A Phase 2 interventional study of Clonazepam tablets and tongue pads in Burning Mouth Syndrome and Glossodynia, sponsored by Wroclaw Medical University. Completed at 1 site in Poland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-22.
Sponsored by Wroclaw Medical University · Phase 2, Interventional, and Treatment
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
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
45 studies on the registry are indexed under Burning Mouth Syndrome; 6 are open to participants now.
This study's enrollment of 58 is above the median of 44 across 36 interventional studies indexed under Burning Mouth Syndrome.
Browse Burning Mouth Syndrome studies →Wroclaw Medical University is the lead sponsor of 99 studies on the registry; 29 are open to participants now.
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Exclusion Criteria:
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)
Drug: Clonazepam tablets
patients wearing tongue pads 3 times a day for 20 minutes for 4 weeks to exclude parafunctions
Device: tongue pads
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)
Also known as: patients treating with clonazepam
wearing a tongue pad 3 times a day for 20 minutes for 4 weeks
Also known as: patients treating with tonque pads
assessment of pain
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
Time frame: 1 month and 3 months after therapy
Assessment of the depression patients diagnosed with BMS.
Assessment depression Beck depresion scale Questionnaire scale from 0 to 28 0 no deppresion 28 depression
Time frame: 1 month and 3 months after therapy
Assessment of the sleepiness patients diagnosed with BMS.
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
Time frame: 1 month and 3 months after therapy
assessment of side effects : slowness
assessment of side effects when taking clonazepam such as dry mouth, slowness, was assessed on the basis of surveys with patients
Time frame: 1 month and 3 months after therapy
Plan to share: No
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Ran from Jan 2019 to primary completion in Apr 2020, 14 months.
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Studies of the drug tested here: Clonazepam
Wroclaw Medical University