Clinical and Patient-Centered Outcomes of Full-Mouth Ultrasonic Debridement for Periodontitis: A Randomized Controlled Trial Comparing Piezoelectric and Magnetostrictive Devices
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Pain perception
研究概览
简要总结
The treatment of periodontitis requires the removal of dental biofilm through both professional mechanical plaque removal and at-home oral hygiene practices. This study aims to compare clinical and psychological outcomes following professional treatment using either piezoelectric or magnetostrictive ultrasonic devices.
详细描述
Patients diagnosed with periodontitis will be screened for eligibility criteria. A comprehensive full-mouth periodontal assessment will be conducted by a calibrated examiner to determine the severity and extent of the disease. Subsequently, patients will receive oral hygiene instructions, and group allocation will be revealed using a sealed envelope. Based on the assigned group, full-mouth ultrasonic debridement will be performed by a trained operator. Patient perceptions regarding the treatment will then be recorded. After three months, patients will return for a follow-up periodontal evaluation.
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
- Double (Participant, 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
- •>18 years
- •periodontitis of stage 1 and 2
- •absence of systemic chronic disease
排除标准
- •anticoagulants treatment
- •antibiotic treatment 3 months before the screening visit
结局指标
主要结局
Pain perception
时间窗: through study completition, on average 6 months
vas scale (0-10) for perception of pain after treatment
vibration
时间窗: through study completition, on average 6 months
vas scale (0-10) for perception of vibration after treatment
noise
时间窗: through study completition, on average 6 months
vas scale (0-10) for perception of noise after treatment
次要结局
- pocket closure(through study completition, on average 6 months)
研究者
Nicola Discepoli
Associate Professor
University of Siena