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

Completed

• Conditions: Burning Mouth Syndrome

• Registration Number: NCT00862576
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2006-06
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Status Verified: 2009-03
• Study First Submitted: 2009-03-16
• Study First Submitted QC: 2009-03-16
• Last Update Submitted: 2009-03-16
• Study First Posted: 2009-03-17
• Last Update Posted: 2009-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sleep quality and quantity

Trial Locations

Locations (1)

University of California; 🇺🇸 San Francisco, California, United States