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临床试验/NCT07009015
NCT07009015招募中不适用

The Effect Of Health Education Intervention Program In Improving Knowledge, Attitude, And Practice Of Oral Health Among Male Primary School Children In Al-Lith Saudi Arabia: A Clustered Randomised Control Trial

Universiti Putra Malaysia2 个研究点 分布在 1 个国家目标入组 430 人开始时间: 2024年3月1日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
430
试验地点
2
主要终点
Knowledge on oral health status

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
10 Years 至 11 Years(Child)
性别
Male
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

Knowledge on oral health status

时间窗: (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

时间窗: (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

时间窗: (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.

次要结局

  • 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))
  • 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))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohammed Khalid Salem Alsharif

Principal Investigator

Universiti Putra Malaysia

研究点 (2)

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