Relationship of Periodontitis and Cardiovascular Risk in Patients With Rheumatoid Arthritis
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| ClinicalTrials.gov Identifier: NCT03506165 |
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Recruitment Status :
Enrolling by invitation
First Posted : April 24, 2018
Last Update Posted : July 24, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Rheumatoid Arthritis Periodontitis | Combination Product: Periodontal treatment | Not Applicable |
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 : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 100 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Other |
| Official Title: | Relationship of Periodontitis to Subclinical Atherosclerosis and Long Term Cardiovascular Risk in Patients With Rheumatoid Arthritis |
| Actual Study Start Date : | April 1, 2019 |
| Estimated Primary Completion Date : | May 2021 |
| Estimated Study Completion Date : | September 2021 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Rheumatoid Arthritis with Periodontitis
Rheumatoid Arthritis patients with Periodontitis diagnosed after oral examination then treated with Periodontal treatment
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Combination Product: Periodontal treatment
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
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- 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
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03506165
| Egypt | |
| Assiut university hospitals | |
| Assiut, Egypt | |
| Principal Investigator: | Salah | Assiut University |
| Responsible Party: | Shaimaa Salah, principal Investigator, Assiut University |
| ClinicalTrials.gov Identifier: | NCT03506165 |
| Other Study ID Numbers: |
17200186 |
| First Posted: | April 24, 2018 Key Record Dates |
| Last Update Posted: | July 24, 2020 |
| Last Verified: | July 2020 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Arthritis Arthritis, Rheumatoid Periodontitis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |
Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Periodontal Diseases Mouth Diseases Stomatognathic Diseases |