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

NCT05706493 | Completed DMC

• 1 other identifier: PER 3312007
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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

Conditions

Periodontal Diseases; Rheumatoid Arthritis

Keywords

periodontitis; rheumatoid arthritis; anti citrullinated protein antibodies; peptidyl arginine deminase enzyme; gingival crevicular fluid (GCF)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in Clinical attachment Loss

  at baseline and 3 months

• Change in Probing depth

  at baseline and 3 months

• Change in Plaque index (PI)

  at baseline and 3 months

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Rheumatoid patients

You may qualify if:

• Rheumatoid patients fulfilling the ACR criteria for the classification of RA
• years
• Both genders
• Presence of at least 8 teeth

You may not qualify if:

• Smoking
• Diabetes Mellitus
• Pregnant females
• Patients who had undergone periodontal treatment within last 3 months
• Antibiotic therapy during last 3 months
• Other autoimmune diseases

Sponsors & Collaborators

• Misr International University: lead

Study Sites (1)

Faculty of oral and dental medicine, Misr international university

Cairo, 12345, Egypt

Location

MeSH Terms

Conditions

Periodontal Diseases; Arthritis, Rheumatoid; Periodontitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Shahinaz Al ashiry, asso.Prof

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

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 4 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2023
• First Posted: January 31, 2023
• Study Start: March 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: February 1, 2025
• Last Updated: January 13, 2026

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)