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

NCT00862576 | Completed

• 1 other identifier: H1113-29221
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Burning Mouth Syndrome

Keywords

Burning Mouth Syndrome; Sleep; Neuropathic pain; Glossodynia; Chronic pain; Orofacial pain

Outcome Measures

Primary Outcomes (1)

• Sleep quality and quantity

Study Arms (2)

1

Burning Mouth Syndrome Group

2

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Seen at the Oral Medicine Clinic at the University of California, San Francisco

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Burning Mouth Syndrome; Neuralgia; Glossalgia; Chronic Pain; Facial Pain

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Tongue Diseases

Study Officials

• Nita Chainani-Wu, DMD, MS, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Sol Jr. Silverman, MA, DDS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 16, 2009
• First Posted: March 17, 2009
• Study Start: June 1, 2006
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: March 17, 2009

Record last verified: 2009-03

Locations

US (1)