Burning Mouth Disorder (BMD) - A Neuropathic Pain Disorder
Burning Mouth Disorder (BMD) - A Neuropathic Pain Disorder
This study is currently recruiting participants.
Verified by Charite University, Berlin, Germany, March 2009
First Received: July 19, 2007 Last Updated: March 31, 2009 History of Changes
Sponsors and Collaborators: Charite University, Berlin, Germany
Deutsche Gesellschaft für Zahn-, Mund- und Kieferheilkunde e.V.
Information provided by: Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT00504387
Purpose

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.

Condition
Burning Mouth Disorder
Burning Mouth Syndrome
Oral Burning
Taste Disorder
Neuropathic Orofacial Pain

MedlinePlus related topics: Mouth Disorders Taste and Smell Disorders
U.S. FDA Resources
Study Type: Observational
Study Design: Prospective
Official Title: Burning Mouth Disorder (BMD) - a Neuropathic Pain Disorder? An Investigation Using Qualitative and Quantitative Sensory Testing (QST)

Further study details as provided by Charite University, Berlin, Germany:

Estimated Enrollment: 12
Study Start Date: April 2007
Groups/Cohorts
A
Patients with a primary burning mouth disorder Pain (VAS 0-10): 3<x<9 Patient understands and speaks german Age: >18 years
B
Age and sex matched persons/patients who do not have any history of an oral burning sensation or a burning mouth disorder.

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.
Eligibility

Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Sampling Method: Non-Probability Sample
Study Population

Tertiary care clinic
Criteria

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

Exclusion Criteria:

* Tumor
* HIV/AIDS
* Diabetes mellitus
* untreated hypothyroidism
* gastroesophageal reflux disease
* Sjögren's disease
* Salivatory 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-HCl
* Xerostomia
* Pregnancy
* Psychiatric disorder

Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00504387

Contacts
Contact: Markus R Fussnegger, Dr. +49 30 450 562713 markus.fussnegger@charite.de

Locations
Germany
Charité - Universitätsmedizin Berlin, Center for dental and craniofacial sciences, Department of restorative dentistry Recruiting
Berlin, Germany, D-14197
Principal Investigator: Markus R Fussnegger, Dr.
Sub-Investigator: Alexander Alter, Dr.
Sponsors and Collaborators
Charite University, Berlin, Germany
Deutsche Gesellschaft für Zahn-, Mund- und Kieferheilkunde e.V.
Investigators
Study Chair: Wolfgang B Freesmeyer, Prof. 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
More Information

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. Review.
Forssell H, Jaaskelainen S, Tenovuo O, Hinkka S. Sensory dysfunction in burning mouth syndrome. Pain. 2002 Sep;99(1-2):41-7.
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):332-7.
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. Review.
Formaker BK, Frank ME. Taste function in patients with oral burning. Chem Senses. 2000 Oct;25(5):575-81.
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-i219. No abstract available.

Responsible Party: Charite University, Berlin, Germany ( Prof. Dr. W. B. Freesmeyer, Dr. M. R. Fussnegger )
Study ID Numbers: EA4/036/06
Study First Received: July 19, 2007
Last Updated: March 31, 2009
ClinicalTrials.gov Identifier: NCT00504387 History of Changes
Health Authority: Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:
Burning mouth disorder
Taste disorder
Quantitative sensory testing
Gustatory testing
Neuropathic orofacial pain

Study placed in the following topic categories:
Mouth Diseases
Signs and Symptoms
Sensation Disorders
Taste Disorders
Facies
Facial Pain
Mental Disorders
Neurologic Manifestations
Pain
Stomatognathic Diseases
Somatoform Disorders
Burning Mouth Syndrome

Additional relevant MeSH terms:
Burning Mouth Syndrome
Mouth Diseases
Syndrome
Sensation Disorders
Disease
Facial Pain
Nervous System Diseases
Pain
Taste Disorders
Signs and Symptoms
Pathologic Processes
Mental Disorders
Neurologic Manifestations
Stomatognathic Diseases
Somatoform Disorders

ClinicalTrials.gov processed this record on May 05, 2009
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