Effectiveness of Sealed In-office Bleaching Technique: Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Tooth sensitivity
研究概览
简要总结
Thus, the aim of this study is to evaluate the sealed bleaching technique on tooth sensitivity and bleaching efficacy. The hypothesis is that the sealed bleaching technique reduce the tooth sensitivity when compared to conventional technique, without alters the bleaching efficacy.
详细描述
This is a randomized, single-blind, and controlled trial with a parallel group and an equal allocation rate to receive either one of two treatments, whereas the sealed technique is the experimental intervention and the conventional technique is control one.
PICO Question:
P (Population) - Patients of dentistry service of Federal University of Sergipe.
I: (Intervention) - In-office bleaching using 35% hydrogen peroxide bleaching agent covered with a customized tray.
C: (Control) - In-office bleaching using 35% hydrogen peroxide bleaching agent covered without a customized tray.
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
- Double (Investigator, 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
- •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, Alemanha)
- •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;
- •Non-attendance to any session of evaluation or bleaching;
研究组 & 干预措施
Sealed bleaching Protocol
The 35% hydrogen peroxide gel will be mixed and applied over the buccal surfaces of teeth. The bleaching agent will remain for 45-min application without replacement of peroxide. However, a customized tray will be placed over the bleaching agent during entire permanence of peroxide (45 minutes).
干预措施: Tooth bleaching (Drug)
Conventional Bleaching Protocol
The 35% hydrogen peroxide gel will be mixed and applied over the buccal surfaces of teeth. The bleaching agent will remain for 45-min application without replacement of peroxide.
干预措施: Tooth bleaching (Drug)
结局指标
主要结局
Tooth sensitivity
时间窗: During the bleaching procedure
The tooth sensitivity will be assessed using a Visual analogue (VAS) and verbal scales. VAS consisted of a 10-cm color scale from green (no sensitivity) to red (unbearable sensitivity). A slightly air-stream will be applied over the buccal surfaces of the central incisors, and the patients will record their sensitivity perception by pointing with a pen on the scale. The distance between the marking and the border of scale, relative to the absence of sensitivity will be measured. The measurements will be scored according to: 0 - until 2-cm; 1 - between 2.1 and 4-cm; 2 - between 4.1 and 6-cm; 3 - between 6.1 and 8-cm; 4 - between 8.1 and 10-cm. For verbal scale, the patient will relate her/his level of sensitivity in a scale from 0 to 4, while 0 = none, 1 = mild, 2 = moderate, 3 = considerable, and 4 = severe. Participants presenting score different from 0 for any scale in this evaluation time will be excluded.
次要结局
- Bleaching Effectiveness(Before the bleaching procedures and 7 days after this.)
研究者
André Luis Faria e Silva
Dr
Universidade Federal de Sergipe