Division of Dentistry, School of Medical Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, UK.
Cochrane Oral Health, Division of Dentistry, School of Medical Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, UK.
Cochrane Database Syst Rev. 2021 Mar 15;3(3):CD014545. doi: 10.1002/14651858.CD014545.
The detection and diagnosis of caries at the earliest opportunity is fundamental to the preservation of tooth tissue and maintenance of oral health. Radiographs have traditionally been used to supplement the conventional visual-tactile clinical examination. Accurate, timely detection and diagnosis of early signs of disease could afford patients the opportunity of less invasive treatment with less destruction of tooth tissue, reduce the need for treatment with aerosol-generating procedures, and potentially result in a reduced cost of care to the patient and to healthcare services.
To determine the diagnostic accuracy of different dental imaging methods to inform the detection and diagnosis of non-cavitated enamel only coronal dental caries.
Cochrane Oral Health's Information Specialist undertook a search of the following databases: MEDLINE Ovid (1946 to 31 December 2018); Embase Ovid (1980 to 31 December 2018); US National Institutes of Health Ongoing Trials Register (ClinicalTrials.gov, to 31 December 2018); and the World Health Organization International Clinical Trials Registry Platform (to 31 December 2018). We studied reference lists as well as published systematic review articles.
We included diagnostic accuracy study designs that compared a dental imaging method with a reference standard (histology, excavation, enhanced visual examination), studies that evaluated the diagnostic accuracy of single index tests, and studies that directly compared two or more index tests. Studies reporting at both the patient or tooth surface level were included. In vitro and in vivo studies were eligible for inclusion. Studies that explicitly recruited participants with more advanced lesions that were obviously into dentine or frankly cavitated were excluded. We also excluded studies that artificially created carious lesions and those that used an index test during the excavation of dental caries to ascertain the optimum depth of excavation.
Two review authors extracted data independently and in duplicate using a standardised data extraction form and quality assessment based on QUADAS-2 specific to the clinical context. Estimates of diagnostic accuracy were determined using the bivariate hierarchical method to produce summary points of sensitivity and specificity with 95% confidence regions. Comparative accuracy of different radiograph methods was conducted based on indirect and direct comparisons between methods. Potential sources of heterogeneity were pre-specified and explored visually and more formally through meta-regression.
We included 104 datasets from 77 studies reporting a total of 15,518 tooth sites or surfaces. The most frequently reported imaging methods were analogue radiographs (55 datasets from 51 studies) and digital radiographs (42 datasets from 40 studies) followed by cone beam computed tomography (CBCT) (7 datasets from 7 studies). Only 17 studies were of an in vivo study design, carried out in a clinical setting. No studies were considered to be at low risk of bias across all four domains but 16 studies were judged to have low concern for applicability across all domains. The patient selection domain had the largest number of studies judged to be at high risk of bias (43 studies); the index test, reference standard, and flow and timing domains were judged to be at high risk of bias in 30, 12, and 7 studies respectively. Studies were synthesised using a hierarchical bivariate method for meta-analysis. There was substantial variability in the results of the individual studies, with sensitivities that ranged from 0 to 0.96 and specificities from 0 to 1.00. For all imaging methods the estimated summary sensitivity and specificity point was 0.47 (95% confidence interval (CI) 0.40 to 0.53) and 0.88 (95% CI 0.84 to 0.92), respectively. In a cohort of 1000 tooth surfaces with a prevalence of enamel caries of 63%, this would result in 337 tooth surfaces being classified as disease free when enamel caries was truly present (false negatives), and 43 tooth surfaces being classified as diseased in the absence of enamel caries (false positives). Meta-regression indicated that measures of accuracy differed according to the imaging method (Chi(4) = 32.44, P < 0.001), with the highest sensitivity observed for CBCT, and the highest specificity observed for analogue radiographs. None of the specified potential sources of heterogeneity were able to explain the variability in results. No studies included restored teeth in their sample or reported the inclusion of sealants. We rated the certainty of the evidence as low for sensitivity and specificity and downgraded two levels in total for risk of bias due to limitations in the design and conduct of the included studies, indirectness arising from the in vitro studies, and the observed inconsistency of the results.
AUTHORS' CONCLUSIONS: The design and conduct of studies to determine the diagnostic accuracy of methods to detect and diagnose caries in situ are particularly challenging. Low-certainty evidence suggests that imaging for the detection or diagnosis of early caries may have poor sensitivity but acceptable specificity, resulting in a relatively high number of false-negative results with the potential for early disease to progress. If left untreated, the opportunity to provide professional or self-care practices to arrest or reverse early caries lesions will be missed. The specificity of lesion detection is however relatively high, and one could argue that initiation of non-invasive management (such as the use of topical fluoride), is probably of low risk. CBCT showed superior sensitivity to analogue or digital radiographs but has very limited applicability to the general dental practitioner. However, given the high-radiation dose, and potential for caries-like artefacts from existing restorations, its use cannot be justified in routine caries detection. Nonetheless, if early incidental carious lesions are detected in CBCT scans taken for other purposes, these should be reported. CBCT has the potential to be used as a reference standard in diagnostic studies of this type. Despite the robust methodology applied in this comprehensive review, the results should be interpreted with some caution due to shortcomings in the design and execution of many of the included studies. Future research should evaluate the comparative accuracy of different methods, be undertaken in a clinical setting, and focus on minimising bias arising from the use of imperfect reference standards in clinical studies.
尽早发现龋病并进行诊断对于保护牙组织和维护口腔健康至关重要。传统上，放射线检查被用于补充常规的视觉触觉临床检查。准确、及时地发现和诊断早期疾病，可以为患者提供机会进行侵袭性较小的治疗，减少对气溶胶生成程序的治疗需求，并可能降低患者和医疗服务的护理成本。
确定不同牙科成像方法的诊断准确性，以发现和诊断非窝沟性釉质冠部龋病。
Cochrane 口腔健康信息专家检索了以下数据库：MEDLINE Ovid（1946 年至 2018 年 12 月 31 日）；Embase Ovid（1980 年至 2018 年 12 月 31 日）；美国国立卫生研究院正在进行的试验注册（ClinicalTrials.gov，截至 2018 年 12 月 31 日）；以及世界卫生组织国际临床试验注册平台（截至 2018 年 12 月 31 日）。我们还研究了参考文献列表以及已发表的系统评价文章。
我们纳入了比较一种牙科成像方法与参考标准（组织学、挖掘、增强的视觉检查）的诊断准确性的研究设计，评估单一指标测试诊断准确性的研究，以及直接比较两种或多种指标测试的研究。报告了在患者或牙面水平的研究都被包括在内。体内和体外研究都符合纳入标准。明确招募进展性病变患者的研究（这些病变明显进入牙本质或明显有龋洞）被排除在外。我们还排除了人工制作龋损的研究，以及那些在挖掘龋病以确定挖掘深度的最佳深度时使用指标测试的研究。
两位综述作者使用标准的数据提取表格，以独立和重复的方式提取数据，并根据 QUADAS-2 进行质量评估，该评估特定于临床背景。使用双变量层次方法确定诊断准确性，以产生具有 95%置信区间的敏感性和特异性汇总点。根据方法之间的间接和直接比较，对不同射线照相方法的比较准确性进行了评估。预先指定了潜在的异质性来源，并通过视觉和更正式的元回归进行了探索。
我们纳入了 77 项研究的 104 个数据集，共涉及 15518 个牙面或牙面。最常报道的成像方法是模拟射线照相（51 项研究中有 55 个数据集）和数字射线照相（40 项研究中有 42 个数据集），其次是锥形束计算机断层扫描（CBCT）（7 项研究中有 7 个数据集）。只有 17 项研究是在临床环境中进行的体内研究设计。没有一项研究在所有四个领域都被认为是低偏倚风险的，但 16 项研究在所有领域都被认为是适用度关注低的。患者选择领域有最多的研究被认为是高偏倚风险（43 项研究）；索引测试、参考标准、流程和时间领域分别有 30、12 和 7 项研究被认为是高偏倚风险。使用层次双变量方法对个体研究进行了综合分析。个别研究的结果存在很大差异，敏感性范围从 0 到 0.96，特异性从 0 到 1.00。对于所有成像方法，估计的综合敏感性和特异性点分别为 0.47（95%置信区间 0.40 至 0.53）和 0.88（95%置信区间 0.84 至 0.92）。在一个包含 1000 个牙面、釉质龋患病率为 63%的队列中，这将导致 337 个牙面在真正存在釉质龋时被归类为无病（假阴性），43 个牙面在无釉质龋时被归类为有病（假阳性）。元回归表明，准确性的衡量标准因成像方法而异（Chi(4) = 32.44, P < 0.001），CBCT 观察到的敏感性最高，模拟射线照相的特异性最高。没有指定的潜在混杂源能够解释结果的变异性。没有研究将修复牙纳入样本或报告包括密封剂。我们将证据的确定性评级为敏感性和特异性低，并因研究设计和实施的局限性、来自体外研究的间接性以及结果的不一致性而总共降低了两个级别。
确定用于检测和诊断原位龋的方法的诊断准确性的研究设计和进行具有特别大的挑战性。低确定性证据表明，影像学检测或诊断早期龋病可能敏感性较差，但特异性较好，导致潜在疾病进展的假阴性结果相对较多。如果不进行治疗，将错过提供专业或自我保健实践以阻止或逆转早期龋病病变的机会。然而，病变检测的特异性相对较高，人们可能会认为开始非侵入性管理（如使用局部氟化物）的风险较低。CBCT 对模拟或数字射线照相的敏感性优于，但其在一般牙医中的适用性非常有限。然而，鉴于其辐射剂量高，以及现有修复体可能出现类似龋病的伪影，其在常规龋病检测中不能被证明是合理的。尽管如此，如果在其他目的的 CBCT 扫描中偶然发现早期牙本质龋损，这些应该报告。CBCT 有可能成为这类诊断研究的参考标准。尽管本综述采用了稳健的方法，但由于许多纳入研究的设计和执行存在缺陷，结果应谨慎解释。未来的研究应评估不同方法的比较准确性，在临床环境中进行，并侧重于最大限度地减少临床研究中使用不完美参考标准引起的偏倚。
