Neurogenic Mechanisms in Burning Mouth Syndrome (BMS17)
This study is currently recruiting participants.
Verified by University of Copenhagen, April 2009
First Received: April 2, 2009 No Changes Posted
Sponsored by: University of Copenhagen
Information provided by: University of Copenhagen
ClinicalTrials.gov Identifier: NCT00875537
Purpose
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.
Condition Intervention Phase
Burning Mouth Syndrome
Other: Capsaicin oral gel 0.025%
Other: Capsaicin oral gel 0.01%
Phase 0
Drug Information available for: Capsaicin
U.S. FDA Resources
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
Further study details as provided by University of Copenhagen:
Primary Outcome Measures:
* 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. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
* 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. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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
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
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
Ages Eligible for Study: 18 Years to 70 Years
Genders Eligible for Study: Female
Accepts Healthy Volunteers: Yes
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00875537
Locations
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
Sponsors and Collaborators
University of Copenhagen
More Information
No publications provided
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
Keywords provided by University of Copenhagen:
Burning mouth syndrome
neuropathy
inflammation
tongue mucosa
tongue innervation
dysgeusia
Study placed in the following topic categories:
Mouth Diseases
Antipruritics
Peripheral Nervous System Agents
Stomatognathic Diseases
Capsaicin
Inflammation
Burning Mouth Syndrome
Additional relevant MeSH terms:
Antipruritics
Mouth Diseases
Disease
Physiological Effects of Drugs
Capsaicin
Pharmacologic Actions
Pathologic Processes
Sensory System Agents
Syndrome
Therapeutic Uses
Stomatognathic Diseases
Peripheral Nervous System Agents
Dermatologic Agents
Burning Mouth Syndrome
ClinicalTrials.gov processed this record on April 17, 2009
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Pamela Carter says: | 2010-10-18 13:39:48 |
| I have BMS how do I join your trial for treatment? | ||
Comments: 1