Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00504387
Other study ID # EA4/036/06
Secondary ID
Status Recruiting
Phase N/A
First received July 19, 2007
Last updated December 20, 2012
Start date April 2007
Est. completion date December 2013

Study information

Verified date December 2012
Source Charite University, Berlin, Germany
Contact Markus R Fussnegger, Dr.
Phone +49 30 450 562713
Email markus.fussnegger@charite.de
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 12
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Time Perspective: Prospective


Locations

Country Name City State
Germany Charité - Universitätsmedizin Berlin, Center for dental and craniofacial sciences, Department of restorative dentistry Berlin

Sponsors (2)

Lead Sponsor Collaborator
Markus R. Fussnegger Deutsche Gesellschaft für Zahn-, Mund- und Kieferheilkunde e.V.

Country where clinical trial is conducted

Germany, 

References & Publications (6)

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. — View Citation

Formaker BK, Frank ME. Taste function in patients with oral burning. Chem Senses. 2000 Oct;25(5):575-81. — View Citation

Forssell H, Jääskeläinen S, Tenovuo O, Hinkka S. Sensory dysfunction in burning mouth syndrome. Pain. 2002 Sep;99(1-2):41-7. — View Citation

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. Review. — View Citation

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):332-7. — View Citation

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. No
See also
  Status Clinical Trial Phase
Completed NCT04475614 - Therapeutic Options for Treatment of Burning Mouth Syndrome N/A
Completed NCT00374673 - Efficacy of Transcranial Magnetic Stimulation (TMS) in Chronic Idiopathic Pain Disorders Phase 3
Completed NCT02964728 - Botulinum Toxin in Burning Mouth Syndrome Phase 2
Completed NCT04535973 - Hormonal Status and Quality of Life in Female Postmenopausal Patients With Burning Mouth Syndrome
Recruiting NCT06040190 - Effect of Treatments on Pain and Quality of Life in Individual With Burning Mouth Syndrome Phase 4
Not yet recruiting NCT05059418 - Burning Mouth Syndrome - New Diagnostic Criteria and Treatment N/A
Recruiting NCT01867151 - Effect of Gluten Free Diet in Patients With Burning Mouth Syndrome N/A
Completed NCT05872789 - Impact of Diazepam 1% Oral Gel Efficacy in Burning Mouth Syndrome N/A
Completed NCT05871580 - Effect to the Photobiomodulation in the Burning Mouth Syndrome N/A
Recruiting NCT05309070 - The Efficacy of N-acetyl-cysteine in the Treatment of Burning Mouth Syndrome N/A
Completed NCT05399238 - Thermography and Burning Mouth Syndrome
Completed NCT02580734 - Efficacy of Melatonin in Burning Mouth Syndrome (BMS) N/A
Completed NCT02382029 - Acupuncture Versus Clonazepam in Burning Mouth Syndrome Phase 0
Recruiting NCT05819697 - Reducing Patient Memory Recall in the Burning Mouth Patient Population
Completed NCT02757612 - Study Evaluating the Laser Diode Effect Burning Mouth Syndrome N/A
Completed NCT00862576 - A Study of the Association of Sleep Dysfunction and Burning Mouth Syndrome N/A
Not yet recruiting NCT04189367 - Treatment of Burning Mouth Syndrome With Integration of Traditional Chinese Medicine and Western Medicine Phase 3
Completed NCT00001524 - Thalidomide to Treat Oral Lesions in HIV-Infected Patients Phase 2
Recruiting NCT04481841 - Head Yuanshi Dian Therapy in Burning Mouth Syndrome Early Phase 1
Completed NCT02686359 - Opiorphin Levels in Fluids of Burning Mouth Syndrome Patients (OPIODYN) N/A