Non-Surgical Periodontal Treatment With an Oscillating Ultrasonic Device With Adjunctive Root Polishing. A Randomized, Comparative, Prospective Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Probing Pocket Depth
研究概览
简要总结
Non-surgical periodontal treatment leads to periodontal inflammation resolution and amelioration of the clinical periodontal indices via the microbial load reduction. Additionally, non-surgical periodontal treatment can be performed with different instruments. Ultrasonic scalers with or without hand scalers are more frequently used during Phase I periodontal treatment, however the one who performs the treatment is committed to choose the tools that according to his judgment will lead to the best clinical outcomes following non-surgical periodontal therapy. The aim of this study was to evaluate the effectiveness of non-surgical periodontal treatment with a new oscillating ultrasonic device (Paro) with adjunctive root polishing versus traditional scaling and root planing with ultrasonic device and hand instruments, 3 and 6 months after treatment, at patients diagnosed with chronic periodontitis stage II, III and IV.
详细描述
Non-surgical periodontal treatment leads to periodontal inflammation resolution and amelioration of the clinical periodontal indices via the microbial load reduction. Additionally, non-surgical periodontal treatment can be performed with different instruments. Ultrasonic scalers with or without hand scalers are more frequently used during Phase I periodontal treatment, however the one who performs the treatment is committed to choose the tools that according to his judgment will lead to the best clinical outcomes following non-surgical periodontal therapy. The aim of this study was to evaluate the effectiveness of non-surgical periodontal treatment with a new oscillating ultrasonic device (Paro) with adjunctive root polishing versus traditional scaling and root planing with ultrasonic device and hand instruments, 3 and 6 months after treatment, at patients diagnosed with chronic periodontitis stage II, III and IV.
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 (Participant)
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
- •Systematically healthy adults
- •Signed informed consent
- •Periodontal disease diagnosis
- •Absence of periodontal treatment the previous 12 months
排除标准
- •Medical history that interferes with the healing process (CVD, organ transplantation, renal or hepatic failure etc)
- •Antibiotic and anti-inflammatory intake up to 1 month before treatment initiation
- •Pharmaceutically induced gingival enlargement
- •Pregnancy/ lactation
研究组 & 干预措施
Group 1
Conventional Periodontal Treatment, scaling and root planing with ultrasonic device and hand instruments
干预措施: Non-surgical periodontal treatment with U/S scalers and hand instruments (Procedure)
Group 2
Periodontal treatment with Vector/Paro
干预措施: Periodontal treatment with U/S scalers and Vector/Paro (Procedure)
结局指标
主要结局
Probing Pocket Depth
时间窗: From enrollment to the end of post-treatment monitoring at 6 months
Measurement from Free Gingival Margin to the base of the sulcus/pocket, in millimeters
次要结局
- Clinical Attachment Levels(From enrollment to the end of post-treatment monitoring at 6 months)
- Bleeding on probing(From enrollment to the end of post-treatment monitoring at 6 months)
- Root Dentin Hypersensitivity(From enrollment to the end of post-treatment monitoring at 6 months)
- Pain perception after treatment(From enrollment to the end of post-treatment monitoring at 6 months)
- Recession(From enrollment to the end of post-treatment monitoring at 6 months)