Analysis of the Treatment of Non-surgical Peri-implant Mucositis Treatment in Patients With Tissue-level (TL) and Bone-level (BL) Implants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Bleeding on Probing (BOP) changes
研究概览
简要总结
This study is designed to compare the resolution of inflammation of naturally-occurring peri-implant mucositis (PM) at tissue-level (TL) and bone-level (BL) implants after non-surgical mechanical debridement.
详细描述
Group A: Peri-implant mucositis (PM) at tissue-level (TL) implants after non-surgical mechanical debridement.
Group B: Peri-implant mucositis (PM) bone-level (BL) implants after non-surgical mechanical debridement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female aged > 18 years
- •TL and BL titanium implants with smooth necks supporting cemented or screw-retained single-unit crowns diagnosed with PM (Berglundh, et al.,2018)
- •Implants placed in both arches
- •Patients with gingivitis or treated periodontitis (i.e., absence of residual PD > 5 mm)
- •Presence of at least 2 mm of keratinized mucosa at implant sites.
排除标准
- •presence of medical conditions contraindicating treatment of peri-implant mucositis,
- •regular use of anti-inflammatory drugs or antibiotics within 3 months prior to study enrollment
- •Presence of systemic diseases
- •Pregnant and lactating females
- •Smokers > 10 cigarettes/day
- •Use of inflammatory drugs or antibiotics within 3 months prior to study recruitment
- •Implants with modified (i.e. micro-rough) necks
- •Interproximal open contacts between implant restoration and adjacent teeth
- •Peri-implantitis (Renvert, et al., 2018)
研究组 & 干预措施
Tissue level implant Group
Evaluation of healing of peri-implant mucositis after non-surgical supra and subgingival debridement in patients with tissue level implant
Primary outcome
The primary outcome will be based on probing depth (PD)
干预措施: Bleeding on Probing change reduction following peri-implant mucositis non surgical therapy (Other)
Bone level implant Group
Evaluation of healing of peri-implant mucositis after non-surgical supra and subgingival debridement in patients with bone level implant
Primary outcome
The primary outcome will be the change in Bleeding on Probing (BOP) (Lang, Joss, Orsanic, Gusberti, Siegrist, 1986).
干预措施: Bleeding on Probing change reduction following peri-implant mucositis non surgical therapy (Other)
结局指标
主要结局
Bleeding on Probing (BOP) changes
时间窗: Baseline (T0), 3-months (T1) and at 6-months (T2)
Changes over time in BOP changes (percentage)
次要结局
- Full mouth plaque score (FMPS) changes(Baseline (T0), 3-months (T1) and at 6-months (T2))
研究者
Gaetano Isola, DDS, PhD
Researcher
University of Messina