Impact of Oral Health Program on Al-Lith Children's KAP
ConditionDental Caries in Children
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age10-11
SponsorUniversiti Putra Malaysia
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Students who are medically ill at the time of conducting the study.
Students that are absent while conducting the study.
Trial design
Design model
Parallel
Treatments tested in this trial
The oral health education intervention program
Other interventionThe 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.
Treatment groups
430 Participants
are divided into 2 treatment groupsGroup A: The oral health education intervention programOther 1 intervention
Group B: Control group: No InterventionNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
(Timepoint 1 = Baseline, Timepoint 2 = 8-weeks post intervention, Timepoint 3 = 16-weeks post intervention)2
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.
Time frame
(Timepoint 1 = Baseline, Timepoint 2 = 8-weeks post intervention, Timepoint 3 = 16-weeks post intervention)3
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.
Time frame
(Timepoint 1 = Baseline, Timepoint 2 = 8-weeks post intervention, Timepoint 3 = 16-weeks post intervention)Secondary outcomes
1
Self efficacy
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."
Time frame
(Timepoint 1 = Baseline, Timepoint 2 = 8-weeks post intervention, Timepoint 3 = 16-weeks post intervention)2
Social support Appraisals
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.
Time frame
(Timepoint 1 = Baseline, Timepoint 2 = 8-weeks post intervention, Timepoint 3 = 16-weeks post intervention)Sponsors and contacts
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Source ClinicalTrials.gov