Consequences of Anti-interleukin 6 Immunotherapy Treatment for Rheumatoid Arthritis on Periodontium
- Conditions
- PeriodontitisRheumatoid Arthritis
- Interventions
- Other: oral exam and
- Registration Number
- NCT01806974
- Lead Sponsor
- Nantes University Hospital
- 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 Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 16
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description patient with parodontitis oral exam and Patient with rheumatoid arthritis and pparodontitis. Patient without parodontitis oral exam and Patient with rheumatoid arthritis but periodontally healthy
- Primary Outcome Measures
Name Time Method Clinical attachment level 6 month Gain or loss obtained by periodontal probing.
- Secondary Outcome Measures
Name Time Method 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.
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.
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
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.
Trial Locations
- Locations (2)
Brest University Hospital
🇫🇷Brest, France
Nantes University Hospital
🇫🇷Nantes, France