Clinical trial NCT00875537: Neurogenic Mechanisms in Burning Mouth Syndrome
Official title: Neurogenic Mechanisms in Burning Mouth Syndrome With Focus on Localization and Desensibilization of Vanilloid Receptor TRPV1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burning Mouth Syndrome
Keywords: Burning mouth syndrome
neuropathy
inflammation
tongue mucosa
tongue innervation
dysgeusia
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2009-04-03
Enrollment: 22
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: 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.
timeFrame: 6 months
Secondary outcomes:
measure: 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.
timeFrame: 6 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Odontology, Section of Oral Medicine, Clinical Oral Physiology, Oral Pathology & Anatomy
Study officials:
References: