Clinical trial NCT05112224: A Model-based Health Education Program to Improve Oral Health in School Going Children
Official title: Effectiveness of a Health Education Program Using Health Belief Model to Improve Oral Health in School Going Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Health
Keywords: Oral health
Gingival health
Health education
Decayed teeth
Lead sponsor: Baqiyatallah Medical Sciences University
Sponsor class: OTHER
First posted: 2021-11-08
Enrollment: 112
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One group received the intervention and another received the routine program.
Primary purpose: PREVENTION

Brief summary: This was a randomized controlled trial to assess how an education program based on health belief model (HBM) may affect oral health status in the elementary school going children. For this, a convenient sample including 112 school going children aged between 6-12 years old were recruited and randomized into intervention or control groups. Education program consisted five weekly session each lasted for 1 hour approximately. Based on the main constructs of the HBM, each session was organized and a combination of educational methods were used in the intervention group while the control group only received the routine program provided by the dental clinic. Measures such as papillary bleeding index; decayed, missing, filled teeth (DMFT) and a scale based on the HBM were used for data collection. Three months after the intervention the measures were administered again and comparisons between baseline and follow-up were done.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Decayed, missing and filled teeth
timeFrame: Five months
measure: Gingival health
timeFrame: Five months
measure: Constructs of health belief model
timeFrame: Five months
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Baqiyatallah University of Medical Sciences
Study officials:
affiliation: Baqiyatallah Medical Sciences University
name: Mohsen Saffari, PhD.
role: STUDY_CHAIR
References: