EVALUATION OF CLINICAL EFFICACY AND SENSIBILITY OF BLEACHING AGENT 37% CARBAMIDE PEROXIDE IN-OFFICE TOOTH BLEACHING: CLINICAL TRIAL RANDOMIZED CONTROLLED
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 主要终点
- Color evaluation
研究概览
简要总结
Objectives: This study will determine the clinical efficacy of bleaching agent 37% carbamide peroxide compared to 35% hydrogen peroxide on the change of color scores in anterior superior teeth, in-office bleaching technique after 7, 14 and 37 days; and the Risk to the tooth sensitivity before, during and 24 hours after the procedure.
Materials and Methods: Fifty patients will be selected for this single-blind, parallel, randomized-controlled clinical trial. The whitening treatment with 37% carbamide peroxide or 35% hydrogen peroxide (control) will be carried out in a single application of 45 minutes for two sessions with a 7-day interval. The sensitivity level will be assessed before, during and 24 hours after the procedure using verbal and analogic visual analogue (VAS) scales. Color alteration will be assessed by a bleach guide scale 7 days after each session and 30 days after the last session. Relative risk to sensitivity will be calculated and adjusted by session; while comparison of overall risk will performed by McNemar's test. Data on the sensitivity level for both scales will be subjected to the Mann-Whitney tests (α = 0.05). The color change will be measured with a spectrophotometer using the CIE L * a * b * and the L*, a * and b * parameter delta data, and ΔE and Δ00, will be individually subjected to two-way repeated measures ANOVA test to compare the two bleaching techniques at each evaluation time (α = 0.05).
详细描述
Methods & Materials: This clinical trial was approved by the Scientific Review Committee and by the Committee for the Protection of Human Subjects of the local university (CAAE 50511415.1.0000.5546).
Trial design: This study will be a randomized-controlled, single-blind clinical trial with a parallel design. The patients included will be submitted to two in-office bleaching sessions with a 7-day interval receiving 35% hydrogen peroxide (control) or 37% carbamide peroxide in a single application of 45 minutes; while the same treatments will be allocated for each session. The study will be conducted at the clinic of the School of Dentistry of the local university from May 2016 to December 2016.
Participants: Patients included in this clinical trial will be at least 18 years old with good oral health. Patients with any of the six upper anterior teeth with caries, restoration, severe discoloration (e.g., stains caused by tetracycline), enamel hypoplasia, gingival recession, dentin exposure, pulpitis, or endodontics will be excluded. Participants submitted to previous bleaching procedures, presenting prior tooth sensitivity, pregnant or breastfeeding will be also excluded. Only patients presenting all six upper anterior teeth with shade mismatching with 2.5 M2 (Vita Bleach guide 3D-Master scale, Vita-Zahnfabrik, Bad Sackingen, Germany) or darker will be included.
Sample Size Calculation:
The sample calculation will be based on the primary continuous outcome for superiority control. Power of the test will be set at 80%, considering a type I error of 0.05; for a minimum detectable difference between treatments 25%, based on a prior study using similar bleaching agent, while a coefficient of variation of 30% of control treatment will be expected. The calculation resulted in fifty patients, through the formula used n = f(α/2, β) × [p1 × (100 - p1) + p2 × (100 - p2)] / (p2 - p1)2. The calculation resulted in fifty patients.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients included in this clinical trial will be at least 18 years old with good oral health. Only patients presenting canine upper teeth with shade mismatching with 2.5 M2 (Vita Bleach guide 3D-Master scale, Vita-Zahnfabrik, Bad Sackingen, Germany) or darker will be included.
排除标准
- •Patients with any of the six upper anterior teeth with caries, restoration, severe discoloration (e.g., stains caused by tetracycline), enamel hypoplasia, gingival recession, dentin exposure, pulpitis, or endodontics will be excluded. Participants submitted to previous bleaching procedures, presenting prior tooth sensitivity, pregnant or breastfeeding will be also excluded.
研究组 & 干预措施
37% Carbamide Peroxide
- no Gingival dam protection (as manufacturer´s instruction)
- 37% Carbamide Peroxide application (2 sessions of 45 minutes)
- Tooth sensitivity (Verbal and visual scale) and color evaluation
干预措施: 37% Carbamide Peroxide (Drug)
35% Hydrogen Peroxide
- Gingival dam protection (as manufacturer´s instruction)
- 35% Hydrogen Peroxide application (2 sessions of 45 minutes)
- Tooth sensitivity (Verbal and visual scale) and color evaluation
干预措施: 35% hydrogen Peroxide (Drug)
结局指标
主要结局
Color evaluation
时间窗: Prior to bleaching procedure, after 7, 14 and 37 days.
Clinical efficacy of bleaching agent 37% carbamide peroxide compared to 35% hydrogen peroxide (active control). The color change will be measured with a spectrophotometer using the CIE L \* a \* b \* and the L\*, a \* and b \* parameter delta data, and ΔE and Δ00.
次要结局
- Risk to the tooth sensitivity(During the bleaching procedure, immediately after bleaching agent removal and up to 24 hours after each session.)
- Level of tooth sensitivity(During the bleaching procedure, immediately after bleaching agent removal and up to 24 hours after each session.)
研究者
Aline Carvalho Peixoto
Principal Investigator
Universidade Federal de Sergipe