Clinical trial NCT04884503: Evaluation of the Effectiveness of the Selected Method of Treatment of Primary Burning Mouth Syndrome
Official title: Assessment of the Effectiveness of the Selected Treatment Method and Psychological Disorders of Primary Burning Mouth Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Burning Mouth Syndrome
Glossodynia
Keywords: BMS, , clonazepam, BMS psychological disturbance
Lead sponsor: Wroclaw Medical University
Sponsor class: OTHER
First posted: 2021-05-13
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

60 patients were qualified for the study, of which 57 patients, including 34 women and 23 men, aged 47-77 years, took part in the program.

Pain assessment The symptoms of pain intensity BMS were assessed using the VAS (Visual Analog Scale) The duration of burning was also assessed, the type of burning according to Levis, the occurrence of taste disturbances and their determination, subjective feeling of dry mouth, place of burning sensation: tongue, palate, lips, mucosa of the mouth vestibule with gums, cheek mucosa The psychologist cooperating in the project conducted and then interpreted four psychological tests: STAI (state and trait anxiety inventory) and the Beck Anxiety Scale BAI and the Beck Depression Scale BDI. Moreover, the WHOQOL quality of life test was carried out - according to WHO

A follow-up examination was performed on the day of treatment completion and 3 months later

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: assessment of pain
timeFrame: 1 month and 3 months after therapy
measure: Assessment of the depression patients diagnosed with BMS.
timeFrame: 1 month and 3 months after therapy
measure: Assessment of the sleepiness patients diagnosed with BMS.
timeFrame: 1 month and 3 months after therapy
measure: assessment of side effects : slowness
timeFrame: 1 month and 3 months after therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Wrocław
country: Poland
facility: Jacek Zborowski
state: Dolnoslaskie
Study officials:
affiliation: Wroclaw Medical University
name: tomasz konopka, prof
role: STUDY_DIRECTOR
References: