Alibegovic Lamija, Trullenque-Eriksson Anna, Ortiz-Vigón Alberto, Guerrero Adrián, Donati Mauro, Bressan Eriberto, Karlsson Karolina, Dionigi Carlotta, Regidor Erik, Ichioka Yuki, Tomasi Cristiano, Ghensi Paolo, Schaller Dennis, Abrahamsson Ingemar, Berglundh Tord, Derks Jan
Department of Periodontology, Institute of Odontology, The Sahlgrenska Academy at University of Gothenburg, Gothenburg, Sweden.
Clínica Ortiz-Vigón, PerioCentrum, Bilbao, Spain.
Clin Oral Implants Res. 2025 Apr;36(4):436-448. doi: 10.1111/clr.14393. Epub 2024 Dec 20.
To evaluate the potential mid-term benefit of the use of a bone substitute material in the reconstructive surgical treatment of peri-implantitis.
A total of 120 subjects (127 implants) affected by peri-implantitis were followed over 3 years in a multicenter randomized clinical trial. Participants had been randomized to either control (access flap surgery) or test group (access flap surgery and bone substitute material). Clinical, radiographic, and patient-reported outcomes were assessed. The primary outcome was a composite measure including probing pocket depth ≤ 5 mm, absence of bleeding and suppuration on probing, soft tissue recession ≤ 1 mm, and implant neither reoperated nor lost. In an additional outcome (disease resolution), we allowed for one bleeding site and did not consider recession.
While 14 implants (11%) were lost and a second surgical intervention had been performed at 3 implants (2.4%), pronounced improvements of clinical parameters were noted at remaining implants in both treatment groups at the 3-year follow-up. This was illustrated by a 3.2-3.5 mm reduction in probing pocket depth and a marginal bone level gain of 1.1-1.3 mm. The primary composite outcome, however, was only achieved at 14% of implants. The second composite outcome defining disease resolution was accomplished at 39% of implants. Patient-reported outcomes were generally favorable.
At 3 years, the use of a bone substitute material in the surgical therapy of peri-implantitis did not result in a clear benefit over access flap surgery alone.
ClinicalTrials.gov identifier: NCT0307706.
评估使用骨替代材料在种植体周围炎重建性外科治疗中的中期潜在益处。
在一项多中心随机临床试验中，对120名患有种植体周围炎的受试者（127颗种植体）进行了3年的随访。参与者被随机分为对照组（翻瓣手术）或试验组（翻瓣手术和骨替代材料）。评估了临床、影像学和患者报告的结果。主要结局是一项综合指标，包括探诊深度≤5毫米、探诊时无出血和化脓、软组织退缩≤1毫米，且种植体既未再次手术也未丢失。在另一个结局（疾病缓解）中，允许有一个出血部位，且不考虑退缩情况。
虽然有14颗种植体（11%）丢失，3颗种植体（2.4%）进行了二次手术干预，但在3年随访时，两个治疗组中其余种植体的临床参数均有明显改善。这表现为探诊深度减少3.2 - 3.5毫米，边缘骨水平增加1.1 - 1.3毫米。然而，主要综合结局仅在14%的种植体上实现。定义疾病缓解的第二个综合结局在39%的种植体上达成。患者报告的结果总体良好。
在3年时，在种植体周围炎的外科治疗中使用骨替代材料相较于单纯翻瓣手术并未带来明显益处。
ClinicalTrials.gov标识符：NCT0307706
