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
- 1
- 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
研究组 & 干预措施
Interventional
Device Laser diode parameters: spot size of 0.04 mm2, average power (output) of 40 mW and 0.4 J per irradiation point, energy density of 10 J cm2, irradiation time of 10 seconds per point
1 session per week during 4 session
干预措施: laser diode (Radiation)
Comparator
laser probe inactive for similar duration as for the laser diode group; only a beep sound was produced by the laser machine
1 session per week during 4 session
干预措施: laser diode (Radiation)
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