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Burning Mouth Disorder (BMD) - A Neuropathic Pain Disorder

NCT ID: NCT00504387

Last Updated: 2012-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-04-30

Study Completion Date

2013-12-31

Brief Summary

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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

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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.

Conditions

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Burning Mouth Syndrome Taste Disorder Orofacial Pain

Keywords

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Burning mouth disorder Taste disorder Quantitative sensory testing Gustatory testing Neuropathic orofacial pain Oral burning

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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A: Patients

Patients with a primary burning mouth disorder Pain (VAS 0-10): 3\<x\<9 Patient understands and speaks german Age: \>18 years

No interventions assigned to this group

B: Controls

Age and sex matched persons/patients who do not have any history of an oral burning sensation or a burning mouth disorder.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

UNKNOWN

Sponsor Role collaborator

Markus R. Fussnegger

OTHER

Sponsor Role lead

Responsible Party

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Markus R. Fussnegger

Assistent professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ingrid Peroz, PD Dr.

Role: STUDY_CHAIR

Charité - Universitätsmedizin Berlin, Center for dental and craniofacial sciences, Department of restorative dentistry, Assmannshauser Str. 4-6, D-14197 Berlin

Markus R Fussnegger, Dr.

Role: STUDY_DIRECTOR

Charité - Universitätsmedizin Berlin, Center for dental and craniofacial sciences, Department of restorative dentistry, Assmannshauser Str. 4-6, D-14197 Berlin

Locations

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Charité - Universitätsmedizin Berlin, Center for dental and craniofacial sciences, Department of restorative dentistry

Berlin, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Markus R Fussnegger, Dr.

Role: CONTACT

Phone: +49 30 450 562713

Email: [email protected]

References

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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. doi: 10.1177/154411130301400405.

Reference Type BACKGROUND
PMID: 12907696 (View on PubMed)

Forssell H, Jaaskelainen S, Tenovuo O, Hinkka S. Sensory dysfunction in burning mouth syndrome. Pain. 2002 Sep;99(1-2):41-7. doi: 10.1016/s0304-3959(02)00052-0.

Reference Type BACKGROUND
PMID: 12237182 (View on PubMed)

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):332-337. doi: 10.1016/j.pain.2005.03.028.

Reference Type BACKGROUND
PMID: 15911160 (View on PubMed)

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. doi: 10.1155/2003/654735.

Reference Type BACKGROUND
PMID: 14657979 (View on PubMed)

Formaker BK, Frank ME. Taste function in patients with oral burning. Chem Senses. 2000 Oct;25(5):575-81. doi: 10.1093/chemse/25.5.575.

Reference Type BACKGROUND
PMID: 11015329 (View on PubMed)

Bartoshuk LM, Snyder DJ, Grushka M, Berger AM, Duffy VB, Kveton JF. Taste damage: previously unsuspected consequences. Chem Senses. 2005 Jan;30 Suppl 1:i218-9. doi: 10.1093/chemse/bjh192. No abstract available.

Reference Type BACKGROUND
PMID: 15738123 (View on PubMed)

Other Identifiers

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EA4/036/06

Identifier Type: -

Identifier Source: org_study_id