The Use of Erythritol Powder and Locally Derived Metronidazole for the Non-surgical Treatment of Peri-implant Mucositis and Peri-implantitis.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- probing pocket depth change
研究概览
简要总结
20 consecutive adult implant patients, presenting the signs of peri-implant mucositis (probing depth ≥4 mm combined with bleeding and/or pus on probing) or initial peri-implantitis (probing depth ≥4 mm, bleeding and suppuration plus radiographic loss of supporting bone ≤30% compared with the situation after implant placement) will be included.
Sites will be treated by ultrasonic debridement of the pocket, performed using a piezoceramic ultrasonic device. For the purpose, a Tip will be connected to the Handpiece Led (5 minutes/pocket) . Then, it will be followed by the subgingival use of erythritol powder applied by the use of Handpiece connected to an airflow unit 2x5 seconds/pocket. At this time the subgingival delivery of metronidazole gel will be provided. After instrumentation, patients will rinse with chlorhexidine 0.20% 3 times/day for 2 weeks.
At baseline, 1 month, 3 months and 6 months the following parameters will be evaluated: Probing Pocket depth (PPD), Bleeding on Probing (BoP), Clinical Attachment Level (CAL).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients suffering from peri-implant mucositis or peri-implantitis
排除标准
- •Heavy smokers current pregnant history of malignancy long-term steroidal or antibiotic therapy
研究组 & 干预措施
ultrasonic, erythritol, metronidazole gel
干预措施: ultrasonic (Procedure)
ultrasonic, erythritol, metronidazole gel
干预措施: erythritol (Procedure)
ultrasonic, erythritol, metronidazole gel
干预措施: metronidazole gel (Drug)
结局指标
主要结局
probing pocket depth change
时间窗: baseline, 6 months
bleeding on probing change
时间窗: baseline, 6 months
clinical attachment level change
时间窗: baseline, 6 months
次要结局
未报告次要终点