Prevalence and Progression of Periodontitis in Ankylosing Spondylitis

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ankylosing Spondylitis Ankylosis Arthritis Axial Spondyloarthritis Bone Diseases Joint Diseases Mouth Diseases Musculoskeletal Diseases Periodontal Diseases Periodontitis Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing Stomatognathic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

prevalence rate of periodontitis

Time frame: At enrollment

Secondary outcomes

carriage rate of P. gingivalis

Time frame: At enrollment
progression of periodontitis

Time frame: 12 and 24 week

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2014
First posted: Dec 17, 2012
Registry last updated: Jun 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed