Study Evaluating the Laser Diode Effect on Burning Mouth Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Pain
研究概览
简要总结
The aim of this study was to report the effect of laser diode on the treatment of burning mouth syndrome (BMS)
Patients were randomly allocated to two different groups:
the first one (group A) underwent Laser diode whereas the second one (group B) received Laser diode inactive
详细描述
The inclusion criteria were as follows: (a) oral burning sensation, at least in the last 6 months; (b) no detection of oral mucosal lesions; and (c) ability to complete the present clinical trial. The exclusion criteria were as follows: (a) diagnosis of Sjögren syndrome on the basis of European criteria ; (b) previous head and neck radiotherapy; (c) diagnosed lymphoma; (d) hepatitis C infection; (c) pregnant or breast-feeding women
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •diagnosis of burning mouth syndrome in accordance the International Classification of Headaches: continuous symptoms of oral burning or pain on a daily or almost daily basis, during all or part of the day for more than 6 months
排除标准
- •history of head and neck malignancy, radiation therapy to the head and neck area, poorly managed diabetes mellitus, chronic thyroid disease, or known Sjogren's disease and pregnant
结局指标
主要结局
Pain
时间窗: 4 weeks
VAS (Visual Analog Scale).
次要结局
- xerostomia(4 weeks)
- oral quality of life(4 weeks)
- anxiety and depression(4 weeks)
研究者
Pia Lopez Jornet
MD,DDS,PhD
Universidad de Murcia