Burning Mouth Syndrome Clinical Trial
Official title:
Neurogenic Mechanisms in Burning Mouth Syndrome With Focus on Localization and Desensibilization of Vanilloid Receptor TRPV1
Burning mouth syndrome (BMS) is characterized by a bilateral burning sensation in the
anterior tongue, hard palate and lips in the absence of any clinical or laboratory findings.
The term syndrome implicates the simultaneous presence of oral dryness (xerostomia) and
altered taste (dysgeusia) in addition to the burning sensation in the oral mucosa. BMS is
most often seen in women and is more frequent during menopause. The etiology and
pathogenesis are still unclear but recent studies suggest that BMS is a neuropathic pain
condition.
The objectives of the study are:
- To clarify potential neurogenic mechanisms behind BMS using immunohistochemistry (IH)
to characterize the localization and distribution of peripheral nerve fibres,
neuropeptides like substance P, calcitonin gene-related peptide, nerve growth factor,
nerve growth factor receptor, PGP 9.5 neuronal marker and TRPV1 as well as
inflammatory/structural changes.
- To perform a randomized double blind cross-over intervention study to examine the
efficacy and safety of topical application of capsaicin oral gel (on the tongue) to
relieve the burning sensation in patients with BMS.
Data which support the hypothesis that BMS is a neuropathic pain condition include amongst others a recent clinically controlled study that has shown up-regulation of TRPV1-positive nerve fibres in tongue mucosa in patients with BMS. The vanilloid receptor-1 (TRPV1) is a voltage-dependent cation channel expressed by the unmyelinated C-nociceptive nerve fibres and the receptor may be activated by capsaicin (from chili peppers), heat and H+. Capsaicin binds to the TRPV1 receptor causing depolarization of the C-nociceptors. Prolonged activation of these neurons by capsaicin depletes pre-synaptic substance P and makes them unable to report pain. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04475614 -
Therapeutic Options for Treatment of Burning Mouth Syndrome
|
N/A | |
| Completed |
NCT00374673 -
Efficacy of Transcranial Magnetic Stimulation (TMS) in Chronic Idiopathic Pain Disorders
|
Phase 3 | |
| Completed |
NCT02964728 -
Botulinum Toxin in Burning Mouth Syndrome
|
Phase 2 | |
| Completed |
NCT04535973 -
Hormonal Status and Quality of Life in Female Postmenopausal Patients With Burning Mouth Syndrome
|
||
| Recruiting |
NCT06040190 -
Effect of Treatments on Pain and Quality of Life in Individual With Burning Mouth Syndrome
|
Phase 4 | |
| Not yet recruiting |
NCT05059418 -
Burning Mouth Syndrome - New Diagnostic Criteria and Treatment
|
N/A | |
| Recruiting |
NCT01867151 -
Effect of Gluten Free Diet in Patients With Burning Mouth Syndrome
|
N/A | |
| Completed |
NCT05872789 -
Impact of Diazepam 1% Oral Gel Efficacy in Burning Mouth Syndrome
|
N/A | |
| Completed |
NCT05871580 -
Effect to the Photobiomodulation in the Burning Mouth Syndrome
|
N/A | |
| Recruiting |
NCT05309070 -
The Efficacy of N-acetyl-cysteine in the Treatment of Burning Mouth Syndrome
|
N/A | |
| Completed |
NCT05399238 -
Thermography and Burning Mouth Syndrome
|
||
| Completed |
NCT02580734 -
Efficacy of Melatonin in Burning Mouth Syndrome (BMS)
|
N/A | |
| Completed |
NCT02382029 -
Acupuncture Versus Clonazepam in Burning Mouth Syndrome
|
Phase 0 | |
| Recruiting |
NCT05819697 -
Reducing Patient Memory Recall in the Burning Mouth Patient Population
|
||
| Completed |
NCT02757612 -
Study Evaluating the Laser Diode Effect Burning Mouth Syndrome
|
N/A | |
| Completed |
NCT00862576 -
A Study of the Association of Sleep Dysfunction and Burning Mouth Syndrome
|
N/A | |
| Not yet recruiting |
NCT04189367 -
Treatment of Burning Mouth Syndrome With Integration of Traditional Chinese Medicine and Western Medicine
|
Phase 3 | |
| Completed |
NCT00001524 -
Thalidomide to Treat Oral Lesions in HIV-Infected Patients
|
Phase 2 | |
| Recruiting |
NCT04481841 -
Head Yuanshi Dian Therapy in Burning Mouth Syndrome
|
Early Phase 1 | |
| Completed |
NCT02686359 -
Opiorphin Levels in Fluids of Burning Mouth Syndrome Patients (OPIODYN)
|
N/A |