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临床试验/NCT03514290
NCT03514290已完成不适用

Effect of Low-level Laser Therapy on Post-bleaching Sensitivity and Color Change: a Clinical, Randomized and Double-blind Study

Universidade Federal do Para1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2016年7月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
21
试验地点
1
主要终点
Dental sensitivity induced by office bleaching

研究概览

简要总结

Objective: The objective of this clinical study was to evaluate low-level laser (LLL) therapy in tooth sensitivity and in effecting color change after in-officer bleaching treatment across three weeks of treatment.

Methods: Twenty-one volunteers were evaluated through the split-mouth model, so that the right and left maxillary/mandibular quadrants were randomized and allocated to one of two groups: GPLACEBO - the laser tip was positioned without the emission of light (placebo effect) + tooth bleaching with 35% hydrogen peroxide (HP); GLASER - treated with LLL + tooth bleaching with 35% HP. To assess tooth sensitivity, a modified visual analogue scale (VAS) was used after an evaporative stimulus (stimulated pain) and a daily pain questionnaire (unstimulated pain) was also applied. A spectrophotometer was used to measure the color. Three bleaching sessions were performed, with intervals of 7 days. Sensitivity results were tested using Friedman test for intra-group evaluation and Wilcoxon test for inter-group evaluation and ANOVA for color change.

详细描述

Twenty-one volunteers were evaluated through the split-mouth model, so that the right and left maxillary/mandibular quadrants were randomized and allocated to one of two groups: GPLACEBO - the laser tip was positioned without the emission of light (placebo effect) + tooth bleaching with 35% hydrogen peroxide (HP); GLASER - treated with LLL + tooth bleaching with 35% HP. To assess tooth sensitivity, a modified visual analogue scale (VAS) was used after an evaporative stimulus (stimulated pain) and a daily pain questionnaire (unstimulated pain) was also applied. A spectrophotometer was used to measure the color. Three bleaching sessions were performed, with intervals of 7 days.

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, Investigator)

盲法说明

Only principal investigator performed the clinical research steps. A single evaluator performed the assessment of the dental sensitivity without knowing which treatment was applied. The volunteers evaluated in this study also did not know which hemi-arch received the LLL.

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Do not have previous dental sensitivity
  • •The canine had to be shade A2 or darker.

排除标准

  • •Enamel hypoplasia
  • •Gingival recession
  • •Dentin exposure
  • •Visible cracks on buccal enamel

研究组 & 干预措施

GPLACEBO

Placebo Comparator

the laser tip was positioned without the emission of light (placebo effect) + tooth bleaching with 35% hydrogen peroxide (HP).

干预措施: Placebo (Other)

GLASER

Experimental

treated with Low-lever laser + tooth bleaching with 35% hydrogen peroxide (HP).

干预措施: Low-lever laser (Radiation)

GLASER

Experimental

treated with Low-lever laser + tooth bleaching with 35% hydrogen peroxide (HP).

干预措施: Tooth bleaching (Other)

GPLACEBO

Placebo Comparator

the laser tip was positioned without the emission of light (placebo effect) + tooth bleaching with 35% hydrogen peroxide (HP).

干预措施: Tooth bleaching (Other)

结局指标

主要结局

Dental sensitivity induced by office bleaching

时间窗: change in baseline sensitivity at the 3rd bleaching session

Evaporative stimulus (stimulated pain) using air jet from a triple syringe and a daily pain questionnaire (unstimulated pain). Both methods were associated with a modified visual analogue scale was used: 0 (pain absent); 1 (mild pain); 2 (moderate pain) and 3 (severe pain).

次要结局

  • Color change promoted by tooth bleaching(change in baseline color at the 3rd bleaching session)

研究者

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

Cecy Martins Silva

Full professor

Universidade Federal do Para

研究点 (1)

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