Dental Health Services Research Unit, Dundee Dental School, The University of Dundee, 9th Floor, Park Place, Dundee, DD1 4HN, UK.
NHS Education for Scotland, Edinburgh, UK.
BMC Oral Health. 2021 Jul 9;21(1):336. doi: 10.1186/s12903-021-01637-6.
Dental caries is one of the most prevalent non-communicable disease globally and can have serious health sequelae impacting negatively on quality of life. In the UK most adults experience dental caries during their lifetime and the 2009 Adult Dental Health Survey reported that 85% of adults have at least one dental restoration. Conservative removal of tooth tissue for both primary and secondary caries reduces the risk of failure due to tooth-restoration, complex fracture as well as remaining tooth surfaces being less vulnerable to further caries. However, despite its prevalence there is no consensus on how much caries to remove prior to placing a restoration to achieve optimal outcomes. Evidence for selective compared to complete or near-complete caries removal suggests there may be benefits for selective removal in sustaining tooth vitality, therefore avoiding abscess formation and pain, so eliminating the need for more complex and costly treatment or eventual tooth loss. However, the evidence is of low scientific quality and mainly gleaned from studies in primary teeth.
This is a pragmatic, multi-centre, two-arm patient randomised controlled clinical trial including an internal pilot set in primary dental care in Scotland and England. Dental health professionals will recruit 623 participants over 12-years of age with deep carious lesions in their permanent posterior teeth. Participants will have a single tooth randomised to either the selective caries removal or complete caries removal treatment arm. Baseline measures and outcome data (during the 3-year follow-up period) will be assessed through clinical examination, patient questionnaires and NHS databases. A mixed-method process evaluation will complement the clinical and economic outcome evaluation and examine implementation, mechanisms of impact and context. The primary outcome at three years is sustained tooth vitality. The primary economic outcome is net benefit modelled over a lifetime horizon. Clinical secondary outcomes include pulp exposure, progession of caries, restoration failure; as well as patient-centred and economic outcomes.
SCRiPT will provide evidence for the most clinically effective and cost-beneficial approach to managing deep carious lesions in permanent posterior teeth in primary care. This will support general dental practitioners, patients and policy makers in decision making. Trial Registration Trial registry: ISRCTN.
ISRCTN76503940. Date of Registration: 30.10.2019. URL of trial registry record: https://www.isrctn.com/ISRCTN76503940?q=ISRCTN76503940%20&filters=&sort=&offset=1&totalResults=1&page=1&pageSize=10&searchType=basic-search .
龋齿是全球最普遍的非传染性疾病之一，可对生活质量产生严重的健康后果。在英国，大多数成年人一生中都会经历龋齿，2009 年的《成人牙科健康调查》报告称，85%的成年人至少有一项牙齿修复。对于原发性和继发性龋齿，保守地去除牙齿组织可以降低因牙修复、复杂骨折以及剩余牙面更容易受到进一步龋齿影响而导致的失败风险。然而，尽管龋齿很普遍，但对于放置修复体之前去除多少龋齿以获得最佳效果，尚无共识。与完全或接近完全去除龋齿相比，选择性去除龋齿的证据表明，选择性去除龋齿可能有助于维持牙齿活力，从而避免脓肿形成和疼痛，从而避免更复杂和昂贵的治疗或最终牙齿缺失。然而，证据的科学质量较低，主要来自于初级牙齿的研究。
这是一项在苏格兰和英格兰初级牙科护理中进行的实用、多中心、双臂患者随机对照临床试验，包括内部试点。牙科保健专业人员将在 12 年内招募 623 名患有深龋病变的恒牙后牙患者。参与者将随机分配到选择性龋齿去除或完全龋齿去除治疗组中的单个牙齿。基线测量和结果数据（在 3 年随访期间）将通过临床检查、患者问卷和 NHS 数据库进行评估。混合方法的过程评估将补充临床和经济结果评估，并检查实施、影响机制和背景。三年的主要结果是维持牙齿活力。主要的经济结果是终身模型的净效益。临床次要结果包括牙髓暴露、龋齿进展、修复失败；以及以患者为中心和经济结果。
SCRiPT 将为管理初级保健中恒牙深龋病变最具临床效果和成本效益的方法提供证据。这将支持普通牙科医生、患者和决策者做出决策。试验注册 试验登记处：ISRCTN。
ISRCTN76503940。登记日期：2019 年 10 月 30 日。试验登记网址记录：https://www.isrctn.com/ISRCTN76503940?q=ISRCTN76503940%20&filters=&sort=&offset=1&totalResults=1&page=1&pageSize=10&searchType=basic-search。
