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Sponsored by: |
University of Copenhagen |
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Information provided by: | University of Copenhagen |
ClinicalTrials.gov Identifier: | NCT00875537 |
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:
Condition | Intervention | Phase |
---|---|---|
Burning Mouth Syndrome |
Other: Capsaicin oral gel 0.025% Other: Capsaicin oral gel 0.01% |
Phase 0 |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Dose Comparison, Crossover Assignment, Safety/Efficacy Study |
Official Title: | Neurogenic Mechanisms in Burning Mouth Syndrome With Focus on Localization and Desensibilization of Vanilloid Receptor TRPV1 |
Estimated Enrollment: | 26 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Capsaicin oral gel 0.01%: Active Comparator |
Other: Capsaicin oral gel 0.01%
Application 3 times daily for 14 days on the tongue, followed by 14 days wash-out
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Capsaicin oral gel 0.025%: Active Comparator |
Other: Capsaicin oral gel 0.025%
Application 3 times daily for 14 days on the tongue, followed by 14 days wash-out
|
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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Denmark | |
Department of Odontology, Section of Oral Medicine, Clinical Oral Physiology, Oral Pathology & Anatomy | Recruiting |
Copenhagen, Denmark, 2200 | |
Contact: Anne Marie Lynge Pedersen, Assoc Prof, PhD,DDS +4535326729 amp@odont.ku.dk | |
Contact: Lis Andersen Torpet, Assoc Prof, PhD, DDS +4535326721 la@odont.ku.dk | |
Principal Investigator: Anne Marie Lynge Pedersen, Assoc Prof, PhD, DDS |
Responsible Party: | Department of Odontology, Faculty of Health Sciences, University of Copenhagen ( Anne Marie Lynge Pedersen/associate professor, PhD, DDS ) |
Study ID Numbers: | H-A-2008-118 |
Study First Received: | April 2, 2009 |
Last Updated: | April 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00875537 History of Changes |
Health Authority: | Denmark: Danish Medicines Agency; Denmark: Ethics Committee; Denmark: Danish Dataprotection Agency; Denmark: The Regional Committee on Biomedical Research Ethics |
Burning mouth syndrome neuropathy inflammation |
tongue mucosa tongue innervation dysgeusia |
Mouth Diseases Dysgeusia Antipruritics Peripheral Nervous System Agents |
Stomatognathic Diseases Capsaicin Inflammation Burning Mouth Syndrome |
Mouth Diseases Disease Physiological Effects of Drugs Capsaicin Pharmacologic Actions Pathologic Processes Sensory System Agents |
Syndrome Therapeutic Uses Antipruritics Stomatognathic Diseases Peripheral Nervous System Agents Dermatologic Agents Burning Mouth Syndrome |