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临床试验/NCT05279950
NCT05279950Unknown不适用

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

University of Siena2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2022年4月10日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nicola Discepoli

Professor

University of Siena

研究点 (2)

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