METHODS: The study followed a split-mouth, double-blind, and randomized controlled clinical design for a duration of 3 years. Twenty-two eligible patients with 44 implants were randomly assigned to two groups: Group 1 (one-piece zirconia abutment with zirconia base, n = 22) and Group 2 (two-piece zirconia abutment with titanium base, n = 22). The primary outcome was the technical complication rate. Additionally, survival rates, cytokines concentrations in peri-implant crevicular fluid (PICF), peri-implant conditions, marginal bone loss, and pink/white esthetics score (PES/WES) were assessed as secondary outcomes.
RESULTS: Twelve of 22 patients attended the 1-year follow-up (due to the COVID pandemic), and 19 patients attended the 3-year examination. Two abutments in Group 1 were fractured after 10 and 12 months in function. Additionally, one screw loosening occurred in Group 1 at 1-year follow-up. The 3-year technical complication rate was significantly higher in Group 1 than that in Group 2 (15.79% vs. 0%, p < .001). The 3-year implant survival rate was 100% in both groups. The concentration of IFN-γ in PICF was significantly upregulated in Group 2 (p = .018). Furthermore, the IL-6 concentration was positively correlated with BOP% (p = .020).
CONCLUSIONS: Two-piece zirconia abutments exhibited superior technical performance compared to one-piece designs during a 3-year follow-up in the anterior region. However, further long-term research is necessary to verify the immunological stability of two-piece zirconia abutments.
方法:这项研究遵循张口,双盲,和随机对照临床设计,为期3年。将22例符合条件的44个植入物的患者随机分为两组:第1组(带有氧化锆基底的一体式氧化锆基台,n=22)和第2组(带有钛基的两件式氧化锆基台,n=22)。主要结果是技术并发症发生率。此外,存活率,种植体周围液(PICF)中的细胞因子浓度,种植体周围条件,边缘性骨丢失,粉红/白色美学评分(PES/WES)作为次要结局.
结果:22名患者中有12名参加了为期1年的随访(由于COVID大流行),19名患者参加了为期3年的检查。第1组的两个基牙在功能上10和12个月后断裂。此外,随访1年时,第1组出现1个螺钉松动.第1组的3年技术并发症发生率明显高于第2组(15.79%vs.0%,p<.001)。两组的3年植入物生存率均为100%。PICF中IFN-γ的浓度在第2组中显著上调(p=.018)。此外,IL-6浓度与BOP%呈正相关(p=0.020)。
结论:两片式氧化锆基台在前部区域进行了3年的随访期间,与单件式设计相比,表现出优越的技术性能。然而,需要进一步的长期研究来验证两件式氧化锆基台的免疫学稳定性。