Department of Conservative Dentistry, Faculty of Dentistry, Cairo University, 11 EL-Saraya St. Manial, Cairo, 11553, Egypt.
Faculty of Dentistry, Beni-Suef University, Beni Suef, Egypt.
BMC Oral Health. 2023 Jun 17;23(1):402. doi: 10.1186/s12903-023-03102-y.
Open gingival embrasures form complex aesthetic and functional problems. This clinical trial assessed the bioclear matrix using injection molding technique against conventional celluloid matrix technique in management of black triangle.
A total of 26 participants were randomly divided into two groups (13 participants each) according to the technique used. In group (A) celluloid conventional matrix method was used, while in group (B) bioclear matrix with injection molding technique was used. The different outcomes (Esthetic evaluation, marginal integrity and patient satisfaction) were evaluated following the FDI criteria by two blinded examiners. The evaluation was done at (T0) (immediate after restoration); (T6) after 6 months; and (T12) after 12 months. Statistical analysis was done as categorical and ordinal data were presented as frequency and percentage values. Categorical data were compared using fisher's exact test. Intergroup comparisons for ordinal data were analyzed utilizing the Mann-Whitney U test, while intragroup comparisons were analyzed using Friedman's test followed by the Nemenyi post hoc test. The significance level was set at p ≤ 0.05 within all tests.
Regarding radiographic marginal integrity and marginal adaptation, the bioclear matrix group revealed superior results when compared to celluloid matrix group with a significant difference between both groups at all intervals (p < 0.05); however no significant difference was detected at different intervals. While for proximal anatomical form and esthetic anatomical form, as well as phonetics and food impaction, all cases in both groups were successful with no statistical significant difference between groups. For the periodontal response, there was no significant difference between groups. However, there was a significant difference between scores measured at different intervals, with T0 being significantly different from other intervals (p < 0.001). Marginal staining revealed that there was no significant difference between groups. While, a significant difference between scores measured at different intervals.
The restorative management of the black triangle with both protocols was able to deliver superior aesthetic and good marginal adaptation; suitable biological properties; with adequate survival time. Both techniques were almost equally successful, however they are depending on the operator skills.
The clinical trial was registered in the ( www.
gov/ ) database in 23/07/2020; with the unique identification number NCT04482790.
开龈间隙形成复杂的美学和功能问题。本临床试验采用注塑技术的 bioclear 基质，与传统的赛璐珞基质技术对照，评估其在黑三角管理中的应用。
根据使用的技术，将 26 名参与者随机分为两组（每组 13 名）。在组（A）中使用赛璐珞常规基质法，而在组（B）中使用注塑 bioclear 基质法。使用两位盲检员根据 FDI 标准评估不同的结果（美学评估、边缘完整性和患者满意度）。评估在（T0）（修复后即刻）；（T6）在 6 个月后；以及（T12）在 12 个月后进行。分类数据以频数和百分比表示，有序数据采用 Fisher 确切检验进行比较。对组间有序数据进行组间比较，采用 Mann-Whitney U 检验，组内比较采用 Friedman 检验，然后进行 Nemenyi 事后检验。所有检验的显著性水平均设为 p≤0.05。
在放射学边缘完整性和边缘适应性方面，bioclear 基质组的结果优于赛璐珞基质组，两组在所有时间点均有显著差异（p<0.05）；然而，不同时间点之间没有发现显著差异。在近中解剖形态和美学解剖形态以及语音和食物嵌塞方面，两组所有病例均成功，组间无统计学差异。两组牙周反应无显著差异。然而，在不同时间点测量的评分之间存在显著差异，T0 与其他时间点有显著差异（p<0.001）。边缘染色显示组间无显著差异。然而，在不同时间点测量的评分之间存在显著差异。
两种方案治疗黑三角都能提供良好的美学效果和良好的边缘适应性；具有合适的生物学特性；具有足够的生存时间。两种技术都几乎同样成功，但这取决于操作人员的技能。
该临床试验于 2020 年 7 月 23 日在（www.clinicaltrials.gov）数据库中注册；注册号为 NCT04482790。
