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

University of California San Francisco (UCSF)

Status: Completed

Conditions: Burning Mouth Syndrome

Study type: Observational

Funder types: Other

Identifiers

NCT00862576

H1113-29221

Details and patient eligibility

About

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.

Enrollment: 55 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

55 participants in 2 patient groups

1

Description:

Burning Mouth Syndrome Group

2

Description:

Control Group