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种植体周骨缺损的重建:一项多中心随机试验。

Reconstruction of Peri-implant Osseous Defects: A Multicenter Randomized Trial.

机构信息

Department of Periodontology, Operative and Preventive Dentistry, University of Bonn, Bonn, Germany

Department of Periodontology, Operative and Preventive Dentistry, University of Bonn, Bonn, Germany.

出版信息

J Dent Res. 2016 Jan;95(1):58-66. doi: 10.1177/0022034515610056. Epub 2015 Oct 8.

DOI:10.1177/0022034515610056
PMID:26450511
Abstract

There is a paucity of data for the effectiveness of reconstructive procedures in the treatment of peri-implantitis. The objective of this study was to compare reconstruction of peri-implant osseous defects with open flap debridement (OFD) plus porous titanium granules (PTGs) compared with OFD alone. Sixty-three patients (36 female, 27 male; mean age 58.4 y [SD 12.3]), contributing one circumferential peri-implant intraosseous defect, were included in a multinational, multicenter randomized trial using a parallel-group design. After OFD and surface decontamination using titanium brushes and hydrogen peroxide, 33 defects received PTGs. The implants were not submerged. All patients received adjunctive perioperative systemic antibiotics. The primary outcome variable (defect fill) was assessed on digitalized radiographs. Clinical measurements of probing depth (PPD), bleeding on probing (BoP), suppuration, and plaque were taken by blinded examiners. After 12 mo, the test group (OFD plus PTG) showed a mean radiographic defect fill (mesial/distal) of 3.6/3.6 mm compared with 1.1/1.0 in the control group (OFD). Differences were statistically significant in favor of the test group (P < 0.0001). The OFD plus PTG group showed a mean reduction in PPD of 2.8 mm compared with 2.6 mm in the OFD group. BoP was reduced from 89.4% to 33.3% and from 85.8% to 40.4% for the test and control groups, respectively. There was no significant difference in complete resolution of peri-implantitis (PPD ≤4 mm and no BoP at six implant sites and no further bone loss), because this finding was accomplished at 30% of implants in the test group and 23% of implants in the control group. Reconstructive surgery using PTGs resulted in significantly enhanced radiographic defect fill compared with OFD. However, limitations in the lack of ability to discern biomaterial from osseous tissue could not be verified to determine new bone formation. Similar improvements according to clinical measures were obtained after both surgical treatment modalities (ClinicalTrials.gov NCT02406001).

摘要

在治疗种植体周围炎方面,重建手术的有效性数据很少。本研究的目的是比较骨缺损重建与开放式翻瓣清创术(OFD)加多孔钛颗粒(PTG)和单独 OFD 的效果。63 名患者(36 名女性,27 名男性;平均年龄 58.4 岁[SD 12.3]),每个患者有一个环形种植体周围骨内缺损,参与了一项使用平行组设计的多国多中心随机试验。在 OFD 和使用钛刷和过氧化氢进行表面去污后,33 个缺损部位接受了 PTG 治疗。种植体未被淹没。所有患者均接受辅助围手术期全身抗生素治疗。主要结局变量(缺损填充)通过数字化射线照相进行评估。由盲法检查者进行探诊深度(PPD)、探诊出血(BoP)、溢脓和菌斑的临床测量。12 个月后,试验组(OFD+PTG)的平均放射学缺损填充(近/远中)为 3.6/3.6mm,而对照组(OFD)为 1.1/1.0mm。试验组的差异具有统计学意义(P<0.0001)。OFD+PTG 组的 PPD 平均减少 2.8mm,而 OFD 组为 2.6mm。BoP 分别从试验组的 89.4%降至 33.3%,从对照组的 85.8%降至 40.4%。在种植体周围炎完全缓解方面(6 个种植体位点的 PPD≤4mm,无 BoP,无进一步骨吸收)没有显著差异,因为试验组有 30%的种植体和对照组有 23%的种植体达到这一结果。与 OFD 相比,使用 PTG 的重建手术可显著提高放射学缺损填充。然而,由于无法从骨组织中辨别生物材料,因此无法验证重建手术是否导致新骨形成。两种手术治疗方式均获得了类似的临床改善(ClinicalTrials.gov NCT02406001)。

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