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临床试验/NCT07115433
NCT07115433尚未招募不适用

Effectiveness of a School-Based Oral Health Promotion Program on Oral Health Practices, Behaviour, Self-Efficacy, and Clinical Outcomes Among Primary School Children: A Randomized Controlled Trial

Universiti Putra Malaysia3 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2025年8月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
600
试验地点
3
主要终点
Oral Hygiene

研究概览

简要总结

Schools provide an ideal setting for early interventions. Evidence suggests that educational programs incorporating behavioural change theories can improve oral hygiene practices and clinical outcomes.

A School-Based Oral Health Promotion Program on Oral Health Practices, Behaviour, Self-Efficacy, and Clinical Outcomes Among Primary School Children for six months, while the control group will receive no intervention, only routine care.

详细描述

Poor oral health in children leads to pain, absenteeism, and impaired quality of life. Schools provide an ideal setting for early interventions. Evidence suggests that educational programs incorporating behavioural change theories can improve oral hygiene practices and clinical outcomes.

A School-Based Oral Health Promotion Program on Oral Health Practices, Behaviour, Self-Efficacy, and Clinical Outcomes Among Primary School. The oral health promotion intervention will be implemented through weekly interactive sessions lasting 30-40 minutes over six months. These sessions, conducted by trained dental educators and teachers, will use animations, storytelling, demonstrations, and role-plays to teach proper toothbrushing, the importance of fluoride toothpaste, healthy eating habits, and the need for regular dental visits. Children will participate in supervised toothbrushing once a week, supported by peer ambassadors who reinforce daily practices. Educational leaflets and videos will engage parents, while posters in classrooms serve as reminders. Follow-up assessments, including questionnaires and clinical indices, will be conducted at six months, while the control group will receive no intervention, only routine care.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

Investigators and outcome assessors will be blinded

入排标准

年龄范围
6 Years 至 8 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Children aged 6-8 years enrolled in selected schools
  • •Written informed consent from parents/guardians and assent from children

排除标准

  • •Children with systemic conditions affecting oral health
  • •Those currently in other oral health interventions

研究组 & 干预措施

Control group

No Intervention

The control group will be given no intervention other than they will receive routinely

Intervention group

Experimental

Arm Description: The oral health promotion intervention will be implemented through weekly interactive sessions lasting 30-40 minutes over a period of six months. These sessions, conducted by trained dental educators and teachers, will use animations, storytelling, demonstrations, and role-plays to teach proper toothbrushing, the importance of fluoride toothpaste, healthy eating habits, and the need for regular dental visits. Children will participate in supervised toothbrushing once a week, supported by peer ambassadors who reinforce daily practices. Educational leaflets and videos will engage parents, while posters in classrooms serve as reminders. Follow-up assessments, including questionnaires and clinical indices, will be conducted at six months.

干预措施: School-Based Oral Health Promotion Program (Behavioral)

结局指标

主要结局

Oral Hygiene

时间窗: 6-months

Oral Hygiene will be assessed by the presence of debris (plaque) and calculus (tartar) on selected tooth surfaces, measured by the Simplified Oral Hygiene Index (OHI-S) Individual Debris Index (DI-S) and Calculus Index (CI-S): Each of the six surfaces is scored individually for both debris and calculus using a 0-3 scale: 0: No debris or calculus is present. 1. Debris or calculus covers less than one-third of the surface. 2. Debris or calculus covers between one-third and two-thirds of the surface. 3. Debris or calculus covers more than two-thirds of the surface. Good: 0.0 - 1.2 Fair: 1.3 - 3.0 Poor: 3.1 - 6.0

Gingival score

时间窗: 6 months

Gingival score assessed by the gingival score index: 0: Normal gingiva, no inflammation. 1. Mild inflammation - slight color change and edema (swelling), no bleeding on probing. 2. Moderate inflammation - redness, edema, glazing, and bleeding on probing. 3. Severe inflammation - marked redness, edema, ulceration, and tendency towards spontaneous bleeding. The index typically uses a scale of 0 to 3, with 0 representing normal gingiva and higher scores indicating increasing severity of inflammation

Plaque score

时间窗: 6 months

Plaque score index: 0: No plaque. 1. Separate flecks of plaque at the gum line. 2. A thin band of plaque along the gum line. 3. A band of plaque wider than 1mm but covering less than one-third of the tooth. 4. Plaque covering one-third to two-thirds of the tooth. 5. Plaque covering more than two-thirds of the tooth. Higher scores indicate more plaque and poorer oral hygiene.

次要结局

  • oral health practices(6 months)
  • Oral Health Impact Profile.(6 months)

研究者

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

Arshed Muhammad

PhD

Universiti Putra Malaysia

研究点 (3)

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