Neurogenic Mechanisms in Burning Mouth Syndrome (BMS17)

This study has been completed.
Sponsor:
Information provided by:
University of Copenhagen
ClinicalTrials.gov Identifier:
NCT00875537
First received: April 2, 2009
Last updated: February 22, 2011
Last verified: June 2010

April 2, 2009
February 22, 2011
January 2009
April 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00875537 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Neurogenic Mechanisms in Burning Mouth Syndrome
Neurogenic Mechanisms in Burning Mouth Syndrome With Focus on Localization and Desensibilization of Vanilloid Receptor TRPV1

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.

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.

Interventional
Phase 0
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Burning Mouth Syndrome
  • 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
  • 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 0.01%
    Intervention: Other: Capsaicin oral gel 0.01%
  • Active Comparator: Capsaicin oral gel 0.025%
    Intervention: Other: Capsaicin oral gel 0.025%
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
June 2010
April 2010   (final data collection date for primary outcome measure)

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
Female
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00875537
H-A-2008-118
Yes
Anne Marie Lynge Pedersen/associate professor, PhD, DDS, Department of Odontology, Faculty of Health Sciences, University of Copenhagen
University of Copenhagen
Not Provided
Not Provided
University of Copenhagen
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP