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A Study of the Association of Sleep Dysfunction and Burning Mouth Syndrome

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ClinicalTrials.gov Identifier: NCT00862576
Recruitment Status : Completed
First Posted : March 17, 2009
Last Update Posted : March 17, 2009
Sponsor:
Information provided by:
University of California, San Francisco

Brief Summary:

This is a case control study of the association between burning mouth syndrome and sleep dysfunction. Cases will comprise of patients diagnosed with burning mouth syndrome at the UCSF oral medicine clinic. Controls will include patients with leukoplakia, pigmented lesions, traumatic lesions, benign tumors, mucoceles, and pemphigoid matched on age (5 years) and gender to the cases. New patients as well as those presenting for follow-up visits will be eligible.

Each case and control subject will be administered the following 4 questionnaires by interview: (1) enrollment questionnaire (2) Sleep scale from the medical outcomes study (MOS), (3) current sleep status scale and (4) a numerical rating scale for measurement of oral symptoms.

Cases (BMS patients) will be followed in the clinic or by telephone contact once per month for the following 6 months and questionnaires 1 (question 6 only), 2, 3 and 4 will be administered by interview.


Condition or disease
Burning Mouth Syndrome

Study Type : Observational
Actual Enrollment : 55 participants
Observational Model: Case Control
Official Title: A Study of the Association of Sleep Dysfunction and Burning Mouth Syndrome
Study Start Date : June 2006
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns
U.S. FDA Resources

Group/Cohort
1
Burning Mouth Syndrome Group
2
Control Group



Primary Outcome Measures :
  1. Sleep quality and quantity


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Seen at the Oral Medicine Clinic at the University of California, San Francisco
Criteria

Inclusion Criteria:

  • Cases will comprise of patients diagnosed with burning mouth syndrome at the UCSF oral medicine clinic.
  • Controls will include patients with leukoplakia, pigmented lesions, traumatic lesions, aphthous ulcers, reticular oral lichen planus, benign tumors, mucoceles, and pemphigoid matched on age (5 years) and gender to the cases.
  • New patients as well as those presenting for follow-up visits will be eligible.

Exclusion Criteria:

  • Age below 18 years
  • Pregnancy
  • Systemic corticosteroid therapy within the previous 2 weeks.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00862576


Locations
United States, California
University of California
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Nita Chainani-Wu, DMD, MS, PhD University of California, San Francisco
Principal Investigator: Sol Jr. Silverman, MA, DDS University of California, San Francisco

Responsible Party: Nita Chainani-Wu, Health Sciences Assistant Clinical Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00862576     History of Changes
Other Study ID Numbers: H1113-29221
First Posted: March 17, 2009    Key Record Dates
Last Update Posted: March 17, 2009
Last Verified: March 2009

Keywords provided by University of California, San Francisco:
Burning Mouth Syndrome
Sleep
Neuropathic pain
Glossodynia
Chronic pain
Orofacial pain

Additional relevant MeSH terms:
Syndrome
Burns
Burning Mouth Syndrome
Disease
Pathologic Processes
Wounds and Injuries
Mouth Diseases
Stomatognathic Diseases