Prevalence and Progression of Periodontitis in Ankylosing Spondylitis
NCT ID: NCT01750528
Last Updated: 2014-06-10
Study Results
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Basic Information
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COMPLETED
168 participants
OBSERVATIONAL
2012-09-30
2014-05-31
Brief Summary
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* 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
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Ankylosing spondylitis
patients aged 18 years or more who meet the 1984 modified New York criteria
No interventions assigned to this group
Control
age- (± 3 years) and gender-matched volunteers who do not have inflammatory arthropathy.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
80 Years
ALL
Yes
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Yun Jong Lee
Associate Professor
Principal Investigators
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Yun Jong Lee, M.D.
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Bundang Hospital
Locations
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Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Countries
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References
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Pischon N, Pischon T, Gulmez E, Kroger J, Purucker P, Kleber BM, Landau H, Jost-Brinkmann PG, Schlattmann P, Zernicke J, Burmester GR, Bernimoulin JP, Buttgereit F, Detert J. Periodontal disease in patients with ankylosing spondylitis. Ann Rheum Dis. 2010 Jan;69(1):34-8. doi: 10.1136/ard.2008.097212.
Kang EH, Lee JT, Lee HJ, Lee JY, Chang SH, Cho HJ, Choi BY, Ha YJ, Park KU, Song YW, Van Dyke TE, Lee YJ. Chronic Periodontitis Is Associated With Spinal Dysmobility in Patients With Ankylosing Spondylitis. J Periodontol. 2015 Dec;86(12):1303-13. doi: 10.1902/jop.2015.150202. Epub 2015 Aug 20.
Other Identifiers
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IMM 12-0004
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
IMM 12-0004
Identifier Type: -
Identifier Source: org_study_id
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