Contribution of the a* Parameter to Dental Bleaching After Combined Bleaching: A Prospective Non-randomized Single-arm Interventional Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in Whiteness Index for Dentistry (WID)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Previous tooth bleaching treatment
- •Pregnancy
- •Breastfeeding
- •Restorations in anterior teeth
- •Presence of diseases affecting tooth color
- •Conditions that may interfere with study outcomes
研究组 & 干预措施
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.
干预措施: Combined Dental Bleaching (Procedure)
结局指标
主要结局
Change in Whiteness Index for Dentistry (WID)
时间窗: 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).
次要结局
- Change in L* parameter(Baseline to end of treatment (up to 12 weeks).)
- Change in a* parameter(Baseline to end of treatment (up to 12 weeks).)
- Change in b* parameter(Baseline to end of treatment (up to 12 weeks))
- Correlation between WID and CIELab parameters(At end of treatment (up to 12 weeks).)
研究者
José Amengual Lorenzo
Assistant Professor of Stomatology
University of Valencia
