Burning Mouth SyndromePhase 2NCT04884503
Evaluation of the Effectiveness of the Selected Method of Treatment of Primary Burning Mouth Syndrome
A Phase 2 study testing Clonazepam tablets and tongue pads in people with Burning Mouth Syndrome and Glossodynia, run by Wroclaw Medical University at 1 site in Poland.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Burning Mouth Syndrome, Glossodynia
- What is being tested?
- Clonazepam tablets and tongue pads
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 sitePoland
- Study dates
- 12 Jan 2019to 6 Sep 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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,
Show all 10Show fewer
- oncological treatment (radiotherapy),
- pregnant women,
- the occurrence of clinical pathologies in the oral cavity that may cause pain,
- deficiencies of vitamin B12, folic acid
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Being tested
- Clonazepam tablets, tongue pads
- Keywords
- BMS, , clonazepam, BMS psychological disturbance
- Medical subject headings
- Burning Mouth Syndrome, Glossalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clonazepam tabletsDrug
Also called patients treating 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)
tongue padsDevice
Also called patients treating with tonque pads
wearing a tongue pad 3 times a day for 20 minutes for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Patients diagnosed with BMS traeting with Clonazepam | Experimental | 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) Receives: Drug: Clonazepam tablets |
| Patients diagnosed with BMS treating with tongue pads | Active comparator | patients wearing tongue pads 3 times a day for 20 minutes for 4 weeks to exclude parafunctions Receives: Device: tongue pads |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 1 month and 3 months after therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start12 Jan 2019
- Primary completion3 Apr 2020
- Study completion6 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burning Mouth SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wroclaw Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- tomasz konopka, prof, Study director, Wroclaw Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04884503
- Sponsor's protocol ID
- Kb668/2018
- Status last verified
- May 2021
- First submitted
- 27 Apr 2021
- Last updated
- 22 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effectiveness of the Selected Treatment Method and Psychological Disorders of Primary Burning Mouth Syndrome
- ClinicalTrials.gov ID
- NCT04884503
- Acronym / sponsor ID
- Kb668/2018
- Conditions
- Burning Mouth Syndrome, Glossodynia
- Keywords
- BMS, , clonazepam, BMS psychological disturbance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Wroclaw Medical UniversityUniversity, hospital or other
- Study start
- 12 Jan 2019 (actual)
- Primary completion
- 3 Apr 2020 (actual)
- Study completion
- 6 Sep 2020 (actual)
- First posted
- 13 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients diagnosed with BMS traeting with Clonazepam | Experimental | Drug: Clonazepam tabletsDosing 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 | Active comparator | Device: tongue padspatients wearing tongue pads 3 times a day for 20 minutes for 4 weeks to exclude parafunctions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- V and VII nerve neuralgia
- patients with uncontrolled diabetes mellitus,
- thyroid disease, anemia,
- Sjogren's disease and
- connective tissue disease (fibromyalgia),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clonazepam tabletsAlso: patients treating with clonazepamDosing 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 | Patients diagnosed with BMS traeting with Clonazepam |
| tongue padsAlso: patients treating with tonque padswearing a tongue pad 3 times a day for 20 minutes for 4 weeks | Device | Patients diagnosed with BMS treating with tongue pads |
Primary outcome
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2021.
- Individual participant dataSharing planned: No
Related trials for Burning Mouth Syndrome
Not yet recruiting
Improving Prescribing Quality for Oral Mucosal Disorders Using a Pharmacist-Led Model
Oral Lichen Planus, Recurrent Aphthous Stomatitis
Recruiting
MucoLock™ for Treatment of Stomatitis
Stomatitis, Pain
RecruitingObservational study
Reducing Patient Memory Recall in the Burning Mouth Patient Population
Burning Mouth Syndrome
Active, not recruiting
Photobiomodulation Therapy vs. Alpha-Lipoic Acid in Burning Mouth Syndrome Treatment
Burning Mouth Syndrome, Low Level Laser Therapy
Not yet recruiting
Burning Mouth Syndrome: Effects of Occlusal Splint Therapy
Burning Mouth Syndrome, Orofacial Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
tomasz konopka, prof study director
Wroclaw Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Clonazepam tablets and tongue pads in people with Burning Mouth Syndrome and Glossodynia, run by Wroclaw Medical University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessment of pain (time frame: 1 month and 3 months after therapy). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2021.