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Clinical Trials/NCT03506165
NCT03506165
Unknown
Not Applicable

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

Assiut University1 site in 1 country100 target enrollmentApril 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Rheumatoid Arthritis
Sponsor
Assiut University
Enrollment
100
Locations
1
Primary Endpoint
Framingham risk score Low (<10%), Moderate (11-19%) and high risk (>20).
Last Updated
5 years ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2019
End Date
September 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Shaimaa Salah

principal Investigator

Assiut University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Framingham risk score Low (<10%), Moderate (11-19%) and high risk (>20).

Time Frame: 30 minute

Examine if there is association between periodontitis with cardiovascular disease risk in patients with RA

Study Sites (1)

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