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Gingival Wetness and Gingival Crevicular Fluid Volume in Patients With Dry Mouth

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00750828
Recruitment Status : Completed
First Posted : September 11, 2008
Last Update Posted : September 11, 2008
Sponsor:
Information provided by:
Hacettepe University

Tracking Information
First Submitted Date September 10, 2008
First Posted Date September 11, 2008
Last Update Posted Date September 11, 2008
Study Start Date January 2004
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
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 Gingival Wetness and Gingival Crevicular Fluid Volume in Patients With Dry Mouth
Official Title Gingival Wetness and Gingival Crevicular Fluid Volume in Patients With Dry Mouth
Brief Summary The investigators questioned whether patients with dry mouth complaints display any reduction in residual saliva coating the gingiva and other selected mucosal surfaces. We further intended to test the hypothesis that Gingival Crevicular Fluid volume in patients with dry mouth could be different from that of control subjects. Correlations between gingival/mucosal wetness; and unstimulated whole salivary flow rate or minor salivary gland secretion rates and the correlations between clinical periodontal status and salivary measures were also attempted.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population

The data for this study were taken from 28 subjects at the Department of Periodontology, Hacettepe University from 2004 to 2007. The study group consisted of 14 patients with dry mouth complaints. All of them had the diagnosis of Sjögren's syndrome and ten of them were on therapy for sicca symptoms.

Fourteen randomly selected age-matched systemically healthy females were also included as a control group

Condition
  • Xerostomia
  • Sjogren's Syndrome
Intervention Not Provided
Study Groups/Cohorts Not Provided
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: September¬†10,¬†2008)
28
Original Actual Enrollment Same as current
Actual Study Completion Date March 2008
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • For test group dry mouth complaints and with a diagnosis ofSjogren's Syndrome

Exclusion Criteria:

  • Other medical problems that effect salivary glands
Sex/Gender
Sexes Eligible for Study: Female
Ages 46 Years to 56 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT00750828
Other Study ID Numbers Hacettepe # FON 03/6-14
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Burak Demiralp, Hacettepe University Faculty of Dentistry Department of Periodontology
Study Sponsor Hacettepe University
Collaborators Not Provided
Investigators
Study Director: Burak Demiralp, DDS PhD Hacettepe University Faculty of Dentistry Department of Periodontology
PRS Account Hacettepe University
Verification Date September 2008