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Trial record 9 of 20 for:    "Burning Mouth Syndrome"

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

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ClinicalTrials.gov Identifier: NCT00862576
Recruitment Status : Completed
First Posted : March 17, 2009
Last Update Posted : March 17, 2009
Sponsor:
Information provided by:
University of California, San Francisco

Tracking Information
First Submitted Date March 16, 2009
First Posted Date March 17, 2009
Last Update Posted Date March 17, 2009
Study Start Date June 2006
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 16, 2009)
Sleep quality and quantity
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Study of the Association of Sleep Dysfunction and Burning Mouth Syndrome
Official Title A Study of the Association of Sleep Dysfunction and Burning Mouth Syndrome
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case Control
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Seen at the Oral Medicine Clinic at the University of California, San Francisco
Condition Burning Mouth Syndrome
Intervention Not Provided
Study Groups/Cohorts
  • 1
    Burning Mouth Syndrome Group
  • 2
    Control Group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 16, 2009)
55
Original Actual Enrollment Same as current
Actual Study Completion Date June 2008
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00862576
Other Study ID Numbers H1113-29221
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Nita Chainani-Wu, Health Sciences Assistant Clinical Professor, University of California, San Francisco
Study Sponsor University of California, San Francisco
Collaborators Not Provided
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
PRS Account University of California, San Francisco
Verification Date March 2009