A Model-based Health Education Program to Improve Oral Health in School Going Children

NCT05112224 | Completed

• 1 other identifier: BMSU.1395.63789
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Health

Keywords

Oral health; Gingival health; Health education; Decayed teeth

Outcome Measures

Primary Outcomes (3)

• Number of Decayed, missing and filled teeth

  Measured by decayed, missing and filled teeth (DMFT) score

  Five months

• Gingival health

  Measured by papillary bleeding index

  Five months

• Constructs of health belief model

  Measured by health belief model (HBM) questionnaire

  Five months

Study Arms (2)

Educational Intervention

EXPERIMENTAL

An educational program based on HBM that was conducted using five one-hour sessions.

Behavioral: Education program based on health belief model to improve oral health

Control

NO INTERVENTION

Control group only received the education program provided by the dental clinic.

Interventions

Education program based on health belief model to improve oral health BEHAVIORAL

Five weekly sessions each one lasted for one hour to encourage participants to follow healthy behaviors on oral health.

Educational Intervention

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baqiyatallah Medical Sciences University: lead

Study Sites (1)

Baqiyatallah University of Medical Sciences

Tehran, 1435916471, Iran

Location

MeSH Terms

Conditions

Health Education; Dental Caries

Condition Hierarchy (Ancestors)

Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Mohsen Saffari, PhD.

  Baqiyatallah Medical Sciences University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The dentist and data analyzer were blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: One group received the intervention and another received the routine program.

Study Record Dates

• First Submitted: October 19, 2021
• First Posted: November 8, 2021
• Study Start: May 1, 2017
• Primary Completion: September 30, 2017
• Study Completion: September 30, 2017
• Last Updated: November 8, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)