Implantoplasty as Adjunct to Combined Surgical Therapy of Peri-Implantitis: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Rate of disease resolution
研究概览
简要总结
Implantoplasty entails polishing of the implant surface during the surgical therapy of peri-implantitis. Given the controversy behind implantoplasty as surface decontamination method in the treatment of peri-implantitis, the goal of this clinical trial is to assess the clinical resolution and radiographic bone gain in peri-implantitis sites treated by means of reconstructive therapy (Inteross® + autogenous bone, Sigmagraft, CA, USA) + implantoplasty in combined defects when compared to the extent of implantoplasty along the exposed implant surface upon the clinical resolution and radiographic bone gain in peri-implantitis sites treated by means of reconstructive therapy (Inteross® + autogenous bone, Sigmagraft, CA, USA).
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •All patients in age of 18 to 80, non-smokers
- •With no presence of systemic disease or medication known to alter bone metabolism, and partial or complete edentulous patients that have no active periodontal disease.
- •Peri-implantitis defined according to the EFP/AAP consensus meeting
- •Combined defect configuration
排除标准
- •Pregnancy or lactation
- •History of or current smokers
- •Uncontrolled medical conditions,
- •Cement-retained restoration
- •Lacking keratinized mucosa (≤2mm) on the lingual or buccal implant sites.
研究组 & 干预措施
Implantoplasty
Implantoplasty to all the implant surface
干预措施: Implantoplasty (Procedure)
Implantoplasty on the supracrestal component
Implantoplasty only in the supra-crestal component and the infra bony hydrogen peroxide
干预措施: Implantoplasty (Procedure)
结局指标
主要结局
Rate of disease resolution
时间窗: 12 months after surgery
pocket depth \<6mm, no bleeding on probing, no suppuration, no progressive bone loss
次要结局
未报告次要终点
研究者
Alberto Monje
Head
Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain