The Role of Xerostomia in Burning Mouth Syndrome: Case - Control Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- The role of Xerostomia in Burning Mouth Syndrome: case - control study
研究概览
简要总结
Objectives: to evaluate xerostomia and salivary flow in patients with burning mouth syndrome (BMS) treated with amitriptyline before and after the use of antixerostomic topical medication.
Methods: In this case-control double-blinded study, we enrolled 38 patients with BMS diagnosed according to the (IASP). The subjects were randomly divided into two groups: Study Group: 19 patients whom received topical medication of urea 10% and Control Group: 19 patients whom received placebo to apply at the oral cavity 3-4 times per day, during three months. The patients were evaluated before and after the above treatment. Finally, data were statistically analyzed.
It is know that BMS is eventually associated to reduced salivary flow (Cho et al.,2010; Kho et al., 2010; Marino et al., 2010) and to abnormal salivary composition (increasing concentrations of K+, Na+, Cl-, Ca+2, IgA, amylase) (Patton et al., 2007). Even in the absence of hyposalivation, patients may complain of xerostomia and dry mouth (Cho et al.,2010; Kho et al., 2010; Marino et al., 2010; Thomson, 2005). These patients also have several sensory losses even in taste and smell function, recently described (Siqueira et al., 2006a; Siqueira et al., 2006b; Siviero et al., 2011).
详细描述
Materials and Methods In this case-control double-blinded study, we enrolled 38 patients with BMS diagnosed according to the International Association for the Study of Pain (IASP) (17), that had been followed at the Craniofacial Pain Clinic of Hospital das Clinicas, School of Medicine of the University of Sao Paulo. All subjects were informed about the purposes of the study, and all signed the informed consent. The protocol had been approved by the local Ethics Committee. No patient had hyposalivation at the moment of diagnosis by the quantitative evaluation. All patients had been treated with 25mg-50mg of amitriptyline within the last three months. They underwent laboratory tests and careful exam to exclude other causes of burning mouth (10).
The exclusion criteria were other facial pain syndromes, other causes for abnormal salivation, other neuropathies or primary diseases associated to burning mouth, inability to answer the questions and / or tests
The subjects were randomly divided into two groups:
- Study Group: 19 patients received topical medication of urea 10% to be applied at the oral cavity 3-4 times per day, during three months.
- Control Group: 19 patients received placebo (5% sodium carboxymethylcellulose, 0.15% methyl paraben and 10% glycerol in distilled water qsp 100g) to be applied at the oral cavity 3-4 times per day, during three months.
The patients were evaluated before and after the above treatment with the following instruments:
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
- 37 Years 至 88 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients had been treated with 25mg-50mg of amitriptyline within the last three months. They underwent laboratory tests and careful exam to exclude other causes of burning mouth
排除标准
- •other facial pain syndromes, other causes for abnormal salivation, other neuropathies or primary diseases associated to burning mouth, inability to answer the questions and / or tests
研究组 & 干预措施
Study Group
19 patients whom received topical medication of urea 10%
干预措施: Uréia (Drug)
Control Group
19 patients whom received placebo
干预措施: Placebo (Drug)
结局指标
主要结局
The role of Xerostomia in Burning Mouth Syndrome: case - control study
时间窗: three years
次要结局
未报告次要终点