Faculty of Dentistry, Department of Restorative Dentistry, Hacettepe University, Sıhhıye, 06100, Ankara, Turkey.
Clin Oral Investig. 2021 Apr;25(4):1715-1727. doi: 10.1007/s00784-020-03472-5. Epub 2020 Aug 3.
To compare the clinical behavior of a universal light-curing, ultra-fine particle hybrid composite and successor of this material in class I and II cavities after 60 months.
Forty patients (21 females, 19 males) with ages ranging between 18 and 38 years (23.15 ± 5.15) received 80 (13 Cl I and 67 Cl II) resin composite restorations (Charisma/Charisma Classic, Kulzer GmbH) in combination with an etch and rinse adhesive system (Gluma 2Bond) under rubber dam isolation. Two experienced operators performed all the restorations. Restorations were evaluated by the other two examiners according to the FDI criteria at baseline and at 6, 12, 18, 24, 36, 48 and 60 months. Surface characteristics of one restoration selected randomly were examined under a scanning electron microscope (SEM) at each recall. Data were analyzed statistically (p < 0.05).
After 60 months, recall rate was 90%. None of the restorations failed. Three restorations from Charisma and 4 from the Charisma Classic group showed minor surface staining. Twelve Charisma and 14 Charisma Classic restorations were scored as 2 for margin staining. Four restorations from both groups showed minor shade deviations but no significant difference was observed between the two restorative materials for any criteria evaluated after 60 months (p > 0.05). SEM evaluations were in accordance with the clinical findings.
Both materials exhibited clinically similar and successful performance over the 60-month observation period.
A new formulation of resin composite may not always perform better clinical performances.
ClinicalTrials.gov : NCT02888873.
比较一种通用光固化、超微颗粒混合复合材料及其后续材料在 I 类和 II 类窝洞中的临床行为,随访时间为 60 个月。
40 名患者(21 名女性,19 名男性)年龄在 18 至 38 岁之间(23.15±5.15),共接受 80 个(13 个 Cl I 和 67 个 Cl II)树脂复合修复体(Charisma/Charisma Classic,Kulzer GmbH),并结合酸蚀-冲洗粘结系统(Gluma 2Bond)在橡皮障隔离下进行。由两名经验丰富的操作者进行所有修复。在基线和 6、12、18、24、36、48 和 60 个月时,由另外两名检查者根据 FDI 标准对修复体进行评估。每次复诊时,随机选择一个修复体,通过扫描电子显微镜(SEM)检查其表面特性。数据采用统计学方法进行分析(p<0.05)。
60 个月后,召回率为 90%。无修复体失败。Charisma 组的 3 个修复体和 Charisma Classic 组的 4 个修复体出现轻微表面染色。Charisma 组的 12 个和 Charisma Classic 组的 14 个修复体的边缘染色评分为 2。两组中有 4 个修复体出现轻微的颜色偏差,但在 60 个月后,两种修复材料在任何评估标准上均无显著差异(p>0.05)。SEM 评估结果与临床发现相符。
在 60 个月的观察期内,两种材料均表现出临床相似且成功的性能。
新配方的树脂复合材料并不一定总是具有更好的临床性能。
ClinicalTrials.gov:NCT02888873。