Dental Biomaterials Research Chair, Dental Health Department, College of Applied Medical Sciences, King Saud University, Riyadh, Saudi Arabia.
Dental Services Development Team, Dental Services Department, Riyadh Second Health Cluster, Ministry of Health, Riyadh, Saudi Arabia.
Trials. 2023 Feb 20;24(1):118. doi: 10.1186/s13063-023-07111-8.
Dental caries is one of the most common diseases affecting children world widely as well as in the Kingdom of Saudi Arabia. Supervised tooth brushing programs are implemented throughout the world to provide young children's developing teeth with additional fluoride as a form of dental caries prevention. While school-based supervised tooth brushing programs have been proven to improve young children's oral health, virtual supervised teeth brushing programs have not been assessed. The purpose of this protocol is to assess the impact of virtual supervised tooth brushing on caries experience and quality of life among primary school students in Riyadh, Saudi Arabia.
This is a cluster randomized controlled trial comparing a virtual supervised tooth brushing program against no intervention applied. A total of 1192 (596 in each group) 8-9-year-old children in Riyadh primary schools, Saudi Arabia, will be recruited for the trial. Schools (cluster) will be randomly selected and allocated to either group. Clinical assessment for caries experience will be conducted in six points (baseline, + 3 months, + 6 months, + 12 months, + 24 months, + 36 months) by dental hygienists using the World Health Organization criteria. Data on sociodemographic behavioral factors and children's quality of life will be collected with every clinical assessment through a structured questionnaire. The primary outcome is the change in caries experience (the number of teeth with untreated dental caries, filled and missing teeth) in both primary and permanent teeth over 36 months.
Virtual education as well as some health consultation through the pandemic period had enabled an effective IT infrastructure in Saudi Arabia. Virtual supervised tooth brushing is a proposed initiative. It is also an opportunity for targeting a large portion of the population with a high level of disease as a quarter of the Saudi population is younger than 15 years. This project should provide high level evidence on the effectiveness of virtual supervised tooth brushing. The findings should potentially inform policies related to the continuation/implementation of school-based programs in Saudi Arabia.
ClinicalTrials.gov, ID: NCT05217316. Registered on 19 January 2022.
龋齿是一种在全球范围内普遍存在的儿童疾病,在沙特阿拉伯也不例外。全世界都在实施监督刷牙计划,为儿童正在发育的牙齿提供额外的氟化物,以此作为预防龋齿的一种形式。虽然已证实学校监督刷牙计划可改善儿童的口腔健康,但尚未评估虚拟监督刷牙计划。本方案旨在评估虚拟监督刷牙对沙特阿拉伯利雅得小学生龋齿患病情况和生活质量的影响。
这是一项比较虚拟监督刷牙与不干预的集群随机对照试验。将从沙特阿拉伯利雅得的小学招募 1192 名(每组 596 名)8-9 岁儿童参加该试验。学校(集群)将被随机选择并分配到干预组或对照组。由口腔卫生保健员使用世界卫生组织标准在 6 个时间点(基线、+3 个月、+6 个月、+12 个月、+24 个月、+36 个月)进行龋齿患病情况的临床评估。通过结构问卷,在每次临床评估时收集社会人口统计学行为因素和儿童生活质量的数据。主要结局是 36 个月内恒牙和乳牙未治疗龋齿、已填充和缺失牙齿的数量变化。
虚拟教育以及在疫情期间的一些健康咨询使得沙特阿拉伯具备了有效的 IT 基础设施。虚拟监督刷牙是一个提议中的计划。它也是一个针对高患病人群的机会,因为四分之一的沙特人口年龄在 15 岁以下。该项目应提供关于虚拟监督刷牙有效性的高级别证据。研究结果可能为与在沙特阿拉伯继续/实施基于学校的计划相关的政策提供信息。
ClinicalTrials.gov,编号:NCT05217316。于 2022 年 1 月 19 日注册。