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临床试验/NCT05835453
NCT05835453已完成不适用

PATIENT SATISFACTION WITH AT-HOME DENTAL BLEACHING USING VIVERA OR ESSIX RETAINERS: A RANDOMIZED CLINICAL TRIAL

Universidad Rey Juan Carlos2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年9月14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
40
试验地点
2
主要终点
Patient´s satisfaction

研究概览

简要总结

The aim of this project is to clinically evaluate patient satisfaction, whitening efficacy, tooth sensitivity, and gingival irritation during at-home whitening with 10% carbamide peroxide using an Essix-type retainer or a Vivera retainer.

详细描述

Forty patients (n=40) will be randomized as to which side will receive the type of bleaching tray, essix-type retairner or Vivera retainer. The at-home bleaching will be performed with 10% carbamide peroxide (Opalescence PF 10%) for 2 hours The treatment lasted 4 weeks, although as each retainer was worn every other day, the actual application time was 2 weeks. Patient´s satisfaction will be evaluated at baseline, after one, two weeks, and 4 weeks with an apropriate questionnaire using a visual analog scale (EVA 0-10). The color will be assessed at baseline, after one, two and four weeks using subjective color guides (VITA Classical and VITA Bleachguide 3D-MASTER) and a objective digital spectrophotometer (VITA Easyshade). The intensity and absolute risk of tooth sensitivity and gingival irritation will also be determined with a visual analog scale (EVA 0-10). Color change between groups will be compared by paired Student´s t-test. The absolute risk of tooth sensitivity and gingival irritation for both groups will be compared by McNemar test. Also, odds ratios, confidence intervals, and Spearman correlation will be determined. The intensity of tooth sensitivity, gingival irritation and patient´s satisfaction will be compared by paired Student´s t-test. The level of statistical significance accepted will be 5% for all analyses.

研究设计

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

盲法说明

It will be a single-blind study in which only the evaluator will not know the designation of the groups because he has not participated in the study's randomization and implementation process. Due to the tray test and demonstration of the bleaching procedure, the operator and the participant cannot be blinded.

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Patient´s satisfaction

时间窗: Baseline, after one, two and four weeks

It will be measured with a questionnaire using a visual analog scale (EVA), when a essix-type retairner or Vivera retainer is used to perform a at home bleaching treatment with 10% carbamide peroxide.

次要结局

  • Intensity and absolute risk of tooth sensitivity(Baseline, after one, two, four weeks, and at 1 month after bleaching treatment)
  • Intensity and absolute risk of gingival irritation(Baseline, after one, two, four weeks, and at 1 month after bleaching treatment)
  • Color change evaluation(Baseline, after one, two and four weeks)
  • Intensity and absolute risk of tooth sensitivity(Baseline, after one, two, four weeks, and at 1 month after bleaching treatment)
  • Intensity and absolute risk of gingival irritation(Baseline, after one, two, four weeks, and at 1 month after bleaching treatment)

研究者

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

Isabel Giráldez de Luis

Assistant Professor

Universidad Rey Juan Carlos

研究点 (2)

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