Outcome Indicators of Non-surgical Therapy of Peri-implantitis: a 6-months
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Disease resolution
研究概览
简要总结
Objectives: To identify patient and implant indicators influencing the non-surgical therapeutic outcomes of peri-implantitis at 6-months follow-up.
Material and methods: This prospective cohort study included patients with at least one implant diagnosed with peri-implantitis according to the 2017 World Workshop. Non-surgical therapy consisted in a mechanical debridement of the peri-implant pockets combined with the metronidazole 500 mg every 8 hours during 7 days. At baseline and at 6 months, clinical and radiographic variables were collected to calculate the success of the therapy. The influence of patient and implant/prosthetic variables on disease resolution were assessed trough simple and multiple logistic regression analysis at patient and implant level using generalized estimation equations models.
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
- •Subjects over 18 years old
- •At least one implant in function for more than 1 year diagnosed with peri-implantitis following the case definition of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions (Berglundh et al., 2018).
排除标准
- •Previous surgical therapy of peri-implantitis
- •Allergy to metronidazole
- •Clinical implant mobility
- •Pregnancy or lactating females
- •Previous non-surgical treatment (i.e., submucosal debridement) of the affected implants at least 12 months before
- •Use of systemic antibiotics during the previous 3 months as well as use of systemic antibiotics for endocarditis prophylaxis,
- •Systemic diseases, medications, or conditions that may compromise wound healing and influence the outcome of the therapy.
结局指标
主要结局
Disease resolution
时间窗: 6 months
Probing pocket depth reduction to 5 mm without bleeding on probing (BoP) or \<5 mm irrespective to BoP in all implant sites together with lack of progression of peri-implant bone loss
次要结局
- Changes(From baseline to 6 months)
- Plaque index (PI)(From baseline to 6 months)
- Changes in Bleeding on probing (BoP)(From baseline to 6 months)
- Changes in soft tissue margin(From baseline to 6 months)
- Changes in Suppuration on probing (BoP)(From baseline to 6 months)
- Changes in PPD(From baseline to 6 months)
研究者
Javi Vilarrasa
Clinical Professor
Universitat Internacional de Catalunya