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

January 11, 2026 updated by: Misr International University

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

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

Study Overview

Status

Completed

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 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.

Study Type

Observational

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 12345
        • Faculty of oral and dental medicine, Misr international university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Rheumatoid patients

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the level of anti-citrullinated protein antibodies (ACPAs)
Time Frame: at baseline and 3 months
assessment of the level of anti-citrullinated protein antibodies (ACPAs) in gingival crevicular fluid
at baseline and 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Clinical attachment Loss
Time Frame: at baseline and 3 months
measuring the distance from the cemento enamel junction to the base of the pocket in mm
at baseline and 3 months
Change in Probing depth
Time Frame: at baseline and 3 months
measuring the distance from the gingival margin to the base of the pocket in mm
at baseline and 3 months
Change in Plaque index (PI)
Time Frame: at baseline and 3 months
it is a score (0,1,2 and 3) where: 0 = No plaque in the gingival area. 1 = A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may only be recognized by running a probe across the tooth surface. 2 = Moderate accumulation of soft deposits within the gingival pocket, on the gingival margin and/or adjacent tooth surface, which can be seen by the naked eye. 3 = Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface
at baseline and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Misr International University

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Actual)

January 1, 2025

Study Completion (Actual)

February 1, 2025

Study Registration Dates

First Submitted

January 23, 2023

First Submitted That Met QC Criteria

January 23, 2023

First Posted (Actual)

January 31, 2023

Study Record Updates

Last Update Posted (Actual)

January 13, 2026

Last Update Submitted That Met QC Criteria

January 11, 2026

Last Verified

January 1, 2024

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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