DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017