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as the recruitment rate was very low, a futility study was conducted and it was decided to discontinue inclusions
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patient with parodontitis | Other | Patient with rheumatoid arthritis and pparodontitis. |
|
| Patient without parodontitis | Other | Patient with rheumatoid arthritis but periodontally healthy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oral exam and | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical attachment level | Gain or loss obtained by periodontal probing. | 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 month |
| Quantification of periodontopathogenic germs |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Assem SOUEIDAN | Nantes UH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brest University Hospital | Brest | France | ||||
| Nantes University Hospital |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D010518 | Periodontitis |
| D007249 | Inflammation |
| D010514 | Periodontal Pocket |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D003945 | Diagnosis, Oral |
| ID | Term |
|---|---|
| D003813 | Dentistry |
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|
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. |
| 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. | 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. | 6 month |
| Assessment of inflammation | Assessment of inflammation through Bleeding On Probing | 6 month |
| Assessment of oral hygiene level | Assessment of oral hygiene level with plaque Index | 6 month |
| Nantes |
| France |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |