Evaluation of the Effectiveness of the Selected Method of Treatment of Primary Burning Mouth Synd… (NCT04884503) | Clinical Trial Compass
CompletedPhase 2
Evaluation of the Effectiveness of the Selected Method of Treatment of Primary Burning Mouth Syndrome
Poland58 participantsStarted 2019-01-12
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
assessment of pain
Timeframe: 1 month and 3 months after therapy
2
Assessment of the depression patients diagnosed with BMS.
Timeframe: 1 month and 3 months after therapy
3
Assessment of the sleepiness patients diagnosed with BMS.