Afrashtehfar Kelvin I, Alfallaj Hayam A, Fernandez Eduardo, Hussaini Souheil
Department of Reconstructive Dentistry and Gerodontology, School of Dental Medicine, University of Bern, Bern, Switzerland.
Private Practice, Abu Dhabi City, UAE.
Evid Based Dent. 2025 Mar;26(1):29-31. doi: 10.1038/s41432-024-01073-9. Epub 2024 Oct 14.
This multi-center, randomized clinical trial compared the long-term outcomes of guided bone regeneration (GBR) with open flap debridement (OFD) in treating peri-implantitis-related bony defects with ≥3 osseous walls over 36 months. The study aimed to evaluate the healing potential of GBR using a deproteinized bovine bone mineral (DBBM) graft and native bilayer collagen membrane (NBCM) compared to OFD without the use of graft materials.
Sixty-six individuals diagnosed with peri-implantitis were randomly assigned to either GBR (34 patients) or OFD (32 patients). The OFD group served as the control, where inflamed tissue was removed and the implant surface decontaminated using 3% hydrogen peroxide, but no bone graft was placed. The GBR group received DBBM and NBCM for defect reconstruction. Radiographic defect fill (RDF), probing pocket depth (PPD), bleeding on probing (BOP), suppuration (SUP), mucosal recession (MREC), and patient-reported outcomes (PROs) were assessed over the study duration. Post-surgical care included azithromycin, ibuprofen, and chlorhexidine rinses.
The study involved baseline assessments, surgical interventions, and follow-ups at 6, 12, and 36 months. Supportive peri-implant therapy was provided every 3 months during the additional 24-month follow-up.
Primary outcome was RDF at 36 months. Secondary outcomes included PPD, BOP, SUP, MREC, and PROs. Descriptive statistics and ANCOVA models were used for analysis.
At 36 months, GBR resulted in a mean RDF of 2.13 ± 1.26 mm, compared to 1.64 ± 1.54 mm with OFD (p = .18). No significant differences were found in PPD, BOP, SUP, REC, or PROs between the groups. Treatment success (defined as no additional bone loss, PPD ≤ 5 mm, no BOP, and no SUP) was achieved in 46.2% of GBR cases and 20% of OFD cases (p = 0.053).
GBR provided improved short-term defect fill and higher treatment success compared to OFD, although the differences were not statistically significant. Both procedures maintained clinical parameters over 36 months, with similar patient satisfaction (PROs) observed for GBR and OFD. The adjunct use of DBBM and NBCM may offer clinical benefits for peri-implantitis cases with specific bony defect morphology.
这项多中心随机临床试验比较了引导骨再生(GBR)与开放式翻瓣清创术(OFD)治疗骨壁≥3层的种植体周围炎相关骨缺损36个月的长期疗效。该研究旨在评估与不使用移植材料的OFD相比,使用脱蛋白牛骨矿物质(DBBM)移植物和天然双层胶原膜(NBCM)的GBR的愈合潜力。
66例被诊断为种植体周围炎的个体被随机分配到GBR组(34例患者)或OFD组(32例患者)。OFD组作为对照组,去除炎症组织并用3%过氧化氢对种植体表面进行去污,但不植入骨移植材料。GBR组接受DBBM和NBCM进行缺损重建。在研究期间评估影像学缺损填充(RDF)、探诊袋深度(PPD)、探诊出血(BOP)、化脓(SUP)、黏膜退缩(MREC)和患者报告结局(PROs)。术后护理包括阿奇霉素、布洛芬和洗必泰冲洗。
该研究包括基线评估、手术干预以及在6、12和36个月时的随访。在额外的24个月随访期间,每3个月提供一次种植体周围支持性治疗。
主要结局是36个月时的RDF。次要结局包括PPD、BOP、SUP、MREC和PROs。使用描述性统计和协方差分析模型进行分析。
在36个月时,GBR组的平均RDF为2.13±1.26mm,而OFD组为1.64±1.54mm(p = 0.18)。两组在PPD、BOP、SUP、REC或PROs方面未发现显著差异。GBR组46.2%的病例和OFD组20%的病例实现了治疗成功(定义为无额外骨丢失、PPD≤5mm、无BOP且无SUP)(p = 0.053)。
与OFD相比,GBR在短期缺损填充方面有所改善,治疗成功率更高,尽管差异无统计学意义。两种手术在36个月内均维持了临床参数,GBR和OFD的患者满意度(PROs)相似。DBBM和NBCM的辅助使用可能对具有特定骨缺损形态的种植体周围炎病例具有临床益处。