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

NCT ID: NCT07009015

Last Updated: 2025-07-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 430 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2027-08-30

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.

Detailed Description

Background: Dental caries is a global public health concern and impacts children's health. Good oral health status at a young age is essential for children's development, general health, and well-being. Therefore, a lack of knowledge, attitude, and practice on oral health will affect children's development, overall health, and well-being. This study aims to evaluate a brief oral health intervention in schools by a primary dental care practitioner in improving the knowledge, practice, and attitude toward oral health care among primary school children in Al Lith City, Saudi Arabia. A cluster randomized controlled trial (CRCT) will be conducted in four schools in Al Lith City, Saudi Arabia, among children aged 10 to 11 years old. Methods: 160 children will receive classroom-based interactive educational sessions delivered by a dental care professional and receive take-home literature on oral health. The first session will focus on developing the participant's knowledge and attitude toward oral health. In contrast, the second session will cover topics on behavioural skills improvement to apply the knowledge and skills gained from the first session to improve their targeted behaviours of oral hygiene and eating habits. All children will complete a questionnaire on oral health knowledge, attitude, and practice before, immediately after, and six months following the intervention. Data will be analyzed using SPSS. Data will be presented by descriptive statistics. Chi-square test will be used to determine the association between the variables of the study. One Way-ANOVA will determine the mean differences for the selected variables. A generalized Estimating Equations (GEE) will be used to test the effect of the oral health education program on the outcomes between and within the groups. Expected Results: School-based preventative oral health education delivered by primary dental care practices can improve children's knowledge of oral health and some aspects of oral hygiene behaviour. There are significant differences will be detected in eating habits and eating patterns.

Conditions

Dental Caries in Children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

The oral health education intervention program

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.

Group Type: OTHER

The oral health education intervention program

Intervention Type: 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.

Control group: No Intervention

They will have their regular curriculums and normal activity routine.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

The oral health education intervention program

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Universiti Putra Malaysia

OTHER

Sponsor Role: lead

Responsible Party

Mohammed Khalid Salem Alsharif

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmad Iqmer Nashriq Mohd Nazan, PhD

Role: STUDY_DIRECTOR

Universiti Putra Malaysia

Locations

Universiti Putra Malaysia

Serdang, Selangor, Malaysia

Site Status: RECRUITING

Countries

Malaysia

Central Contacts

Mohammed Alsharif, Master

Role: CONTACT

mksharef@gmail.com

+60145690140

Ahmad Iqmer Nashriq Mohd Nazan

Role: CONTACT

iqmernashriq@upm.edu.my

+603-9769 2941

Facility Contacts

Ahmad Iqmer Nashriq Mohd Nazan, PhD

Role: primary

iqmernashriq@upm.edu.my

+603-9769 2941

Mohammed Alsharif, Master

Role: backup

mksharef@gmail.com

+60145690140

Other Identifiers

MKSalemAlsharif

Identifier Type: -

Identifier Source: org_study_id