Clinical and Patient Centred Outcome Performance of Full Mouth Ultrasonic Debridement Carried Out for the Treatment of Periodontitis Performed Either by Piezoelectric or Magnetostrictive Device. A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- noise
研究概览
简要总结
Treatment of periodontitis requires removal of dental biofilm both through professional mechanical plaque removal and domiciliar oral hygiene procedures. This study aims to compare biometric and psychological results after professional treatment of periodontitis carried out by piezoelectric or magnetostrictive ultrasonic devices.
详细描述
Patients diagnosed with periodontitis will be assessed for eligibility criteria. Full-mouth periodontal assessment will be performed by an examiner to detect severity and extension of the disease. Thereafter, patient will receive oral hygiene instruction and a closed envelope with patient allocation will be opened. After the allocation to the intervention group, full-mouth ultrasonic debridement will be delivered to the patient by an operator and information about patient perception will be collected. Three months later, patients will be recalled for a new periodontal assessment.
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
- 性别
- All
- 接受健康志愿者
- 是
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
noise
时间窗: through study completition, 1 year
vas scale (0-10) for perception of noise after treatment
vibration
时间窗: through study completition, 1 year
vas scale (0-10) for perception of vibration after treatment
Pain perception
时间窗: through study completition, 1 year
vas scale (0-10) for perception of pain after treatment
次要结局
- pocket closure(through study completition, 1 year)
研究者
Nicola Discepoli
Professor
University of Siena
