Preemptive Use of Etodolac on Tooth Sensitivity Caused by In-office Bleaching: a Randomized, Triple-blind, Controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 主要终点
- Risk to the tooth sensitivity
研究概览
简要总结
Objectives: This study will determine the effectiveness of preemptive administration of etodolac on risk and intensity of tooth sensitivity caused by in-office bleaching using 35% hydrogen peroxide.
Materials and Methods: Fifty patients will be selected for this triple-blind, randomized, cross-over, placebo-controlled clinical trial. Etodolac (400 mg) or placebo will be administrated in a single-dose 1 hour prior to bleaching procedure. The whitening treatment with 35% hydrogen peroxide will be carried out in two sessions with a 7-day interval. Tooth sensitivity will be assessed before, during and 24 hours after the procedure using analog visual and verbal scales. Color alteration will be assessed by a bleach guide scale 7 days after each 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 and color shade will be subjected to the Friedman, Wilcoxon and Mann-Whitney tests, respectively (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 37578714.4.0000.5546).
Trial design:
This study will be a randomized, triple-blind, placebo-controlled clinical trial with a cross-over design. The patients included will be submitted to two in-office bleaching sessions receiving placebo (control) or etodolac prior to the bleaching procedure; while different treatments will be allocated for each session. A delay of 1 week between the sessions (wash-out) will be established. The study will be conducted at the clinic of the School of Dentistry of the local university from November 2014 to July 2015.
Participants:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, 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 all six upper anterior teeth with shade mismatching with 2.5 M2 (Vita Bleachguide 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, known allergy to any component of medication used in the study, pregnant or breastfeeding will be also excluded.
研究组 & 干预措施
Placebo
Placebo - (inert content)
干预措施: Placebo (Drug)
Experimental -
400 mg of NAISE etodolac
干预措施: Etodolac (Drug)
结局指标
主要结局
Risk to the tooth sensitivity
时间窗: During the bleaching treatment.
The tooth sensitivity will be evaluated using a 5-point Verbal rating scale (VRS), where 0 = none, 1 = mild, 2 = moderate, 3 = considerable and 4 = severe. Score different from 0 will determine presence of sensitivity. The risk of tooth sensitivity will be determined by relative risk assessed by ratio between absolute risk of experimental condition by those observed in control. The 95% confidence interval will be calculated.
次要结局
- Level of tooth sensitivity - after the procedure(24 hours after the Bleaching procedure)
- Level of tooth sensitivity - during procedure(During the Bleaching procedure)
- Risk after tooth sensitivity - after the procedure(24 hours after the Bleaching procedure)
研究者
Flavia Pardo Salata Nahsan
Clinical Professor
Universidade Federal de Sergipe