Clinical Trial: Consequences of Anti-interleukin 6 Immunotherapy Treatment for Rheumatoid Arthritis on Periodontium
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: 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
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.
Detailed Summary:
Sponsor: Nantes University Hospital
Current Primary Outcome: Clinical attachment level [ Time Frame: 6 month ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Detection of periodontopathogenic germs [ Time Frame: 6 month ]Detection of periodontopathogenic germs by RT - PCR - Q wich the bacterial samples will be made at the outset of the study and 6 month after the beginning of anti IL6 treatment.
- Quantification of periodontopathogenic germs [ Time Frame: 6 month ]Quantification of periodontopathogenic germs by RT - PCR - Q wich the bacterial samples will be made at the outset of the study and 6 month after the beginning of anti IL6 treatment.
- Detection of inflammation markers in the gingival fluid [ Time Frame: 6 month ]Detection and quantification of inflammation markers in the gingival fluid : IL-1, IL-6, IL-8, IL-10, IL-12, IL-15, IL-17, TGF- beta, TNF-alpha, IL-4 et IFn-gamma.
- Quantification of inflammation markers in the gingival fluid [ Time Frame: 6 month ]Quantification of inflammation markers in the gingival fluid : IL-1, IL-6, IL-8, IL-10, IL-12, IL-15, IL-17, TGF- beta, TNF-alpha, IL-4 et IFn-gamma.
- Assessment of inflammation [ Time Frame: 6 month ]Assessment of inflammation through Bleeding On Probing
- Assessment of oral hygiene level [ Time Frame: 6 month ]Assessment of oral hygiene level with plaque Index
Original Secondary Outcome: Same as current
Information By: Nantes University Hospital
Dates:
Date Received: March 6, 2013
Date Started: December 2012
Date Completion:
Last Updated: November 2, 2015
Last Verified: November 2015