Prevalence and Progression of Periodontitis in Ankylosing Spondylitis

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01750528
• Other study ID #: IMM 12-0004
• Secondary ID: IMM 12-0004
• Status: Completed
• Phase: N/A
• First received: September 5, 2012
• Last updated: June 8, 2014
• Start date: September 2012
• Est. completion date: May 2014

Study information

• Verified date: June 2014
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Periodontitis
• Spondylitis
• Spondylitis, Ankylosing

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Pischon N, Pischon T, Gülmez E, Kröger 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. Epub . — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prevalence rate of periodontitis		At enrollment	No
Secondary	carriage rate of P. gingivalis		At enrollment	No
Secondary	progression of periodontitis		12 and 24 week	No