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NCT Number: NCT05706493

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

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

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Key information

Conditions

Periodontal Diseases Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Mouth Diseases Musculoskeletal Diseases Periodontitis Rheumatic Diseases Rheumatoid Arthritis Skin and Connective Tissue Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of oral and dental medicine, Misr international university

Cairo, 12345, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Clinical attachment Loss

    Time frame: Baseline

    measuring the distance from the cemento enamel junction to the base of the pocket in mm

  2. Probing depth

    Time frame: Baseline

    measuring the distance from the gingival margin to the base of the pocket in mm

Sponsors and collaborators

Lead sponsor

Misr International University

Other

Registry information

Official study title

Association Between Severity of Periodontitis and the Level of Anti-citrullinated Protein Antibodies (ACPAs) in Rheumatoid Arthritis Patients

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 31, 2023
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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