Ankylosing SpondylitisNCT01750528
Prevalence and Progression of Periodontitis in Ankylosing Spondylitis
An observational study of Ankylosing Spondylitis and Periodontitis, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Ankylosing Spondylitis, Periodontitis
- How many people
- 168 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2012to May 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
Official title: The Prevalence and the Progression of Periodontitis in Ankylosing Spondylitis (AS) Patients Versus Non-AS Population
- 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.
Read more
- 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
- Conditions
- Ankylosing Spondylitis, Periodontitis
- Medical subject headings
- Spondylitis, Ankylosing, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
prevalence rate of periodontitis
Measured: At enrollment
Secondary outcomes (2)
carriage rate of P. gingivalis
Measured: At enrollment
progression of periodontitis
Measured: 12 and 24 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2012 (estimated)
- Study startSep 2012
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ankylosing SpondylitisStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yun Jong Lee, Seoul National University Bundang Hospital
- Investigators
- Yun Jong Lee, M.D., Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01750528
- Sponsor's protocol ID
- IMM 12-0004
- Other IDs
- IMM 12-0004
- Status last verified
- Jun 2014
- First submitted
- 5 Sep 2012
- Last updated
- 10 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 19126560Kang 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.
PubMed 26291296
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence and the Progression of Periodontitis in Ankylosing Spondylitis (AS) Patients Versus Non-AS Population
- ClinicalTrials.gov ID
- NCT01750528
- Acronym / sponsor ID
- IMM 12-0004
- Conditions
- Ankylosing Spondylitis, Periodontitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 17 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
- 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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
prevalence rate of periodontitis
Time frame: At enrollment
2 secondary outcomes
carriage rate of P. gingivalis
Time frame: At enrollment
progression of periodontitis
Time frame: 12 and 24 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2014.
- Background: PubMed 19126560Pischon 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.
- Derived from this study: PubMed 26291296Kang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yun Jong Lee, M.D. principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankylosing Spondylitis and Periodontitis, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence rate of periodontitis (time frame: At enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01750528, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2014.