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Relationship of Periodontitis and Cardiovascular Risk in Patients With Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis, Periodontitis

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Periodontal treatment
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Rheumatoid Arthritis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Assiut university hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Rheumatoid Arthritis with Periodontitis

Rheumatoid without Periodontitis

Arm Description

Rheumatoid Arthritis patients with Periodontitis diagnosed after oral examination then treated with Periodontal treatment

Rheumatoid Arthritis patients without Periodontitis diagnosed after oral examination with. No interventions

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 28, 2018
Last Updated
July 22, 2020
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT03506165
Brief Title
Relationship of Periodontitis and Cardiovascular Risk in Patients With Rheumatoid Arthritis
Official Title
Relationship of Periodontitis to Subclinical Atherosclerosis and Long Term Cardiovascular Risk in Patients With Rheumatoid Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
May 2021 (Anticipated)
Study Completion Date
September 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis, Periodontitis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rheumatoid Arthritis with Periodontitis
Arm Type
Experimental
Arm Description
Rheumatoid Arthritis patients with Periodontitis diagnosed after oral examination then treated with Periodontal treatment
Arm Title
Rheumatoid without Periodontitis
Arm Type
No Intervention
Arm Description
Rheumatoid Arthritis patients without Periodontitis diagnosed after oral examination with. No interventions
Intervention Type
Combination Product
Intervention Name(s)
Periodontal treatment
Intervention Description
oral hygiene instructions, periodontal debridement and removal of other etiologic factors
Primary Outcome Measure Information:
Title
Framingham risk score Low (<10%), Moderate (11-19%) and high risk (>20).
Description
Examine if there is association between periodontitis with cardiovascular disease risk in patients with RA
Time Frame
30 minute

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Salah
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assiut university hospitals
City
Assiut
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
20872595
Citation
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Results Reference
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25180621
Citation
Gibofsky A. Epidemiology, pathophysiology, and diagnosis of rheumatoid arthritis: A Synopsis. Am J Manag Care. 2014 May;20(7 Suppl):S128-35.
Results Reference
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PubMed Identifier
23044162
Citation
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Results Reference
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PubMed Identifier
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Citation
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Citation
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Citation
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Citation
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Citation
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Citation
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Citation
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Results Reference
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Relationship of Periodontitis and Cardiovascular Risk in Patients With Rheumatoid Arthritis

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