- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00504387
Burning Mouth Disorder (BMD) - A Neuropathic Pain Disorder
December 20, 2012 updated by: Markus R. Fussnegger
Burning Mouth Disorder (BMD) - a Neuropathic Pain Disorder? An Investigation Using Qualitative and Quantitative Sensory Testing (QST)
Oral burning can have a multitude of reasons.
Recent neurophysiologic study results suggest that a primary burning mouth disorder (BMD) may be a peripheral and/or a central neuropathic disorder.
The aim of this study is to first identify patients with a primary burning mouth disorder by excluding other possible causes for oral burning.
By means of qualitative and quantitative sensory testing and a gustatory examination in the individual patient the investigators want to find out whether neurosensory differences exist between patients with a primary BMD and controls and whether gustatory and neurosensory deficits always coexist in BMD-patients.
Study Overview
Status
Unknown
Conditions
Detailed Description
Oral burning can have many different etiologies.
Secondary burning mouth disorders (BMD) due to systemic (i.e.
diabetes, nutritional deficiencies, allergies), local (i.e.
Candidiasis, Lichen planus) or functional factors (i.e.
tongue parafunctional activities, mouth breathing) are usually fairly easy to identify and are treated by eliminating the respective cause.
A primary BMD as a specific disease is a challenging disorder with regard to assessment and treatment for both, the patient and the dentist.
The prevailing hypothesis of a predominantly psychological cause is questioned by recent research results.
The typical burning sensation, the partly efficacy of medication that is usually used in chronic, neuropathic pains and recent neurophysiologic studies and finally the finding of a degeneration of epithelial nerve fibers in BMD patients give reason to assume a peripheral and/or central neuropathic etiology.
That is, the transduction of nociceptive stimuli in the orofacial region and the transmission and modulation of the nociceptive input might be altered.
The hypothesis of a disorder of the gustatory system assumes that gustatory input has an inhibitory influence on the trigeminal nociceptive system.
A hypogeusia or ageusia, maybe caused by peripheral nerve degeneration that has been found in BMD patients would therefore lead to a decreased gustatory input which in turn gives way to a central disinhibition of trigeminal nociception, leading to a more painful perception in the oral region.
The aim of this study is to first identify patients with a primary burning mouth disorder by excluding other possible causes for oral burning.
By means of qualitative and thermal quantitative sensory testing and a gustatory examination in the individual patient we want to find out whether neurosensory differences exist between patients with a primary BMD and controls and whether gustatory and neurosensory deficits always coexist in BMD-patients.
Study Type
Observational
Enrollment (Anticipated)
12
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Markus R Fussnegger, Dr.
- Phone Number: +49 30 450 562713
- Email: markus.fussnegger@charite.de
Study Locations
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Berlin, Germany, D-14197
- Recruiting
- Charité - Universitätsmedizin Berlin, Center for dental and craniofacial sciences, Department of restorative dentistry
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Principal Investigator:
- Markus R Fussnegger, Dr.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Tertiary care clinic
Description
Inclusion Criteria:
- Primary burning sensation of the tongue, lip or other oral structure
- Average pain intensity between 3 and 9 (VAS-Scale 0-10)
- Written, informed consent
- patient speaks German
- Age > 18 years old
Exclusion Criteria:
- Tumor
- HIV/AIDS
- Diabetes mellitus
- untreated hypothyroidism
- gastroesophageal reflux disease
- Sjögren's disease
- Salivary gland disease
- Vitamin B-, folic acid- and iron deficiency
- Medications causing hyposalivation
- Inflammatory, viral, bacterial, fungal, autoimmune and other diseases of the oral mucosa
- Insufficient prosthodontics
- Allergy against acrylic resin of prosthesis
- Allergy against Chinin-hydrochloride
- Xerostomia
- Pregnancy
- Psychiatric disorder
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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A: Patients
Patients with a primary burning mouth disorder Pain (VAS 0-10): 3<x<9 Patient understands and speaks german Age: >18 years
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B: Controls
Age and sex matched persons/patients who do not have any history of an oral burning sensation or a burning mouth disorder.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
---|---|
Neurosensory differences between Burning Mouth Disorder patients and controls.
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The aim of the present study is to identify patients with idiopathic BMD.
By way of qualitative and quantitative sensory testing (QST) and gustatory tests we want to find out whether neurosensory differences exist between patients with BMD and controls without any oral burning sensation.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Ingrid Peroz, PD Dr., Charité - Universitätsmedizin Berlin, Center for dental and craniofacial sciences, Department of restorative dentistry, Assmannshauser Str. 4-6, D-14197 Berlin
- Study Director: Markus R Fussnegger, Dr., Charité - Universitätsmedizin Berlin, Center for dental and craniofacial sciences, Department of restorative dentistry, Assmannshauser Str. 4-6, D-14197 Berlin
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Scala A, Checchi L, Montevecchi M, Marini I, Giamberardino MA. Update on burning mouth syndrome: overview and patient management. Crit Rev Oral Biol Med. 2003;14(4):275-91. doi: 10.1177/154411130301400405.
- Forssell H, Jaaskelainen S, Tenovuo O, Hinkka S. Sensory dysfunction in burning mouth syndrome. Pain. 2002 Sep;99(1-2):41-7. doi: 10.1016/s0304-3959(02)00052-0.
- Lauria G, Majorana A, Borgna M, Lombardi R, Penza P, Padovani A, Sapelli P. Trigeminal small-fiber sensory neuropathy causes burning mouth syndrome. Pain. 2005 Jun;115(3):332-337. doi: 10.1016/j.pain.2005.03.028.
- Grushka M, Epstein JB, Gorsky M. Burning mouth syndrome and other oral sensory disorders: a unifying hypothesis. Pain Res Manag. 2003 Fall;8(3):133-5. doi: 10.1155/2003/654735.
- Formaker BK, Frank ME. Taste function in patients with oral burning. Chem Senses. 2000 Oct;25(5):575-81. doi: 10.1093/chemse/25.5.575.
- Bartoshuk LM, Snyder DJ, Grushka M, Berger AM, Duffy VB, Kveton JF. Taste damage: previously unsuspected consequences. Chem Senses. 2005 Jan;30 Suppl 1:i218-9. doi: 10.1093/chemse/bjh192. No abstract available.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2007
Primary Completion (Anticipated)
December 1, 2013
Study Completion (Anticipated)
December 1, 2013
Study Registration Dates
First Submitted
July 19, 2007
First Submitted That Met QC Criteria
July 19, 2007
First Posted (Estimate)
July 20, 2007
Study Record Updates
Last Update Posted (Estimate)
December 21, 2012
Last Update Submitted That Met QC Criteria
December 20, 2012
Last Verified
December 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Nervous System Diseases
- Pain
- Neurologic Manifestations
- Wounds and Injuries
- Neuromuscular Diseases
- Stomatognathic Diseases
- Peripheral Nervous System Diseases
- Sensation Disorders
- Burns
- Disease
- Neuralgia
- Somatoform Disorders
- Mouth Diseases
- Facial Pain
- Taste Disorders
- Burning Mouth Syndrome
Other Study ID Numbers
- EA4/036/06
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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