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Evaluation of Sensitivity and Color Change of Different Protocols of In-office Dental Bleaching

2026年5月12日 更新者:Marcos de Oliveira Barceleiro、Universidade Federal Fluminense
Clinical randomized single-blind trial, used to measure the level of tooth sensitivity (TS) after in-office dental bleaching sessions, on volunteers using a modified visual analog scale (VAS). The investigators selected for this study, 40 participants with color 2M2 or darker (Using OM1 - 5M3 Vita bleaching shade guide). The investigators performed two bleaching sessions with a 40% hydrogen peroxide gel with a 1-week interval. Participants were enrolled in two groups. In one group, the bleaching product was used according to manufacturer's instructions (40-minutes application in each section). In the other group, the bleaching product was used in two 20-minutes applications in each section.The investigators recorded the TS up to 48h with a VAS scale and the color at baseline and 30 days after bleaching with a value-oriented shade guide and a spectrophotometer. The risk and intensity of TS and the color change were compared between the two groups.

研究概览

详细说明

Two weeks before the bleaching procedures, selected volunteers from the city of Nova Friburgo, (Rio de Janeiro, Brazil) received a dental screening and a dental prophylaxis with pumice and water in a rubber cup and signed an informed consent form.

This was a randomized, single-blind (evaluators), parallel and equivalence trial with an equal allocation rate between groups.

A total of 71 participants were examined in a dental chair to check if they met the inclusion and exclusion criteria. A total of 40 participants were included in this study. The participants were randomly divided in the 40-minutes or 2x20-minutes groups.

During the in-office sessions, participants had the gingival tissue isolated of the teeth using a light-cured resin dam (Opal Dam, Ultradent Products International, Salt Lake, Utah, USA). After that, the 40% hydrogen peroxide gel (Opalescence Boost, Ultradent) was applied in one 40-min application according to the manufacturer's directions in all upper and lower incisors, canines and premolars, or was applied in the same teeth, but during 2 x 20-min applications, with no interval between them. After 20 minutes, the bleaching gel was removed with water spray before the second 20 minutes application. After 7 days this procedure was repeated using the same protocols.

Color evaluation was performed before and 30 days after the end of the bleaching treatment using a subjective (value oriented shade guide Vita Lumin, Vita Zahnfabrik, Bad Sackingen, Germany) and an objective method (Easyshade spectrophotometer, Vident, Brea, CA, USA). Color evaluation was done in a room under artificial lightning conditions without interference from outside light.

For the subjective examination, the shadeguide's 16 tabs were arranged from highest (B1) to lowest (C4) value. Changes in the scale were treated as representing a continuous and approximately linear ranking. Color was measured in the middle third of the facial surface of the right upper canine at baseline and 30 days after bleaching to calculate the variations in color towards the lighter end of the scale (Delta Shade Guide Units - DSGU).

One calibrated operator measured the color in all participants using the Vita Easyshade spectrophotomer (Easyshade, Vident, Brea, CA, USA) before and 30 days after the bleaching therapy. The L*, a* and b* parameters were recorded. L* represents the value from 0 (black) to 100 (white) and a* and b* represent the shade, where a* is the measurement along the red-green axis and b* is the measurement along the yellow-blue axis. Color change was calculated between the two assessment periods (DE) using the formula: DE = [(DL*)2 + (Da*)2 + (Db*)2]1/2.

The patients recorded their perception of TS during the first and second bleaching sessions using the visual analogue scale VAS. This scale employs a 10-cm horizontal line with words "no pain" at one end and "worst pain" at the opposite end. Participants recorded whether they experienced TS during the treatment up to 1 h after the bleaching, from 1 h to 24 hand from 24h to 48 h after bleaching. In the 30-day recall, patients were also asked if they experienced pain during this 30-day period. As two bleaching sessions were performed, the VAS score obtained in both bleaching sessions was considered for statistical purposes. These values

研究类型

介入性

注册 (实际的)

40

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Rio de Janeiro
      • Nova Friburgo、Rio de Janeiro、巴西、28625-650
        • Universidade Federal Fluminense - School of Dentistry

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

描述

Inclusion Criteria:

  • The selected volunteers should:

    • Present Good general state of health
    • Be at least 18 years of age
    • Have an acceptable oral hygiene
    • Present the upper and lower arches without absence of teeth of first premolar right to the left first premolar.
    • Have anterior teeth with any kind of restoration.
    • Be No smoker
    • Have the upper right canine with color 2M2 or darker

Exclusion Criteria:

  • The selected volunteers should not:

    • Have medical history of diseases that can affect the results of the study
    • Have made use of cigarettes in the last 30 days
    • Have some important pathology in the oral cavity
    • Be pregnant
    • Be breastfeeding
    • Have moderate advanced periodontal disease;
    • Have consumed drugs, alcool or any medication that can cover the results, as other types of anti-inflammatories or painkillers;
    • Have used products indicated for dental sensitivity, as desensitizing toothpaste or similar product
    • Present gingival recession
    • Present exacerbated hypersensitivity history

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
有源比较器:Bleaching 40 minutes
Patients will have their teeth bleached in-office using 40% Hydrogen Peroxide (commercial available product - Opalescence Boost, Ultradent Products International) in two sections with 7 days of interval between sections. In each section, the product will be used during 40 minutes according to manufacturer's instructions.
Patients will have their teeth bleached in-office using 40% Hydrogen Peroxide (commercial available product - Opalescence Boost, Ultradent Products International) in two sections with 7 days of interval between sections. In each section, the product will be used during 40 minutes according to manufacturer's instructions.
实验性的:Bleaching 2x20 minutes
Patients will have their teeth bleached in-office using 40% Hydrogen Peroxide (commercial available product - Opalescence Boost, Ultradent Products International) in two sections with 7 days of interval between sections. In each section, the product will be used during 20 minutes, will be removed (with water) and a new application of 20 minutes will be made.
Patients will have their teeth bleached in-office using 40% Hydrogen Peroxide (commercial available product - Opalescence Boost, Ultradent Products International) in two sections with 7 days of interval between sections. In each section, the product will be used during 20 minutes, will be removed with water, and another application of 20 minutes will be made.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Tooth sensitivity
大体时间:1 hour after dental bleaching session
Visual Analogic Scale (0-100) for Tooth Sensitivity. In this case, zero means no sensitivity (a better outcome and 100 means higher sensitivity (worse outcome).
1 hour after dental bleaching session
Tooth sensitivity
大体时间:24 hours after dental bleaching session
Visual Analogic Scale (0-100) for Tooth Sensitivity. In this case, zero means no sensitivity (a better outcome and 100 means higher sensitivity (worse outcome).
24 hours after dental bleaching session
Tooth sensitivity
大体时间:48 hours after dental bleaching session
Visual Analogic Scale (0-100) for Tooth Sensitivity. In this case, zero means no sensitivity (a better outcome and 100 means higher sensitivity (worse outcome).
48 hours after dental bleaching session

次要结果测量

结果测量
措施说明
大体时间
Color change with scale
大体时间:30 days after dental bleaching session
Objective color evaluation comparing tooth color against a comercial color scale from A1 to D4
30 days after dental bleaching session
Color change with spectrophotometer
大体时间:30 days after dental bleaching session
Objective color evaluation using a spectrophotometer
30 days after dental bleaching session

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:MARCOS O BARCELEIRO, PhD、Full Professor

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年10月1日

初级完成 (实际的)

2026年1月20日

研究完成 (估计的)

2026年9月30日

研究注册日期

首次提交

2026年5月12日

首先提交符合 QC 标准的

2026年5月12日

首次发布 (实际的)

2026年5月19日

研究记录更新

最后更新发布 (实际的)

2026年5月19日

上次提交的符合 QC 标准的更新

2026年5月12日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • UFFBleachingProtocols

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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