The Prevalence and the Progression of Periodontitis in Ankylosing Spondylitis (AS) Patients Versus Non-AS Population

Seoul National University Hospital1 site in 1 country168 target enrollmentSeptember 2012

Overview

Our hypotheses on the relationship between periodontitis and AS are as follows;
- The prevalence of periodontitis is higher in AS patients group than that of non-AS control group
- Anti-TNF-α therapy would favorably affect the disease course of periodontitis.
Based on our hypotheses, the specific objectives of the present proposal are as follows;
- The primary objective is to compare the prevalence rate of periodontitis between AS patient group and non-AS group.
- The secondary objectives will be:
  - To observe the carriage rate of P. gingivalis in AS and non-AS groups
  - To identify clinical parameters associated with the severity of periodontitis in AS group.
  - To compare the progression of periodontitis at weeks 12 and 24 between AS and non-AS groups or between AS patients with and without anti-TNF-α treatment

Registry

clinicaltrials.gov

Start Date

September 2012

End Date

May 2014

Last Updated

11 years ago

Study Type

Observational

Sex

All

Sponsor

Responsible Party

Principal Investigator

Yun Jong Lee

Associate Professor

Seoul National University Bundang Hospital

•Age ≥ 18 years
•Subjects giving informed written consent
•In case of AS patients, subjects to meet the 1984 modified New York criteria for AS.
•In case of controls, subjects without a history of inflammatory arthropathy

•Subjects having received periodontitis treatment including scaling within 6 months before study participation.
•Subjects with a history of taking antibiotics including prophylactic anti-tuberculosis agents within 3 months before study participation.
•Subjects with a hitory of taking immuno-suppresives (methotrexate, leflunomide, tacrolimus, cyclosporin, or azathioprine) or any dose of glucocorticoids (oral or pareneral) within 3 months before study participation.
•Subjects with a history of diabetes mellitus.
•Subjects with aggressive periodontitis requiring open flap debriment at enrollment immediately.
•Subjects with a hitory of clinical inflammatory bowel disease.
•Subjects with active infection, which can make an influence on the levels of acute phase reactants.
•Subjects with any other condition to render the patient unable to understand the scope of the study or preclude the patient from following the protocol in the physician's opinion.