Prevalence and Progression of Periodontitis in Ankylosing Spondylitis

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01750528

Enrollment

168

Registered

2012-12-17

Start date

2012-09-30

Completion date

2014-05-31

Last updated

2014-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankylosing Spondylitis, Periodontitis

Brief summary

1. 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. 2. 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

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

Inclusion criteria

* 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

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame
prevalence rate of periodontitis	At enrollment

Secondary

Measure	Time frame
carriage rate of P. gingivalis	At enrollment
progression of periodontitis	12 and 24 week

Countries

South Korea

Outcome results