Rheumatoid Arthritis | Full Mouth Disinfection and Antibiotics for Periodontitis in High or Moderate Disease Activity Rheumatoid Arthritis
Rheumatoid Arthritis research study
What is the primary objective of this study?
The purpose of this study is to determine whether full mouth disinfection in combination with one week antibiotic amoxicillin plus metronidazole antibiotic therapy is improving periodontitis and disease activity of rheumatoid arthritis.
Who is eligible to participate?
Inclusion Criteria: - Written informed consent - Age 18 years or older - Diagnosis of rheumatoid arthritis according to the ACR/EULAR 2010 classification criteria plus both serological, high titer (>3x ULN) rheumatoid factor and CCP antibody titer - Severe chronic periodontitis (clinical attachment loss >/= 5mm at two separate locations) - DAS 28 > 4.2 at screening and inclusion (within 28 days after screening) and 1 out of two additional disease activity criteria: 1. Synovial hyperplasia >22/66 points on basis of 22 joints, or at least 1/3 of the maximum score when analyzes in at least selected 5 joints of interest OR 2. Serum CRP > 10 mg/l at screening and at inclusion - Stable doses for >=3 months, if currently under synthetic or recombinant disease modifying anti-rheumatic drugs. If under anti-CD20 treatment: last rituximab infusion >90 days before inclusion. - Systemic corticosteroids <= 10 mg and stable for at least 14 days - Nonsteroidal-antirheumatic drugs and peripheral analgesics at stable doses for at least 14 days Exclusion Criteria: - Intolerance to amoxicillin und azithromycin (EBV infection, lymphatic leukemia, exanthema), general hypersensitivity to any beta-lactam antibiotics, intolerance to metronidazole or local anaesthesia - Current intake of allopurinol or probenicid, oral anticoagulation, disulfiram, phenobarbital phenytoin, lithium or ciclosporin - Seizures - Severe cardial electric conduction blockade - Recent myocardial infraction or instable coronary vessel disease, non-compensated myocardial insufficiency or heart failure - Non-compensated arterial hypertension - Genetic cholinesterase deficiency - General hemorrhagic diathesis or intake of oral anticoagulants - Intake of monoaminooxidase inhibitors or tricyclic antidepressants - Liver insufficiency - Renal failure (eGFR < 30 ml/min) - Hemoglobin <10 g/dl - Leukocytes < 3/nl - Neutrophils < 1/nl - Platelets < 100/nl - ALAT oder ASAT > 3x ULN - Pregnancy or breastfeeding - Psychiatric or any other condition which could, to the opinion of the investigator, interfere with the compliance of this protocol
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: February 2014
Completed Date: October 25, 2017
Primary Outcome: Improvement in the rheumatoid arthritis disease activity index (DAS28ESR-3v) by >=1.2 points
Secondary Outcome: Improvement in the rheumatoid arthritis disease activity score (DAS28ESR-3v) by >=1.2 points
Study sponsors, principal investigator, and references
Principal Investigator: Burkhard Möller, MD
Lead Sponsor: University Hospital Inselspital, Berne
Collaborator: University of Bern
Aimetti M, Romano F, Guzzi N, Carnevale G. Full-mouth disinfection and systemic antimicrobial therapy in generalized aggressive periodontitis: a randomized, placebo-controlled trial. J Clin Periodontol. 2012 Mar;39(3):284-94. doi: 10.1111/j.1600-051X.2011.01795.x. Epub 2012 Jan 4.