- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05706493
Association Between Periodontitis and the Level of Anti-citrullinated Protein Antibodies in Rheumatoid Arthritis
Association Between Severity of Periodontitis and the Level of Anti-citrullinated Protein Antibodies (ACPAs) in Rheumatoid Arthritis Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
the relationship between rheumatoid arthritis and periodontal disease is crucial and has been explained via a complex interplay of genetic, environmental, and hormonal factors that influence the host immune tolerance leading to both disease characteristics.
The aim of this study is to clinically investigate the correlation between the levels of anti-citrullinated protein antibodies (ACPAs) in gingival crevicular fluid and the severity of periodontal disease and rheumatoid arthritis in rheumatoid arthritis (RA) patients Materials and Methods: a total of 62 participants suffering from periodontitis and rheumatoid arthritis will be referred from the Badr Hospital (Faculty of Medicine, Helwan University) to Misr international university's dental clinic complex. Gingival crevicular fluid (GCF) samples will be collected from the patients . Assessment of ACPAs will be quantified using enzyme-linked immunoassay (ELISA) as the primary outcome Assessment of 2ry outcomes includes clinical periodontal and RA parameters
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Cairo, Egypt, 12345
- Faculty of oral and dental medicine, Misr international university
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Rheumatoid patients fulfilling the ACR criteria for the classification of RA
- 18 years
- Both genders
- Presence of at least 8 teeth
Exclusion Criteria:
- Smoking
- Diabetes Mellitus
- Pregnant females
- Patients who had undergone periodontal treatment within last 3 months
- Antibiotic therapy during last 3 months
- Other autoimmune diseases
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
rhematoid arthritis patients
assessment of different periodontal parameters and gingival crevicular fluid sampling will be done
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the level of anti-citrullinated protein antibodies (ACPAs)
Time Frame: Baseline
|
assessment of the level of anti-citrullinated protein antibodies (ACPAs) in gingival crevicular fluid
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical attachment Loss
Time Frame: Baseline
|
measuring the distance from the cemento enamel junction to the base of the pocket in mm
|
Baseline
|
|
Probing depth
Time Frame: Baseline
|
measuring the distance from the gingival margin to the base of the pocket in mm
|
Baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Zainab Hafez, Lecturer, Lecturer, faculty of oral and dental medicine misr international university
- Principal Investigator: Yahia Hassan, Lecturer, Lecturer, faculty of oral and dental medicine misr international university
- Study Director: Shahinaz Al ashiry, asso.Prof, Associate Professor, faculty of oral and dental medicine misr international universit
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PER 3312007
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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