Feldspathic and Lithium Disilicate Onlays with a 2-Year Follow-Up: Split-Mouth Randomized Clinical Trial

Abstract The present study was a prospective, controlled, randomized, clinical short-term trial aiming to evaluate the clinical performance of adhesively luted, lithium disilicate and feldspathic glass-ceramics onlays over a period up to 2 years. A total of 11 patients (7 female, 4 male; age range: 18-60 years, mean age: 39 years) were selected for this study. Each patient received a maximum of two restorations per group in a split-mouth-design. LD: Eleven onlays, performed with lithium disilicate-based ceramic (IPS e.max CAD, Ivoclar Vivadent, Schaan, Liechtenstein), and FP: Eleven onlays, performed with feldspathic ceramic (Vita Mark II, Vita Zanhfabrik, Bad Säckingen). Recalls were performed at 2 weeks (baseline = R1), 1 year (R2) and 2 years (R3) after the cementation by three calibrated blinded independent investigators using mirrors, magnifying eyeglasses, probes and bitewing radiographs. The postoperative sensitivity, secondary caries, marginal integrity, marginal discoloration, color match, surface roughness, tooth integrity, and restoration integrity were evaluated. The Friedman test was used to determine if there was a statistically significant difference in time-to-time comparison of the parameters in the ceramics restorations. A total of 95.4% of the restorations were clinically acceptable at the 2-year recall, without a difference for any evaluation parameter for both ceramic materials. Based on the 2-year data, the CAD-CAM onlays manufactured with feldspathic and lithium-disilicate based ceramics showed similar clinical performance.摘要：本研究为一项前瞻性、对照随机的短期临床试验，旨在评估粘接固位的二硅酸锂（lithium disilicate）与长石质玻璃陶瓷（feldspathic glass-ceramics）高嵌体（onlays）的2年内临床性能。本研究共纳入11例患者（女性7例，男性4例；年龄范围18~60岁，平均年龄39岁），所有患者均采用分口试验设计（split-mouth-design），每个材料组最多可为其完成2颗修复体。其中LD组：11颗高嵌体采用二硅酸锂基陶瓷制作（IPS e.max CAD，义获嘉伟瓦登特公司，沙恩，列支敦士登）；FP组：11颗高嵌体采用长石质陶瓷制作（Vita Mark II，Vita Zanhfabrik，巴登萨克辛根，德国）。分别于粘接修复后2周（基线，记为R1）、1年（R2）及2年（R3）进行复诊随访，由3名经过校准的盲法独立研究者采用口镜、放大眼镜、探针及咬合翼片（bitewing radiographs）完成检查。本研究评估的指标包括术后敏感、继发龋、边缘完整性、边缘着色、颜色匹配度、表面粗糙度、牙体完整性及修复体完整性。采用弗里德曼检验（Friedman test）分析两种陶瓷修复体各参数在不同时间点的统计学差异。结果显示，2年复诊随访时95.4%的修复体临床可接受，两种陶瓷材料的所有评估参数均无显著差异。基于2年随访数据，采用长石质与二硅酸锂基陶瓷制作的计算机辅助设计与制造（CAD-CAM）高嵌体具有相似的临床性能。