Effect of Sodium Fluoride at 1.1%, Associated or Not With the Low-level Light Therapy in the Prevention of Post-bleaching Sensitivity: a Randomized, Double-blind, Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 主要终点
- Stimulated pain intensity measure (P5)
研究概览
简要总结
To investigate the effects of desensitizing agents on the dental bleaching process, testing the hypothesis that they may prevent dental sensitivity.
详细描述
The objective of this double blind, randomized and controlled clinical study, was to evaluate the efficacy of 1.1% sodium fluoride associated with LLLT (Low Level Laser Therapy) on teeth that were exposed to 35% hydrogen peroxide during 4 weeks of bleaching treatment. Methods: 25 volunteers were evaluated through the split-mouth model, where the hemiarcates were ranzomized and later allocated in one of the experimental groups: G-FLUOR+LASER - constitutes the group treated with LLLT + 1.1% sodium fluoride; and G-FLUOR - constitutes the group treated with placebo + 1.1% sodium fluoride .
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Absence of active carious lesions;
- •Good oral hygiene;
- •Do not present hypersensitivity;
- •Do not smoke;
- •Not being pregnant.
排除标准
- •Presence of periodontal disease;
- •Presence of cracks or fractures;
- •Presence of restorations and prostheses;
- •Presence of gastroesophageal dysfunction;
- •Patients with severe internal dental dimming.
研究组 & 干预措施
G-FLUOR+LASER
The corresponding hemiarcade received the application of Low Level Laser Therapy as a desensitizing treatment prior to in-office dental bleaching, followed by the application of 1.1% sodium fluoride after dental bleaching.
干预措施: Low Level Laser Therapy (Device)
G-FLUOR+LASER
The corresponding hemiarcade received the application of Low Level Laser Therapy as a desensitizing treatment prior to in-office dental bleaching, followed by the application of 1.1% sodium fluoride after dental bleaching.
干预措施: 1.1% Sodium Fluoride (Drug)
G-FLUOR+LASER
The corresponding hemiarcade received the application of Low Level Laser Therapy as a desensitizing treatment prior to in-office dental bleaching, followed by the application of 1.1% sodium fluoride after dental bleaching.
干预措施: In-office dental bleaching (Drug)
G-FLUOR
The correspondent hemiarcade received only the positioning of the inactive laser tip (placebo), prior to in-office dental bleaching, followed by the application of 1.1% sodium fluoride as a desensitizing treatment after dental bleaching
干预措施: 1.1% Sodium Fluoride (Drug)
G-FLUOR
The correspondent hemiarcade received only the positioning of the inactive laser tip (placebo), prior to in-office dental bleaching, followed by the application of 1.1% sodium fluoride as a desensitizing treatment after dental bleaching
干预措施: In-office dental bleaching (Drug)
结局指标
主要结局
Stimulated pain intensity measure (P5)
时间窗: 4 weeks
Self reported stimulated pain intensity assessed weekly, by modified visual scale, at baseline, after first, second, third and fourth in-office bleaching application. Each item is scored 0-3 (0 = no pain; 3 = pain as bad as can be).
次要结局
- Recurrence of stimulated pain(2 months)
- Non-stimulated pain intensity measure, (P28)(28 days)
研究者
Cecy Martins Silva
Associate Professor
Universidade Federal do Para