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

NCT ID: NCT04884503

Last Updated: 2021-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-12
• Study Completion Date: 2020-09-06

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

Conditions

Burning Mouth Syndrome; Glossodynia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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)

Group Type: EXPERIMENTAL

Clonazepam tablets

Intervention Type: 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)

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

Group Type: ACTIVE_COMPARATOR

tongue pads

Intervention Type: DEVICE

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

Interventions

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)

Intervention Type: DRUG

tongue pads

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

Intervention Type: DEVICE

Other Intervention Names

patients treating with clonazepam; patients treating with tonque pads

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wroclaw Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

tomasz konopka, prof

Role: STUDY_DIRECTOR

Wroclaw Medical University

Locations

Jacek Zborowski

Wroclaw, Lower Silesian Voivodeship, Poland

Countries

Poland

Other Identifiers

Kb668/2018

Identifier Type: -

Identifier Source: org_study_id