Efficacy of a 6% Hydrogen Peroxide Tooth Bleaching Agent Without Ligth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Efectiveness by color difference ( using the spectrophotometer Vita Easy Shade)
研究概览
简要总结
The present study investigates whether it is possible to achieve equally satisfactory results between 37.5% hydrogen peroxide gel and 6% gel for teeth bleaching. A prospective, double-blind, randomized clinical trial was carried out. A total of 33 patients were selected from the clinic of the Faculty of Dentistry at the University of Chile. The patients included men and women over 18 years old without prior tooth whitening treatments, tooth decay, or restorations of the upper front teeth. The patients had tooth colors of A3 or less according to the Vita Classical scale, which was determined with a Vita Easy® Shade spectrophotometer. The study was carried out with a "split-mouth" design. One side of each mouth was randomly treated with 37.5% hydrogen peroxide, and the other side was bleached with 6% hydrogen peroxide. Each group received 3 to 12 minutes of treatment with the respective gel applications. Two sessions of bleaching were carried out each week. Color was assessed at 7 different sessions for 3 months. The spectrophotometer was used to measure the total variation of color (ΔE) between the baseline (session 1) and different measurement times (sessions 2-7). We compared ΔE for both agents using the Mann-Whitney test.
详细描述
- Materials and methods
2.1. Study design This study was a double-blind, randomized, prospective clinical trial. The study was conducted according to the recommendations of CONSORT (Consolidated Standards of Reporting Trials) while following the principles of the Helsinki Convention.
2.2. Description of the sample 2.2.1. Selection of the sample
A total of 33 patients were selected from the clinic of the Faculty of Dentistry at the University of Chile. The patients had been seeking whitening treatment and volunteered to participate in the study. The selected patients had to meet all the inclusion criteria and signed informed consent forms (appendix 1) adopted by the Ethics Committee of Faculty of Dentistry. The inclusion criteria were the following:
- Age over 18 years (both sexes)
- 6 present upper front teeth
- No caries
- No restorations (anterosuperior group)
- No previous whitening treatments
- Tooth color value of A3 or less (Vita Classical scale), which was determined with a spectrophotometer (Vita Easy Shade® Compact) on the middle third of the vestibular surface of the maxillary lateral incisors
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age over 18 years (both sexes)
- •6 present upper front teeth
- •No caries
- •No restorations (anterosuperior group)
- •No previous whitening treatments
- •Tooth color value of A3 or less (Vita Classical scale), which was determined with a spectrophotometer (Vita Easy Shade® Compact) on the middle third of the vestibular surface of the maxillary lateral incisors
排除标准
- •Pregnant or nursing mothers
- •In pharmacological treatment
- •Bruxism and patients who reported prior tooth sensitivity
- •Previous tooth whitening (either at home or professionally)
- •Visible dental cracks, developmental defects or teeth stained by tetracycline or fluorosis in the anterosuperior group
- •Treatment with fixed appliances
- •Periodontal disease or cancer
研究组 & 干预措施
37.5% gel
37.5% gel to bleach teeth
干预措施: gel HP (Drug)
6% gel
6% gel to bleach teeth
干预措施: gel HP (Drug)
结局指标
主要结局
Efectiveness by color difference ( using the spectrophotometer Vita Easy Shade)
时间窗: 1 month
The shade was determined using the obtained parameters L\*, a\*, and b\* by Spectrophotometer . The color alteration after each session was given by the differences between the values obtained at the session and the baseline (∆E). ∆E was calculated using the following formula: ΔE = \[(ΔL\*)2 + (Δa\*)2 + (Δb\*)2\]1/2 .
次要结局
未报告次要终点
研究者
Eduardo Fernandez
Profesor
University of Chile