Multicenter, Prospective Study, on the Consequences of Anti-interleukin 6 Immunotherapy Treatment for Rheumatoid Arthritis on: - Healthy and Pathological Periodontium - The Level of Expression of Some Markers of Inflammation and Periodontal Pathogenic Bacteria in Periodontal Sulci and Periodontal Pockets
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Rheumatoid Arthritis
- Sponsor
- Nantes University Hospital
- Enrollment
- 16
- Locations
- 2
- Primary Endpoint
- Clinical attachment level
- Status
- Terminated
- Last Updated
- 10 years ago
Overview
Brief Summary
Rheumatoid arthritis and periodontitis are two inflammatory diseases that share many pathophysiological similarities as some inflammatory mediators like TNF-alpha, IL-1, Il-6, Il-17, Il-12 et Il-17, RANK-L, or OPG The most severe or progressive forms of rheumatoid arthritis require in 10-30% of cases, the use of biotherapies such as anti-TNF-alpha, anti CD-20 and anti-lL-6. All these treatments results in, among other things, an increased risk of infection, both viral and bacterial.
These new biotherapies could have an impact on periodontal status
- either by favouring sub gingival colonization of root surfaces by periodontal pathogenic bacteria and initiate periodontitis or exacerbate pre-existing periodontitis,
- or a positive modulation of the host response by inhibiting bone resorption of the alveolar process.
To date, very few studies have been conducted on this subject which is really a translational research, involving several medical specialties.
Investigators
Eligibility Criteria
Inclusion Criteria
- •patient over 18 years presenting a rheumatoid arthritis and for which an anti IL6 biotherapy treatment is prescribed.
- •At least 18 permanent teeth in the mouth at least 3 teeth with a healthy periodontal status
- •Having expressed their written free and informed consent
Exclusion Criteria
- •Hypersensitivity to any of the following components : tocilizumab, saccharose, polysorbate 80, phosphate disodique dodécahydrate, phosphate monosodique dehydrate
- •Severe or active infections
- •Systemic Pathology affecting the immune system including Sjögren's syndrome
- •Surgery in the previous month
- •HIV positive
- •Alcoholic
- •Toxicoman
- •Antibiotic treatment in the last 2 months
- •Legally protected patients
Outcomes
Primary Outcomes
Clinical attachment level
Time Frame: 6 month
Gain or loss obtained by periodontal probing.
Secondary Outcomes
- Quantification of periodontopathogenic germs(6 month)
- Quantification of inflammation markers in the gingival fluid(6 month)
- Detection of periodontopathogenic germs(6 month)
- Assessment of inflammation(6 month)
- Assessment of oral hygiene level(6 month)
- Detection of inflammation markers in the gingival fluid(6 month)