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

Not Applicable

Recruiting

• Conditions: Dental Caries in Children

• Registration Number: NCT07009015
• Lead Sponsor: Universiti Putra Malaysia

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.

Study Timeline

• Study Start: 2024-03-01
• Study First Submitted: 2025-05-21
• Study First Submitted QC: 2025-05-28
• Status Verified: 2025-06
• Primary Completion: 2025-06-01
• Study First Posted: 2025-06-06
• Last Update Submitted: 2025-06-07
• Last Update Posted: 2025-06-11
• Study Completion: 2027-07-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 430

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Knowledge on oral health status	(Timepoint 1 = Baseline, Timepoint 2 = 8-weeks post intervention, Timepoint 3 = 16-weeks post intervention)	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.
Attitude on oral health status	(Timepoint 1 = Baseline, Timepoint 2 = 8-weeks post intervention, Timepoint 3 = 16-weeks post intervention)	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.
Practice on oral health status	(Timepoint 1 = Baseline, Timepoint 2 = 8-weeks post intervention, Timepoint 3 = 16-weeks post intervention)	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.

Secondary Outcome Measures

Name	Time	Method
Self efficacy	(Timepoint 1 = Baseline, Timepoint 2 = 8-weeks post intervention, Timepoint 3 = 16-weeks post intervention)	A seven-item self-reported questionnaire will be used to assess students' self-efficacy towards oral health, with respondents rating their confidence on a 5-point Likert scale ranging from "Not confident" to "Completely confident." \[1\] https://ppl-ai-file-upload.s3.amazonaws.com/web/direct-files/attachments/17344637/cfccb2dc-8ef0-49a3-abec-e053b176b418/Abstract.docx; --- Answer from Perplexity: pplx.ai/share
Oral hygiene behaviors	(Timepoint 1 = Baseline, Timepoint 2 = 8-weeks post intervention, Timepoint 3 = 16-weeks post intervention)	Students' oral hygiene behavior will be assessed by asking how frequently they brushed or flossed their teeth in the past month, with response options ranging from "Never" to "Two or more times a day."
Social support Appraisals	(Timepoint 1 = Baseline, Timepoint 2 = 8-weeks post intervention, Timepoint 3 = 16-weeks post intervention)	The Social Support Appraisals Scale is a 23-item questionnaire with five response options that measures the extent to which individuals feel loved, esteemed, and involved with family, friends, and others.

Trial Locations

Locations (1)

Universiti Putra Malaysia; 🇲🇾 Serdang, Selangor, Malaysia