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

Rheumatoid Arthritis Clinical Trial

Official title:

Association Between Severity of Periodontitis and the Level of Anti-citrullinated Protein Antibodies (ACPAs) in Rheumatoid Arthritis Patients Before and After Non-surgical Periodontal Treatment (Pre and Post Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05706493
• Other study ID #: PER 3312007
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: August 2025

Study information

• Verified date: January 2024
• Source: Misr International University
• Contact: Zainab Hafez, Lecturer
• Phone: +01221334637
• Email: zeinab.hafez[@]miuegypt.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Periodontal Diseases
• Periodontitis
• Rheumatoid Arthritis

Intervention

Other:
• Non surgical periodontal treatment
Non-surgical periodontal treatment will be performed using ultrasonic scaler and subgingival curettes

Locations

Country	Name	City	State
Egypt	Faculty of oral and dental medicine, Misr international university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Misr International University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the level of anti-citrullinated protein antibodies (ACPAs)	assessment of the level of anti-citrullinated protein antibodies (ACPAs) in gingival crevicular fluid	at baseline and 3 months
Secondary	Change in Clinical attachment Loss	measuring the distance from the cemento enamel junction to the base of the pocket in mm	at baseline and 3 months
Secondary	Change in Probing depth	measuring the distance from the gingival margin to the base of the pocket in mm	at baseline and 3 months
Secondary	Change in Plaque index (PI)	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