We aimed to evaluate the impact of 2 visual diagnostic strategies for assessing secondary caries and managing permanent posterior restorations on long-term survival. We conducted a diagnostic cluster-randomized clinical trial with 2 parallel groups using different diagnostic strategies: (C+AS) based on caries assessment, marginal adaptation, and marginal staining aspects of the FDI (World Dental Federation) criteria and (C) based on caries assessment using the Caries Associated with Restorations or Sealants (CARS) criteria described by the International Caries Detection and Assessment System (ICDAS). The treatment for the restoration was conducted based on the decision made following the allocated diagnostic strategy. The restorations were then clinically reevaluated for up to 71 mo. The primary outcome was restoration failure (including tooth-level failure: pain, endodontic treatment, and extraction). Cox regression analyses with shared frailty were conducted in the intention-to-treat population, and hazard ratios (HRs) and 95% confidence intervals (95% CIs) were derived. We included 727 restorations from 185 participants and reassessed 502 (69.1%) restorations during follow-up. The evaluations occurred between 6 and 71 mo. At baseline, C led to almost 4 times fewer interventions compared with the C+AS strategy. A total of 371 restorations were assessed in the C group, from which 31 (8.4%) were repaired or replaced. In contrast, the C+AS group had 356 restorations assessed, from which 113 (31.7%) were repaired or replaced. During follow-up, 34 (9.2%) failures were detected in the restorations allocated to the C group and 30 (8.4%) allocated to the C+AS group in the intention-to-treat population, with no significant difference between the groups (HR = 0.83; 95% CI = 0.51 to 1.38; P = 0.435, C+AS as reference). In conclusion, a diagnostic strategy focusing on marginal defects results in more initial interventions but does not improve longevity over the caries-focused strategy, suggesting the need for more conservative approaches.

中文翻译：

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修复管理的诊断策略：70 个月的随机对照试验。


我们的目的是评估两种视觉诊断策略对评估继发龋和管理永久后牙修复体对长期生存的影响。我们进行了一项诊断整群随机临床试验，有 2 个平行组使用不同的诊断策略：(C+AS) 基于 FDI（世界牙科联合会）标准的龋齿评估、边缘适应和边缘染色方面，(C) 基于使用国际龋齿检测和评估系统 (ICDAS) 描述的与修复体或封闭剂相关的龋齿 (CARS) 标准进行龋齿评估。修复治疗是根据分配的诊断策略做出的决定进行的。然后对修复体进行长达 71 个月的临床重新评估。主要结局是修复失败（包括牙齿水平失败：疼痛、牙髓治疗和拔牙）。在意向治疗人群中进行了具有共同衰弱的 Cox 回归分析，并得出了风险比 (HR) 和 95% 置信区间 (95% CI)。我们纳入了 185 名参与者的 727 个修复体，并在随访期间重新评估了 502 个 (69.1%) 修复体。评估发生在 6 至 71 个月之间。在基线时，与 C+AS 策略相比，C 导致的干预措施减少了近 4 倍。 C组总共评估了371个修复体，其中31个（8.4%）被修复或更换。相比之下，C+AS 组评估了 356 个修复体，其中 113 个（31.7%）被修复或更换。随访期间，意向治疗人群中分配给 C 组的修复体检测到 34 例（9.2%）失败，分配给 C+AS 组的修复体检测到 30 例（8.4%）失败，组间无显着差异（HR = 0.83；95% CI = 0。51至1.38； P = 0.435，C+AS 作为参考）。总之，关注边缘缺陷的诊断策略会导致更多的初始干预，但与关注龋齿的策略相比并不能延长寿命，这表明需要采取更保守的方法。