Burning Mouth Disorder (BMD) - A Neuropathic Pain Disorder
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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) |
- 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 |
Tertiary care clinic
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| Contact: Markus R Fussnegger, Dr. | +49 30 450 562713 | markus.fussnegger@charite.de |
| 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. | |
| 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:
|
Burning Mouth Syndrome Facial Pain Pain Burns Mouth Diseases Neuralgia Taste Disorders Somatoform Disorders Stomatognathic Diseases |
Wounds and Injuries Neurologic Manifestations Nervous System Diseases Peripheral Nervous System Diseases Neuromuscular Diseases Signs and Symptoms Sensation Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 22, 2013