Association Between Periodontitis and the Level of Anti-citrullinated Protein Antibodies in Rheumatoid Arthritis

NCT ID: NCT05706493

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 36 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2025-02-01

Brief Summary

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 before and after non-surgical periodontal treatment and the severity of periodontal disease and rheumatoid arthritis in rheumatoid arthritis (RA) patients

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 before and after non-surgical periodontal treatment and the severity of periodontal disease and rheumatoid arthritis in rheumatoid arthritis (RA) patients Materials and Methods: a total of 40 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 before performing periodontal therapy (baseline). Assessment of ACPAs will be quantified using enzyme-linked immunoassay (ELISA) as the primary outcome at baseline and after 3 months. Assessment of 2ry outcomes includes clinical periodontal and RA parameters at baseline and after 3 months.

Conditions

Periodontal Diseases; Rheumatoid Arthritis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Non-surgical periodontal treatment

assessment of different periodontal parameters and gingival crevicular fluid sampling will be done then non surgical periodontal treatment will be performed then after 3 months re assessment of the periodontal parameters and gingival crevicular fluid sampling will be done

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Misr International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zainab Hafez, Lecturer

Role: PRINCIPAL_INVESTIGATOR

Lecturer, faculty of oral and dental medicine misr international university

Yahia Hassan, Lecturer

Role: PRINCIPAL_INVESTIGATOR

Lecturer, faculty of oral and dental medicine misr international university

Shahinaz Al ashiry, asso.Prof

Role: STUDY_DIRECTOR

Associate Professor, faculty of oral and dental medicine misr international universit

Locations

Faculty of oral and dental medicine, Misr international university

Cairo, , Egypt

Countries

Egypt

Other Identifiers

PER 3312007

Identifier Type: -

Identifier Source: org_study_id