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Contribution of a* to Dental Bleaching After Combined Dental Bleaching

2026年4月30日 更新者:José Amengual Lorenzo、University of Valencia

Contribution of the a* Parameter to Dental Bleaching After Combined Bleaching: A Prospective Non-randomized Single-arm Interventional Clinical Study

A prospective, non-randomized, single-arm interventional clinical study with a before-after design will be conducted to assess changes in CIELab color parameters and the Whiteness Index for Dentistry (WID) following a standardized combined dental bleaching protocol. The study aims to evaluate the contribution of the a* parameter (green-red axis) to overall dental whiteness.

研究概览

地位

尚未招聘

条件

详细说明

Tooth whitening is one of the most commonly requested aesthetic dental treatments, requiring objective and reproducible methods to quantify color changes. The CIELab color system (L*, a*, b*) and the Whiteness Index for Dentistry (WID) are widely used for this purpose.

While increases in L* and decreases in b* are recognized as the main contributors to dental whitening, the role of the a* parameter remains unclear. Variations in a*, including the presence of negative values or changes in sign during treatment, have been insufficiently studied.

A prospective, non-randomized, single-arm interventional clinical study with a before-after design will be conducted to evaluate changes in L*, a*, b*, and WID following a combined dental bleaching protocol consisting of an in-office phase with hydrogen peroxide and an at-home phase with carbamide peroxide.

Spectrophotometric measurements will be performed at baseline, after the in-office phase, and after completion of the at-home phase. The study will also analyze the relationship between changes in CIELab parameters and WID.

The study will be conducted in accordance with ethical standards and will be approved by the corresponding institutional review board. All participants will provide written informed consent prior to inclusion.

研究类型

介入性

注册 (估计的)

10

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。

学习联系方式

  • 姓名:José Amengual-Lorenzo, PhD
  • 电话号码:+34616941167
  • 邮箱:jose.amengual@uv.es

研究联系人备份

  • 姓名:Rubén Agustín Panadero, MSc; Phd
  • 电话号码:+34653098901
  • 邮箱:ruben.agustin@uv.es

学习地点

    • Valencia
      • Valencia、Valencia、西班牙、46010
        • University of Valencia
        • 接触:
        • 接触:
        • 首席研究员:
          • José Amengual-Lorenzo, PhD

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

  • Age 18 to 65 years
  • Good oral health
  • Presence of natural anterior teeth (incisors, canines, premolars)
  • Anterior teeth without restorations
  • Indication for tooth bleaching treatment
  • Ability to comply with study procedures and visits

Exclusion Criteria

  • Smoking
  • Previous tooth bleaching treatment
  • Pregnancy
  • Breastfeeding
  • Restorations in anterior teeth
  • Presence of diseases affecting tooth color
  • Conditions that may interfere with study outcomes

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:治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Combined Dental Bleaching
Participants will undergo a combined dental bleaching treatment consisting of an in-office phase followed by an at-home phase using custom trays.
The intervention consists of an in-office bleaching phase with two 20-minute applications of 40% hydrogen peroxide, followed by an at-home bleaching phase using 16% carbamide peroxide applied with custom trays for 90 minutes daily. Treatment will continue until color stabilization is achieved, defined as a change in WID of less than 2.6 units between two consecutive weekly measurements.

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
Change in Whiteness Index for Dentistry (WID)
大体时间:From baseline to end of treatment (up to 12 weeks).
Change in WID values calculated from CIELab parameters (L*, a*, b*) between baseline and the end of treatment (up to 12 weeks).
From baseline to end of treatment (up to 12 weeks).

次要结果测量

结果测量
措施说明
大体时间
Change in L* parameter
大体时间:Baseline to end of treatment (up to 12 weeks).
Difference in L* values between baseline and the end of treatment (up to 12 weeks) measured using spectrophotometry.
Baseline to end of treatment (up to 12 weeks).
Change in a* parameter
大体时间:Baseline to end of treatment (up to 12 weeks).
Difference in a* values between baseline and the end of treatment (up to 12 weeks), including assessment of sign changes.
Baseline to end of treatment (up to 12 weeks).
Change in b* parameter
大体时间:Baseline to end of treatment (up to 12 weeks)
Difference in b* values between baseline and the end of treatment (up to 12 weeks), measured using spectrophotometry.
Baseline to end of treatment (up to 12 weeks)
Correlation between WID and CIELab parameters
大体时间:At end of treatment (up to 12 weeks).
Assessment of the relationship between changes in WID and changes in L*, a*, and b*.
At end of treatment (up to 12 weeks).

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:José Amengual-Lorenzo、University of Valencia

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 (估计的)

2026年10月1日

初级完成 (估计的)

2027年7月1日

研究完成 (估计的)

2027年7月1日

研究注册日期

首次提交

2026年3月25日

首先提交符合 QC 标准的

2026年4月23日

首次发布 (实际的)

2026年5月1日

研究记录更新

最后更新发布 (实际的)

2026年5月6日

上次提交的符合 QC 标准的更新

2026年4月30日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

其他研究编号

  • Bleaching_aStar_WID_2026
  • Application Reference 2026-ODO (其他标识符:Ethics Committee University of Valencia)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

Individual participant data will not be shared, as this is not necessary to achieve the study's objectives or to interpret the results. All findings will be summarized statistically without revealing individual participant information, thereby ensuring privacy and confidentiality. Individual anonymized data will not be shared, as aggregated data is sufficient to ensure scientific transparency and the reproducibility of the results.

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

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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