Neurogenic Mechanisms in Burning Mouth Syndrome

NCT ID: NCT00875537

Last Updated: 2017-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2010-06-30

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.

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.

Conditions

Burning Mouth Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Capsaicin oral gel 0.01%

Group Type: ACTIVE_COMPARATOR

Capsaicin oral gel 0.01%

Intervention Type: OTHER

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

Capsaicin oral gel 0.025%

Group Type: ACTIVE_COMPARATOR

Capsaicin oral gel 0.025%

Intervention Type: OTHER

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

Interventions

Capsaicin oral gel 0.025%

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

Intervention Type: OTHER

Capsaicin oral gel 0.01%

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

Intervention Type: OTHER

Other Intervention Names

Capsicum, extract from chilipepper; Capsicum, extract from chilipepper

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

Anne Marie Lynge Pedersen

Associate Professor, PhD, DDS

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Copenhagen, , Denmark

Countries

Denmark

Other Identifiers

H-A-2008-118

Identifier Type: -

Identifier Source: org_study_id