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

Not Applicable

Completed

• Conditions: Periodontal Diseases; Rheumatoid Arthritis
• Interventions: Other: Non surgical periodontal treatment

• Registration Number: NCT05706493
• Lead Sponsor: Misr International University

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.

Study Timeline

• Study First Submitted: 2023-01-23
• Study First Submitted QC: 2023-01-23
• Study First Posted: 2023-01-31
• Status Verified: 2024-01
• Study Start: 2024-03-01
• Primary Completion: 2025-01-01
• Study Completion: 2025-02-01
• Last Update Submitted: 2025-02-08
• Last Update Posted: 2025-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Non-surgical periodontal treatment	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

Primary Outcome Measures

Name	Time	Method
Change in the level of anti-citrullinated protein antibodies (ACPAs)	at baseline and 3 months	assessment of the level of anti-citrullinated protein antibodies (ACPAs) in gingival crevicular fluid

Secondary Outcome Measures

Name	Time	Method
Change in Clinical attachment Loss	at baseline and 3 months	measuring the distance from the cemento enamel junction to the base of the pocket in mm
Change in Plaque index (PI)	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
Change in Probing depth	at baseline and 3 months	measuring the distance from the gingival margin to the base of the pocket in mm

Trial Locations

Locations (1)

Faculty of oral and dental medicine, Misr international university; 🇪🇬 Cairo, Egypt