The contribution of inflamed gums to rheumatoid arthritis

Not Applicable

Completed

• Conditions: PeriodontitisRheumatoid Arthritis; Musculoskeletal Diseases; 1. Periodontitis2. Rheumatoid Arthritis

• Registration Number: ISRCTN17950307
• Lead Sponsor: Coimbra Rheumatology Association (ARCo)

Brief Summary

2024 Results article in https://pubmed.ncbi.nlm.nih.gov/39002123/ (added 16/07/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-14
• Study Completion: 2020-07-01
• Last Update Posted: 29 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

1. 18-70 years old
2. RA diagnosis according to ACR/EULAR 2010 criteria
3. Capable of understanding the study protocol and willing to provide informed consent for clinical evaluation.
4. DAS28 PCR = 3,1 (with no change in medication, dose, or formulation in RA treatment during the 3 months preceding Phase 1 periodontal evaluation and 32 weeks after)
5. Presence of at least six natural teeth
6. Moderate to Severe CP diagnosis (Clinical Attachment Level > 3mm)
7. Available for all study visits over 32 weeks

Exclusion Criteria

1. Pregnant or breastfeeding
2. Smoking habits (past or current)
4. Chronic respiratory disease that could lead to a present state of respiratory insufficiency
5. Presence of other conditions associated with increased CRP, namely:
5.1. Other inflammatory rheumatic diseases other than RA.
5.2. Other active inflammatory diseases (IBD, chronic infections, etc.)
5.3. Current/actual neoplastic diagnosis/treatment
6. History of infection/ antibiotic therapy within the preceding 4 weeks
7. History of periodontal therapy 6 months prior to the examination;
8. Planned hospitalization for pre-existing condition apart from RA within 32 weeks after Phase 1 periodontal evaluation
9. Hypersensitivity to chlorhexidine digluconate.
10. Contraindications to dental local anesthetic.
11. Current and past (last 6 months) participation in another intervention study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CRP levels measured using blood sample analysis at baseline, 8weeks, 24 weeks

Secondary Outcome Measures

Name	Time	Method
1. Periodontal and joint clinical parameters measured using medical evaluation at baseline, 8weeks, 24 weeks<br>2. Subgingival bacterial plaque: quantification of several known pathogens RT-PCR (P. gingivalis, T. forsythensis, T. denticola, P. intermedia, A.a. and F. Nucleatum) measured using laboratorial analysis (RT-PCR) of collected subgingival bacterial plaque at baseline, 8weeks, 24 weeks<br>3. Antibodies anti-citrullinated proteins measured using blood sample analysis at baseline, 8weeks, 24 weeks<br>4. Serum Cytokines (pro and anti-inflammatory) measured using blood sample analysis at baseline, 8weeks, 24 weeks