PDF(Pubmed)
Abstract：
BACKGROUND: 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.
METHODS: 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.
BACKGROUND: 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.
BACKGROUND: NCT05512156.
METHODS: 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.
BACKGROUND: 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.
BACKGROUND: NCT05512156.
摘要：
背景：儿童龋齿是一个主要的全球健康问题，在沙特阿拉伯是一个特殊的公共卫生挑战。龋齿会引起疼痛，感染和负面影响生活质量。作为沙特阿拉伯人口口腔健康改善工作的一部分，该项目旨在评估幼儿园有监督的刷牙计划的有效性。
方法：本研究是一项整群随机对照试验。入学始于2022年9月，在利雅得的20所随机选择的幼儿园进行了两个学年（2022-2024年）。数据收集阶段将于2024年9月完成。十所幼稚园被随机分配接受监督刷牙,十所照常接受治疗,这是一年一度的口腔健康意识访问。主要终点将是通过衰变（进入牙本质）测量的明显衰变经历的恶化，从基线到随访第二年的缺失和填充牙齿（d3mft）。次要终点将是受影响的牙齿数量的增加。利雅得地区的先验子群，学校类型(公共，私人),儿童性别和基线时先前衰变的存在/不存在，将被分析。我们需要244个可评估端点，使用80%的幂来满足样本量要求。此外,行为问卷，生活质量,正在部署过程监控和成本分析。
背景：沙特卫生部法哈德国王医疗城机构审查委员会批准了这项研究（22-083E/2022年3月）。数据分析已获得格拉斯哥大学医学兽医和生命科学研究伦理委员会的批准（200220194/2023年3月）。这项研究的结果将通过在科学会议和科学期刊上的演讲进行传播。
背景：NCT05512156。
方法：本研究是一项整群随机对照试验。入学始于2022年9月，在利雅得的20所随机选择的幼儿园进行了两个学年（2022-2024年）。数据收集阶段将于2024年9月完成。十所幼稚园被随机分配接受监督刷牙,十所照常接受治疗,这是一年一度的口腔健康意识访问。主要终点将是通过衰变（进入牙本质）测量的明显衰变经历的恶化，从基线到随访第二年的缺失和填充牙齿（d3mft）。次要终点将是受影响的牙齿数量的增加。利雅得地区的先验子群，学校类型(公共，私人),儿童性别和基线时先前衰变的存在/不存在，将被分析。我们需要244个可评估端点，使用80%的幂来满足样本量要求。此外,行为问卷，生活质量,正在部署过程监控和成本分析。
背景：沙特卫生部法哈德国王医疗城机构审查委员会批准了这项研究（22-083E/2022年3月）。数据分析已获得格拉斯哥大学医学兽医和生命科学研究伦理委员会的批准（200220194/2023年3月）。这项研究的结果将通过在科学会议和科学期刊上的演讲进行传播。
背景：NCT05512156。
