Department of Oral Diagnostics, Digital Health and Health Research Services, Charité - Universitätsmedizin Berlin, Berlin, Germany.
Division of Dentistry, School of Medical Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, UK.
Cochrane Database Syst Rev. 2021 Jul 19;7(7):CD013039. doi: 10.1002/14651858.CD013039.pub2.
Traditionally, cavitated carious lesions and those extending into dentine have been treated by 'complete' removal of carious tissue, i.e. non-selective removal and conventional restoration (CR). Alternative strategies for managing cavitated or dentine carious lesions remove less or none of the carious tissue and include selective carious tissue removal (or selective excavation (SE)), stepwise carious tissue removal (SW), sealing carious lesions using sealant materials, sealing using preformed metal crowns (Hall Technique, HT), and non-restorative cavity control (NRCC).
To determine the comparative effectiveness of interventions (CR, SE, SW, sealing of carious lesions using sealant materials or preformed metal crowns (HT), or NRCC) to treat carious lesions conventionally considered to require restorations (cavitated or micro-cavitated lesions, or occlusal lesions that are clinically non-cavitated but clinically/radiographically extend into dentine) in primary or permanent teeth with vital (sensitive) pulps.
An information specialist searched four bibliographic databases to 21 July 2020 and used additional search methods to identify published, unpublished and ongoing studies. SELECTION CRITERIA: We included randomised clinical trials comparing different levels of carious tissue removal, as listed above, against each other, placebo, or no treatment. Participants had permanent or primary teeth (or both), and vital pulps (i.e. no irreversible pulpitis/pulp necrosis), and carious lesions conventionally considered to need a restoration (i.e. cavitated lesions, or non- or micro-cavitated lesions radiographically extending into dentine). The primary outcome was failure, a composite measure of pulp exposure, endodontic therapy, tooth extraction, and restorative complications (including resealing of sealed lesions).
Pairs of review authors independently screened search results, extracted data, and assessed the risk of bias in the studies and the overall certainty of the evidence using GRADE criteria. We measured treatment effects through analysing dichotomous outcomes (presence/absence of complications) and expressing them as odds ratios (OR) with 95% confidence intervals (CI). For failure in the subgroup of deep lesions, we used network meta-analysis to assess and rank the relative effectiveness of different interventions.
We included 27 studies with 3350 participants and 4195 teeth/lesions, which were conducted in 11 countries and published between 1977 and 2020. Twenty-four studies used a parallel-group design and three were split-mouth. Two studies included adults only, 20 included children/adolescents only and five included both. Ten studies evaluated permanent teeth, 16 evaluated primary teeth and one evaluated both. Three studies treated non-cavitated lesions; 12 treated cavitated, deep lesions, and 12 treated cavitated but not deep lesions or lesions of varying depth. Seventeen studies compared conventional treatment (CR) with a less invasive treatment: SE (8), SW (4), two HT (2), sealing with sealant materials (4) and NRCC (1). Other comparisons were: SE versus HT (2); SE versus SW (4); SE versus sealing with sealant materials (2); sealant materials versus no sealing (2). Follow-up times varied from no follow-up (pulp exposure during treatment) to 120 months, the most common being 12 to 24 months. All studies were at overall high risk of bias. Effect of interventions Sealing using sealants versus other interventions for non-cavitated or cavitated but not deep lesions There was insufficient evidence of a difference between sealing with sealants and CR (OR 5.00, 95% CI 0.51 to 49.27; 1 study, 41 teeth, permanent teeth, cavitated), sealing versus SE (OR 3.11, 95% CI 0.11 to 85.52; 2 studies, 82 primary teeth, cavitated) or sealing versus no treatment (OR 0.05, 95% CI 0.00 to 2.71; 2 studies, 103 permanent teeth, non-cavitated), but we assessed all as very low-certainty evidence. HT, CR, SE, NRCC for cavitated, but not deep lesions in primary teeth The odds of failure may be higher for CR than HT (OR 8.35, 95% CI 3.73 to 18.68; 2 studies, 249 teeth; low-certainty evidence) and lower for HT than NRCC (OR 0.19, 95% CI 0.05 to 0.74; 1 study, 84 teeth, very low-certainty evidence). There was insufficient evidence of a difference between SE versus HT (OR 8.94, 95% CI 0.57 to 139.67; 2 studies, 586 teeth) or CR versus NRCC (OR 1.16, 95% CI 0.50 to 2.71; 1 study, 102 teeth), both very low-certainty evidence. CR, SE, SW for deep lesions The odds of failure were higher for CR than SW in permanent teeth (OR 2.06, 95% CI 1.34 to 3.17; 3 studies, 398 teeth; moderate-certainty evidence), but not primary teeth (OR 2.43, 95% CI 0.65 to 9.12; 1 study, 63 teeth; very low-certainty evidence). The odds of failure may be higher for CR than SE in permanent teeth (OR 11.32, 95% CI 1.97 to 65.02; 2 studies, 179 teeth) and primary teeth (OR 4.43, 95% CI 1.04 to 18.77; 4 studies, 265 teeth), both very low-certainty evidence. Notably, two studies compared CR versus SE in cavitated, but not deep lesions, with insufficient evidence of a difference in outcome (OR 0.62, 95% CI 0.21 to 1.88; 204 teeth; very low-certainty evidence). The odds of failure were higher for SW than SE in permanent teeth (OR 2.25, 95% CI 1.33 to 3.82; 3 studies, 371 teeth; moderate-certainty evidence), but not primary teeth (OR 2.05, 95% CI 0.49 to 8.62; 2 studies, 126 teeth; very low-certainty evidence). For deep lesions, a network meta-analysis showed the probability of failure to be greatest for CR compared with SE, SW and HT.
AUTHORS' CONCLUSIONS: Compared with CR, there were lower numbers of failures with HT and SE in the primary dentition, and with SE and SW in the permanent dentition. Most studies showed high risk of bias and limited precision of estimates due to small sample size and typically limited numbers of failures, resulting in assessments of low or very low certainty of evidence for most comparisons.
传统上,已经对窝沟龋和延伸到牙本质的龋损进行了“完全”去除龋坏组织的治疗,即非选择性去除和常规修复(CR)。管理窝沟或牙本质龋损的替代策略去除的龋坏组织较少或不进行去除,包括选择性龋坏组织去除(或选择性挖掘(SE))、逐步龋坏组织去除(SW)、使用密封材料密封龋损、使用预成型金属冠密封(HT)和非修复性窝洞控制(NRCC)。
确定干预措施(CR、SE、SW、使用密封材料或预成型金属冠密封窝洞(HT)或 NRCC)在原发性或永久性牙髓活力(敏感)的牙齿中治疗通常需要修复的龋损的相对有效性(磨牙或近中磨牙窝沟龋损,或临床上无窝沟但临床上/放射学上延伸到牙本质的非窝沟或微窝沟龋损)。
信息专家检索了四个文献数据库,截至 2020 年 7 月 21 日,并使用其他检索方法来确定已发表、未发表和正在进行的研究。纳入标准为:随机临床试验比较了不同水平的龋坏组织去除,如上文所述,彼此之间、安慰剂或不治疗。参与者有恒牙或乳牙(或两者兼有),以及活力牙髓(即无不可逆性牙髓炎/牙髓坏死),以及通常需要修复的龋损(即窝沟龋损,或放射学上不窝沟但延伸到牙本质的非窝沟或微窝沟龋损)。主要结局是失败,这是牙髓暴露、根管治疗、拔牙和修复并发症(包括密封后再次密封)的综合衡量指标。
我们将对搜索结果进行筛选、提取数据,并评估研究的偏倚风险和使用 GRADE 标准评估证据的总体确定性。我们通过分析二项结局(并发症的存在/不存在)来测量治疗效果,并以比值比(OR)和 95%置信区间(CI)表示。对于深龋的亚组失败,我们使用网络荟萃分析来评估和排名不同干预措施的相对有效性。
我们纳入了 27 项研究,共 3350 名参与者和 4195 颗/个牙齿/病变,这些研究分别在 11 个国家进行,发表时间在 1977 年至 2020 年之间。24 项研究采用平行组设计,3 项为劈裂口设计。两项研究仅纳入成年人,20 项研究仅纳入儿童/青少年,五项研究同时纳入两者。10 项研究评估了恒牙,16 项评估了乳牙,一项评估了两者。三项研究比较了非窝沟龋;12 项研究比较了窝沟但不深的龋损,12 项研究比较了窝沟但不深的龋损或病变深度不同的龋损。17 项研究比较了常规治疗(CR)与侵袭性较小的治疗方法:SE(8)、SW(4)、两种 HT(2)、密封剂材料(4)和 NRCC(1)。其他比较包括:SE 与 HT(2);SE 与 SW(4);SE 与密封剂材料(2);密封剂材料与不密封(2)。随访时间从治疗过程中的牙髓暴露(无随访)到 120 个月不等,最常见的是 12 至 24 个月。所有研究的总体偏倚风险均较高。
对于非窝沟或窝沟但不深的龋损,与 CR 相比,使用密封剂进行密封的效果如何:与 CR(OR 5.00,95%CI 0.51 至 49.27;1 项研究,41 颗牙,恒牙,窝沟)相比,密封与 CR(OR 3.11,95%CI 0.11 至 85.52;2 项研究,82 颗乳牙,窝沟)或不治疗(OR 0.05,95%CI 0.00 至 2.71;2 项研究,103 颗恒牙,非窝沟)相比,密封剂的失败可能性更小,但我们将所有这些都评估为非常低确定性证据。HT、CR、SE、NRCC 治疗原发性牙髓活力(敏感)的窝沟但不深的龋损:与 CR 相比,HT(OR 8.35,95%CI 3.73 至 18.68;2 项研究,249 颗牙;低确定性证据)的失败可能性更高,与 NRCC(OR 0.19,95%CI 0.05 至 0.74;1 项研究,84 颗牙,极低确定性证据)的失败可能性更低。与 HT(OR 8.94,95%CI 0.57 至 139.67;2 项研究,586 颗牙)或 CR(OR 1.16,95%CI 0.50 至 2.71;1 项研究,102 颗牙)相比,SE 的失败可能性差异无统计学意义,均为极低确定性证据。对于深龋损,CR 与 SW 的效果如何:与 SW(OR 2.06,95%CI 1.34 至 3.17;3 项研究,398 颗牙;中等确定性证据)相比,CR(OR 2.43,95%CI 0.65 至 9.12;1 项研究,63 颗牙;极低确定性证据)的失败可能性更高。与 SE(OR 11.32,95%CI 1.97 至 65.02;2 项研究,179 颗牙)和 SE(OR 4.43,95%CI 1.04 至 18.77;4 项研究,265 颗牙)相比,CR(OR 4.43,95%CI 1.04 至 18.77;4 项研究,265 颗牙)的失败可能性更高,均为极低确定性证据。值得注意的是,两项研究比较了 CR 与 SE 在窝沟但不深的龋损中的效果,结果表明两者的结局差异无统计学意义(OR 0.62,95%CI 0.21 至 1.88;204 颗牙;极低确定性证据)。SW(OR 2.25,95%CI 1.33 至 3.82;3 项研究,371 颗牙;中等确定性证据)的失败可能性高于 SE(OR 2.05,95%CI 0.49 至 8.62;2 项研究,126 颗牙;极低确定性证据),但在乳牙中则相反(OR 2.05,95%CI 0.49 至 8.62;2 项研究,126 颗牙;极低确定性证据)。对于深龋损,网络荟萃分析显示与 SE、SW 和 HT 相比,CR 的失败概率最高。
与 CR 相比,HT 和 SE 在初级牙列中,SE 和 SW 在恒牙列中失败的可能性较低。大多数研究显示,由于样本量小且通常失败病例数量有限,导致偏倚风险高且估计精度有限,因此大多数比较的证据确定性均为低或极低。