Comparison of the Efficacy and Quality of Life of Three Bleaching Products
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change on visually determination of tooth colour
研究概览
简要总结
The aims of this study are: to compare the efficacy of three different dental bleaching products; to evaluate colour relapse following dental bleaching treatment at 1, 3 and 6 months follow up; to evaluate the impact in quality of life from dental bleaching treatments.
Products to be used represent three different techniques and formulations: in office, universal tray and custom tray (respectively VivaStyle Paint On Plus (Ivoclar Vivadent, Liechtenstein), Opalescence GO 6% (Ultradent, USA) and Opalescence PF 15% (Ultradent, USA).
All products contain 6% hydrogen peroxide or its equivalent.
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
- None
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
- •Be at least 18 years old
- •Be willing to refrain from use of tobacco products during the study
- •Be willing to sign an informed consent form
- •At least one teeth 13,11,21,23,33,43 has a gradable VITA shade A3,5 or darker by clinical assessment
排除标准
- •Teeht with restorations in frontal teeth
- •Patients with untreated periodontitis or caries
- •Patients with fixed orthodontics appliances
- •Patients with know allergies to ingredients
- •Patients who are nursing or pregnant
- •Patients with severe systemic illnesses
- •Patients with development tooth anomalies
- •Patients with non vital anterior teeth
- •Patients with insufficient oral hygiene
研究组 & 干预措施
Group A
Dental bleaching with PaintOn Plus, HP 6%, 6x10min, two sessions
干预措施: Dental bleaching with PaintOn Plus VivaStyle (Other)
Group A
Dental bleaching with PaintOn Plus, HP 6%, 6x10min, two sessions
干预措施: Dental Bleaching impact in quality of life with PaintOn Plus Vivastyle (Other)
Group B
Dental bleaching with Opalescence GO, HP 6%, 10x60min
干预措施: Dental bleaching with Opalescence GO (Other)
Group B
Dental bleaching with Opalescence GO, HP 6%, 10x60min
干预措施: Dental Bleaching impact in quality of life with Opalescence GO (Other)
Group C
Dental bleaching with Opalescence PF, CP 16%, 14x60h
干预措施: Dental bleaching with Opalescence PF (Other)
Group C
Dental bleaching with Opalescence PF, CP 16%, 14x60h
干预措施: Dental Bleaching impact in quality of life with Opalescence PF (Other)
结局指标
主要结局
Change on visually determination of tooth colour
时间窗: 2 weeks (before and after treatment)
Determination of tooth colour using a visual tooth shade guide
Change on spectrophotometer determination of tooth colour
时间窗: 2 weeks (before and after treatment)
Determination of tooth colour using a spectrophotometer
Subjective evaluation of tooth colour change during follow-up
时间窗: 1, 3 and 6 months
Determination of tooth colour relapse using visual tooth shade guide (VITA shade guide)
Change on quality of life during treatment and follow-up
时间窗: 2 weeks (before and after treatment), 1 month, 3 months and 6 months
Impact on quality of life using an oral quality of life measuring questionnaire, the Oral Health Impact Profile 14 (OHIP-14). The OHIP-14 ranges from 0 to 56 (final sum of all the seven subscales), with higher scores indicating poorer quality of life.
Objective evaluation of tooth colour change during follow-up
时间窗: 1, 3 and 6 months
Determination of tooth colour relapse using a spectrophotometer
次要结局
未报告次要终点