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Completed

NCT Number: NCT00875537

Neurogenic Mechanisms in Burning Mouth Syndrome

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.

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Key information

Conditions

Burning Mouth Syndrome Dysgeusia Inflammation Mouth Diseases Nervous System Diseases Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Stomatognathic Diseases Taste Disorders

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Odontology, Section of Oral Medicine, Clinical Oral Physiology, Oral Pathology & Anatomy

Copenhagen, 2200, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Capsaicin oral gel 0.025%

Other

Application 3 times daily for 14 days on the tongue, followed by 14 days wash-out

Other names: Capsicum, extract from chilipepper

Capsaicin oral gel 0.01%

Other

Application 3 times daily for 14 days on the tongue, followed by 14 days wash-out

Other names: Capsicum, extract from chilipepper

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Registry information

Official study title

Neurogenic Mechanisms in Burning Mouth Syndrome With Focus on Localization and Desensibilization of Vanilloid Receptor TRPV1

Acronym: BMS17

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Apr 3, 2009
Registry last updated
Mar 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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