Impact of Oral Health Program on Al-Lith Children's KAP

NCT07009015 | Recruiting

• 1 other identifier: MKSalemAlsharif
• Study Type: interventional
• Target: 430
• Locations: 1 country
• Sites: 1

Brief Summary

Dental caries remains a significant global public health issue, particularly affecting children's health, development, and well-being, with inadequate knowledge, attitudes, and practices around oral health exacerbating these impacts. To address this, a cluster randomized controlled trial will be conducted in four primary schools in Al Lith City, Saudi Arabia, targeting children aged 10 to 11 years. The intervention involves interactive, classroom-based educational sessions led by a dental care professional, supplemented by take-home materials, focusing first on enhancing knowledge and attitudes, and then on developing behavioral skills for improved oral hygiene and eating habits. Participants' knowledge, attitudes, and practices will be assessed via questionnaires before, immediately after, and six months post-intervention, with data analyzed using SPSS through descriptive statistics, chi-square tests, One Way-ANOVA, and Generalized Estimating Equations. The study expects that school-based oral health education will significantly improve children's oral health knowledge and certain hygiene behaviors, as well as positively influence eating habits and patterns.

Conditions

Dental Caries in Children

Keywords

Dental caries; Oral health status; Knowledge; Attitude; Practice

Outcome Measures

Primary Outcomes (3)

• Knowledge on oral health status

  The oral health knowledge assessment consists of eighteen multiple-choice questions scored as correct (1) or incorrect (0), categorized into four domains (dentition, dental caries, gingivitis, and oral cancer), and combined into a composite index with a total possible score ranging from 0 to 18.

  (Timepoint 1 = Baseline, Timepoint 2 = 8-weeks post intervention, Timepoint 3 = 16-weeks post intervention)

• Attitude on oral health status

  A 12-item, five-point Likert scale questionnaire wiil be used to assess attitudes toward maintaining oral hygiene, with five negatively worded items inversely recoded, yielding total scores ranging from 12 to 60.

  (Timepoint 1 = Baseline, Timepoint 2 = 8-weeks post intervention, Timepoint 3 = 16-weeks post intervention)

• Practice on oral health status

  There are 12 multiple-choice questions in this part. The correct answers will be coded as the highest score, and the wrong answers will be coded as '0'. There is a maximum score of 18 and a minimum of 0.

  (Timepoint 1 = Baseline, Timepoint 2 = 8-weeks post intervention, Timepoint 3 = 16-weeks post intervention)

Secondary Outcomes (2)

• Self efficacy

  (Timepoint 1 = Baseline, Timepoint 2 = 8-weeks post intervention, Timepoint 3 = 16-weeks post intervention)

• Social support Appraisals

  (Timepoint 1 = Baseline, Timepoint 2 = 8-weeks post intervention, Timepoint 3 = 16-weeks post intervention)

Study Arms (2)

The oral health education intervention program

OTHER

The intervention program aims to enhance students' oral health knowledge, attitudes, and behaviors over a one-month school term through educational and practical sessions, with its effectiveness assessed before and after the intervention using a closed-ended questionnaire.

Other: The oral health education intervention program

Control group: No Intervention

NO INTERVENTION

They will have their regular curriculums and normal activity routine.

Interventions

The oral health education intervention program OTHER

The intervention program will be designed to improve oral health knowledge, attitudes, and behaviors among students over a one-month school term, carefully scheduled to avoid disrupting regular academic activities. The program consists of initial sessions focused on building students' understanding and appreciation of oral health and healthy eating habits, followed by sessions aimed at developing practical behavioral skills. The effectiveness of the program will be evaluated at three points-before the intervention, two months after, and four months post-intervention-using a closed-ended questionnaire to assess changes in knowledge, attitudes, and practices.

The oral health education intervention program

Eligibility Criteria

• Age: 10 Years - 11 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Primary school male students.
• Aged 10 to 11 years old.
• Students who have at least one of their parent's consents to participate in the study.

You may not qualify if:

• Students who are medically ill at the time of conducting the study.
• Students that are absent while conducting the study.

Sponsors & Collaborators

• Universiti Putra Malaysia: lead

Study Sites (1)

Universiti Putra Malaysia

Serdang, Selangor, 43300, Malaysia

RECRUITING

MeSH Terms

Conditions

Dental Caries; Behavior

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Ahmad Iqmer Nashriq Mohd Nazan, PhD

  Universiti Putra Malaysia

  STUDY DIRECTOR

Central Study Contacts

Mohammed Alsharif, Master

CONTACT

+60145690140; mksharef@gmail.com

Ahmad Iqmer Nashriq Mohd Nazan

CONTACT

+603-9769 2941; iqmernashriq@upm.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized Controlled Trial (RCT)

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: June 6, 2025
• Study Start: March 1, 2024
• Primary Completion: July 30, 2025
• Study Completion (Estimated): August 30, 2027
• Last Updated: July 15, 2025

Record last verified: 2025-07

Locations

MY (1)