Relationship of Periodontitis and Cardiovascular Risk in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

Relationship of Periodontitis to Subclinical Atherosclerosis and Long Term Cardiovascular Risk in Patients With Rheumatoid Arthritis

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03506165
• Other study ID #: 17200186
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: September 2021

Study information

• Verified date: July 2020
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Rheumatoid arthritis (RA) is one of the most common autoimmune inflammatory arthritis affecting 0.5 to 1% population worldwide characterized by synovitis, increased inflammatory markers and progressive bone and cartilage erosion. RA is associated with an increased cardiovascular morbidity and mortality compared with the general population.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: September 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Periodontitis
• Rheumatoid Arthritis

Intervention

Combination Product:
• Periodontal treatment
oral hygiene instructions, periodontal debridement and removal of other etiologic factors

Locations

Country	Name	City	State
Egypt	Assiut university hospitals	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (11)

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, Ménard HA, Moreland LW, Naden RL, Pincus T, Smolen JS, Stanislawska-Biernat E, Symmons D, Tak PP, Upchurch KS, Vencovský 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. — View Citation

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. Review. — View Citation

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. — View Citation

Gibofsky A. Epidemiology, pathophysiology, and diagnosis of rheumatoid arthritis: A Synopsis. Am J Manag Care. 2014 May;20(7 Suppl):S128-35. — View Citation

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. Epub 2007 May 21. — View Citation

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. — View Citation

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. Review. — View Citation

Liljestrand JM, Paju S, Pietiäinen M, Buhlin K, Persson GR, Nieminen MS, Sinisalo J, Mäntylä 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. — View Citation

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. — View Citation

Pischon N, Pischon T, Kröger J, Gülmez 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 . — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Framingham risk score Low (<10%), Moderate (11-19%) and high risk (>20).	Examine if there is association between periodontitis with cardiovascular disease risk in patients with RA	30 minute