Prevalence and Progression of Periodontitis in Ankylosing Spondylitis

Study Overview
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Brief Summary
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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

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

Conditions
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Ankylosing Spondylitis, Periodontitis

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ankylosing spondylitis<br>patients aged 18 years or more who meet the 1984 modified New York criteria | |
| Control<br>age- (± 3 years) and gender-matched volunteers who do not have inflammatory arthropathy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevalence rate of periodontitis |  | At enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| carriage rate of P. gingivalis |  | At enrollment | 
| progression of periodontitis |  | 12 and 24 week |