NCT03540290Unknown不适用
Treatment of Peri-implant Mucositis by Means of Implant Decontamination and Modification of the Implant Supported-prosthesis
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Evaluate modified sulcus Bleeding Index changes at 3 and 6 months, by the modification of the implant prosthesis in order to facilitate oral hygiene, hygiene instructions and surface decontamination
研究概览
简要总结
To test the modification of the implant prosthesis, in order to facilitate access to biofilm control, in combination with decontamination of the implant surface by means of an ultrasonic device with a plastic tip and plastic curettes, in comparison with the decontamination of the implant surface by means of an ultrasonic device with a plastic tip and plastic curettes, and no modification of the implant prosthesis.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) Presence of, at least, one titanium implant exhibiting peri-implant mucositis, defined as bleeding on gentle probing (0.15 N) in at least one peri-implant site.
- •(2) No signs of loss of supporting bone after initial bone remodelling. In cases where baseline radiograph is available, it will be used for comparison, otherwise a maximum of 2 mm of crestal bone loss will be accepted (5).
- •(3) Single tooth and bridgework restoration with an inappropriate prosthesis design or contour which difficult oral hygiene access (overcontoured prosthesis, prostheses presenting closed embrasures, an abrupt emergence profile or excessive buccal flanges).
- •(4) Presence of >1 mm of keratinized peri-implant mucosa.
- •(5) A good level of oral hygiene, defined as an O'Leary et al. plaque index <25% (16).
- •(6) Absence of systemic diseases that could influence the outcome of the therapy (i.e. controlled diabetes, with HbA1c<7, patients will be included).
- •(7) Non-smoker or light smoking status in smokers (<10 cigarettes/day).
排除标准
- •(1) Untreated periodontal conditions.
- •(2) Pregnant or lactating women.
- •(3) Patients who received systemic antibiotics in the last 3 months.
- •(4) Patients who received treatment of PM in the past 3 months.
- •(5) Patients receiving corticoids or medications known to have effect on gingival growth i.e. calcium channel antagonists, immunosuppressants or antiepileptic drugs.
- •In those cases diagnosed with peri-implantitis, individualized treatment will be provided, apart from the present study.
结局指标
主要结局
Evaluate modified sulcus Bleeding Index changes at 3 and 6 months, by the modification of the implant prosthesis in order to facilitate oral hygiene, hygiene instructions and surface decontamination
时间窗: 1, 3 and 6 months
次要结局
未报告次要终点
研究者
Beatriz de Tapia
Clinical professor
Universitat Internacional de Catalunya
研究点 (2)
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