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临床试验/NCT04356911
NCT04356911已完成不适用

The Association of Strontium Chloride With Photobiomodulation in the Control of Tooth Post-bleaching Sensitivity: Clinical Trial, Randomized, Double-blind and Split-mouth.

Universidade Federal do Para2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Efficacy of desensitizer treatment in the control of tooth post-bleaching sensitivity (P21)

研究概览

简要总结

This study investigated the effects of the association of strontium chloride with photobiomodulation on the dental bleaching process, testing the hypothesis that they may control dental sensitivity post-bleaching teeth.

详细描述

The objective of this double-blind, randomized, controlled clinical study was to evaluate the effect of 10% strontium chloride associated with photobiomodulation (FBM) on teeth exposed to 35% hydrogen peroxide during 3 weeks of whitening treatment. Methods: 50 volunteers were evaluated by the split mouth model, where the hemiarchy patients were randomized and subsequently allocated to one of the experimental groups: PLACEBO (negative control) - group with no desensitizing treatment, only bleached; FBM (positive control) - group treated with placebo gel and application of the LLLT (Low Level Laser Therapy); ESTRÔNCIO (positive control) - group treated with 10% strontium chloride and simulation of LLLT application (without light emission); and FBM + ESTRÔNCIO - group treated with LLLT + 10% strontium chloride.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 31 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • good oral hygiene
  • absence of active caries lesions
  • never having undergone previous whitening therapy
  • not present dental hypersensitivity
  • don't be a smoker
  • not be pregnant
  • present at least 28 teeth in the oral cavity.

排除标准

  • volunteers who were under orthodontic treatment,
  • presence of periodontal disease
  • dental cracks or fractures
  • restorations and prostheses on anterior teeth
  • extensive molar restorations
  • gastroesophageal disorders
  • severe internal dental darkening
  • presence of dentinal exposure in anterior and / or posterior teeth.

结局指标

主要结局

Efficacy of desensitizer treatment in the control of tooth post-bleaching sensitivity (P21)

时间窗: 21 days

Self-reported pain intensity was assessed daily, during 21 days, through self-perception questionnaire, answered by the patients from the first tooth bleaching session until one week after the last session. The evaluation was performed by each patient, according to a modified visual analog scale, as follows: 0- no pain, 1 mild pain, 2 - moderate pain and 3 -severe pain.

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

Cecy Martins Silva

Associate Professor

Universidade Federal do Para

研究点 (2)

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