Preemptive Use of Piroxicam-beta-Cyclodextrin on Tooth Sensitivity Caused by In-office Bleaching: Randomized, Triple-blind, Controlled Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Risk to Tooth sensitivity
研究概览
简要总结
Objectives: This study aims to evaluate the effectiveness of preemptive administration of non-steroidal anti-inflammatory Piroxicam-beta-Cyclodextrin on risk and level of tooth sensitivity caused by in-office bleaching procedures using 35% hydrogen peroxide.
Fifty patients will be selected for this triple-blind, randomized, cross-over, placebo-controlled clinical trial. Piroxicam-beta-Cyclodextrin (200 mg) or placebo will be administrated in a single-dose thirty minutes 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 Immediately before bleaching agent removal and up to 24 hours after each session 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 Fisher's exact test. Data on the sensitivity level for both scales and color shade will be subjected to the Mann-Whitney and Friedman tests, respectively (α = 0.05).
详细描述
Methods & Materials:
This clinical trial was approved by the Scientific Review Committee and by the Ethics Committee on Research Involving Humans at the University Hospital of the Federal University of Sergipe (CAAE 50511415.1.0000.5546).
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 Piroxicam-beta-Cyclodextrin 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 December 2016 to May 2017.
Participants:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Triple Blind (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least 18 years old patients of both genders presenting good general/oral health;
- •All maxillary anterior teeth presenting shade equal or darker than 2,5M2 at Vita bleachguide guide (Vita-Zahnfabrik, Germany);
- •Signed the form accepting to participate of this study.
排除标准
- •Presence of caries lesions, restorations and/or endodontic treatment at any maxillary anterior teeth.
- •Undergone tooth-whitening procedures;
- •Pregnant/lactating;
- •Presence of periodontal diseases;
- •Presence of severe tooth discoloration by tetracycline stains or fluorosis;
- •Any kind of medicine, bruxism habits or any other pathology that can cause sensitivity (such as recession, dentin exposure);
- •Continuous use of drugs with anti-inflammatory actions;
- •Presence of tooth hypersensitivity at baseline measurement;
- •Any known adverse effects caused by Piroxicam-beta-Cyclodextrin;
- •Non-attendance to any session of evaluation or bleaching.
研究组 & 干预措施
Piroxicam-beta-Cyclodextrin
Intervention: Drug Piroxicam-beta-Cyclodextrin
干预措施: Piroxicam-Beta-Cyclodextrin (Drug)
Piroxicam-beta-Cyclodextrin
Intervention: Drug Piroxicam-beta-Cyclodextrin
干预措施: Placebo (Drug)
Placebo
Intervention: Drug Placebo
干预措施: Piroxicam-Beta-Cyclodextrin (Drug)
Placebo
Intervention: Drug Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Risk to Tooth sensitivity
时间窗: up to 24 hours after each session. [Safety Issue: Yes]
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 to Tooth sensitivity(up to 24 hours after each session.[Safety Issue: Yes)
研究者
Aline Carvalho Peixoto
Principal Investigator
Universidade Federal de Sergipe