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Prevalence and Progression of Periodontitis in Ankylosing Spondylitis

This study is currently recruiting participants.
Verified April 2013 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Yun Jong Lee, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT01750528
First received: September 5, 2012
Last updated: April 18, 2013
Last verified: April 2013
History of Changes
  Purpose

  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

Condition
Ankylosing Spondylitis
Periodontitis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: The Prevalence and the Progression of Periodontitis in Ankylosing Spondylitis (AS) Patients Versus Non-AS Population

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • prevalence rate of periodontitis [ Time Frame: At enrollment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • carriage rate of P. gingivalis [ Time Frame: At enrollment ] [ Designated as safety issue: No ]
  • progression of periodontitis [ Time Frame: 12 and 24 week ] [ Designated as safety issue: No ]

Estimated Enrollment: 168
Study Start Date: September 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01750528

Locations
Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
Contact: Yun Jong Lee, M.D>     82317877009     yn35@snubh.org    
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Yun Jong Lee, M.D. Seoul National University Bundang Hospital
  More Information

Publications:

Responsible Party: Yun Jong Lee, Associate Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01750528     History of Changes
Other Study ID Numbers: IMM 12-0004, IMM 12-0004
Study First Received: September 5, 2012
Last Updated: April 18, 2013
Health Authority: South Korea: Institutional Review Board

Additional relevant MeSH terms:
Periodontitis
Spondylitis
Spondylitis, Ankylosing
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Bone Diseases, Infectious
Infection
 Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis

ClinicalTrials.gov processed this record on May 23, 2013