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Neurogenic Mechanisms in Burning Mouth Syndrome (BMS17)

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ClinicalTrials.gov Identifier: NCT00875537
Recruitment Status : Completed
First Posted : April 3, 2009
Last Update Posted : March 14, 2017
Sponsor:
Information provided by (Responsible Party):
Anne Marie Lynge Pedersen, University of Copenhagen

Study Description
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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.

Condition or disease Intervention/treatment Phase
Burning Mouth Syndrome Other: Capsaicin oral gel 0.025% Other: Capsaicin oral gel 0.01% Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Neurogenic Mechanisms in Burning Mouth Syndrome With Focus on Localization and Desensibilization of Vanilloid Receptor TRPV1
Study Start Date : January 2009
Actual Primary Completion Date : April 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns
Drug Information available for: Capsaicin

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Responsible Party: Anne Marie Lynge Pedersen, Associate Professor, PhD, DDS, University of Copenhagen
ClinicalTrials.gov Identifier: NCT00875537     History of Changes
Other Study ID Numbers: H-A-2008-118
First Posted: April 3, 2009    Key Record Dates
Last Update Posted: March 14, 2017
Last Verified: March 2017

Keywords provided by Anne Marie Lynge Pedersen, University of Copenhagen:
Burning mouth syndrome
neuropathy
inflammation
 tongue mucosa
tongue innervation
dysgeusia

Additional relevant MeSH terms:
Syndrome
Burns
Burning Mouth Syndrome
Disease
Pathologic Processes
Wounds and Injuries
Mouth Diseases
 Stomatognathic Diseases
Capsaicin
Antipruritics
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs