Status:
COMPLETED
Therapeutic Management of Periodontitis and Clinical Manifestations of Rheumatoid Arthritis
Lead Sponsor:
University Hospital, Toulouse
Conditions:
Periodontitis
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Although RA pathomechanisms remains incompletely understood, periodontitis and RA share pathogenic features : genetic and environmental influences, chronic inflammatory disease, immunoregulatory imbal...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- rheumatoid arthritis diagnosed for at least one year
- DAS28 score between 3.2 and 5.1
- no change to medication, dosage or formulation in RA treatment during the 3 months preceding the screening visit
- subject available for all study visits over three months in the Dental Care Departments (V1 to V4)
- subjects with at least six natural teeth with root
- 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.
- subject has given his informed consent: 1 week cooling-off period
- EXCLUSION CRITERIA:
- subject will not qualify for enrolment if he presents at least one of the following: 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
- have a planned hospitalization within 4 months after the screening visit
- subject suffering from one or more known infectious diseases (HIV, hepatitis, infectious mononucleosis),
- subject suffering from known clinically significant renal disease (creatinine clearance \<60 ml/min), or liver disease,
- unbalanced diabetes
- have a known risk of endocarditis,
- have a permanent pacemaker,
- subject taking antithrombotic treatment,
- subject having severe difficulties in understanding written and spoken French
- for females: are pregnant or intending to become pregnant, or lactating
- subject suffering from a chronic disorder that requires chronic or intermittent use of antibiotics,
- subject having known hypersensitivity to chlorhexidine gluconate
- are participating in another intervention study
- have known contraindications to both amoxicillin and clindamycin
- have known contraindications to dental local anesthetic.
Exclusion
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT02779179
Start Date
November 1 2010
End Date
November 1 2016
Last Update
December 10 2025
Active Locations (2)
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1
CHU de Bordeaux
Bordeaux, France, 33000
2
Pôle Odontologie Hôpital Purpan - Pavillon Rayer
Toulouse, France, 31059