Regenerative Surgical Treatment of Peri-implantitis Using Nanobone With or Without Simvastatin: A 6-month Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Clinical attachment level (CAL)
研究概览
简要总结
The aim of this study was to evaluate the effect of using a synthetic bone substitute with or without simvastatin on regenerative surgical treatment of bone defects associated with peri-implantitis in a 6- months randomized controlled clinical trial.
A total of 30 patients diagnosed with peri-implantitis were randomly assigned to one of two surgical treatment groups (group I: synthetic bone substitute (NanoBone), group II: NanoBone with simvastatin). Clinical measurements included probing pocket depth (PPD), clinical attachment level (CAL), plaque index (PI), modified sulcus bleeding index (mSBI) and mucosal recession (MR). Radiographic bone fill was evaluated at baseline and after 6- months.
详细描述
The study was designed as a prospective single-center, parallel group, 6 month randomized clinical trial evaluating the effect of a bone substitute; NanoBone® (Artoss GmbH, Rostock, Germany) (group 1, control group) compared to the same bone substitute with simvastatin (Corvast 80 mg, Egyphar, Egypt) (group 2, test group) for RST of peri-implantitis. A total of 30 patients suffering from peri-implantitis who needed regenerative treatment of at least one peri-implant bone defect were selected and only one implant per patient (the most severe) was evaluated in the treatment groups. The criteria for diagnosing peri-implantitis is based on the consensus report of the eighth European Workshop on Periodontology [34] ; the presence of a peri-implant marginal bone loss ≥2 mm based on baseline periapical radiographs after delivery of the final restoration and bleeding on probing (BOP) and/or suppuration with or without concomitant deepening of peri-implant pockets.
Clinical and radiographic evaluation were conducted at baseline and 6 months postoperatively. Grouping was done using a random number table generated by a third party. They were numbered according to the order of enrolment and assigned to group I or group II. The grouping results were sealed in an opaque envelope and kept by an independent third party. For each patient, cards opened immediately before the surgical procedures. Treatment assignment in each patient was registered by the clinician who assisted in the operations and kept concealed until the completion of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
A single examiner blinded to the treatment assignment was responsible for evaluating the clinical parameters
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age > 18 years,
- •having at least one implant demonstrating bone defect ≥3 mm, which presented a probing depth of ≥5 mm with BOP and/or suppuration, implants had to be in function for >12 months,
- •no implant mobility and no evidence of occlusal overload,
- •no evidence of occlusal overload
- •presence of at least 2 mm of keratinized attached mucosa .
排除标准
- •serious systemic diseases, medications or conditions that would contraindicate periodontal surgery and compromise wound healing,
- •history of taking systemic antibiotic during the past 3 months,
- •pregnant or lactating females,
- •implants previously augmented with bone substitute or placed in grafted bone,
- •implants previously treated for peri-implantitis,
- •a mobile implant.
结局指标
主要结局
Clinical attachment level (CAL)
时间窗: 6 months
Clinical attachment level (CAL) defined as probing pocket depth + mucosal recession
次要结局
- probing pocket depth(6 months)
- plaque index (PI)(6 months)
- Bleeding on probing (BoP)(6 months)
- The change in bone level (BL)(6 months)
- Mucosal recession (MR)(6 months)
研究者
Reham Lotfy Aggour
Associate professor of Oral Medicine, diagnosis & Periodontology
October 6 University