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

NCT ID: NCT00862576

Last Updated: 2009-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

55 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-06-30

Study Completion Date

2008-06-30

Brief Summary

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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

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Conditions

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Burning Mouth Syndrome

Study Design

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Observational Model Type

CASE_CONTROL

Study Groups

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1

Burning Mouth Syndrome Group

No interventions assigned to this group

2

Control Group

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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University of California, San Francisco

Principal Investigators

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Nita Chainani-Wu, DMD, MS, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Sol Jr. Silverman, MA, DDS

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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H1113-29221

Identifier Type: -

Identifier Source: org_study_id

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