Assessment of the Effectiveness of the Selected Treatment Method and Psychological Disorders of Primary Burning Mouth Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Assessment of the depression patients diagnosed with BMS.
研究概览
简要总结
The burning mouth syndrome (BMS) is a chronic pain syndrome of the oral mucosa. Feels like experiencing a burning sensation, pain, stinging, or numbness in the mouth along with a feeling of dryness, paraesthesia, taste disturbance or hypersensitivity.The complaints are usually bilateral, of moderate intensity, they persist for a minimum of 4-6 months and concern the clinically unchanged membrane mucous.The psychiatric aspect of BMS is very important. The presence of BMS has been shown to be associated with depression, increased anxiety levels, hypochondria, and carcinophobia and emotional instability
详细描述
The burning mouth syndrome (BMS) is a chronic pain syndrome of the oral mucosa. Patients have experiencing a burning sensation, pain, stinging, or numbness in the mouth along with a feeling of dryness, paraesthesia, taste disturbance or hypersensitivity. The complaints are usually bilateral, of moderate intensity, they persist for a minimum of 4-6 months and concern the clinically unchanged membrane mucous.The psychiatric aspect of BMS is very important. The presence of BMS has been shown to be associated with depression, increased anxiety levels, hypochondria, and carcinophobia and emotional instability
The first step is to determine the specific type of BMS, i.e. to exclude a causal relationship with the existing local factors, general diseases and medications taken.
The pathophysiology of Primary Burning Mouth Syndrome is unclear. Due to the lack of morphological changes in the oral cavity with the simultaneous occurrence of troublesome pain symptoms, it is now assumed that pain in BMS has a neuropathic mechanism.
Among the psychotropic drugs, the most commonly used in the treatment of BMS was clonazepam, a drug with anticonvulsant and anxiolytic properties .
In this study, the investigators used clonazepam because of which it has proven effectiveness in therapy in combination with a tongue protector made for the purpose of the test. Use of a tongue protector in the form of a bag put on it 3 times a day is relatively new method of treatment, which is to exclude the detachment of the tongue's para-function on burning.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, 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
- 是
入选标准
- •History of BMS for at least 6 months
- •no clinical changes in the oral cavity that are clinically verifiable and may affect symptoms,
- •no previous BMS therapy
- •age over 18
排除标准
- •V and VII nerve neuralgia
- •patients with uncontrolled diabetes mellitus,
- •thyroid disease, anemia,
- •Sjogren's disease and
- •connective tissue disease (fibromyalgia),
- •patients after prior surgical / neurosurgical treatment of the head,
- •oncological treatment (radiotherapy),
- •pregnant women,
- •the occurrence of clinical pathologies in the oral cavity that may cause pain,
- •deficiencies of vitamin B12, folic acid
研究组 & 干预措施
Patients diagnosed with BMS traeting with Clonazepam
Dosing of clonazepam was as follows: in the first week, 1 mg to be sucked for 2 minutes, then swallowed (once a day in the morning), in the second week, 1 mg to be sucked for 2 minutes, and then swallowed (twice a day in the morning and one hour before falling asleep), in the third week, 1 mg to be sucked for 2 minutes and in the fourth week 1 mg to be sucked for 2 minutes, then swallowed (once a day in the morning)
干预措施: Clonazepam tablets (Drug)
Patients diagnosed with BMS treating with tongue pads
patients wearing tongue pads 3 times a day for 20 minutes for 4 weeks to exclude parafunctions
干预措施: tongue pads (Device)
结局指标
主要结局
Assessment of the depression patients diagnosed with BMS.
时间窗: 1 month and 3 months after therapy
Assessment depression Beck depresion scale Questionnaire scale from 0 to 28 0 no deppresion 28 depression
assessment of pain
时间窗: 1 month and 3 months after therapy
combining the use of clonazepam versus the group wearing a tongue protector Tongue protector was use in order to exclude occlusal parafunction. VAS (visual analog scale) was use to asses pain score before and after therapy scale from 0 to 10 0 no pain 10 maximum pain
assessment of side effects : slowness
时间窗: 1 month and 3 months after therapy
assessment of side effects when taking clonazepam such as dry mouth, slowness, was assessed on the basis of surveys with patients
Assessment of the sleepiness patients diagnosed with BMS.
时间窗: 1 month and 3 months after therapy
assessment of side effects when taking clonazepam such as sleepiness was assessed on the basis of surveys with patients: Athenian Insomnia Scale Questionnaire scale from 0 to 24 0 no sleep disorders 24 insomnia
次要结局
未报告次要终点