Burning Mouth Disorder (BMD) - A Neuropathic Pain Disorder

NCT00504387 | Unknown

• 1 other identifier: EA4/036/06
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Burning Mouth Syndrome; Taste Disorder; Orofacial Pain

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Tertiary care clinic

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Markus R. Fussnegger: lead
• Deutsche Gesellschaft für Zahn-, Mund- und Kieferheilkunde e.V.: collaborator

Study Sites (1)

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

Berlin, D-14197, Germany

RECRUITING

Related Publications (6)

• 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.

  PMID: 12907696 BACKGROUND

• 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.

  PMID: 12237182 BACKGROUND

• 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.

  PMID: 15911160 BACKGROUND

• 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.

  PMID: 14657979 BACKGROUND

• 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.

  PMID: 11015329 BACKGROUND

• 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.

  PMID: 15738123 BACKGROUND

MeSH Terms

Conditions

Burning Mouth Syndrome; Taste Disorders; Facial Pain

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain

Study Officials

• 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 CHAIR

• Markus R Fussnegger, Dr.

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

  STUDY DIRECTOR

Central Study Contacts

Markus R Fussnegger, Dr.

CONTACT

+49 30 450 562713; markus.fussnegger@charite.de

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistent professor

Study Record Dates

• First Submitted: July 19, 2007
• First Posted: July 20, 2007
• Study Start: April 1, 2007
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 21, 2012

Record last verified: 2012-12

Locations

DE (1)