A Scalable, Equity-focused, Teacher-delivered, School-based Oral Health Intervention for Pakistani Lower Secondary Schoolchildren: a Pragmatic Cluster-randomized Effectiveness-implementation Trial (Smile Smarts-PK)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,055
- 试验地点
- 1
- 主要终点
- DENTAL HEALTH PRACTICES AND BEHAVIOUR
研究概览
简要总结
This was a pragmatic, two-arm, and parallel-group, superiority cluster-randomized controlled trial with 1:1 allocation of clusters (schools) to either the Smile Smarts-PK intervention arm or the control arm. The trial settings were lower secondary schools (classes 5-8) in the Punjab, Pakistan. Punjab is the most populous province of Pakistan; it has many public and low-cost private schools that serve lower- and middle-income communities.
详细描述
Oral diseases are among the most common non-communicable conditions affecting children worldwide and disproportionately burden those in low- and middle-income countries. Robust evidence from pragmatic, theory-informed, school-based cluster-randomized trials in South Asia remains scarce. We evaluated the effectiveness of Smile Smarts-PK, a scalable teacher-delivered oral health intervention embedded within routine lower secondary school systems in Pakistan.
Methods It is a parallel, pragmatic, school-level cluster-randomized controlled trial in 50 lower secondary schools in Pakistan. Schools were randomly assigned (1:1) to either the Smile Smarts-PK intervention or usual school practice. The intervention was teacher-delivered, integrated into routine academic schedules, and informed by the Health Belief Model. Primary outcomes at 12 months were clinical oral health indices: Debris Index-Simplified (DI-S), Calculus Index-Simplified (CI-S), Oral Hygiene Index-Simplified (OHI-S). Secondary outcomes included plaque index, children's oral health knowledge, observed and self-reported oral health behaviours, and maternal knowledge, attitudes, and practices. Analyses were by intention to treat using linear mixed-effects models accounting for clustering at the school level.
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
In this study, masking, also known as blinding, refers to the practice of concealing the allocation of participants to intervention groups from outcome assessors and investigators involved in data collection and analysis.
Masking helps minimize bias that could occur if those assessing the outcomes are aware of the participants' assigned interventions. In this case, both the outcome assessors and investigators are masked, meaning they are unaware of which participants received the interactive oral care lessons (experimental group) and which participants were in the control group.
入排标准
- 年龄范围
- 10 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 10 to 15 years. Enrollment at one of the selected schools.
- •Consent obtained from parents or legal guardians for participation in the study.
排除标准
- •Children and their parents who did not give assent and consent to participate in the study.
- •Children with severe oral health issues require immediate medical attention.
- •Children with special needs affecting their ability to participate in the oral health education interventions.
研究组 & 干预措施
Smile Smarts-PK
The intervention group is given the Smile Smarts-PK intervention. It is s a multi-theory, multicomponent oral health promotion intervention grounded in a multi-level theoretical framework integrating the Health Belief Model (HBM) and Social Cognitive Theory (SCT). In addition, the delivery strategy is viewed through an implementation science lens, implementation theory, to strengthen understanding not only of effectiveness but also of reach, adoption, fidelity, and future maintenance.
干预措施: Smile Smarts (Behavioral)
Control group
Participants assigned to Arm 2 serve as the control group and do not receive any intervention during the study except for routine school activities
结局指标
主要结局
DENTAL HEALTH PRACTICES AND BEHAVIOUR
时间窗: 6 MONTHS
The primary outcome is dental health practices and behaviour will be assessed using a pre-validated questionnaire derived from a reference study with a reliability score of 0.719. The questionnaire comprises 12 questions, where questions 1-6 pertain to awareness and questions 7-12 assess practices. The scoring range is from 0 to 12, with higher scores indicating better dental health practices and behavior.
Oral Hygiene Status
时间窗: 12 month
The change in the Simplified Oral Hygiene Index (OHI-S) from baseline to 12 months served as the primary endpoint. The OHI-S scores debris and calculus on six index surfaces (scores 0-3 each), with the summed component means creating an overall score ranging from 0 (good hygiene) to 6 (poor hygiene). Scores were categorized as good (0.0-1.2), fair (1.3-3.0), or poor (3.1-6.0). The primary analysis focused on the change in mean OHI-S score at both the individual and cluster levels
次要结局
- ORAL HEALTH RELATED QUALITY OF LIFE(6 months)
- GINGIVAL SCORE(6 MONTHS)
- PLAQUE SCORE(6 MONTHS)
- PLAQUE SCORE(12 months)
- Observed toothbrushing performance(12 months)
- Self-Reported Oral Hygiene Behaviors(12 months)
- Mothers' Knowledge, Attitudes, and Practices (KAP)(12 months)
研究者
Arshed Muhammad
PhD studentship
Universiti Putra Malaysia