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临床试验/NCT05853523
NCT05853523已完成2 期

The Desensitizing Treatment Effects of the Laser and Ozone on Dentin Hypersensitivity: In-vivo Comparison

University of L'Aquila2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2021年2月27日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
44
试验地点
2
主要终点
Change from Baseline in Pain on the 10-point Visual Analogue Scale (VAS) immediately after treatment

研究概览

简要总结

The goal of this split mouth clinical trial is to compare clinical efficacy of diode laser and gas ozone in the treatment of dentine hypersensitivity (DHS) of non-carious-cervical lesion. The main questions it aims to answer are:

  • gas ozone affects dentine hypersensitivity?
  • diode laser affects dentine hypersensitivity? Participants, affected of DHS , were treated with gas ozone and diode laser.The pain severity was quantified according to the Visual Analogue Scale (VAS) before and after the treatmens.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Stimulated dentine hypersensitivity greater than 6 on visual analogue scale (VAS)
  • DHS affected two teeth, not contiguous, of different mouth semiarch.

排除标准

  • Periodontal surgery in the last 3 month
  • Use of desensitizing paste in the last 3 month
  • Pregnant or breastfeeding state
  • Teeth with caries, reconstructions, pulpits congenital anomalies, fracture, and occlusal interferences.

结局指标

主要结局

Change from Baseline in Pain on the 10-point Visual Analogue Scale (VAS) immediately after treatment

时间窗: 5 minutes

Two stimuli were adopted to assess the degree of dentine hypersensitivities: evaporative test and tactile test. For the evaporative test, the teeth were trigged by a single operator, experienced, and trained, with a jet of air at a pressure of 45-60 psi at a distance of 2 mm from the buccal surface for 35 s. For the tactile test, the pain was triggered using a probe gently touched the dentine exposed in mesiodistal direction. The patient quantified the pain with the visual analogue scale (VAS) giving a value in the range from 1 (minimum pain) to 10 (maximum pain). The highest value of the pain stimulated by the two methods was registered.

Pain on the 10-point Visual Analogue Scale (VAS) at 6 months from treatment

时间窗: 6 months

Two stimuli were adopted to assess the degree of dentine hypersensitivities: evaporative test and tactile test. For the evaporative test, the teeth were trigged by a single operator, experienced, and trained, with a jet of air at a pressure of 45-60 psi at a distance of 2 mm from the buccal surface for 35 s. For the tactile test, the pain was triggered using a probe gently touched the dentine exposed in mesiodistal direction. The patient quantified the pain with the visual analogue scale (VAS) giving a value in the range from 1 (minimum pain) to 10 (maximum pain). The highest value of the pain stimulated by the two methods was registered.

Pain on the 10-point Visual Analogue Scale (VAS) at 3 months from treatment

时间窗: 3 months

Two stimuli were adopted to assess the degree of dentine hypersensitivities: evaporative test and tactile test. For the evaporative test, the teeth were trigged by a single operator, experienced, and trained, with a jet of air at a pressure of 45-60 psi at a distance of 2 mm from the buccal surface for 35 s. For the tactile test, the pain was triggered using a probe gently touched the dentine exposed in mesiodistal direction. The patient quantified the pain with the visual analogue scale (VAS) giving a value in the range from 1 (minimum pain) to 10 (maximum pain). The highest value of the pain stimulated by the two methods was registered.

次要结局

未报告次要终点

研究者

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

Maurizio D'Amario

Dott. Maurizio D'Amario

University of L'Aquila

研究点 (2)

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