Burning Mouth Disorder (BMD) - A Neuropathic Pain Disorder

• Conditions: Burning Mouth Syndrome; Taste Disorder; Orofacial Pain

• Registration Number: NCT00504387
• Lead Sponsor: Markus R. Fussnegger

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.

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 Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-07-19
• Study First Submitted QC: 2007-07-19
• Study First Posted: 2007-07-20
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-20
• Last Update Posted: 2012-12-21
• Primary Completion: 2013-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Charité - Universitätsmedizin Berlin, Center for dental and craniofacial sciences, Department of restorative dentistry; 🇩🇪 Berlin, Germany