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

Burning Mouth Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04884503
• Other study ID #: Kb668/2018
• Status: Completed
• Phase: Phase 2
• Start date: January 12, 2019
• Est. completion date: September 6, 2020

Study information

• Verified date: May 2021
• Source: Wroclaw Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: September 6, 2020
• Est. primary completion date: April 3, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Burning Mouth Syndrome
• Burns
• Syndrome

Intervention

Drug:
• Clonazepam tablets
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)

Device:
• tongue pads
wearing a tongue pad 3 times a day for 20 minutes for 4 weeks

Locations

Country	Name	City	State
Poland	Jacek Zborowski	Wroclaw	Dolnoslaskie

Sponsors (1)

Lead Sponsor	Collaborator
Wroclaw Medical University

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 month and 3 months after therapy
Primary	Assessment of the depression patients diagnosed with BMS.	Assessment depression Beck depresion scale Questionnaire; scale from 0 to 28 0 no deppresion 28 depression	1 month and 3 months after therapy
Primary	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	1 month and 3 months after therapy
Primary	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	1 month and 3 months after therapy