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

Primary Purpose

Burning Mouth Syndrome, Glossodynia

Status
Completed
Phase
Phase 2
Locations
Poland
Study Type
Interventional
Intervention
Clonazepam tablets
tongue pads
Sponsored by
Wroclaw Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burning Mouth Syndrome focused on measuring BMS, , clonazepam, BMS psychological disturbance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Jacek Zborowski

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Patients diagnosed with BMS traeting with Clonazepam

Patients diagnosed with BMS treating with tongue pads

Arm Description

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 wearing tongue pads 3 times a day for 20 minutes for 4 weeks to exclude parafunctions

Outcomes

Primary Outcome Measures

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
Assessment of the depression patients diagnosed with BMS.
Assessment depression Beck depresion scale Questionnaire scale from 0 to 28 0 no deppresion 28 depression
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
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

Secondary Outcome Measures

Full Information

First Posted
April 27, 2021
Last Updated
July 15, 2021
Sponsor
Wroclaw Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04884503
Brief Title
Evaluation of the Effectiveness of the Selected Method of Treatment of Primary Burning Mouth Syndrome
Official Title
Assessment of the Effectiveness of the Selected Treatment Method and Psychological Disorders of Primary Burning Mouth Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
January 12, 2019 (Actual)
Primary Completion Date
April 3, 2020 (Actual)
Study Completion Date
September 6, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wroclaw Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burning Mouth Syndrome, Glossodynia
Keywords
BMS, , clonazepam, BMS psychological disturbance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients diagnosed with BMS traeting with Clonazepam
Arm Type
Experimental
Arm Description
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)
Arm Title
Patients diagnosed with BMS treating with tongue pads
Arm Type
Active Comparator
Arm Description
patients wearing tongue pads 3 times a day for 20 minutes for 4 weeks to exclude parafunctions
Intervention Type
Drug
Intervention Name(s)
Clonazepam tablets
Other Intervention Name(s)
patients treating with clonazepam
Intervention Description
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
Device
Intervention Name(s)
tongue pads
Other Intervention Name(s)
patients treating with tonque pads
Intervention Description
wearing a tongue pad 3 times a day for 20 minutes for 4 weeks
Primary Outcome Measure Information:
Title
assessment of pain
Description
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
Title
Assessment of the depression patients diagnosed with BMS.
Description
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
Title
Assessment of the sleepiness patients diagnosed with BMS.
Description
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
Title
assessment of side effects : slowness
Description
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

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
tomasz konopka, prof
Organizational Affiliation
Wroclaw Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Jacek Zborowski
City
Wrocław
State/Province
Dolnoslaskie
ZIP/Postal Code
52-311
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No

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

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