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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05112224
Other study ID # BMSU.1395.63789
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2017
Est. completion date September 30, 2017

Study information

Verified date October 2021
Source Baqiyatallah Medical Sciences University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 112
Est. completion date September 30, 2017
Est. primary completion date September 30, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 12 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Education program based on health belief model to improve oral health
Five weekly sessions each one lasted for one hour to encourage participants to follow healthy behaviors on oral health.

Locations

Country Name City State
Iran, Islamic Republic of Baqiyatallah University of Medical Sciences Tehran

Sponsors (1)

Lead Sponsor Collaborator
Baqiyatallah Medical Sciences University

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Decayed, missing and filled teeth Measured by decayed, missing and filled teeth (DMFT) score Five months
Primary Gingival health Measured by papillary bleeding index Five months
Primary Constructs of health belief model Measured by health belief model (HBM) questionnaire Five months
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