Trial record 1 of 12 for:    "Burning mouth syndrome"
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A Study of the Association of Sleep Dysfunction and Burning Mouth Syndrome

This study has been completed.
Sponsor:
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00862576
First received: March 16, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  Purpose

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.


Condition
Burning Mouth Syndrome

Study Type: Observational
Study Design: Observational Model: Case Control
Official Title: A Study of the Association of Sleep Dysfunction and Burning Mouth Syndrome

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Sleep quality and quantity [ Designated as safety issue: No ]

Enrollment: 55
Study Start Date: June 2006
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Burning Mouth Syndrome Group
2
Control Group

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00862576

Locations
United States, California
University of California
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Nita Chainani-Wu, DMD, MS, PhD University of California, San Francisco
Principal Investigator: Sol Jr. Silverman, MA, DDS University of California, San Francisco
  More Information

No publications provided

Responsible Party: Nita Chainani-Wu, Health Sciences Assistant Clinical Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00862576     History of Changes
Other Study ID Numbers: H1113-29221
Study First Received: March 16, 2009
Last Updated: March 16, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Burning Mouth Syndrome
Sleep
Neuropathic pain
Glossodynia
Chronic pain
Orofacial pain

Additional relevant MeSH terms:
Burning Mouth Syndrome
Burns
Mouth Diseases
Stomatognathic Diseases
Wounds and Injuries

ClinicalTrials.gov processed this record on July 26, 2014