Matos Thalita de Paris, da Cruz Kaliane Rodrigues, Favoreto Michael Willian, Castro Andrea Dos Santos de, Cardoso Mylena de Abreu, Baratto-Filho Flares, Araujo Cristiano Miranda de, Aguirre-Balseca Mauricio, Reis Alessandra, Loguercio Alessandro D
Department of Restorative Dentistry, Tuiuti University of Parana, Padre Ladislau Kula, 395, Santo Inácio, Curitiba, Paraná, 82010-210, Brazil.
Facultad de Ciencias de la Salud, Carrera de Odontologia, Universidad De Los Hemisferios, Quito, Ecuador.
J Dent. 2025 Feb;153:105519. doi: 10.1016/j.jdent.2024.105519. Epub 2024 Dec 8.
This double-blind, split-mouth, randomized equivalence clinical trial aimed to evaluate the 18-month clinical performance of an ormocer-based single-shade resin composite compared with an ormocer-based multi-shade resin composite in non-carious cervical lesions (NCCLs).
One hundred and twenty restorations were performed on NCCLs with two restorative materials (n = 60): Admira Fusion X-tra resin composite (ormocer-based single-shade), and Admira Fusion resin composite (ormocer-based multi-shade). After rubber dam isolation, a universal adhesive was applied in the selective enamel etching strategy. For both groups, restorations were inserted incrementally and light-cured. The restorations were clinically evaluated at 6, 12, and 18 months according to the updated FDI (World Dental Federation) criteria. Statistical analysis was performed using Friedman repeated measures ANOVA by rank and Mann-Whitney test for pairwise significance (α = 0.05).
All restorations were evaluated after 18 months, and nine restorations were lost. Fracture of the material and retention rates (95 % confidence interval [CI]) were 93 % (84-97 CI) for the ormocer-based single-shade and 91 % (82-96 CI) for the ormocer-based multi-shade, with no statistical differences between them (p > 0.05). The absolute risk (95 % CI) was 0.8 (0.2 to 3.1).
The updated FDI evaluation criteria showed equivalent results for ormocer-based single-shade and ormocer-based multi-shade after 18 months.
Using an ormocer-based single-shade resin composite in NCCLs is advisable due to its convenience, ease of application, and lower cost compared to ormocer-based multi-shade composites without compromising clinical performance.
本双盲、半口、随机等效性临床试验旨在评估基于有机硅氧烷陶瓷的单色调树脂复合材料与基于有机硅氧烷陶瓷的多色调树脂复合材料在非龋性颈部病变（NCCLs）中的18个月临床性能。
使用两种修复材料（n = 60）对NCCLs进行了120次修复：Admira Fusion X-tra树脂复合材料（基于有机硅氧烷陶瓷的单色调）和Admira Fusion树脂复合材料（基于有机硅氧烷陶瓷的多色调）。在橡皮障隔离后，采用选择性釉质酸蚀策略应用通用粘结剂。对于两组，修复体均采用分层插入并光固化。根据更新后的FDI（世界牙科联盟）标准，在6个月、12个月和18个月时对修复体进行临床评估。采用Friedman重复测量方差分析进行统计分析，并采用Mann-Whitney检验进行两两显著性检验（α = 0.05）。
18个月后对所有修复体进行了评估，9个修复体脱落。基于有机硅氧烷陶瓷的单色调材料的断裂率和保留率（95%置信区间[CI]）分别为93%（84 - 97 CI）和基于有机硅氧烷陶瓷的多色调材料的91%（82 - 96 CI），两者之间无统计学差异（p > 0.05）。绝对风险（95% CI）为0.8（0.2至3.1）。
更新后的FDI评估标准显示，18个月后基于有机硅氧烷陶瓷的单色调和多色调材料的结果相当。
在NCCLs中使用基于有机硅氧烷陶瓷的单色调树脂复合材料是可取的，因为与基于有机硅氧烷陶瓷的多色调复合材料相比，它具有便利性、易于应用且成本较低的优点，同时不影响临床性能。
