Neurogenic Mechanisms in Burning Mouth Syndrome - Full Text View

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Neurogenic Mechanisms in Burning Mouth Syndrome With Focus on Localization and Desensibilization of Vanilloid Receptor TRPV1

Resource links provided by NLM:

MedlinePlus related topics: Burns

Drug Information available for: Capsaicin

U.S. FDA Resources

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
Study Completion Date:	June 2010
Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Capsaicin oral gel 0.01%	Other: Capsaicin oral gel 0.01% Application 3 times daily for 14 days on the tongue, followed by 14 days wash-out Other Name: Capsicum, extract from chilipepper
Active Comparator: Capsaicin oral gel 0.025%	Other: Capsaicin oral gel 0.025% Application 3 times daily for 14 days on the tongue, followed by 14 days wash-out Other Name: Capsicum, extract from chilipepper

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
Copenhagen, Denmark, 2200

Sponsors and Collaborators

University of Copenhagen

More Information

No publications provided

Responsible Party:	Anne Marie Lynge Pedersen/associate professor, PhD, DDS, Department of Odontology, Faculty of Health Sciences, University of Copenhagen
ClinicalTrials.gov Identifier:	NCT00875537 History of Changes
Other Study ID Numbers:	H-A-2008-118
Study First Received:	April 2, 2009
Last Updated:	February 22, 2011
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

Additional relevant MeSH terms:

Burning Mouth Syndrome
Burns
Mouth Diseases
Stomatognathic Diseases
Wounds and Injuries
Capsaicin
Sensory System Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antipruritics
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012