Data Sheet 1_The effect of the modified basic package of oral care on adolescent dental caries status in Zambia; a cluster randomized trial.pdf

BackgroundThe Basic Package of Oral Care (BPOC) was developed by the World Health Organization (WHO) in order to improve oral health care worldwide, yet evidence of its effectiveness is scarce. This study primarily assessed the outcome of applying modified BPOC on dental caries prevalence and secondarily on knowledge and behaviors related to dental caries among adolescents in Copperbelt Province, Zambia.
MethodsA parallel arms cluster randomized field trial including 22 public secondary schools (11-intevention, 11-control) was carried out between January 2021 and March 2023 in Copperbelt Province, Zambia. A validated questionnaire collected data with respect to socio-demographics, knowledge, and dental caries-related behaviors. The caries assessment spectrum and treatment (CAST) instrument was used to examine the spectrum of carious lesions during the baseline, and the follow-up data collection phases. The 1st and 2nd follow up exams were conducted at 18 and 24 months after baseline, respectively. The intervention group received a six-month duration modified BPOC intervention while, the control group continued with their routine oral self-care. The analysis was based on the intention-to-treat protocol using generalized estimating equations (GEE), and the results were reported as OR (95% CI).
ResultsOut of 1,794 participants at baseline, 1,690 (94.2%) and 1,597 (89.0%) were examined at the 1st and 2nd follow up intervals, respectively. Dental caries models showed significant interaction at 18 and 24 months [OR (95% CI) = 0.7 (0.6, 0.8), p < 0.001]. Adequate knowledge and use of fluoridated toothpaste models were the only secondary outcomes with significant interactions at 18 and 24 months follow up. Stratified analysis at 18 and 24 months showed that the intervention group had better outcomes for adequate knowledge, use of fluoridated toothpaste and dental caries.
ConclusionThe modified BPOC was effective in reducing the prevalence of dental caries, improving knowledge on dental caries, and increasing the frequency of using fluoridated toothpaste among Zambian adolescents.

Clinical Trial Registration[https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=24046], identifier [PACTR202210624926299].

背景
口腔护理基础包（Basic Package of Oral Care, BPOC）由世界卫生组织（World Health Organization, WHO）制定，旨在改善全球口腔卫生保健服务，但相关有效性的实证证据仍较为匮乏。本研究首要评估改良版BPOC应用于赞比亚铜带省青少年的龋齿患病率效果，次要评估其对该群体龋齿相关知识与行为的影响。
方法
本研究于2021年1月至2023年3月在赞比亚铜带省开展一项平行组整群随机现场试验，共纳入22所公立中学（干预组、对照组各11所）。研究采用经过信效度检验的问卷收集社会人口学特征、知识水平及龋齿相关行为数据。在基线及随访数据采集阶段，均使用龋齿评估谱与治疗（Caries Assessment Spectrum and Treatment, CAST）工具对龋损情况进行检查。首次与第二次随访检查分别于基线后18个月、24个月开展。干预组接受为期6个月的改良BPOC干预，对照组则维持常规口腔自我护理。本分析遵循意向性治疗（intention-to-treat, ITT）原则，采用广义估计方程（generalized estimating equations, GEE）进行统计分析，结果以比值比（OR, 95%置信区间CI）形式报告。
结果
基线时共纳入1794名参与者，首次、第二次随访分别完成1690人（占比94.2%）与1597人（占比89.0%）的检查。龋齿模型分析显示，在18个月及24个月随访时均存在显著交互效应[OR(95%CI)=0.7(0.6, 0.8), p<0.001]。充足的龋齿相关知识水平与含氟牙膏使用情况，是仅有的两项在18、24个月随访时呈现显著交互效应的次要结局指标。分层分析结果显示，在18、24个月随访时，干预组在充足龋齿知识掌握、含氟牙膏使用及龋齿患病率方面均表现更优。
结论
改良版BPOC可有效降低赞比亚青少年的龋齿患病率，提升其龋齿相关知识水平，并增加其使用含氟牙膏的频率。
临床试验注册：[https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=24046]，识别号：[PACTR202210624926299]。