Long-term Clinical Evaluation of In-office Dental Bleaching Using a Violet Light (405-410 nm)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Color alteration
研究概览
简要总结
The objective of this clinical study is to evaluate the effect of the whitening treatment performed with the violet LED light (405-410 nm), with or without a bleaching gel, on the tooth color changes (immediate and long-term), tooth sensitivity, satisfaction of participants in relation to the technique and impact on their quality of life. After being informed of the objectives of the study, 200 participants will be selected and randomly divided into a treatment group (n = 25): G1 - 35% hydrogen peroxide (HP) (4 sessions, 1 session/week); G2 - 30% carbamide peroxide (CP) (4 sessions, 1 session/week); G3 - Violet LED (405-410 nm, 4 sessions, 1 session/week); G4 - Violet LED (405-410 nm, 4 sessions, 2 sessions/week); G5 - Violet LED associated to 35% hydrogen peroxide (4 sessions, 1 session / week); G6 - Violet LED associated to 30% carbamide peroxide (4 sessions, 1 session / week); G7 - hybrid technique HP (Violet LED + application of 35% hydrogen peroxide + violet LED) (4 sessions, 1 session/week); G8 - Hybrid technique CP HP (Violet LED + application of 30% carbamide peroxide + violet LED) (4 sessions, 1 session/week). The color evaluation will be performed at predetermined times (before and immediately after treatment, 14 days after completion of bleaching and 3, 6 and 12 months after completion of bleaching), and quantitatively evaluated by colorimetric tests (objective and subjective) and spectrophotometry. In addition, it will be evaluated the tooth sensitivity during and after (48 hours) tooth whitening (VAS Scale), satisfaction with the treatment and impact on quality of life (OHIP-14 questionnaire). The data, except for survey data of satisfaction (descriptive evaluation), will be subjected to statistical analysis to determine the homogeneity and normality of the sample and for comparison between treatment groups, considering a 5% significance level.
详细描述
The objective of this clinical study is to evaluate the effect of the whitening treatment performed with the violet LED light (405-410 nm), with or without a bleaching gel, on the tooth color changes (immediate and long-term), tooth sensitivity, satisfaction of participants in relation to the technique and impact on their quality of life.
This study was approved by the research ethics committee of School of Dentistry of University of Sao Paulo (Protocol# 1.981.756). The experimental design is in according to CONSORT. The present research will be a blind, parallel and randomized study with similar allocation between the treatment groups. It will be included 200 participants, selected among the patients of the Special Laboratory of lasers in dentistry (LELO-FOUSP). After being being informed of the objectives of the study the participants will be randomly divided into a treatment group (n = 25):
G1 - In-office bleaching performed with 35% hydrogen peroxide (4 sessions, 1 session/week).
G2 - In-office bleaching performed with 30% carbamide peroxide (4 sessions, 1 session/week).
G3 - In-office bleaching performed with Violet LED (405-410 nm, 4 sessions, 1 session/week).
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 30 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Presence of all the teeth, without restorations or caries on anterior teeth.
- •Patients presenting the canine tooth color A3 (according to Vita classical scale) or darker.
排除标准
- •Patients presenting systemic pathologies
- •Patients presenting periodontal diseases
- •Smokers or patients with systematic use of alcohol
- •Patients presenting teeth with color alterations by tetracycline, fluorosis, endodontic treatments.
- •Patients with historic of self-referenced sensitivity
- •Pregnant or Breastfeeding period patients
- •Presence of restorations on anterior teeth
- •Patients presenting bruxism or systematic use of analgesics or anti-inflammatory drugs
结局指标
主要结局
Color alteration
时间窗: 12 months after the treatment
The color measurement will be blind, in predetermined time (12 months after the treatment). It will be performed with a clinical spectrophotometer.
次要结局
- Patient satisfaction regarding the treatment(14 days after the end of treatment, 3 months after, 6 months after and 12 months after)
- Quality of life of the patients(Immediately after the end of bleaching)
- Color change throughout 6 months with a clinical spectrophotometer(Before, immediately after, 14 days, 3 months and 6 months after bleaching)
- Dental sensitivity(Immediately after the treatment and 48 hours after the treatment)
- Color change throughout 12 months with a visual color scale(Before, immediately after, 14 days, 3 months, 6 months and 12 months after bleaching)
研究者
Patricia Moreira de Freitas
Associate Professor
University of Sao Paulo
