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非创伤性修复治疗与传统修复治疗在龋病管理中的比较

Atraumatic restorative treatment versus conventional restorative treatment for managing dental caries.

作者信息

Dorri Mojtaba, Martinez-Zapata Maria José, Walsh Tanya, Marinho Valeria Cc, Sheiham Deceased Aubrey, Zaror Carlos

机构信息

Department of Restorative Dentistry, Bristol Oral and Dental School, Lower Maudlin Street, Bristol, UK, BS1 2LY.

出版信息

Cochrane Database Syst Rev. 2017 Dec 28;12(12):CD008072. doi: 10.1002/14651858.CD008072.pub2.

Abstract

BACKGROUND

Dental caries is a sugar-dependent disease that damages tooth structure and, due to loss of mineral components, may eventually lead to cavitation. Dental caries is the most prevalent disease worldwide and is considered the most important burden of oral health. Conventional treatment methods (drill and fill) involve the use of rotary burs under local anaesthesia. The need for an electricity supply, expensive handpieces and highly trained dental health personnel may limit access to dental treatment, especially in underdeveloped regions.To overcome the limitations of conventional restorative treatment, the Atraumatic Restorative Treatment (ART) was developed, mainly for treating caries in children living in under-served areas of the world where resources and facilities such as electricity and trained manpower are limited. ART is a minimally invasive approach which involves removal of decayed tissue using hand instruments alone, usually without use of anaesthesia and electrically driven equipment, and restoration of the dental cavity with an adhesive material (glass ionomer cement (GIC), composite resins, resin-modified glass-ionomer cement (RM-GICs) and compomers).

OBJECTIVES

To assess the effects of Atraumatic Restorative Treatment (ART) compared with conventional treatment for managing dental caries lesions in the primary and permanent teeth of children and adults.

SEARCH METHODS

Cochrane Oral Health's Information Specialist searched the following databases: Cochrane Oral Health's Trials Register (to 22 February 2017), the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library, 2017, Issue 1), MEDLINE Ovid (1946 to 22 February 2017), Embase Ovid (1980 to 22 February 2017), LILACS BIREME Virtual Health Library (Latin American and Caribbean Health Science Information database; 1982 to 22 February 2017) and BBO BIREME Virtual Health Library (Bibliografia Brasileira de Odontologia; 1986 to 22 February 2017). The US National Institutes of Health Trials Registry (ClinicalTrials.gov) and the World Health Organization International Clinical Trials Registry Platform were searched for ongoing trials. No restrictions were placed on the language or date of publication when searching the electronic databases.

SELECTION CRITERIA

We included randomised controlled trials (RCTs) with at least six months' follow-up that compared the effects of ART with a conventional restorative approach using the same or different restorative dental materials to treat caries lesions.

DATA COLLECTION AND ANALYSIS

Two review authors independently screened search results, extracted data from included studies and assessed the risk of bias in those studies. We used standard methodological procedures expected by Cochrane to evaluate risk of bias and synthesise data. Where pooling was appropriate we conducted meta-analyses using the random-effects model. We assessed the quality of the evidence using GRADE criteria.

MAIN RESULTS

We included a total of 15 eligible studies randomising 3760 participants in this review. The age of participants across the studies ranged from 3 to 101 years, with a mean of 25.42 years. 48% of participants were male. All included studies were published between 2002 and 2016. Two of the 15 studies declared that the financial support was from companies that manufacture restorative material. Five studies were individually randomised parallel-group studies; six were cluster-randomised parallel-group studies; and four were randomised studies that used a split-mouth design. Eleven studies evaluated the effects of ART on primary teeth only, and four on permanent teeth. The follow-up period of the included studies ranged from 6 months to 36 months. We judged all studies to be at high risk of bias.For the main comparison of ART compared to conventional treatment using the same material: all but two studies used high-viscosity glass ionomer (H-GIC) as the restorative material; one study used a composite material; and one study used resin-modified glass ionomer cement (RM-GIC)).Compared to conventional treatment using H-GIC, ART may increase the risk of restoration failure in the primary dentition, over a follow-up period from 12 to 24 months (OR 1.60, 95% CI 1.13 to 2.27, five studies; 643 participants analysed; low-quality evidence). Our confidence in this effect estimate is limited due to serious concerns over risk of performance and attrition bias. For this comparison, ART may reduce pain during procedure compared with conventional treatment (MD -0.65, 95% CI -1.38 to 0.07; 40 participants analysed; low-quality evidence)Comparisons of ART to conventional treatment using composite or RM-GIC were downgraded to very low quality due to indirectness, imprecision and high risk of performance and attrition bias. Given the very low quality of the evidence from single studies, we are uncertain about the restoration failure of ART compared with conventional treatment using composite over a 24-month follow-up period (OR 1.11, 95% CI 0.54 to 2.29; one study; 57 participants) and ART using RM-GIC in the permanent teeth of older adults with root caries lesions over a six-month follow-up period (OR 2.71, 95% CI 0.94 to 7.81; one study; 64 participants).No studies reported on adverse events or costs.

AUTHORS' CONCLUSIONS: Low-quality evidence suggests that ART using H-GIC may have a higher risk of restoration failure than conventional treatment for caries lesions in primary teeth. The effects of ART using composite and RM-GIC are uncertain due to the very low quality of the evidence and we cannot rely on the findings. Most studies evaluated the effects of ART on the primary dentition.Well-designed RCTs are required that report on restoration failure at clinically meaningful time points, as well as participant-reported outcomes such as pain and discomfort. Due to the potential confounding effects from the use of different dental materials, a robust body of evidence on the effects of ART compared with conventional treatment using the same restoration material is necessary. We identified four ongoing trials that could provide further insights into this area.

摘要

背景

龋齿是一种依赖糖分的疾病,会损害牙齿结构,由于矿物质成分流失,最终可能导致空洞形成。龋齿是全球最普遍的疾病,被认为是口腔健康的最重要负担。传统治疗方法(钻牙补牙)需要在局部麻醉下使用旋转牙钻。对电力供应、昂贵的牙钻以及训练有素的牙科保健人员的需求可能会限制牙科治疗的可及性,尤其是在欠发达地区。为克服传统修复治疗的局限性,开发了非创伤性修复治疗(ART),主要用于治疗生活在世界上资源和设施(如电力和受过培训的人力)有限的服务不足地区的儿童龋齿。ART是一种微创方法,仅使用手动器械去除龋坏组织,通常无需麻醉和电动设备,并用粘结材料(玻璃离子水门汀(GIC)、复合树脂、树脂改性玻璃离子水门汀(RM - GIC)和复合体)修复牙洞。

目的

评估非创伤性修复治疗(ART)与传统治疗相比,对儿童和成人乳牙及恒牙龋损的治疗效果。

检索方法

Cochrane口腔健康信息专家检索了以下数据库:Cochrane口腔健康试验注册库(截至2017年2月22日)、Cochrane对照试验中心注册库(CENTRAL)(Cochrane图书馆,2017年第1期)、MEDLINE Ovid(1946年至2017年2月22日)、Embase Ovid(1980年至2017年2月22日)、LILACS BIREME虚拟健康图书馆(拉丁美洲和加勒比健康科学信息数据库;1982年至2017年2月22日)和BBO BIREME虚拟健康图书馆(巴西牙科学文献;1986年至2017年2月22日)。检索了美国国立卫生研究院试验注册库(ClinicalTrials.gov)和世界卫生组织国际临床试验注册平台以查找正在进行的试验。检索电子数据库时对语言或出版日期没有限制。

选择标准

我们纳入了至少随访6个月的随机对照试验(RCT),这些试验比较了ART与使用相同或不同牙科修复材料的传统修复方法治疗龋损的效果。

数据收集与分析

两位综述作者独立筛选检索结果,从纳入研究中提取数据并评估这些研究的偏倚风险。我们使用Cochrane期望的标准方法程序来评估偏倚风险并汇总数据。在合适的情况下,我们使用随机效应模型进行Meta分析。我们使用GRADE标准评估证据质量。

主要结果

本综述共纳入15项合格研究,随机分配了3760名参与者。各研究中参与者的年龄范围为3至101岁,平均年龄为25.42岁。48%的参与者为男性。所有纳入研究均发表于2002年至2016年之间。15项研究中有两项声明其资金支持来自修复材料制造商。5项研究为个体随机平行组研究;6项为整群随机平行组研究;4项为采用口内对照设计的随机研究。11项研究仅评估了ART对乳牙的效果,4项研究评估了对恒牙的效果。纳入研究的随访期为6个月至36个月。我们判断所有研究均存在高偏倚风险。

对于ART与使用相同材料的传统治疗的主要比较:除两项研究外,所有研究均使用高粘度玻璃离子水门汀(H - GIC)作为修复材料;一项研究使用复合材料;一项研究使用树脂改性玻璃离子水门汀(RM - GIC)。

与使用H - GIC的传统治疗相比,在12至24个月的随访期内,ART可能会增加乳牙列修复失败的风险(OR 1.60,95%CI 1.13至2.27,5项研究;分析了643名参与者;低质量证据)。由于对实施和失访偏倚风险的严重担忧,我们对这一效应估计的信心有限。对于此比较,与传统治疗相比,ART在操作过程中可能会减轻疼痛(MD -0.65,95%CI -1.38至0.07;分析了40名参与者;低质量证据)。

将ART与使用复合材料或RM - GIC的传统治疗进行比较时,由于间接性、不精确性以及实施和失访偏倚的高风险,证据质量被降为极低。鉴于单项研究的证据质量极低,我们不确定在24个月的随访期内,与使用复合材料的传统治疗相比,ART的修复失败情况(OR 1.11,95%CI 0.54至2.29;1项研究;57名参与者)以及在6个月的随访期内,ART对患有根面龋损的老年人恒牙使用RM - GIC的情况(OR 2.71,95%CI 0.94至7.81;1项研究;64名参与者)。

没有研究报告不良事件或成本。

作者结论

低质量证据表明,对于乳牙龋损,使用H - GIC的ART可能比传统治疗有更高的修复失败风险。由于证据质量极低,使用复合材料和RM - GIC的ART的效果尚不确定,我们不能依赖这些研究结果。大多数研究评估了ART对乳牙列的效果。需要设计良好的RCT,报告在具有临床意义的时间点的修复失败情况,以及参与者报告的结果,如疼痛和不适。由于使用不同牙科材料可能产生的潜在混杂效应,需要有大量关于ART与使用相同修复材料的传统治疗效果比较的有力证据。我们确定了4项正在进行的试验,它们可能会为该领域提供进一步的见解。

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