Experimental study of periodontitis and rheumatoid arthritis

Not Applicable

Completed

• Conditions: Musculoskeletal Diseases; Rheumatoid arthritis and periodontitis; Rheumatoid arthritis, unspecified and chronic periodontitis

• Registration Number: ISRCTN79186420
• Lead Sponsor: niversity Hospital of Toulouse (CHU de Toulouse) (France)

Brief Summary

2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23945051 2019 results in https://pubmed.ncbi.nlm.nih.gov/30822490/ (added 19/02/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-03-20
• Study Completion: 2013-06-30
• Last Update Posted: 1 March 2021

Recruitment & Eligibility

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

Inclusion Criteria

1. Male or female, aged 18 years or older
2. Rheumatoid arthritis diagnosed since at least one year
3. Disease Activity Score (DAS 28) score between 3.2 and 5.1
4. No change to medication, dosage or formulation in RA treatment during the 3 months before the inclusion visit
5. At least six natural teeth with root
6. Subject with periodontitis, defined by the presence of one site with periodontal probing depth = 4 mm and clinical attachment level = 3 mm on at least 4 teeth
7. Subject able to understand and willing to provide written informed consent in French
8. Subject affiliated to the security system

Exclusion Criteria

1. Acute oral infection, acute oral pain (including pulpitis), suspicious oral mucosal lesion, severe oral inflammation unrelated to periodontal conditions, or need for immediate tooth extractions
2. Planned hospitalization within 4 months after the screening visit
3. One or more known infectious diseases [Human immunodeficiency virus(HIV), hepatitis, infectious mononucleosis]
4. Known clinically significant renal disease (creatinine clearance <60 ml/min), or liver disease
5. Unbalanced diabetes
6. Known risk of endocarditis
7. Have a permanent pacemaker
8. Antithrombotic treatment
9. Severe difficulties in understanding written and spoken French
10. Pregnant, lactating, or plans to become pregnant during the study
11. Chronic disorder that requires chronic or intermittent use of antibiotics
12. Hypersensitivity to chlorhexidine gluconate
13. Participation in another study with an investigational compound
14. Contraindications to both amoxicillin and clindamycin
15. Contraindications to dental local anesthetic

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference between 3-month and baseline DAS 28 scores

Secondary Outcome Measures

Name	Time	Method
<br> Difference between 3-month and baseline values of the following:<br> 1. American College of Rheumatology (ACR) scores<br> 2. Health Assessment Questionnaire (HAQ) scores<br> 3. General Oral Health Assessment Index (GOHAI) scores<br> 4. Periodontal Inflamed Surface Area (PISA)<br>