Resective Surgical Treatment of Peri-implantitis. A Randomized Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- probing depth
研究概览
简要总结
Surgical treatment of peri-implantitis can be regenerative or resective, depending on defect configuration. The aim of resective therapy of peri-implantitis is to reduce the severity of soft tissue inflammation and stabilize crestal bone levels whilst reducing probing depths.This will be a multicenter randomized controlled trial in which two resective peri-implantitis protocols will be assessed. The aim of this trial is to compare a resective approach in the surgical treatment of peri-implantitis (decontamination performed with titanium brushes and sterile saline) with a resective approach combined with implantoplasty.
详细描述
The aim of the present multicenter randomized controlled trial is to compare a resective approach in the surgical treatment of peri-implantitis (decontamination performed with titanium brushes and sterile saline) with a resective approach combined with implantoplasty.
Primary outcome:
Probing depth (PD) dicrease is defined as the primary pitcome of this study.
Research Hypothesis Based upon previous evidence, our research hypothesis is that the test group (implantoplasty + resective approach) will perform better than the control group (resective surgery alone), namely the alternative hypothesis, in terms of defect resolution (probing depth decrease, absence of bleeding and/or suppuration and absence of progressive bone loss), 18 months after the surgical treatment.
Material and methods The present study has a prospective, multicenter, randomized controlled clinical trial design in which subjects will be consecutively enrolled according to defined inclusion and exclusion criteria. Two centers participating in this study are: Department of Periodontics and Oral Medicine, School of Dental Medicine, University of Belgrade and Department of Periodontology and Protshodontics, Eastman Dental Hospital, Policlinico Umberto I, Rome, Italy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •· Patients >18 years old, able to provide consent and willing to undergo study procedures.
- •Implants in function for at least 1 year.
- •Patients with implant-supported partial/full jaw restorations having at least one implant diagnosed with peri-implantitis (probing pocket depth [PPD] ≥6mm, bleeding/suppuration on probing [BoP/SoP+] and marginal bone loss >2 mm compared to a previous radiographic examination or marginal bone level >3 mm (Berglundh et al. 2018)
- •Patients with suprabony defects and intrabony defects up to 3mm in depth
- •Retrievability of prosthetic reconstructions prior the surgical treatment (i.e. screw-retained restorations or cement-retained restorations which can easily be removed prior to all study visits)
- •According to classification by Monje (Monje, 2019), implants presenting Class II, eventually Class IIIa and Class IIIb
- •No implant mobility
- •No evidence of occlusal overload
- •Satisfactory oral hygiene level (FMPS<25%) and periodontal health or localized periodontal inflammation (FMBS<30%)
- •Treated periodontal disease with adequate periodontal supportive therapy
排除标准
- •· Patients unable or unwilling to comply with study procedures and study visits.
- •Pregnant or nursing women
- •Local conditions that may interfere with surgical treatment (non-treated periodontal disease, acute infections, carious lesions, etc.)
- •Compromised systemic health preventing the patient from attending study visits or representing a contraindication for surgical treatment
- •Patients with uncontrolled systemic conditions which may affect healing (i.e. diabetes mellitus). Diabetic patients will have to document their level of metabolic control by means of HbA1c and will only be included when HbA1c<7%.
- •Patients smoking more than 5 cigarettes per day (self-reported)
- •Patients taking medications known to interfere with gingival or bone metabolism (e.g. calcium channel blockers, bisphosphonates).
结局指标
主要结局
probing depth
时间窗: 18 months
measured distance in milimeters from the mucosal margin to the bottom of the probeable pocket (mm).
次要结局
未报告次要终点
研究者
Iva Milinkovic
Assisstant Professor
University of Belgrade