Surgical Treatment of Peri-implantitis With and Without Adjunctive Use of Antibiotics : a Controlled and Randomized Clinical Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- pocket closure
研究概览
简要总结
The objective of this randomized controlled clinical trial is to evaluate the outcome of treatment of peri-implantitis with or without systemic antibiotics.
Specific aims are to analyze (i) the effect of systemic antibiotics and local antiseptics on the healing process, and (ii) the risk for recurrence of disease following surgical treatment of peri-implantitis.
详细描述
The study is designed as a randomized controlled clinical trial. 100 patients with severe peri-implantitis at one or more implants needing surgical treatment will be recruited. All individuals have to show unremarkable general health and not been using any antibiotics during the 6 months preceding the current examination.
The patients will be randomly assigned to the following :
- test group (T) : surgical treatment with systemic antibiotics,
- control group (C) : surgical treatment without systemic antibiotics. A stratification protocol will be applied regarding distribution of smokers. Two subgroups will be formed among test and control subjects.
- saline group (T1 and C1) : the exposed implant surfaces will be cleaned 3 minutes with saline during the surgical treatment, and,
- antiseptics group (T2 and C2) : the exposed implant surfaces will be cleaned 3 minutes with antiseptics (chlorhexidine 0,2%) during the surgical treatment.
A stratification protocol will be applied regarding distribution of smokers.
Following the baseline examination, patients will randomly be assigned to the various treatment group. Samples from the subgingival microbiota will be obtained before surgical therapy.
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 (Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •peri-implant probing pocket depth > 7 mm on at least one aspect of the implant, together with BOP and/or suppuration,
- •marginal bone loss > 3mm as detected in radiographs.
排除标准
- •implant mobility,
- •peri-implantitis associated bone defects not suitable for pocket elimination therapy,
- •systemic diseases that could influence the outcome of the therapy,
- •penicillin allergy.
研究组 & 干预措施
antibiotics and local antiseptics
systemic antibiotics (2 x 750mg amoxicillin/day) + implant surface decontamination with chlorhexidine gluconate 0,2%
干预措施: Amoxicillin (Drug)
antibiotics and local antiseptics
systemic antibiotics (2 x 750mg amoxicillin/day) + implant surface decontamination with chlorhexidine gluconate 0,2%
干预措施: Chlorhexidine gluconate (Drug)
antibiotics without local antiseptics
systemic antibiotics (2 x 750mg amoxicillin/day) + implant surface decontamination with saline
干预措施: Amoxicillin (Drug)
local antiseptics no antibiotics
no systemic antibiotics + implant surface decontamination with chlorhexidine gluconate 0,2%
干预措施: Chlorhexidine gluconate (Drug)
no antibiotics and no local antiseptics
no systemic antibiotics + implant surface decontamination with saline
干预措施: Saline (Drug)
结局指标
主要结局
pocket closure
时间窗: 6 months, 1 year
absence of probing pocket depth \> 5 mm and no bleeding on probing
bone level stability
时间窗: 1 year
no further peri-implant marginal bone loss in the observation period.
次要结局
- Quantitative and qualitative change in levels of the peri-implant microflora(3 months, 6 months, 1 year)