School of Medicine, Dentistry, and Nursing, University of Glasgow, Glasgow, UK
Saudi Arabia Ministry of Health, Riyadh, Saudi Arabia.
BMJ Open. 2024 Aug 3;14(8):e083504. doi: 10.1136/bmjopen-2023-083504.
Dental caries among children is a major global health problem and is a particular public health challenge in Saudi Arabia. Dental caries cause pain, infection and negatively impact quality of life. As part of population oral health improvement efforts in Saudi Arabia, this project aims to evaluate the effectiveness of a supervised toothbrushing programme in kindergartens.
This study is a cluster randomised controlled trial. Enrolment began in September 2022, for two academic years (2022-2024) on 20 randomly selected kindergartens in Riyadh. The data collection phase will be completed in September 2024. Ten kindergartens are randomly allocated to supervised toothbrushing and 10 to treatment as usual, which is an annual oral health awareness visit. The primary endpoint will be the worsening of obvious decay experience as measured by decayed (into dentine), missing and filled teeth (d3mft) from baseline to the second year of follow-up. The secondary endpoint will be the increase in the number of teeth affected. A priori subgroups of the region of Riyadh, school type (public, private), child sex and presence/absence of prior decay at baseline, will be analysed. We require 244 evaluable endpoints using a power of 80% to meet the sample size requirement. In addition, questionnaires on behaviours, quality of life, process monitoring and cost analysis are being deployed.
Ethics approval for this study was given by the King Fahad Medical City Institutional Review Board in the Saudi Ministry of Health (22-083E/March 2022). The data analysis has been approved by the University of Glasgow Medical Veterinary and Life Sciences Research Ethical Committee (200220194/March 2023). The results of this study will be disseminated through presentations at scientific conferences and in scientific journals.
NCT05512156.
儿童龋齿是全球主要的健康问题之一，在沙特阿拉伯也是一个特别的公共卫生挑战。龋齿会引起疼痛、感染，并对生活质量产生负面影响。作为沙特阿拉伯改善人口口腔健康工作的一部分，本项目旨在评估幼儿园监督刷牙计划的有效性。
这是一项集群随机对照试验。招募于 2022 年 9 月开始，在 2022 年至 2024 年的两个学年期间，在利雅得随机选择的 20 所幼儿园进行。数据收集阶段将于 2024 年 9 月完成。10 所幼儿园被随机分配到监督刷牙组，10 所幼儿园被分配到常规治疗组，即每年进行一次口腔健康意识访问。主要终点是在第二年随访时，根据龋失补牙数（dmft）评估明显龋齿恶化的情况。次要终点是受影响牙齿数量的增加。将对利雅得地区、学校类型（公立、私立）、儿童性别以及基线时是否存在或不存在龋齿等预先设定的亚组进行分析。我们需要使用 80%的功率来满足样本量要求，需要 244 个可评估的终点。此外，还在部署有关行为、生活质量、过程监测和成本分析的问卷。
本研究已获得沙特卫生部法赫德国王医疗城机构审查委员会（22-083E/2022 年 3 月）的伦理批准。格拉斯哥大学医学、兽医和生命科学研究伦理委员会（200220194/2023 年 3 月）已批准数据分析。本研究的结果将通过在科学会议上的演讲和科学期刊上的发表进行传播。
NCT05512156。
