Surgical and Non-surgical Treatment of Peri-implantitis: Multi-center Randomised Controlled Trial of 12-months Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Pocket depth reduction
研究概览
简要总结
This study will compare surgical and non surgical treatments of peri-implantitis. Peri-implantitis is an inflammation around dental implants that can lead to the loss of the implant over time if no treatment is established. The signs of peri-implantitis included bleeding of the gingiva, swelling and redness. Most of times there is no pain. Patients presenting with these characteristics will be included at random to one of the treatment groups. Those allocated to the non-surgical group will received implant cleansing after local anesthesia using adequate instruments. In the surgical group, patients will be submitted to a surgical procedure around the implant for visualization and cleansing also after local anesthesia. All patients will be followed over a 12-month period. The hypothesis is that surgical treatment is better than non-surgical treatment regarding clinical, radiographic, microbiological, and immunological.characteristics.
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 (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals with at least one dental implant with peri-implantitits
- •Individuals with good general health conditions;
- •Individuals presenting at least 10 natural teeth;
- •Individuals with no signs of active periodontitis
排除标准
- •Individuals who received periodontal treatment in the last three months
- •Systemic condition that interferes with treatment such as diabetes
- •Individuals who are taking or have taken antibiotics or anti-inflammatory medication
研究组 & 干预措施
Surgical treatment
Surgical access for scaling and disinfection of dental implant
干预措施: Surgical treatment (Procedure)
Non-surgical treatment
Non-surgical subgingival scaling and disinfection of dental implant
干预措施: Non-surgical treatment (Procedure)
结局指标
主要结局
Pocket depth reduction
时间窗: 12 months
次要结局
- Clinical attachment level changes(12 months)
- Gingival crevicular fluid immune-inflammatory biomarkers(12 motnhs)
- Bleeding on probing(12 months)
- Serum biomarkers of inflammation(12 months)
- Alveolar bone level changes(12 months)
- Subgingival microbiota changes(12 months)
研究者
Alex Nogueira Haas
Associate Professor
Federal University of Rio Grande do Sul