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

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

This study has been completed.
First Received: March 16, 2009 No Changes Posted
Sponsored by: University of California, San Francisco

Information provided by: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00862576

Purpose
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
Burning Mouth Syndrome

U.S. FDA Resources
Study Type: Observational
Study Design: Case Control
Official Title: A Study of the Association of Sleep Dysfunction and Burning Mouth Syndrome

Further study details as provided by University of California, San Francisco:


Primary Outcome Measures:
Sleep quality and quantity [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment: 55
Study Start Date: June 2006
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts
1
Burning Mouth Syndrome Group
2
Control Group

Eligibility

Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
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.
Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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: University of California, San Francisco ( Nita Chainani-Wu, Health Sciences Assistant Clinical Professor )
Study ID Numbers: H1113-29221
Study First Received: March 16, 2009
Last Updated: March 16, 2009
ClinicalTrials.gov Identifier: NCT00862576
History of Changes
Health Authority: United States: Institutional Review Board

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

Study placed in the following topic categories:
Mouth Diseases
Pain
Stomatognathic Diseases
Burning Mouth Syndrome

Additional relevant MeSH terms:
Mouth Diseases
Pathologic Processes
Disease
Syndrome
Stomatognathic Diseases
Burning Mouth Syndrome

ClinicalTrials.gov processed this record on April 13, 2009