Effects of Hydroxychloroquine on Oral Complaints of Sjögren Patients

March 31, 2009 updated by: Ege University

Effects of Hydroxychloroquine on Oral Complaints of Sjögren Patients: a Prospective Sample Study.

Chronic inflammation that comprises the exocrine glands' function leads to xerophthalmia and xerostomia in Sjögren's syndrome. The oral consequences range widely and they are related to decreased salivary output. Hydroxychloroquine may inhibit cholinesterase activity in salivary glands via interference with antigen processing mechanism, and thus, the investigators' hypothesis was that salivary gland function may be improved if treated with hydroxychloroquine. The effects of hydroxychloroquine on the salivary flow rate, subjective and objective parameters of the patients were also assessed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Bornova
      • Izmir, Bornova, Turkey, 35100
        • Ege University School of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

The study group consisted of 30 female patients recently diagnosed as Sjögren's syndrome.

Description

Inclusion Criteria:

  • Patients who were recently diagnosed with primary SS according to American-European criteria and who were scheduled for HCQ treatment in Ege University Faculty of Medicine, Department of Rheumatology

Exclusion Criteria:

  • Sjögren patients consuming alcohol or tobacco

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Sjögren
Pre and post treatment establishment of salivary flow rate, objective and subjective clinical oral complications' severity of the patients using hydroxychloroquine
Drug: Hydroxychloroquine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Salivary flow rate, objective and subjective clinical oral complaints
Time Frame: 2005 Jan-2009 Jan
2005 Jan-2009 Jan

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ege University

Investigators

  • Study Director: Esin Alpoz, Ege University School of Dentistry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

March 31, 2009

First Submitted That Met QC Criteria

March 31, 2009

First Posted (Estimate)

April 1, 2009

Study Record Updates

Last Update Posted (Estimate)

April 1, 2009

Last Update Submitted That Met QC Criteria

March 31, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EAlpoz 1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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