Efficacy of Tooth Bleaching With 35% and 6% Hydrogen Peroxide in Primary Dentition: Study Protocol for a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 38
- 主要终点
- Changes in tooth color
研究概览
简要总结
The aesthetics of dental elements generates great psychological and social impacts, both in the deciduous and permanent dentition. One of the techniques widely used to visually improve the appearance of teeth is bleaching. Bleaching can be performed both at home and in a dental office. In office whitening, the technique used consists of applying the whitening gel to the dental surfaces in concentrations ranging from 25% to 50% of hydrogen peroxide. However, recent studies show that low and medium concentration bleaching agents based on hydrogen peroxide have been effective and present a lower risk of sensitivity to the patient. In view of the above, this study aims to carry out a controlled and randomized clinical trial to compare the effectiveness of dental bleaching in deciduous teeth with hydrogen peroxide at concentrations of 35% and 6%. For this, 38 patients aged 03 to 06 years will be selected, allocated in 2 groups (G1 - Hydrogen Peroxide 35%, n=19 and G2- Hydrogen Peroxide 6%, n=19). Bleaching will be carried out in up to three sessions, with an interval of 7 days between them and the evaluation of color and tooth sensitivity will be carried out 48 hours after each bleaching session. The color assessment will be measured using a digital spectrometer and tooth sensitivity using the Pain Level Scale (Wong-Baker Faces®). Descriptive statistical analysis will be carried out, containing the mean and standard deviation in the calculation and normality and homogeneity tests will be carried out, for subsequent adequate statistical analysis. As a result, it is expected that there is no significant difference between the groups in terms of color variation and that the low-concentration bleaching group has the lowest sensitivity index.
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
- 3 Years 至 6 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age range from 03 to 06 years old;
- •Vital or non-vital teeth (already endodontically treated) with severe to moderate discoloration;
- •No active carious lesions;
- •No lesions in the oral cavity;
- •No report of previous tooth sensitivity.
排除标准
- •Patients who during anamnesis report allergies to dyes or latex, who withdraw from participating in the study, as well as those who do not attend the callbacks, will be excluded.
结局指标
主要结局
Changes in tooth color
时间窗: Baseline and 48 hours after each bleaching session.
The Vita Easyshade® digital spectrometer (VITA Zahnfabrik H. Rauter GmbH \& Co. KG, Germany) will be used for evaluation. The upper left canine will be used as a color reference because it is the most saturated tooth in the arch (greater dentin mass and greater amount of intrinsic pigments).
Changes in tooth sensitivity
时间窗: Baseline and 48 hours after each bleaching session.
It will be explained to the participant that each face drawn in a figure represents a person who has no pain, or some, or a lot of pain. Face 0 doesn't hurt at all. Face 2 hurts a little. Face 4 hurts a little more. Face 6 hurts a lot. Face 8 hurts the most. Face 10 hurts as much as you can imagine, although you don't have to be crying to have this worst pain. The participant will choose the face that best portrays the pain they are experiencing.
次要结局
未报告次要终点
研究者
Sandra Kalil Bussadori
Principal Investigator
University of Nove de Julho
