assigned into trial and control groups using a randomized controlled trial. For trial group 5 education sessions based on HBM were held, whereas control group only received routine education program delivered by the dental clinic. Decayed, missing, filled teeth (DMFT) score, papillary bleeding index, and HBM questionnaire for oral were used for evaluation of the program. Three month after the intervention reassessment was performed and the changes were measured by student t test as well as analysis of covariance test.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Tehran, Iran, Islamic Republic of, 1435916471
- Baqiyatallah University of Medical Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age between 6-12 years old (elementary school going children)
- Attendance of at least one parent (either father or mother) when admission and to take part in the intervention
- Being permanent residents of the enrollment area
- Having medical record in the dental clinic
- Ability to speak and understand Persian
Exclusion Criteria:
- Children with advanced oral diseases or other critical conditions or disabilities
- Those who were using anti-inflammatory agents as a routine
- Those who had used antibiotics in past two weeks
- Children with illiterate parents
- Those on ongoing orthodontic treatments
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Educational Intervention
An educational program based on HBM that was conducted using five one-hour sessions.
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Five weekly sessions each one lasted for one hour to encourage participants to follow healthy behaviors on oral health.
|
|
No Intervention: Control
Control group only received the education program provided by the dental clinic.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Decayed, missing and filled teeth
Time Frame: Five months
|
Measured by decayed, missing and filled teeth (DMFT) score
|
Five months
|
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Gingival health
Time Frame: Five months
|
Measured by papillary bleeding index
|
Five months
|
|
Constructs of health belief model
Time Frame: Five months
|
Measured by health belief model (HBM) questionnaire
|
Five months
|
Collaborators and Investigators
Investigators
- Study Chair: Mohsen Saffari, PhD., Baqiyatallah University of Medical Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- BMSU.1395.63789
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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