PDF(Pubmed)
Abstract：
BACKGROUND: Full pulpotomy has been proposed as an alternative to root canal treatment in teeth with signs and symptoms indicative of irreversible pulpitis (IRP), but the evidence is limited, relying on underpowered studies with a high risk of bias. The aim of this study is to conduct a prospective meta-analysis (PMA) of individual participant data of a series of individual randomised trials to provide robust evidence on the clinical and cost-effectiveness of pulpotomy compared with root canal treatment.
METHODS: Individual participant data will be obtained from a series of randomised trials designed and conducted by a consortium of multi-national investigators with an interest in vital pulp treatment. These individualised trials will be conducted using a specified protocol, defined outcomes, and outcome measures. Ten parallel-group randomised trials currently being conducted in 10 countries will provide data from more than 500 participants. The primary outcome is a composite measure defined as (1) the absence of pain indicative of IRP, (2) the absence of signs and symptoms indicative of acute or chronic apical periodontitis, and (3) the absence of radiographic evidence of failure including radiolucency or resorption. Individual participant data will be obtained, assessed, and checked for quality by two independent reviewers prior to the PMA. Pooled estimates on treatment effects will be generated using a 2-stage meta-analysis approach. The first stage involves a standard regression analysis in each trial to produce aggregate data on treatment effect estimates followed by an inverse variance weighted meta-analysis to combine these aggregate data and produce summary statistics and forest plots. Cost-effectiveness analysis based on the composite outcome will be undertaken as a process evaluation to evaluate treatment fidelity and acceptability by patients and dentists.
RESULTS: The research question and trial protocol were developed and approved by investigators in all 10 sites. All sites use shared resources including study protocols, data collection forms, participant information leaflets, and consent forms in order to improve flow, consistency, and reproducibility. Each site obtained its own Institutional Review Board approval, and trials were registered in appropriate open access platforms. Patient recruitment has started in most sites, as of July 2023.
CONCLUSIONS: PMA offers a rigorous, flexible, and efficient methodology to answer this important research question and provide results with improved generalisability and external validity compared with traditional trials and retrospective meta-analyses. The results of this study will have implications for both the delivery of clinical practice and structured clinical guidelines\' development.
BACKGROUND: PROSPERO CRD42023446809. Registered on 08 February 2023.
METHODS: Individual participant data will be obtained from a series of randomised trials designed and conducted by a consortium of multi-national investigators with an interest in vital pulp treatment. These individualised trials will be conducted using a specified protocol, defined outcomes, and outcome measures. Ten parallel-group randomised trials currently being conducted in 10 countries will provide data from more than 500 participants. The primary outcome is a composite measure defined as (1) the absence of pain indicative of IRP, (2) the absence of signs and symptoms indicative of acute or chronic apical periodontitis, and (3) the absence of radiographic evidence of failure including radiolucency or resorption. Individual participant data will be obtained, assessed, and checked for quality by two independent reviewers prior to the PMA. Pooled estimates on treatment effects will be generated using a 2-stage meta-analysis approach. The first stage involves a standard regression analysis in each trial to produce aggregate data on treatment effect estimates followed by an inverse variance weighted meta-analysis to combine these aggregate data and produce summary statistics and forest plots. Cost-effectiveness analysis based on the composite outcome will be undertaken as a process evaluation to evaluate treatment fidelity and acceptability by patients and dentists.
RESULTS: The research question and trial protocol were developed and approved by investigators in all 10 sites. All sites use shared resources including study protocols, data collection forms, participant information leaflets, and consent forms in order to improve flow, consistency, and reproducibility. Each site obtained its own Institutional Review Board approval, and trials were registered in appropriate open access platforms. Patient recruitment has started in most sites, as of July 2023.
CONCLUSIONS: PMA offers a rigorous, flexible, and efficient methodology to answer this important research question and provide results with improved generalisability and external validity compared with traditional trials and retrospective meta-analyses. The results of this study will have implications for both the delivery of clinical practice and structured clinical guidelines\' development.
BACKGROUND: PROSPERO CRD42023446809. Registered on 08 February 2023.
摘要：
背景：已提出将全髓切除术作为根管治疗的替代方法，用于具有不可逆牙髓炎（IRP）体征和症状的牙齿，但证据有限,依赖能力不足的研究，偏倚风险很高。这项研究的目的是对一系列个体随机试验的个体参与者数据进行前瞻性荟萃分析（PMA），以提供关于牙髓切除术与根管治疗相比的临床和成本效益的有力证据。
方法：个体参与者的数据将从一系列随机试验中获得，这些试验是由对重要牙髓治疗感兴趣的跨国研究人员联盟设计和进行的。这些个性化试验将使用指定的方案进行，定义的结果，和结果措施。目前在10个国家进行的10项平行组随机试验将提供来自500多名参与者的数据。主要结果是一个综合指标，定义为（1）没有指示IRP的疼痛，（2）没有指示急性或慢性根尖周炎的体征和症状，和(3)缺乏失败的影像学证据,包括射线不透性或再吸收。将获得个人参与者数据，评估,并在PMA之前由两名独立审查员检查质量。将使用2阶段荟萃分析方法生成对治疗效果的汇总估计。第一阶段包括在每个试验中进行标准回归分析，以产生有关治疗效果估计的汇总数据，然后进行逆方差加权荟萃分析，以组合这些汇总数据并产生汇总统计数据和森林地块。基于复合结果的成本效益分析将作为过程评估进行，以评估患者和牙医的治疗保真度和可接受性。
结果：研究问题和试验方案是由所有10个研究中心的研究者制定和批准的。所有网站使用共享资源，包括研究协议，数据收集表单，参与者信息传单，和同意书，以改善流动，一致性,和再现性。每个网站都获得了自己的机构审查委员会的批准，试验在适当的开放获取平台注册.大多数地点已经开始招募患者，截至2023年7月。
结论：PMA提供了严格的，灵活,和有效的方法来回答这一重要的研究问题，并提供与传统试验和回顾性荟萃分析相比具有改进的普遍性和外部效度的结果。这项研究的结果将对临床实践的实施和结构化临床指南的制定都有意义。
背景：PROSPEROCRD42023446809.2023年2月8日注册。
方法：个体参与者的数据将从一系列随机试验中获得，这些试验是由对重要牙髓治疗感兴趣的跨国研究人员联盟设计和进行的。这些个性化试验将使用指定的方案进行，定义的结果，和结果措施。目前在10个国家进行的10项平行组随机试验将提供来自500多名参与者的数据。主要结果是一个综合指标，定义为（1）没有指示IRP的疼痛，（2）没有指示急性或慢性根尖周炎的体征和症状，和(3)缺乏失败的影像学证据,包括射线不透性或再吸收。将获得个人参与者数据，评估,并在PMA之前由两名独立审查员检查质量。将使用2阶段荟萃分析方法生成对治疗效果的汇总估计。第一阶段包括在每个试验中进行标准回归分析，以产生有关治疗效果估计的汇总数据，然后进行逆方差加权荟萃分析，以组合这些汇总数据并产生汇总统计数据和森林地块。基于复合结果的成本效益分析将作为过程评估进行，以评估患者和牙医的治疗保真度和可接受性。
结果：研究问题和试验方案是由所有10个研究中心的研究者制定和批准的。所有网站使用共享资源，包括研究协议，数据收集表单，参与者信息传单，和同意书，以改善流动，一致性,和再现性。每个网站都获得了自己的机构审查委员会的批准，试验在适当的开放获取平台注册.大多数地点已经开始招募患者，截至2023年7月。
结论：PMA提供了严格的，灵活,和有效的方法来回答这一重要的研究问题，并提供与传统试验和回顾性荟萃分析相比具有改进的普遍性和外部效度的结果。这项研究的结果将对临床实践的实施和结构化临床指南的制定都有意义。
背景：PROSPEROCRD42023446809.2023年2月8日注册。
