Neurogenic Mechanisms in Burning Mouth Syndrome (BMS17)

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.

Study Overview

• Status: Completed
• Conditions: Burning Mouth Syndrome
• Intervention / Treatment: Other: Capsaicin oral gel 0.01%; Other: Capsaicin oral gel 0.025%

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 Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2200
    • Department of Odontology, Section of Oral Medicine, Clinical Oral Physiology, Oral Pathology & Anatomy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Capsicum, extract from chilipepper

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	6 months

Collaborators and Investigators

• Sponsor: University of Copenhagen

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: April 2, 2009
• First Submitted That Met QC Criteria: April 2, 2009
• First Posted (Estimate): April 3, 2009

Study Record Updates

• Last Update Posted (Actual): March 14, 2017
• Last Update Submitted That Met QC Criteria: March 11, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: inflammation; neuropathy; Burning mouth syndrome; tongue mucosa; tongue innervation; dysgeusia
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Disease; Stomatognathic Diseases; Mouth Diseases; Syndrome; Burns; Burning Mouth Syndrome; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Dermatologic Agents; Antipruritics; Capsaicin
• Other Study ID Numbers: H-A-2008-118