Neurogenic Mechanisms in Burning Mouth Syndrome

NCT00875537 | Completed DMC

• 1 other identifier: H-A-2008-118
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Burning Mouth Syndrome

Keywords

Burning mouth syndrome; neuropathy; inflammation; tongue mucosa; tongue innervation; dysgeusia

Outcome Measures

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.

  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.

  6 months

Study Arms (2)

Capsaicin oral gel 0.01%

ACTIVE COMPARATOR

Other: Capsaicin oral gel 0.01%

Capsaicin oral gel 0.025%

ACTIVE COMPARATOR

Other: Capsaicin oral gel 0.025%

Interventions

Capsaicin oral gel 0.025% OTHER

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

Also known as: Capsicum, extract from chilipepper

Capsaicin oral gel 0.025%

Capsaicin oral gel 0.01% OTHER

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

Also known as: Capsicum, extract from chilipepper

Capsaicin oral gel 0.01%

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• non-smoking female patients with burning mouth syndrome (n=26)
• healthy aged-matched control group (n=10)

You may not qualify if:

• 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
• patients who are able to give informed consent due to physical or mental disabilities

Sponsors & Collaborators

• University of Copenhagen: lead

Study Sites (1)

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

Copenhagen, 2200, Denmark

Location

MeSH Terms

Conditions

Burning Mouth Syndrome; Inflammation; Dysgeusia

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Taste Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, PhD, DDS

Study Record Dates

• First Submitted: April 2, 2009
• First Posted: April 3, 2009
• Study Start: January 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: June 1, 2010
• Last Updated: March 14, 2017

Record last verified: 2017-03

Locations

DK (1)