- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03506165
Relationship of Periodontitis and Cardiovascular Risk in Patients With Rheumatoid Arthritis
Relationship of Periodontitis to Subclinical Atherosclerosis and Long Term Cardiovascular Risk in Patients With Rheumatoid Arthritis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Although inflammation has been shown to contribute substantially to the development of cardiovascular diseases (CVDs) in patients with RA, there is also a high prevalence of traditional CVD-risk factors among these patients.
The elevated risk has been shown to be attributable to combination of both traditional risk factors hypertension, smoking, dyslipidemia and obesity and RA-specific factors rheumatoid factor (RF) positivity, rheumatoid factor (RF) positivity and Disease Activity Score including 28 joints (DAS28).
Periodontitis, a chronic inflammatory disease characterized by loss of the periodontal ligament and alveolar bone, is a major cause of tooth loss.
Periodontal diseases are highly prevalent and can affect up to 90% of the world population with varying degree of disease severity. The prevalence of periodontitis is higher in RA population compared to the healthy individuals.
Studies have reported increased periodontal tissue breakdown in RA patients, certain clinical and pathological similarities exist between both diseases. Pathogenic processes in RA, which is characterized by synovial inflammation and progressive destruction of cartilage and bone, are similar to those in periodontitis.
Periodontitis also has been linked to other diseases known to be associated (higher) with RA as diabetes, CVD, metabolic syndrome, some types of cancer.
Periodontitis is one of the major modifiable risk factor of CVD. Both periodontitis and CVD share common risk factors as smoking, diabetes mellitus, age, socioeconomic status, stress and obesity, which could result in confounding any association between them.
Studies revealed that periodontal treatment improves endothelial function and there was a longitudinal study evaluating the impact of periodontal treatment on c-IMT in people with mild/moderate periodontitis. 6 and 12 months following periodontal treatment, a statistically significant reduction in c-IMT compared to baseline measurements was reported. These associations emphasize the importance of oral health as a common under-recognized factor increasing CV risk.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Assiut, Egypt
- Assiut university hospitals
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- The study participants' will be diagnosed according to 2010 ACR/ EULAR classification criteria of rheumatoid arthritis
Exclusion Criteria:
- Participants with history of CVD event (myocardial infarction, coronary artery disease/reperfusion therapy, stroke, transient ischemic attack) in past or any patient experiencing cardiovascular revascularization surgery or the onset of cerebrovascular disorder within past 6 months or those with serious liver disease or renal disease will be excluded, as well.
Patients with overlap diseases will be excluded
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Rheumatoid Arthritis with Periodontitis
Rheumatoid Arthritis patients with Periodontitis diagnosed after oral examination then treated with Periodontal treatment
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oral hygiene instructions, periodontal debridement and removal of other etiologic factors
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No Intervention: Rheumatoid without Periodontitis
Rheumatoid Arthritis patients without Periodontitis diagnosed after oral examination with.
No interventions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Framingham risk score Low (<10%), Moderate (11-19%) and high risk (>20).
Time Frame: 30 minute
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Examine if there is association between periodontitis with cardiovascular disease risk in patients with RA
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30 minute
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Salah, Assiut University
Publications and helpful links
General Publications
- Solomon DH, Karlson EW, Rimm EB, Cannuscio CC, Mandl LA, Manson JE, Stampfer MJ, Curhan GC. Cardiovascular morbidity and mortality in women diagnosed with rheumatoid arthritis. Circulation. 2003 Mar 11;107(9):1303-7. doi: 10.1161/01.cir.0000054612.26458.b2.
- de Pablo P, Dietrich T, McAlindon TE. Association of periodontal disease and tooth loss with rheumatoid arthritis in the US population. J Rheumatol. 2008 Jan;35(1):70-6. Epub 2007 Nov 15.
- Aletaha D, Neogi T, Silman AJ, Funovits J, Felson DT, Bingham CO 3rd, Birnbaum NS, Burmester GR, Bykerk VP, Cohen MD, Combe B, Costenbader KH, Dougados M, Emery P, Ferraccioli G, Hazes JM, Hobbs K, Huizinga TW, Kavanaugh A, Kay J, Kvien TK, Laing T, Mease P, Menard HA, Moreland LW, Naden RL, Pincus T, Smolen JS, Stanislawska-Biernat E, Symmons D, Tak PP, Upchurch KS, Vencovsky J, Wolfe F, Hawker G. 2010 Rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Arthritis Rheum. 2010 Sep;62(9):2569-81. doi: 10.1002/art.27584.
- Piconi S, Trabattoni D, Luraghi C, Perilli E, Borelli M, Pacei M, Rizzardini G, Lattuada A, Bray DH, Catalano M, Sparaco A, Clerici M. Treatment of periodontal disease results in improvements in endothelial dysfunction and reduction of the carotid intima-media thickness. FASEB J. 2009 Apr;23(4):1196-204. doi: 10.1096/fj.08-119578. Epub 2008 Dec 12.
- Liljestrand JM, Paju S, Pietiainen M, Buhlin K, Persson GR, Nieminen MS, Sinisalo J, Mantyla P, Pussinen PJ. Immunologic burden links periodontitis to acute coronary syndrome. Atherosclerosis. 2018 Jan;268:177-184. doi: 10.1016/j.atherosclerosis.2017.12.007. Epub 2017 Dec 6.
- Gibofsky A. Epidemiology, pathophysiology, and diagnosis of rheumatoid arthritis: A Synopsis. Am J Manag Care. 2014 May;20(7 Suppl):S128-35.
- Hayashi H, Satoi K, Sato-Mito N, Kaburagi T, Yoshino H, Higaki M, Nishimoto K, Sato K. Nutritional status in relation to adipokines and oxidative stress is associated with disease activity in patients with rheumatoid arthritis. Nutrition. 2012 Nov-Dec;28(11-12):1109-14. doi: 10.1016/j.nut.2012.02.009.
- Gonzalez A, Maradit Kremers H, Crowson CS, Ballman KV, Roger VL, Jacobsen SJ, O'Fallon WM, Gabriel SE. Do cardiovascular risk factors confer the same risk for cardiovascular outcomes in rheumatoid arthritis patients as in non-rheumatoid arthritis patients? Ann Rheum Dis. 2008 Jan;67(1):64-9. doi: 10.1136/ard.2006.059980. Epub 2007 May 21.
- Kawar N, Gajendrareddy PK, Hart TC, Nouneh R, Maniar N, Alrayyes S. Periodontal disease for the primary care physician. Dis Mon. 2011 Apr;57(4):174-83. doi: 10.1016/j.disamonth.2011.03.003. No abstract available.
- Pischon N, Pischon T, Kroger J, Gulmez E, Kleber BM, Bernimoulin JP, Landau H, Brinkmann PG, Schlattmann P, Zernicke J, Buttgereit F, Detert J. Association among rheumatoid arthritis, oral hygiene, and periodontitis. J Periodontol. 2008 Jun;79(6):979-86. doi: 10.1902/jop.2008.070501.
- AlJehani YA. Risk factors of periodontal disease: review of the literature. Int J Dent. 2014;2014:182513. doi: 10.1155/2014/182513. Epub 2014 May 20.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17200186
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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