Adjunctive Benefit of Electrolytic Cleaning on Non-surgical Treatment of Peri-implantitis. A 1-year Randomized Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Probing pocket depth
研究概览
简要总结
Evaluate the outcomes of non-surgical therapy of peri-implantitis with the adjunctive use of electrolytic cleaning (Galvo Surge®).
The proposed protocol, focused on the non-surgical treatment of peri-implantitis, will result in a higher percentage of subjects with disease resolution (probing depts ≤ 5mm, absence of BOP and/or SOP and no further bone loss) at 1 year of follow-up.
详细描述
The adjunctive use of electrolytic cleaning (Galvo Surge®) in the non-surgical treatment of peri-implantitis will result in a higher reduction of probing depth than the control group.
The adjunctive use of electrolytic cleaning (Galvo Surge®) in the non-surgical treatment of peri-implantitis will result in a higher radiographic bone fill of the peri-implant defect than the control group.
The adjunctive use of electrolytic cleaning (Galvo Surge®) in the non-surgical treatment of peri-implantitis will result in a lower count of peri-implant pathogens than the control group.
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
- •Partially edentulous patients, rehabilitated with at least one dental implant in the maxilla or mandible;
- •Presence of Peri-implantitis;
- •No implant mobility;
- •Treated periodontal disease;
- •No systemic diseases that could influence the outcome of the therapy (i.e. uncontrolled diabetes, osteoporosis, bisphosphonate medication).
- •Non-smoker or light smoking status in smokers (<10 cigarettes/day).
排除标准
- •(1) Pregnant, lactating women and non-collaborating patients will be excluded from the study.
结局指标
主要结局
Probing pocket depth
时间窗: Assessing the change of probing pocket depth from baseline at 3 months, 6 months and 12 months
Will be calculated as the distance from the gingival peri-implant margin to the bottom of the peri-implant pocket (Mombelli \& Lang, 1994).
Bleeding on probing
时间窗: Assessing the change from bleeding on probing from baseline at 3 months, 6 months and 12 months
will be assessed dichotomously in six sites per implant (Heitz-Mayfield, 2008).
Clinical attachment level
时间窗: Assessing the change from clinical attachment level from baseline at 3 months, 6 months and 12 months
will be calculated as the sum of PPD and REC (distance from the most apical portion of the crown to the bottom of the periodontal pocket)
Recession
时间窗: Assessing the change of recession from baseline at 3 months, 6 months and 12 months
will be measured as the distance from the free marginal mucosa to the most apical portion of the crown.
Radiographic Parameters
时间窗: Assessing the change of the radiographic parameters from baseline at 3 months, 6 months
Radiographic analysis through orthopantomography, periapical intraoral radiographs according to the parallelometric technique (using a silicone bite record so that the radiographs are parallelized and comparable to each other in different timepoints, checking in millimeters the increase or decrease in bone loss).
次要结局
- Microbiological Parameters(Assessing the change of the microbiological parameters from baseline at 3 months, 6 months)
研究者
Vanessa Rocha Rodrigues
Dr
University of Lisbon