Effect of Low-level Light Therapy Associated With Potassium Nitrate in the Control of Post-bleaching Dental Sensitivity: a Randomized, Double-blind, Split-mouth, Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in Stimulated pain intensity in different assessment times (P15)
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 control dental sensitivity.
详细描述
The objective of this double blind, randomized and controlled clinical study, was to evaluate the efficacy of potassium nitrate / sodium fluoride (KNO3 / KF) gel associated with LLLT (Low Level Light Therapy) on teeth that were exposed to 35% hydrogen peroxide during 3 weeks of bleaching treatment. Methods: 50 volunteers were evaluated through the split-mouth model, where the hemiarcates were randomized and later allocated in one of the experimental groups: G1 (negative control)- group with no desensitizing treatment, only bleached; G2 (positive control)- group treated with LLLT + placebo gel; G3- group treated with placebo laser application + 5% KNO3 / 2% KF gel; and G4- group treated with LLLT + 5% KNO3 / 2% KF gel.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, 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
- •Absence of active carious lesions;
- •Never undergone bleaching therapy;
- •Good oral hygiene;
- •Do not present hypersensitivity;
- •Do not smoke;
- •Not being pregnant;
- •Presence of at least 28 teeth in oral cavity.
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;
- •Presence of periodontal disease;
- •Presence of dentin exposure in anterior and/or posterior teeth.
研究组 & 干预措施
G1- Negative Control
Group with no desensitizing treatment. Prior to bleaching therapy, a water-soluble placebo gel, with non-active agent will be applied to dental vestibular surfaces. After bleaching therapy, the LASER tip will be positioned in two points (apical and cervical), without light emission (placebo).
干预措施: In-office dental bleaching (Drug)
G2- LASER (Positive Control)
Group treated with placebo gel before bleaching and with LLLT after in-office bleaching.
干预措施: In-office dental bleaching (Drug)
G2- LASER (Positive Control)
Group treated with placebo gel before bleaching and with LLLT after in-office bleaching.
干预措施: Low Level Laser Therapy (Drug)
G3- KNO3 (Positive Control)
Group treated with desensitizing gel before bleaching and after in-office bleaching, the LASER tip will be positioned in two points (apical and cervical), without light emission (placebo).
干预措施: In-office dental bleaching (Drug)
G3- KNO3 (Positive Control)
Group treated with desensitizing gel before bleaching and after in-office bleaching, the LASER tip will be positioned in two points (apical and cervical), without light emission (placebo).
干预措施: 5% potassium nitrate / 2% sodium fluoride gel (Drug)
G4- KNO3 + LASER
Group treated with desensitizing gel before bleaching and with LLLT after in-office bleaching.
干预措施: In-office dental bleaching (Drug)
G4- KNO3 + LASER
Group treated with desensitizing gel before bleaching and with LLLT after in-office bleaching.
干预措施: Low Level Laser Therapy (Drug)
G4- KNO3 + LASER
Group treated with desensitizing gel before bleaching and with LLLT after in-office bleaching.
干预措施: 5% potassium nitrate / 2% sodium fluoride gel (Drug)
结局指标
主要结局
Change in Stimulated pain intensity in different assessment times (P15)
时间窗: 15 days, with assessments in the 1st, 8th and 15th day of the treatment
The stimulated pain intensity was self reported by the patients with a modified visual analog scale, from 0 to 3, where 0 means "no pain", 1 is "mild pain", 2 is "moderate pain" and 3 is "severe pain". For all groups, the patients evaluated the stimulated pain intensity two times per session: before and after the treatment in the same day. Thus, in total each patient reported the pain intensity 6 times, two times in the first day (1st session), two times in the eighth day (2nd session) and two times in the fifteenth day (3rd session).
次要结局
- Non-stimulated pain intensity measure, (P21)(21 days)
研究者
Cecy Martins Silva
Associate Professor
Universidade Federal do Para