Periodontitis, Rheumatoid Arthritis
Conditions
Keywords
Periodontitis, rheumatoid arthritis, anti-interleukin 6, immunotherapy, inflammation, bacteria, periodontal sulci, periodontal pockets
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.
Interventions
OTHERoral 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.
Sponsors
Nantes University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical attachment level | 6 month | Gain or loss obtained by periodontal probing. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quantification of periodontopathogenic germs | 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 | 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. |
| Detection of periodontopathogenic germs | 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. |
| Assessment of inflammation | 6 month | Assessment of inflammation through Bleeding On Probing |
| Assessment of oral hygiene level | 6 month | Assessment of oral hygiene level with plaque Index |
| Quantification of inflammation markers in the gingival fluid | 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. |
Countries
France
Outcome results
None listed