BMC Oral Health. 2013 Jun 1;13:25. doi: 10.1186/1472-6831-13-25.
There is a lack of evidence for effective management of dental caries (decay) in children's primary (baby) teeth and an apparent failure of conventional dental restorations (fillings) to prevent dental pain and infection for UK children in Primary Care. UK dental schools' teaching has been based on British Society of Paediatric Dentistry guidance which recommends that caries in primary teeth should be removed and a restoration placed. However, the evidence base for this is limited in volume and quality, and comes from studies conducted in either secondary care or specialist practices. Restorations provided in specialist environments can be effective but the generalisability of this evidence to Primary Care has been questioned. The FiCTION trial addresses the Health Technology Assessment (HTA) Programme’s commissioning brief and research question “What is the clinical and cost effectiveness of restoration caries in primary teeth, compared to no treatment?” It compares conventional restorations with an intermediate treatment strategy based on the biological (sealing-in) management of caries and with no restorations.
METHODS/DESIGN: This is a Primary Care-based multi-centre, three-arm, parallel group, patient-randomised controlled trial. Practitioners are recruiting 1461 children, (3-7 years) with at least one primary molar tooth where caries extends into dentine. Children are randomized and treated according to one of three treatment approaches; conventional caries management with best practice prevention, biological management of caries with best practice prevention or best practice prevention alone. Baseline measures and outcome data (at review/treatment during three year follow-up) are assessed through direct reporting, clinical examination including blinded radiograph assessment, and child/parent questionnaires. The primary outcome measure is the incidence of either pain or infection related to dental caries. Secondary outcomes are; incidence of caries in primary and permanent teeth, patient quality of life, cost-effectiveness, acceptability of treatment strategies to patients and parents and their experiences, and dentists’ preferences.
FiCTION will provide evidence for the most clinically-effective and cost-effective approach to managing caries in children's primary teeth in Primary Care. This will support general dental practitioners in treatment decision making for child patients to minimize pain and infection in primary teeth. The trial is currently recruiting patients.
Protocol ID: NCTU: ISRCTN77044005.
对于儿童乳牙龋齿（蛀牙）的有效管理，目前缺乏证据，而且传统的牙科修复（补牙）似乎未能预防英国初级保健儿童的牙痛和感染。英国牙科学校的教学一直基于英国儿童牙科学会的指导建议，该建议建议去除乳牙中的龋齿并放置修复体。然而，这方面的证据基础在数量和质量上都有限，并且来自于在二级保健或专科诊所进行的研究。在专科环境中提供的修复体可能是有效的，但将这种证据推广到初级保健中一直受到质疑。FiCTION 试验解决了卫生技术评估（HTA）计划的委托简报和研究问题“与不治疗相比，用修复体治疗乳牙龋齿的临床和成本效益如何？”它比较了传统修复体与基于龋齿生物（密封）管理的中间治疗策略以及不修复的情况。
方法/设计：这是一项基于初级保健的多中心、三臂、平行组、患者随机对照试验。从业者正在招募 1461 名儿童（3-7 岁），他们至少有一颗磨牙的龋齿延伸到牙本质。根据三种治疗方法之一对儿童进行随机分组和治疗；最佳实践预防下的常规龋齿管理、最佳实践预防下的龋齿生物管理或最佳实践预防单独。基线措施和结果数据（在三年随访期间的复查/治疗时评估）通过直接报告、包括盲法 X 光评估的临床检查以及儿童/家长问卷进行评估。主要结局指标是与龋齿相关的疼痛或感染的发生率。次要结局包括：乳牙和恒牙龋齿的发生率、患者生活质量、成本效益、治疗策略对患者和家长的可接受性及其体验、以及牙医的偏好。
FiCTION 将为管理初级保健中儿童乳牙龋齿最具临床有效性和成本效益的方法提供证据。这将支持普通牙科医生为儿童患者做出治疗决策，以最大程度地减少乳牙的疼痛和感染。该试验目前正在招募患者。
方案 ID：NCTU：ISRCTN77044005。
