Burning Mouth Disorder (BMD) - A Neuropathic Pain Disorder

Sponsor

Markus R. Fussnegger (Other)

Overall Status

Unknown status

CT.gov ID

NCT00504387

Collaborator

Deutsche Gesellschaft für Zahn-, Mund- und Kieferheilkunde e.V. (Other)

Enrollment

Location

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Burning Mouth Syndrome Taste Disorder Orofacial Pain

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 Design

Study Type:

Observational

Anticipated Enrollment :

12 participants

Time Perspective:

Prospective

Official Title:

Burning Mouth Disorder (BMD) - a Neuropathic Pain Disorder? An Investigation Using Qualitative and Quantitative Sensory Testing (QST)

Study Start Date :

Apr 1, 2007

Anticipated Primary Completion Date :

Dec 1, 2013

Anticipated Study Completion Date :

Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

Neurosensory differences between Burning Mouth Disorder patients and controls. []
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Charité - Universitätsmedizin Berlin, Center for dental and craniofacial sciences, Department of restorative dentistry	Berlin		Germany	D-14197

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