Efficacy of therapeutic management of periodontitis on the clinical manifestations of rheumatoid arthritis: a randomized controlled trial

niversity Hospital of Toulouse (CHU de Toulouse) (France)0 个研究点目标入组 22 人开始时间: 2012年3月20日最近更新: 2021年3月1日

适应症

试验速览

•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

•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

发起方

niversity Hospital of Toulouse (CHU de Toulouse) (France)