School of Clinical Dentistry, University of Sheffield, Claremont Crescent, Sheffield, S10 2TA, UK.
York Trials Unit, Department of Health Sciences, Faculty of Sciences ARRC Building, University of York, York, YO10 5DD, UK.
Trials. 2019 Jul 23;20(1):452. doi: 10.1186/s13063-019-3538-6.
Almost one-half of 12-15 year olds living in deprived areas of the UK have dental caries (tooth decay) with few oral health promotion programmes aimed at children of this age. Mobile phone-based interventions such as short messaging service (SMS) interventions have been found effective at changing certain behaviours and improving health outcomes. This protocol describes the BRIGHT Trial, investigating the clinical and cost-effectiveness of a behaviour change intervention-classroom-based session (CBS) embedded in the curriculum and a series of SMS delivered to participants twice daily to remind them to brush their teeth, compared to usual curriculum and no SMS-to reduce the prevalence of dental caries in young people from deprived areas.
To investigate the clinical and cost-effectiveness of a complex intervention to improve the oral health of young people living in deprived areas.
METHODS/DESIGN: This is a school-based, assessor-blinded, two-arm cluster-randomised controlled trial with an internal pilot trial. Overall, the trial will involve approximately 5040 11-13 year olds in 42 schools with a 3-year follow-up. The trial will take place in secondary schools in England, Scotland and Wales. The primary outcome is the presence of carious lesions in permanent teeth at 3 years. Secondary outcomes are: number of carious teeth, frequency of twice-daily toothbrushing, plaque levels, gingivitis, child health-related quality of life and oral health-related quality of life. A cost-utility analysis will be conducted.
The findings of the trial have implications for embedding oral health interventions into school curricula guidance produced by national bodies, including departments for education and dental public health and guideline-development organisations.
ISRCTN registry, ISRCTN12139369 . Registered on 10 May 2017.
在英国贫困地区，近一半 12-15 岁的儿童患有龋齿（蛀牙），针对这个年龄段的儿童的口腔健康促进计划很少。基于手机的干预措施，如短消息服务（SMS）干预措施，已被证明可有效改变某些行为并改善健康结果。本方案描述了 BRIGHT 试验，该试验旨在调查一种行为改变干预措施——课堂为基础的课程（CBS）嵌入课程以及向参与者每日两次发送的一系列提醒他们刷牙的短信，与常规课程和无短信相比，这一干预措施在减少贫困地区年轻人的龋齿患病率方面的临床和成本效益。
调查一种复杂干预措施改善贫困地区年轻人口腔健康的临床和成本效益。
方法/设计：这是一项基于学校、评估员盲法、两臂聚类随机对照试验，有内部试点试验。总体而言，该试验将涉及约 5040 名 11-13 岁的儿童，在 42 所学校中进行，随访期为 3 年。试验将在英格兰、苏格兰和威尔士的中学进行。主要结局是 3 年后恒牙龋齿的存在。次要结局是：龋齿数、每日刷牙两次的频率、牙菌斑水平、牙龈炎、儿童健康相关生活质量和口腔健康相关生活质量。将进行成本效用分析。
该试验的结果对将口腔健康干预措施嵌入国家机构（包括教育和口腔公共卫生部门以及指南制定组织）制定的学校课程指南具有影响。
ISRCTN 注册处，ISRCTN87066204 。2017 年 5 月 10 日注册。
