Treatment of Peri-implant Mucositis and Supportive Peri-implant Therapy Using an Erythritol Air- Polishing Device Versus Conventional Mechanical Debridement: A 6-month Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Plaque score (Loe & Silness)
研究概览
简要总结
The investigators are evaluating the therapeutic outcomes of two cleaning instruments on treating peri-implant mucositis. Peri-implant mucositis is inflammation around an implant that is limited to only the gum tissue and is characterized by bleeding on probing, pus, and without any evidence of bone loss. The investigators wish to compare the amount of inflammation and bacteria through measurements (like probing depth) and by collecting fluid and plaque samples around participants' implant after using one of the two cleaning instruments.
详细描述
Despite the potential benefits of an air-polishing device with erythritol powder, clinical trials using the device as a monotherapy for treating patients with peri-implant mucositis remained limited. Therefore, the primary aim of the present study is to compare clinical outcomes of the non-surgical treatment of peri-implant mucositis and subsequent supportive peri-implant therapy (SPIT) using an erythritol air-polishing device or conventional mechanical debridement. The secondary aim is to compare the resolution of inflammation after non-surgical treatment of peri-implant mucositis and to monitor levels of peri-implant tissues inflammation during supportive peri-implant therapy by using the level of selected pro-inflammatory cytokines.
Up to 60 participants with dental implants will be recruited from patients seeking and/or receiving dental care at the University of Michigan Graduate Periodontics department, until 34 peri-mucositis participants and 17 healthy participants are achieved.
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
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Plaque score (Loe & Silness)
时间窗: Baseline, 2 weeks, 4 weeks, 3 months, and 6 months
To compare plaque scores after non-surgical treatment of peri-implant mucositis. Possible scores range from 0 to 3, with higher scores indicating greater plaque accumulation.
Probing depth measurements
时间窗: Baseline, 2 weeks, 4 weeks, 3 months, and 6 months
To compare probing depth measurements in millimeters after non-surgical treatment of peri-implant mucositis
Gum recession measurement
时间窗: Baseline, 2 weeks, 4 weeks, 3 months, and 6 months
To compare gum recession after non-surgical treatment of peri-implant mucositis
Bleeding on probing scores (Mombelli et al.)
时间窗: Baseline, 2 weeks, 4 weeks, 3 months, and 6 months
To compare bleeding on probing after non-surgical treatment of peri-implant mucositis. Possible scores range from 0 to 3, with higher scores indicating heavier bleeding.
Gingival index (Loe & Silness)
时间窗: Baseline, 2 weeks, 4 weeks, 3 months, and 6 months
To compare gingival index scores after non-surgical treatment of peri-implant mucositis. Possible scores range from 0 to 3, with higher scores indicating greater inflammation.
Bone measurement
时间窗: Baseline, 3 months, and 6 months
Loss of supporting bone measured by standardized radiographs
次要结局
- Inflammatory cytokines levels(Baseline, 2 weeks, 4 weeks, 3 months, and 6 months)
- Bacterial DNA levels(Baseline, 2 weeks, 4 weeks, 3 months, and 6 months)
研究者
Hom-Lay Wang, DDS, MSD, Ph D
Collegiate Professor of Periodontics and Professor of Dentistry
University of Michigan