Department of Conservative and Endodontic Dentistry, Nanfang Hospital, Southern Medical University, 1838 N Guangzhou Rd, Guangzhou, 510515, China.
Trials. 2019 Jul 24;20(1):454. doi: 10.1186/s13063-019-3530-1.
After root canal treatment, most tooth defects need to be restored. Onlay restoration is widely used to restore dental defects. Endocrown is a new type of onlay; however, dentists have yet to obtain a full understanding of the clinical effects of marginal forms of endocrowns. Here, we present a multicenter protocol to compare the clinical efficacy of two marginal forms (flat and 90-degree shoulder) for tooth restoration. The efficacy will be evaluated by marginal fit, marginal discoloration, and integrity of restoration.
The proposed flat and 90-degree shoulder marginal endocrown assessment trial is an open-label, parallel-group, multicenter randomized controlled trial involving two hospitals. A total of 200 patients will be included in this trial, and the following patient inclusion criteria will be applied: good oral hygiene habits, no periodontal diseases, receipt of standard root canal treatment, and need for endocrown restoration. Patients will be enrolled after providing signed informed consent and will be divided into two groups (flat and 90-degree shoulder endocrown) in accordance with a random number table. Treatment allocation will be balanced (1:1). Endocrowns will be cemented by dual-cured luting composite. Clinical evaluations will be performed at baseline and at 24 months after treatment in accordance with modified US Public Health Service criteria by two independent evaluators. The primary outcome will be marginal fit; secondary outcome measures will include debonding, marginal discoloration, and integrity of restoration. All acquired data will be analyzed by an independent statistician. Wilcoxon one-sample tests will be used for intra-group comparisons, and Wilcoxon two-sample tests will be used for inter-group comparisons. The Bonferroni method will be used to correct for multiple comparisons, and hierarchical logistic regression will be applied to determine central effects.
The results of this trial will provide a clinical basis for clinicians to restore teeth by endocrowns and to improve long-term restoration for patients.
ClinicalTrials.gov identifier: NCT03398395. Registered on 12 January 2018.
根管治疗后，大多数牙体缺损需要修复。嵌体修复广泛用于牙体缺损的修复。内冠是一种新型嵌体；然而，牙医们还没有充分了解内冠的边缘形式的临床效果。在这里，我们提出了一个多中心方案，比较两种边缘形式（平边和 90 度肩台）在牙齿修复中的临床效果。将通过边缘适合性、边缘变色和修复体完整性来评估疗效。
拟议的平边和 90 度肩台内冠评估试验是一项开放标签、平行组、多中心随机对照试验，涉及两家医院。本试验共纳入 200 例患者，以下为患者纳入标准：良好的口腔卫生习惯、无牙周病、接受标准根管治疗、需要内冠修复。患者签署知情同意书后将被纳入研究，并根据随机数字表将其分为两组（平边和 90 度肩台内冠）。内冠将通过双固化水门汀复合树脂粘结。根据改良美国公共卫生服务标准，由两名独立评估者在基线和治疗后 24 个月进行临床评估。主要结局指标为边缘适合性；次要结局指标包括脱粘、边缘变色和修复体完整性。所有获得的数据将由独立的统计学家进行分析。采用 Wilcoxon 单样本检验进行组内比较，采用 Wilcoxon 两样本检验进行组间比较。采用 Bonferroni 法进行多重比较，采用层次逻辑回归确定中心效应。
该试验的结果将为临床医生通过内冠修复牙齿提供临床依据，并提高患者的长期修复效果。
ClinicalTrials.gov 标识符：NCT03398395。注册于 2018 年 1 月 12 日。
