Effect of Potassium Oxalate and Potassium Nitrate on Tooth Sensitivity Related to 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
- 47
- 试验地点
- 2
- 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 the use of desensitivity gels prior in office bleaching on risk and intensity of tooth sensitivity caused by in-office bleaching using 35% hydrogen peroxide. Materials and Methods: Fourty seven patients will be selected for this triple-blind, randomized, cross-over, placebo-controlled clinical trial. 10 minutes prior to bleaching procedure, patients will receive the the potassium nitrate 2% and potassium oxalate 5% desensitivity gel application on vestibular surface. 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 and Vita Easy shade spectrophotometer 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 60259316.2.0000.5546).
Trial design:
This study will be a randomized, triple-blinded, placebo-controlled clinical trial, and split mouth study design.
The patients included will be submitted to two in-office bleaching sessions receiving the potassium nitrate 2% and postassium oxalate 5% desensitivity gel application on vestibular surface, for 10 minutes. A delay of 1 week between the sessions will be established. The study will be conducted at the clinic of the School of Dentistry of the local university from November 2016 to October 2017.
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
- 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
- •Patients included in this clinical trial will be at least 18 years old with good oral health;
- •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;
- •Restorations in anterior teeth'
- •Patients with tooth severe discoloration (e.g., stains caused by tetracycline);
- •Presence of enamel hypoplasia;
- •Presence of gingival recession or dentin exposure;
- •Presence of tooth pulpitis or endodontics;
- •Participants submitted to previous bleaching procedures;
- •Patients with prior tooth sensitivity;
- •Patients with known allergy to any component of medication used in the study;
- •Pregnant or breastfeeding will also be also excluded.
研究组 & 干预措施
Control: Potassium Nitrate 2% gel
The patient will receive the application of potassium nitrate 2% gel on vestibular surface teeth, for 10 minutes.
干预措施: Potassium nitrate 2% gel (Device)
Intervention: Potassium Oxalate 5% gel
The patient will receive the application of potassium oxalate 5% gel on vestibular surface teeth, for 10 minutes.
干预措施: Potassium oxalate 5% gel (Device)
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 assessed using a Visual analogue (VAS) and verbal scales. VAS consisted of a 10-cm scale 0 (no sensitivity) 10 (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 the distance from 0, using a digital caliper. 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 the Bleaching procedure)
- Level of tooth sensitivity - after the procedure(24 hours after the Bleaching procedure)
- Bleaching Effectiveness(Before the bleaching procedures and 7 days after this)
- Risk after tooth sensitivity- after the procedure(24 hours after the Bleaching procedure)
研究者
Flavia Pardo Salata Nahsan
Principal Investigator
Universidade Federal de Sergipe