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

Assessment of the Effectiveness of the Selected Treatment Method and Psychological Disorders 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

Study Overview

• Status: Completed
• Conditions: Burning Mouth Syndrome; Glossodynia
• Intervention / Treatment: Drug: Clonazepam tablets; Device: tongue pads

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

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Phase 2

Contacts and Locations

Study Locations

• Poland
  • Dolnoslaskie
    • Wrocław, Dolnoslaskie, Poland, 52-311
      • Jacek Zborowski

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	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); Other Names: patients treating with clonazepam
Active Comparator: 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	Device: tongue pads; wearing a tongue pad 3 times a day for 20 minutes for 4 weeks; Other Names: patients treating with tonque pads

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Wroclaw Medical University
• Investigators: Study Director: tomasz konopka, prof, Wroclaw Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2019
• Primary Completion (Actual): April 3, 2020
• Study Completion (Actual): September 6, 2020

Study Registration Dates

• First Submitted: April 27, 2021
• First Submitted That Met QC Criteria: May 11, 2021
• First Posted (Actual): May 13, 2021

Study Record Updates

• Last Update Posted (Actual): July 22, 2021
• Last Update Submitted That Met QC Criteria: July 15, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: BMS, , clonazepam, BMS psychological disturbance
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Disease; Stomatognathic Diseases; Mouth Diseases; Syndrome; Burns; Burning Mouth Syndrome; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; GABA Modulators; GABA Agents; Anticonvulsants; Clonazepam
• Other Study ID Numbers: Kb668/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No