Prevalence and Progression of Periodontitis in Ankylosing Spondylitis

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

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

Study Overview

• Status: Completed
• Conditions: Periodontitis; Ankylosing Spondylitis

• Study Type: Observational
• Enrollment (Actual): 168

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

1. AS group will consist of patients aged 18 years or more who meet the 1984 modified New York criteria for AS.

   i. AS group receiving anti-TNF-α agents will consists of AS patients who have received adalimumab, etanercept, or infliximab before enrollment (or begin anti-TNF-α agents at enrollment) and keep anti-TNF-α agents for 3 months or more after enrollment.

   ii. AS group not receiving anti-TNF-α agents will consists of AS patients who are treated with a non-steroidal anti-inflammatory drug, sulfasalazine, or non-pharmacological therapy and keep non-anti-TNF-α therapy for 3 months or more after enrollment.

2. Control group will consist of age- (± 3 years) and gender-matched volunteers who do not have inflammatory arthropathy.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Ankylosing spondylitis; patients aged 18 years or more who meet the 1984 modified New York criteria
Control; age- (± 3 years) and gender-matched volunteers who do not have inflammatory arthropathy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
prevalence rate of periodontitis	At enrollment

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Yun Jong Lee, M.D., Seoul National University Bundang Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: September 5, 2012
• First Submitted That Met QC Criteria: December 14, 2012
• First Posted (Estimate): December 17, 2012

Study Record Updates

• Last Update Posted (Estimate): June 10, 2014
• Last Update Submitted That Met QC Criteria: June 8, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Arthritis; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Spinal Diseases; Bone Diseases; Spondylarthropathies; Bone Diseases, Infectious; Ankylosis; Periodontitis; Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
• Other Study ID Numbers: IMM 12-0004 (Other Grant/Funding Number: Abbott Labs)