Prevalence and Progression of Periodontitis in Ankylosing Spondylitis

NCT ID: NCT01750528

Last Updated: 2014-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

168 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-30

Study Completion Date

2014-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ankylosing Spondylitis Periodontitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Yun Jong Lee

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yun Jong Lee, M.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 19126560 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26291296 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IMM 12-0004

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IMM 12-0004

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.