Neurogenic Mechanisms in Burning Mouth Syndrome
Information source: University of Copenhagen
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Burning Mouth Syndrome
Intervention: Capsaicin oral gel 0.025% (Other); Capsaicin oral gel 0.01% (Other)
Phase: Phase 0
Status: Completed
Sponsored by: University of Copenhagen
Summary
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.
Clinical Details
Official title: Neurogenic Mechanisms in Burning Mouth Syndrome With Focus on Localization and Desensibilization of Vanilloid Receptor TRPV1
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Primary outcome: To evaluate the efficacy and safety of topical application of capsaicin oral gel (using to different concentrations) to relieve the burning sensation in patients with BMS and alleviate BMS related symptoms.
Secondary outcome: To characterize the localization and distribution of peripheral nerve fibres, neuropeptides like substance P, calcitonin gene-related peptide, NGF, NGF-R, PGP 9.5 neuronal marker and TRPV1 as well as inflammatory/structural changes.
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- non-smoking female patients with burning mouth syndrome (n=26)
- healthy aged-matched control group (n=10)
Exclusion Criteria:
- pregnancy and lactation (inclusion requires negative pregnancy test)
- women who do not use safe anticonception
- patients with know allergy/hypersensitivity to capsicum and other
capsaicinoid-containing products
- Active infection which requires antibiotic treatment
- use of mouthrinse. The use of these is stopped 14 days before inclusion
- patients who are able to give informed consent due to physical or mental disabilities
Locations and Contacts
Department of Odontology, Section of Oral Medicine, Clinical Oral Physiology, Oral Pathology & Anatomy, Copenhagen 2200, Denmark
Additional Information
Starting date: January 2009
Last updated: February 22, 2011
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