Ultrasonic Surgical Aspirator to Treat Deep Infrabony Defects: A New Flapless Minimally Invasive Approach
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Periodontal healing - Pocket Closure proportion
研究概览
简要总结
The primary outcome of the present study will be assess the percentage of pocket closure and the secondary aim to evaluate the clinical performance in terms of clinical attachment level (CAL) gain, probing pocket depth (PPD) reduction and gingival recession (REC) after the use of cavitron ultrasonic surgical aspirator (CUSA) in deep infrabony defects.
Patients who were previously treated with active periodontal therapy followed by one year of supportive periodontal therapy (at least three sessions) will be additionally treated by the aid of CUSA. Subjects will be reviewed at 7 days, 15 days, 1 month, 3 months and 6 months. These sessions will include supra-gingival professional mechanical plaque removal (PMPR) through the use of erythritol powder plus 14 μm. Clinical measurements of the defects and X-ray with bite block will be taken at baseline and 3 and 6 months.
详细描述
This will be a Phase 2 non-controlled clinical trial performed on patients with infrabony defects to test whether the employment of CUSA for treating periodontal patients:
- Provides benefits in terms of a PPD reduction and CAL gain
- Is comfortable for patients and operators; and is free from adverse events
All subjects included in the study will be consecutive periodontal patients attending a private clinic in Settimo Milanese (Milan, Italy) who will be treated by two operators with similar experience in non surgical produce who performed a specific training for CUSA on a periodontal model.
The clinical procedure will be always performed in a single session. Before intervention, all cases will receive local anaesthesia with 1:100.000 mepivacaine.
All residual pockets ≥ 5 mm will be treated with
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Having received a diagnosis of chronic periodontitis (Armitage 1999)
- •Being treated by full mouth debridement, and supportive periodontal treatment (SPT) in the last year (at least three sessions) by one of the authors
- •Having at least one residual pocket ≥ 5 mm with and intra bony component at least ≥ 2 mm
排除标准
- •Smoking more than ten cigarettes per day
- •Irregular compliance during SPT in the last year; and systemic conditions or therapies known to affect the healing potential of periodontal tissues (e.g., uncontrolled diabetes, oncological conditions, immunosuppressant drugs).
研究组 & 干预措施
Cavitron ultrasonic surgical aspirator
Patients.with periodontitis.
Inclusion criteria:
- Having received a diagnosis of chronic periodontitis (Armitage 1999)
- Being treated by full mouth debridement, and supportive periodontal treatment (SPT) in the last year (at least three sessions)
- Having at least one residual pocket ≥ 5 mm with and intra bony component at least ≥ 2 mm
Exclusion criteria:
- Smoking more than ten cigarettes per day
- Pregnancy
- Irregular compliance during SPT in the last year; and systemic conditions or therapies known to affect the healing potential of periodontal tissues (e.g., uncontrolled diabetes, oncological conditions, immunosuppressant drugs).
干预措施: Cavitron ultrasonic surgical aspirator (Procedure)
结局指标
主要结局
Periodontal healing - Pocket Closure proportion
时间窗: 6 months
Periodontal Pocket Depth (PPD) is the measured distance from the free end of the gingival margin to the bottom of the periodontal pocket. PPD will be measured with the periodontal probe in millimeter (mm) and recorded in the periodontal charting. Successful result would be the achievement of residual PPD \< 5 mm
次要结局
- Adverse effects(1 day)
- Comfort of the operator(1 day)
- Clinical attachment level (CAL) gain(6 months)
- Gingival recession(6 months)
- Comfort of the patient - Visual Analogue Scale (VAS) for pain(1 week)
- Comfort of the patient by interview(1 week)
- Periodontal Pocket Depth (PPD) reduction(6 months)
研究者
Giovanni Lodi
Professor
University of Milan