Potassium Nitrate Influence on Post in Office Bleaching Sensitivity: a Triple Blinded Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Risk to the tooth sensitivity (VAS)
研究概览
简要总结
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 and using different types of potassium nitrate. Materials and Methods: Seventy five 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% or placebo gel application on vestibular surface and Toothpaste 15 days before start the bleaching procedure (group 1: placebo gel + Colgate toothpaste; Group 2: Placebo gel + Nitrate toothpaste Sensodyne and Group 3: Potassium Nitrate + Colgate toothpaste). 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 Vita Guide scale at the end of the last 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 and color shade will be subjected to the Friedman, Wilcoxon (α = 0.05). If necessary, multiple comparation will be done using Tukey's test.
详细描述
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 5% or placebo gel (prior the bleaching session, for 10 minutes), associated to normal toothpaste or potassium nitrate containing toothpaste (15 days prior and during the bleaching procedure).
A delay of 1 week between the sessions will be established.
Participants:
Patients included in this clinical trial will be between 18 and 29 years old with good oral health, all anterior tooth healthy and to agree with TCLE (Term of Free and Informed Consent). Only patients presenting all six upper anterior teeth with shade mismatching with 2.5 M2 (VitaClassicalscale, Vita-Zahnfabrik, Bad Sackingen, Germany).
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
- None
盲法说明
Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 29 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 between 18 and 29 years old with good oral health;
- •All anterior tooth healthy
- •To agree with TCLE (Term of Free and Informed Consent).
- •Only patients presenting all six upper anterior teeth with shade mismatching with 2.5 M2 (VitaClassicalscale, Vita-Zahnfabrik, Bad Sackingen, Germany).
排除标准
- •Patients with any of the six upper anterior teeth with caries
- •Restoration in anterior tooth, 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
- •being pregnant or breastfeeding.
结局指标
主要结局
Risk to the tooth sensitivity (VAS)
时间窗: During the bleaching treatment
The tooth sensitivity will be assessed using a Visual analogue (VAS) scale. 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 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.
Risk to the tooth sensitivity (VRS)
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 (VAS)(During the bleaching treatment)
- Level of tooth sensitivity (VRS)(During the bleaching treatment)
- Risk after tooth sensitivity- after the procedure (VAS)(24 hours after the Bleaching procedure)
- Risk after tooth sensitivity- after the procedure (VRS)(24 hours after the Bleaching procedure)
- Level of tooth sensitivity - after the procedure (VAS)(24 hours after the Bleaching procedure)
- Level of tooth sensitivity - after the procedure (VRS)(24 hours after the Bleaching procedure)
- Bleaching Effectiveness(Before the bleaching procedures (baseline) and end of the treatment (an average of 14 days))
研究者
Flavia Pardo Salata Nahsan
Clinical Professor
Universidade Federal de Sergipe