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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-A01193-36 | Registry Identifier | National Agency of Drug Safety and Health Products |
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Although RA pathomechanisms remains incompletely understood, periodontitis and RA share pathogenic features : genetic and environmental influences, chronic inflammatory disease, immunoregulatory imbalance, bacterial factors, persistence of antigen/peptide and clinical factors (conjunctive and hard tissues destruction). Several hypothesis can be evocated : Gram negative bacterial systemic spreading, inflammatory transmitter substance systemic spreading (IL1, IL6, IL17, PGE2), systemic spreading of bacterial degradation products (LPS for example).
Currently Porphyromonas gingivalis (PG) might be a susceptibility factor to RA because PG has an enzyme, the peptidylarginine deiminase leading to auto antibodies creation and RA increasing. As periodontitis, RA is chronic disease with a cyclic increase evolution, needing a complex pluridisciplinary treatment approach. Recent studies have reported an increased prevalence of RA patients with periodontal disease. Others studies show that periodontal treatment induces a significant decrease of the sedimentation rate and of the DAS28. Periodontitis is suspected to be an independent, aggravating factor in patients with RA (given the definition from NIH : an aggravating factor is something that makes a condition worse). So periodontal treatment cannot be considered as a RA treatment per se. But it is hypothesised that treating periodontitis in RA patients showing signs of periodontitis could result in improvement in RA disease activity. To date the role of periodontitis as an aggravating factor in these patients remains unclear, and only RCT designs can reasonably be used to test this causal hypothesis. There still remains some RA patients who have persistent symptoms and frequent exacerbations despite specialist care and continuous treatment, so results of treating aggravating factors are needed. As the majority of patients will benefit from a systematic evaluation and treatment of aggravating factors, the periodontal treatment strategy need to be tested.
The aim of this randomised controlled trial is to assess the effectiveness of periodontal treatment for rheumatoid arthritis patients.
To assess the effectiveness of periodontal treatment to reduce the severity of rheumatoid arthritis (RA), in patients suffering from both periodontitis and rheumatoid arthritis. The hypothesis is that periodontal treatment reduce the severity of rheumatoid arthritis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate Periodontal treatment group | Experimental |
| |
| Delayed Periodontal treatment Group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Periodontal treatment | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of parodontitis therapeutic care as assessed by variation in DAS28 score | Day 15 and day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of parodontitis therapeutic care as assessed by variation in ACR 20 score | Day 15 and day 90 | |
| Evaluation of parodontitis therapeutic care as assessed by variation in HAQ score | Day 15 and day 90 |
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INCLUSION CRITERIA:
EXCLUSION CRITERIA:
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| Name | Affiliation | Role |
|---|---|---|
| Paul MONSARRAT, MD | Faculté de chirurgie dentaire - Toulouse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Bordeaux | Bordeaux | 33000 | France | |||
| Pôle Odontologie Hôpital Purpan - Pavillon Rayer |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23945051 | Result | Monsarrat P, Vergnes JN, Cantagrel A, Algans N, Cousty S, Kemoun P, Bertrand C, Arrive E, Bou C, Sedarat C, Schaeverbeke T, Nabet C, Sixou M. Effect of periodontal treatment on the clinical parameters of patients with rheumatoid arthritis: study protocol of the randomized, controlled ESPERA trial. Trials. 2013 Aug 14;14:253. doi: 10.1186/1745-6215-14-253. | |
| 30822490 |
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D001168 | Arthritis |
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| ID | Term |
|---|---|
| D010512 | Periodontal Index |
| ID | Term |
|---|---|
| D003753 | Dental Health Surveys |
| D006306 | Health Surveys |
| D011795 | Surveys and Questionnaires |
| D003625 | Data Collection |
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|
| Evaluation of parodontitis therapeutic care as assessed by variation in GOHAI score | Day 15 and day 90 |
| Toulouse |
| 31059 |
| France |
| Monsarrat P, Fernandez de Grado G, Constantin A, Willmann C, Nabet C, Sixou M, Cantagrel A, Barnetche T, Mehsen-Cetre N, Schaeverbeke T, Arrive E, Vergnes JN; ESPERA Group. The effect of periodontal treatment on patients with rheumatoid arthritis: The ESPERA randomised controlled trial. Joint Bone Spine. 2019 Oct;86(5):600-609. doi: 10.1016/j.jbspin.2019.02.006. Epub 2019 Feb 26. |
| D007592 |
| Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D004812 |
| Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D003813 | Dentistry |
| D010517 | Periodontics |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D011636 | Public Health Dentistry |