Neurogenic Mechanisms in Burning Mouth Syndrome (BMS17)
Primary Purpose
Burning Mouth Syndrome
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Capsaicin oral gel 0.025%
Capsaicin oral gel 0.01%
Sponsored by
About this trial
This is an interventional treatment trial for Burning Mouth Syndrome focused on measuring Burning mouth syndrome, neuropathy, inflammation, tongue mucosa, tongue innervation, dysgeusia
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
Sites / Locations
- Department of Odontology, Section of Oral Medicine, Clinical Oral Physiology, Oral Pathology & Anatomy
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Capsaicin oral gel 0.01%
Capsaicin oral gel 0.025%
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00875537
Brief Title
Neurogenic Mechanisms in Burning Mouth Syndrome
Acronym
BMS17
Official Title
Neurogenic Mechanisms in Burning Mouth Syndrome With Focus on Localization and Desensibilization of Vanilloid Receptor TRPV1
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burning Mouth Syndrome
Keywords
Burning mouth syndrome, neuropathy, inflammation, tongue mucosa, tongue innervation, dysgeusia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Capsaicin oral gel 0.01%
Arm Type
Active Comparator
Arm Title
Capsaicin oral gel 0.025%
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Capsaicin oral gel 0.025%
Other Intervention Name(s)
Capsicum, extract from chilipepper
Intervention Description
Application 3 times daily for 14 days on the tongue, followed by 14 days wash-out
Intervention Type
Other
Intervention Name(s)
Capsaicin oral gel 0.01%
Other Intervention Name(s)
Capsicum, extract from chilipepper
Intervention Description
Application 3 times daily for 14 days on the tongue, followed by 14 days wash-out
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Department of Odontology, Section of Oral Medicine, Clinical Oral Physiology, Oral Pathology & Anatomy
City
Copenhagen
ZIP/Postal Code
2200
Country
Denmark
12. IPD Sharing Statement
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Neurogenic Mechanisms in Burning Mouth Syndrome
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