Rior Use of Naproxen on Tooth Sensitivity Reduction After In-office Bleaching: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 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 - during procedure
研究概览
简要总结
This study aims to evaluate the effects of prior use of non-steroidal anti-inflammatory Naproxen on risk and level of tooth sensitivity caused by in-office bleaching procedures.
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)
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
- •At least 18 years old patients of both genders presenting good general/oral health;
- •All maxillary anterior teeth presenting shade equal or darker than 2M2 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 Naproxen;
- •Non-attendance to any session of evaluation or bleaching.
研究组 & 干预措施
Placebo
干预措施: Naproxen (Drug)
Naproxen
干预措施: Naproxen (Drug)
结局指标
主要结局
Risk to Tooth sensitivity - during procedure
时间窗: During the bleaching procedure
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 - during procedure(During the bleaching procedure)
- Risk of tooth sensitivity - after procedure(24 hours after bleaching prcedure)
- Level of tooth sensitivity - after procedure(24 hours after bleaching prcedure)
研究者
André Luis Faria e Silva
Dr.
Universidade Federal de Sergipe