Impact of the Efficacy of Diazepam 1% Oral Gel in Burning Mouth Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Evolution of burning mouth
研究概览
简要总结
Burning mouth syndrome (BMS) is a syndrome characterized by burning and persistent oral pain, ranging from mild to intense, in the absence of organic disorders of the oral cavity and with a major impact on the quality of life of the sufferer. Although several etiological theories have been proposed to explain BMS, none has been universally accepted to date, and its origin remains unclear. Currently, several scientific evidences would suggest that underlying BMS would be alterations in certain neuropathic mechanisms.
The purpose of the study is to evaluate the efficacy of Diazepam 1% oral gel in the treatment of burning mouth syndrome.
详细描述
A double-blind placebo-controlled trial is conducted in order to evaluate the efficacy of Diazepam 1% oral gel and determine the statistical significance of the outcome variables. 40 patients with BMS, in two groups:
- case group with Diazepam 1% oral gel (Galenic formulation)
- control group with placebo in oral gel formulation
Follow-up of 2 months
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •clinically diagnosed with BMS who reported a history of continuous oral burning pain for more than 4 months with no clinical signs that could justify the syndrome
排除标准
- •• clinically diagnosed with BMS who reported a history of continuous oral burning pain for more than 4 months with clinical signs that could justify the syndrome
研究组 & 干预措施
Diazepam 1% Oral gel
Patients were treated with Diazepam 1% oral gel.
干预措施: Diazepam 1% oral gel (Drug)
Placebo
Patients treated with a placebo gel control.
干预措施: Placebo (Drug)
结局指标
主要结局
Evolution of burning mouth
时间窗: 2 Months
Evolution of burning mouth symptoms change through questionnaries. The Visual Pain Analog Scale (VAS) will be used to assess pain, in which the value 0 indicates no pain and the value 100 maximum pain. The Oral Health Impact Profile Short Form (OHIP-14) will be used to assess the impact of oral problems on quality of life, in which the presence or absence of physical pain, functional limitation, psychological distress, physical, psychological and social disabilities, and handicap will be assessed.
次要结局
未报告次要终点
研究者
Gaetano Isola
Principal researcher
University of Catania