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NCT00862576 Clinical Trial

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

Burning Mouth Syndrome Clinical Trial

Official title:
A Study of the Association of Sleep Dysfunction and Burning Mouth Syndrome

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00862576
Other study ID # H1113-29221
Secondary ID
Status Completed
Phase N/A
First received March 16, 2009
Last updated March 16, 2009
Start date June 2006
Est. completion date June 2008

Study information
Verified date March 2009
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 55
Est. completion date June 2008
Est. primary completion date June 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Observational Model: Case Control

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of California San Francisco California

Sponsors (1)
Lead Sponsor Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sleep quality and quantity No
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