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

This study has been completed.

Sponsor:

Information provided by:

Hacettepe University

ClinicalTrials.gov Identifier:

NCT00750828

First received: September 10, 2008

Last updated: NA

Last verified: September 2008

History: No changes posted

Tracking Information

First Received Date ^ICMJE

September 10, 2008

Last Updated Date

September 10, 2008

Start Date ^ICMJE

January 2004

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 ^ICMJE

Observational

Study Design ^ICMJE

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 ^ICMJE

Xerostomia
Sjogren's Syndrome

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

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 ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2008

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

Other medical problems that effect salivary glands

Gender

Female

Ages

46 Years to 56 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Turkey

Administrative Information

NCT Number ^ICMJE

NCT00750828

Other Study ID Numbers ^ICMJE

Hacettepe # FON 03/6-14

Has Data Monitoring Committee

Yes

Responsible Party

Burak Demiralp, Hacettepe University Faculty of Dentistry Department of Periodontology

Study Sponsor ^ICMJE

Hacettepe University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Burak Demiralp, DDS PhD

Hacettepe University Faculty of Dentistry Department of Periodontology

Information Provided By

Hacettepe University

Verification Date

September 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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