Dentine Hypersensitivity Treated With Diode Laser and Amino Fluoride: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- NRS (numerical rating scale)
研究概览
简要总结
The aim of the present report is to evaluate the amino fluoride gel with or without application of diode laser on pain due to dentine hypersensitivity.
NRS (numerical rating scale) index will be used to evaluate the pain suffered by each patient after cold air blow stimulus.
After treatment application, the follow-up timing planned for each patient will be at 1 week, 1 month, 3 months and 6 months
详细描述
The aim of the present report is to evaluate the amino fluoride gel with or without application of diode laser on pain due to dentine hypersensitivity.
The study is designed with a split mouth design. NRS (numerical rating scale) index will be used to evaluate the pain suffered by each patient. The pain response will be stimulated by thermal urge (cold air blow). Teeth will be divided in two groups. The treatment group, treated with 980nm diode laser and amino fluoride gel; the control group, treated only with amino fluoride gel.
The follow-up timing planned for each patient will be at 1 week, 1 month, 3 months and 6 months. In these follow-up sessions a revaluation of the pain response is performed using the NRS index.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Teeth in good periodontal health
- •Good oral hygiene
- •Dentine hypersensitivity: NRS (Numerical Rating Scale) ≥ 3
排除标准
- •Teeth local disease or fractures in treatment area
- •Irreversible teeth necrosis or pulpitis
- •Definitive restorations or veneers
- •Recent use of painkillers or anti-inflammatory drugs,
- •Treatment for dentine Hypersensitivity less than 6 months before the study start
- •Therapies contraindication
研究组 & 干预措施
Laser and Fluoride
The treatment group will be treated with amino-fluoride gel (Elmex Dental Gel, Colgate-Palmolive company, New York, 300 Park Ave, United States) in association 980nm diode laser (doctor smile wiser by Lambda s.p.a. Via dell'Impresa, 1, 36040 Brendola VI, Italy) 1.5 W, pulsed mode 2 mm from tooth surface. For treatment will be used 400 μm diameter and 5 mm long tips of for 4 minutes
干预措施: Laser and Fluoride (Device)
Fluoride
The control group will be treated with amino-fluoride gel (Elmex Dental Gel, Colgate-Palmolive company, New York, 300 Park Ave, United States) for 4 minutes.
干预措施: Fluoride (Other)
结局指标
主要结局
NRS (numerical rating scale)
时间窗: Before treatment and 1 week, 1 month, 3 months, 6 months after treatment
The dentine hypersensitivity will be evaluated with the Numerical Rating Scale ( NRS ), where 0 meant pain absence and 10 a unbearable pain (Hjermstad MJ, Fayers PM, Haugen DF, Caraceni A, Hanks GW, Loge JH, et al. Studies comparing Numerical Rating Scales, Verbal Rating Scales, and Visual Analogue Scales for assessment of pain intensity in adults: a systematic literature review. J Pain Symptom Manage. 2011;41(6):1073-93.)
次要结局
未报告次要终点
研究者
Andrea Scribante
Professor
University of Pavia