Periodontitis and ACPA positive Arthralgia*s; a link by protein citrullinatio

Completed

• Conditions: parodontitis; RA risk group or pre-RA group; 10003816; 10004018

• Registration Number: NL-OMON35274
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

Patients who are ACPA and or RF positive and who have arthralgia*s, aged > 18 years.

Exclusion Criteria

Fullfilling ACR criteria for RA.
Exclusion criteria (according to the SENIEUR protocol 1984)
1. Infection other than periodontitis.
2. Inflammation other than periodontitis (RA, Crohn*s disease, collagen-vascular diseases).
3. Malignancy, past or present.
4. Other conditions which influence the immune system: diabetes, active thyroid disease, myocardial infarction, stroke or recanalisation of the femoral arteries for claudication <6 months prior to the study.
5. Pregnancy including a 6-months post-partum period as well as breastfeeding.
6. Malnutrition.
7. Alcoholism and drug abuse.
8. Pharmacological interference: prescribed medication for the treatment of a defined disease, use of corticosteroids >10mg/day, antibiotic use during 3 months prior to the study.
9. Periodontal treatment prior to the study.
10. Edentulism.

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Clinical parameters:<br /><br>Disease Activity Score 28 joint count (DAS28 and DAS44)<br /><br>Periodontitis: Periodontal Inflamed Surface Area (PISA (Nesse et al. 2008) and<br /><br>extent of alveolar bone loss measured on an panoramic radiograph.<br /><br>Biomarkers: ACPA titer and anti-Pg titer </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Leukocyte count, CRP and ESR.<br /><br>Presence of citrullinated proteins, ACPA and expression of PAD-2 and -4 enzymes<br /><br>in GCF, SF and tissue, cell types present in tissue.<br /><br>Presence of P. gingivalis in subgingival plaque.<br /><br>Presence of HLA-DRB1* shared epitope (SE) alleles.<br /><br>Lymphocyte subsets with an emphasis on CD161 staining </p><br>