A Phase 4 interventional study of oral exam and in Rheumatoid Arthritis and Periodontitis, sponsored by Nantes University Hospital. Terminated at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-11-03.
Sponsored by Nantes University Hospital · Phase 4, Interventional, and Prevention
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
To date, very few studies have been conducted on this subject which is really a translational research, involving several medical specialties.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 16 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →Nantes University Hospital is the lead sponsor of 825 studies on the registry; 195 are open to participants now.
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Exclusion Criteria:
Patient with rheumatoid arthritis and pparodontitis.
Other: oral exam and
Patient with rheumatoid arthritis but periodontally healthy
Other: oral exam and
The study will be conducted with patient presenting a rheumatoid arthritis and for which an anti IL6 biotherapy treatment is planned. Each patient will benefit a record oral exam that will evaluate his periodontal status and on a possible periodontitis associated. Bacterial samples and cytokine will be realized (in defined periodontal pocket or in the most affected periodontal pocket depending of the periodontal status of patients) before the IL6 biotherapy and 6 month after. A periodontal charting will be realized at the same time.
Clinical attachment level
Gain or loss obtained by periodontal probing.
Time frame: 6 month
Detection of periodontopathogenic germs
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.
Time frame: 6 month
Quantification of periodontopathogenic germs
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.
Time frame: 6 month
Detection of inflammation markers in the gingival fluid
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.
Time frame: 6 month
Quantification of inflammation markers in the gingival fluid
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.
Time frame: 6 month
Assessment of inflammation
Assessment of inflammation through Bleeding On Probing
Time frame: 6 month
Assessment of oral hygiene level
Assessment of oral hygiene level with plaque Index
Time frame: 6 month
This study is terminated, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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Nantes University Hospital