Monje Alberto, Navarro-Mesa Sofía, Soldini Costanza, Zappalá Giorgio, Peña Pedro, Navarro Jose Manuel, Pons Ramón
Department of Periodontology and Oral Medicine, University of Michigan, Ann Arbor, Michigan, USA.
Department of Periodontology, Universitat Internacional de Catalunya, Barcelona, Spain.
Clin Implant Dent Relat Res. 2025 Aug;27(4):e70075. doi: 10.1111/cid.70075.
To compare the clinical/radiographic outcomes and the rate of disease resolution of the adjunctive use of electrolysis (GS) or hydrogen peroxide (HP) for mechanical decontamination in the reconstructive treatment of peri-implantitis-related intrabony defects.
A multicenter randomized clinical trial was designed to compare the effectiveness and safety of two strategies for the surface decontamination of crater-like and circumferential intrabony defects subjected to reconstructive therapy. Clinical evaluation was made at baseline (T), 6 months (T) and 12 months (T), while radiographic assessment was carried out at T and T. Disease resolution was the primary outcome. Supportive therapy was administered following surgical treatment. Simple and multiple generalized estimating equations (GEE) models were applied to compare the outcomes achieved and to explore potential confounders. Post hoc power calculation was performed to validate the statistical power of the findings.
Overall, 58 patients completed the study. All the clinical parameters/indices, namely probing pocket depth, modified sulcular bleeding index, suppuration grading index, and width of keratinized mucosa, showed a significant reduction (p < 0.001) from T to T in both tested groups. Mucosal recession increased (p < 0.001) from T to T. Marginal bone level and radiographic defect angle increased (p < 0.001) from T to T. The disease resolution rate was 87.5% for the GS group and 64.5% for the HP group at T (p = 0.08). No major postoperative complications were reported.
Both tested surface decontamination methods are effective in resolving peri-implantitis, in gaining radiographic marginal bone levels, and in enhancing clinical peri-implant conditions in the surgical reconstructive therapy (NCT05615051).
比较在种植体周围炎相关骨内缺损的重建治疗中，辅助使用电解法（GS）或过氧化氢（HP）进行机械去污的临床/影像学结果及疾病缓解率。
设计一项多中心随机临床试验，以比较对接受重建治疗的火山口状和环形骨内缺损进行表面去污的两种策略的有效性和安全性。在基线（T0）、6个月（T1）和12个月（T2）进行临床评估，而在T0和T2进行影像学评估。疾病缓解是主要结局。手术治疗后给予支持性治疗。应用简单和多重广义估计方程（GEE）模型比较所取得的结果并探索潜在的混杂因素。进行事后效能计算以验证研究结果的统计效能。
总体而言，58例患者完成了研究。在两个试验组中，所有临床参数/指标，即探诊袋深度、改良龈沟出血指数、化脓分级指数和角化黏膜宽度，从T0到T2均显著降低（p＜0.001）。从T0到T2，黏膜退缩增加（p＜0.001）。边缘骨水平和影像学缺损角度从T0到T2增加（p＜0.001）。在T2时，GS组的疾病缓解率为87.5%，HP组为64.5%（p = 0.08）。未报告重大术后并发症。
在手术重建治疗中，两种测试的表面去污方法在解决种植体周围炎、获得影像学边缘骨水平以及改善种植体周围临床状况方面均有效（NCT05615051）。
