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 ]

Gain or loss obtained by periodontal probing.


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