Associations Between Periodontitis and Autoimmune Antibodies in Rheumatoid Arthritis Disease

October 14, 2015 updated by: National Taiwan University Hospital
The aim of this case control study is to explore the possible association between periodontal destruction and serum anti-CCP antibodies in RA patients and healthy subjects.

Study Overview

Status

Unknown

Conditions

Detailed Description

In patients with RA, the anti-CCP antibody titer seems positively correlated to their periodontal destruction and disease activity in comparison with healthy subjects.

Study Type

Observational

Enrollment (Actual)

47

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

  • Taiwan
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital

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

60 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Physically healthy persons, especially free of any autoimmune diseases, DM, CVD. No history of periodontal treatment.

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: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum level of anti-cyclic citrullinated peptide/protein antibody
Time Frame: Base line
Lower then 7 Unit/milliliter: negative 7-10 Unit/milliliter: weak positive Higher then 10 Unit/milliliter: positive
Base line
Periodontal pocket depth and clinical attachment level
Time Frame: Baseline
Lower then 4 millimeter: normal Higher then 4 millimeter: diseased/previously diseased
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum level of tumor necrotic factor alpha
Time Frame: Baseline
Recorded in picogram per milliliter
Baseline
Serum level of anti-mutated citrullinated vimentin
Time Frame: Baseline
Recorded in Unit per milliliter
Baseline
Serum level of interleukin 6
Time Frame: Baseline
Recorded in picogram per milliliter
Baseline
Serum level of interleukin 17
Time Frame: Baseline
Recorded in picogram per milliliter
Baseline

Collaborators and Investigators

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

Sponsor

National Taiwan University Hospital

Investigators

  • Study Director: Yi-Wen Chen, PhD, Assistant Professor

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

June 1, 2015

Primary Completion (Actual)

September 1, 2015

Study Completion (Anticipated)

November 1, 2015

Study Registration Dates

First Submitted

September 23, 2015

First Submitted That Met QC Criteria

October 14, 2015

First Posted (Estimate)

October 16, 2015

Study Record Updates

Last Update Posted (Estimate)

October 16, 2015

Last Update Submitted That Met QC Criteria

October 14, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201503116RINA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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