PDF(Pubmed)
Abstract：
BACKGROUND: Dental caries remains a significant problem in England, affecting 11% of 3-year-olds and 23% of 5-year-olds. While current approaches have been extensively investigated, their ability to (1) control pain and infection; (2) prevent hospital admissions, and (3) be implemented within the National Health Service (NHS) contractual arrangements, remains unsatisfactory. Silver diamine fluoride (SDF) is an alternative, non-invasive approach that has proven efficacy in arresting caries progression in primary teeth, principally from studies conducted outside of Europe. Its use in primary dental care in the UK is limited, despite the acknowledged need. The clinical and cost-effectiveness of SDF has not been compared to usual care in the UK. Before a pragmatic randomised controlled trial (RCT) can be conducted to compare SDF to usual care for caries management in young children, there are several uncertainties that require investigation. This study aims to establish whether such an RCT is feasible.
METHODS: This mixed-method parallel design study is a feasibility study with an embedded process evaluation, to compare SDF with usual treatment in primary dental care in the UK. It will be individually randomised, with 13 dentists and therapists, in 8 different dental primary care sites with a sample size of 80 child participants aged 1-8 years old. The aim will be to recruit ten participants per site with equal arm allocation. Follow-up will be for 1 year. The study will inform whether an RCT is feasible by resolving several key uncertainties. The acceptability and implementation of SDF and the research processes will be explored. Patient and Public Involvement and Engagement representatives will be involved throughout recruitment and retention strategies, participant documentation, analysis, engagement and dissemination.
CONCLUSIONS: The ability to conduct an RCT will be evaluated. If feasible, this RCT has the potential to evaluate the effectiveness of a non-invasive approach for the management of untreated caries in young children. A feasibility study also offers the opportunity to consider factors associated with the implementation of SDF at an early stage through a process evaluation that will inform the definitive trial and an implementation strategy for SDF by identifying relevant barriers and facilitators.
BACKGROUND: ClinicalTrials.gov identifier: NCT06092151. Date: 19/10/2023.
METHODS: This mixed-method parallel design study is a feasibility study with an embedded process evaluation, to compare SDF with usual treatment in primary dental care in the UK. It will be individually randomised, with 13 dentists and therapists, in 8 different dental primary care sites with a sample size of 80 child participants aged 1-8 years old. The aim will be to recruit ten participants per site with equal arm allocation. Follow-up will be for 1 year. The study will inform whether an RCT is feasible by resolving several key uncertainties. The acceptability and implementation of SDF and the research processes will be explored. Patient and Public Involvement and Engagement representatives will be involved throughout recruitment and retention strategies, participant documentation, analysis, engagement and dissemination.
CONCLUSIONS: The ability to conduct an RCT will be evaluated. If feasible, this RCT has the potential to evaluate the effectiveness of a non-invasive approach for the management of untreated caries in young children. A feasibility study also offers the opportunity to consider factors associated with the implementation of SDF at an early stage through a process evaluation that will inform the definitive trial and an implementation strategy for SDF by identifying relevant barriers and facilitators.
BACKGROUND: ClinicalTrials.gov identifier: NCT06092151. Date: 19/10/2023.
摘要：
背景：在英格兰，龋齿仍然是一个重大问题，影响11%的3岁儿童和23%的5岁儿童。虽然目前的方法已经被广泛研究，他们的能力（1）控制疼痛和感染；（2）防止住院，和（3）在国家卫生服务（NHS）合同安排内实施，仍然不能令人满意。二氟化银(SDF)是一种替代品，非侵入性方法已被证明在阻止乳牙龋齿进展的疗效，主要来自欧洲以外的研究。它在英国初级牙科护理中的使用有限，尽管公认的需要。SDF的临床和成本效益尚未与英国的常规护理进行比较。在进行实用的随机对照试验（RCT）之前，可以将SDF与幼儿龋齿管理的常规护理进行比较，有几个不确定因素需要调查。本研究旨在确定这种RCT是否可行。
方法：此混合方法并行设计研究是一项具有嵌入式过程评估的可行性研究，将SDF与英国初级牙科护理中的常规治疗进行比较。它将被单独随机化，有13位牙医和治疗师，在8个不同的牙科初级保健中心，样本量为80名1-8岁的儿童参与者。目的是每个站点招募10名参与者，并分配相同的手臂。后续将持续1年。该研究将通过解决几个关键的不确定性来告知RCT是否可行。将探讨SDF的可接受性和实施以及研究过程。患者和公众参与和参与代表将参与整个招聘和保留战略，参与者文档，分析,参与和传播。
结论：将评估进行RCT的能力。如果可行,该RCT有可能评估非侵入性方法治疗幼儿未经治疗的龋齿的有效性.可行性研究还提供了机会，通过过程评估，在早期阶段考虑与SDF实施相关的因素，通过确定相关障碍和促进因素，为SDF的最终试验和实施战略提供信息。
背景：ClinicalTrials.gov标识符：NCT06092151。日期：2023年10月19日。
方法：此混合方法并行设计研究是一项具有嵌入式过程评估的可行性研究，将SDF与英国初级牙科护理中的常规治疗进行比较。它将被单独随机化，有13位牙医和治疗师，在8个不同的牙科初级保健中心，样本量为80名1-8岁的儿童参与者。目的是每个站点招募10名参与者，并分配相同的手臂。后续将持续1年。该研究将通过解决几个关键的不确定性来告知RCT是否可行。将探讨SDF的可接受性和实施以及研究过程。患者和公众参与和参与代表将参与整个招聘和保留战略，参与者文档，分析,参与和传播。
结论：将评估进行RCT的能力。如果可行,该RCT有可能评估非侵入性方法治疗幼儿未经治疗的龋齿的有效性.可行性研究还提供了机会，通过过程评估，在早期阶段考虑与SDF实施相关的因素，通过确定相关障碍和促进因素，为SDF的最终试验和实施战略提供信息。
背景：ClinicalTrials.gov标识符：NCT06092151。日期：2023年10月19日。
