Neurogenic Mechanisms in Burning Mouth Syndrome (BMS17)
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ClinicalTrials.gov Identifier: NCT00875537 |
Recruitment Status :
Completed
First Posted : April 3, 2009
Last Update Posted : March 14, 2017
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Burning Mouth Syndrome | Other: Capsaicin oral gel 0.025% Other: Capsaicin oral gel 0.01% | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 22 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Neurogenic Mechanisms in Burning Mouth Syndrome With Focus on Localization and Desensibilization of Vanilloid Receptor TRPV1 |
Study Start Date : | January 2009 |
Actual Primary Completion Date : | April 2010 |
Actual Study Completion Date : | June 2010 |

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 Name: 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 Name: Capsicum, extract from chilipepper |
- 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 ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00875537
Denmark | |
Department of Odontology, Section of Oral Medicine, Clinical Oral Physiology, Oral Pathology & Anatomy | |
Copenhagen, Denmark, 2200 |
Responsible Party: | Anne Marie Lynge Pedersen, Associate Professor, PhD, DDS, University of Copenhagen |
ClinicalTrials.gov Identifier: | NCT00875537 |
Other Study ID Numbers: |
H-A-2008-118 |
First Posted: | April 3, 2009 Key Record Dates |
Last Update Posted: | March 14, 2017 |
Last Verified: | March 2017 |
Burning mouth syndrome neuropathy inflammation |
tongue mucosa tongue innervation dysgeusia |
Burning Mouth Syndrome Syndrome Burns Disease Pathologic Processes Wounds and Injuries Mouth Diseases |
Stomatognathic Diseases Capsaicin Antipruritics Dermatologic Agents Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |