Influence of Implant Surface Decontamination on the Reconstructive Outcomes of Peri-implantitis: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Resolution of the disease
研究概览
简要总结
Two groups are aimed at being investigated in three centers (CICOM, Clinica Branemark and Clinica Joan Pi)
- Test group: Group electrolytic approach (EA): Mechanical detoxification using curettes + NiTi brushes + EA (GalvoSurge) during 2 minutes
- Control group: Group hydrogen peroxide (HP): Mechanical detoxification using curettes + NiTi brushes + hydrogen peroxide 5% for 2 minutes soaked in a gauze Patients´ group selection will be randomly allocated. For patients whom their personal clinical record # ends in a number from 0 to 4 will be included in the test group, while for patients whom their personal clinical record # ends from 5-9 will be included in the control group.
The infra-osseous component will be regenerated using xenograft (Creos, NB) + autogenous bone in a ratio 1:1 harvested from the adjacent area. A resorbable membrane (Creos, NB) will be placed to compartmentalize the infra-osseous component following a poncho-like approach.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Screw-retained or cement-retained fixed or removable implant-supported prosthesis for a minimum of 36 months.
- •All patients in age of 18 to 80
- •non-smokers
- •no presence of systemic disease or medication known to alter bone metabolism
- •partial or complete edentulous patients that have no active periodontal disease.
排除标准
- •pregnancy or lactation
- •history of or current smokers
- •uncontrolled medical conditions,
- •lacking keratinized mucosa (≤2mm) on the lingual or buccal implant sites,
- •advanced(A) peri-implantitis (>50% of the implant length).
研究组 & 干预措施
Group electrolytic approach (EA)
Mechanical detoxification using curettes + NiTi brushes + EA (GalvoSurge) during 2 minutes
干预措施: Surface decontamination procedure aiming at reconstructive therapy (Device)
Group hydrogen peroxide (HP)
Group hydrogen peroxide (HP): Mechanical detoxification using curettes + NiTi brushes + hydrogen peroxide 5% for 2 minutes soaked in a gauze
干预措施: Surface decontamination procedure aiming at reconstructive therapy (Device)
结局指标
主要结局
Resolution of the disease
时间窗: 12 months
No pocket depth \>6mm, no bleeding on probing, no suppuration, no progressive bone loss
次要结局
- Radiographic bone gain and clinical outcomes(12 months)