Tooth Whitening With Hydrogenperoxide in Adolescents - Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Discoloration
研究概览
简要总结
The specific objective of this study is:
- Evaluate and quantify colorimetric changes in young permanent anterior teeth;
- Compare the efficiency and efficacy of three gels used for self-administered home whitening and an over the counter whitening strip;
- Analyze the increase in dental sensitivity in adolescent patients submitted to home whitening with 6% and 7.5% hydrogen peroxide with and without the addition of calcium (whitening strips);
- Assess sensitivity, comfort and acceptance of whitening strips by patients;
- Assess patient satisfaction with the method and material used for home whitening.
详细描述
The aim of the proposed controlled clinical trial will be to assess colorimetric changes and increased dental sensitivity in adolescent patients submitted to tooth whitening with 6% and 7.5% hydrogen peroxide using home kits with whitening strips. Adolescents aged 12 to 20 years will be allocated to different groups based on treatment (n = 16 per group): 1) placebo; 2) 6.0% hydrogen peroxide (White Class with calcium - FGM); 3) 7.5% hydrogen peroxide (White Class with calcium - FGM); and 4) 7.5% hydrogen peroxide (Oral B 3D White - Oral-B). After the whitening procedures, the participants will be evaluated using a visual analogue scale for tooth sensitivity and digital spectrophotometry for the measurement of changes in color.
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
- Single (Participant)
入排标准
- 年龄范围
- 12 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 12 to 20 years; diagnosis of altered color on maxillary and mandibular anterior teeth with initial color equivalent to A2 on the Vita scale (Vita Zahnfabrik); signed statement of informed consent
排除标准
- •Dental anomalies (malformation, carious lesions, fractures); presence of at least four maxillary and/or mandibular anterior teeth; known adverse reaction to peroxide; use of whitening agents (administered in dental office or at home) in the previous year; currently undergoing orthodontic treatment, orthopedic treatment of the jaws or psychological treatment; use of medication that can alter the color of the teeth, such as ferrous sulfate.
结局指标
主要结局
Discoloration
时间窗: Change of teeth color after 7 days of the beginning of treatment
Color readings of the vestibular region of the maxillary and mandibular anterior teeth will be performed by a previously trained examiner blinded to the allocation of the volunteers to the different groups. A digital spectrophotometer will be used for the colorimetric evaluation. It will be carried out in all groups at the following times: pre-treatment period, immediately following the first treatment period, after seven days, after 30 days, after six months, after 12 months, after 24 months, and after 48 months.
次要结局
- Dental sensitivity(Sensivity alteration after 7 days of the beginning of treatment)
研究者
Sandra Kalil Bussadori
Professor
University of Nove de Julho