NCT03620331已完成不适用
Surgical Treatment of Peri-implantitis With and Without an Initial Non-surgical Approach: a Multi-center Randomized Clinical Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 3
- 主要终点
- Disease Resolution
研究概览
简要总结
Randomized, surgeon and outcome assessor blinded, multi-centric, superiority trial with two parallel groups and a 1:1 allocation ratio with the aim of comparing the surgical treatment of severe peri-implantitis with or without an initial non surgical approach.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
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
- •Any patient having at least one implant affected by severe peri-implantitis, being at least 18 years old and able to sign an informed consent form will be potentially eligible for this trial.
- •Severe peri-implantitis will be defined as peri-implant probing pocket depth [PPD] ≥6 mm in at least 1 site of the implant, together with bleeding and/or suppuration on probing [BoP and/or SoP, respectively] and radiographically documented marginal bone loss/level ≥3 mm (Carcuac et al. 2016) on implants in function by at least 1 year. In case of absence of baseline radiographs, the reference point for baseline bone levels will be considered where bone was likely to be at implant placement.
排除标准
- •Patients fitting to all the inclusion criteria as above will be not included in the study if they appear to be unable to attend to the study-related procedures (including the follow-up visits) or if one or more of the following systemic or local exclusion criteria are found in the enrolment phase.
- •Systemic primary exclusion criteria:
- •compromised general health which contraindicates the study procedures (ASA IV-VI patients);
- •systemic diseases which could influence the outcome of the therapy (uncontrolled diabetes mellitus);
- •pregnant or nursing women;
- •chronic use of corticosteroids or NSAID or immune-modulator drugs (any type and any dose);
- •patients who need use of medications affecting bone metabolism or peri-implant mucosa (bisphosphonates, any type and any dose).
- •Local primary exclusion criteria:
- •history of peri-implantitis treatment on implants to be included in the study (included topical antibiotics);
- •hopeless implants (e.g. mobility) to be included in the study.
- •Secondary exclusion criteria:
- •uncompliant patients (poor oral hygiene 2 weeks after OHI).
结局指标
主要结局
Disease Resolution
时间窗: 1 year post-surgery
Probing Pocket Depth changes
时间窗: 1 year post-surgery
Measured from the mucosal margin to the bottom of the probeable pocket.
次要结局
未报告次要终点
研究者
研究点 (3)
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