NCT00750828

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 11, 2008

Completed
Last Updated

September 11, 2008

Status Verified

September 1, 2008

Enrollment Period

3.9 years

First QC Date

September 10, 2008

Last Update Submit

September 10, 2008

Conditions

Keywords

SalivaSjögren's SyndromeGCFOral Mucosal Wetness

Eligibility Criteria

Age46 Years - 56 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability 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

You may qualify if:

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

You may not qualify if:

  • Other medical problems that effect salivary glands

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Periodontology, Faculty of Dentistry, Hacettepe University,

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

XerostomiaSjogren's Syndrome

Condition Hierarchy (Ancestors)

Salivary Gland DiseasesMouth DiseasesStomatognathic DiseasesArthritis, RheumatoidArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesDry Eye SyndromesLacrimal Apparatus DiseasesEye DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Burak Demiralp, DDS PhD

    Hacettepe University Faculty of Dentistry Department of Periodontology

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 10, 2008

First Posted

September 11, 2008

Study Start

January 1, 2004

Primary Completion

December 1, 2007

Study Completion

March 1, 2008

Last Updated

September 11, 2008

Record last verified: 2008-09

Locations