Burning Mouth Disorder (BMD) - A Neuropathic Pain Disorder

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Charite University, Berlin, Germany
Sponsor:
Collaborator:
Deutsche Gesellschaft für Zahn-, Mund- und Kieferheilkunde e.V.
Information provided by (Responsible Party):
Markus R. Fussnegger, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00504387
First received: July 19, 2007
Last updated: December 20, 2012
Last verified: December 2012
  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 Syndrome
Taste Disorder
Orofacial Pain

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Burning Mouth Disorder (BMD) - a Neuropathic Pain Disorder? An Investigation Using Qualitative and Quantitative Sensory Testing (QST)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Neurosensory differences between Burning Mouth Disorder patients and controls. [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 12
Study Start Date: April 2007
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
A: Patients
Patients with a primary burning mouth disorder Pain (VAS 0-10): 3<x<9 Patient understands and speaks german Age: >18 years
B: Controls
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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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.         
Sponsors and Collaborators
Markus R. Fussnegger
Deutsche Gesellschaft für Zahn-, Mund- und Kieferheilkunde e.V.
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
  More Information

Publications:
Responsible Party: Markus R. Fussnegger, Assistent professor, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT00504387     History of Changes
Other Study ID Numbers: EA4/036/06
Study First Received: July 19, 2007
Last Updated: December 20, 2012
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
Oral burning

Additional relevant MeSH terms:
Taste Disorders
Neuralgia
Disease
Burns
Burning Mouth Syndrome
Mouth Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Pathologic Processes
Wounds and Injuries
Stomatognathic Diseases
Sensation Disorders

ClinicalTrials.gov processed this record on September 16, 2014