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Completed

NCT Number: NCT04884503

Evaluation of the Effectiveness of the Selected Method of Treatment of Primary Burning Mouth Syndrome

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Jacek Zborowski

Wroclaw, Lower Silesian Voivodeship, 52-311, Poland

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clonazepam tablets

Drug

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)

Other names: patients treating with clonazepam

tongue pads

Device

wearing a tongue pad 3 times a day for 20 minutes for 4 weeks

Other names: patients treating with tonque pads

Primary outcomes

  1. assessment of pain

    Time frame: 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

  2. Assessment of the depression patients diagnosed with BMS.

    Time frame: 1 month and 3 months after therapy

    Assessment depression Beck depresion scale Questionnaire

    scale from 0 to 28 0 no deppresion 28 depression

  3. Assessment of the sleepiness patients diagnosed with BMS.

    Time frame: 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

  4. assessment of side effects : slowness

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Wroclaw Medical University

Other

Registry information

Official study title

Assessment of the Effectiveness of the Selected Treatment Method and Psychological Disorders of Primary Burning Mouth Syndrome

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 13, 2021
Registry last updated
Jul 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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