Therapeutic Management of Periodontitis and Clinical Manifestations of Rheumatoid Arthritis (ESPERA)
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|ClinicalTrials.gov Identifier: NCT02779179|
Recruitment Status : Recruiting
First Posted : May 20, 2016
Last Update Posted : February 23, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Periodontitis Rheumatoid Arthritis||Procedure: Periodontal treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy of Therapeutic Management of Periodontitis on the Clinical Manifestations of Rheumatoid Arthritis: the Randomized, Controlled ESPERA Trial.|
|Study Start Date :||November 2010|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
|Experimental: Immediate Periodontal treatment group||
Procedure: Periodontal treatment
|Active Comparator: Delayed Periodontal treatment Group||
Procedure: Periodontal treatment
- Evaluation of parodontitis therapeutic care as assessed by variation in DAS28 score [ Time Frame: Day 15 and day 90 ]
- Evaluation of parodontitis therapeutic care as assessed by variation in ACR 20 score [ Time Frame: Day 15 and day 90 ]
- Evaluation of parodontitis therapeutic care as assessed by variation in HAQ score [ Time Frame: Day 15 and day 90 ]
- Evaluation of parodontitis therapeutic care as assessed by variation in GOHAI score [ Time Frame: Day 15 and day 90 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02779179
|Contact: Paul MONSARRAT, MD||126.96.36.199.55 ext +email@example.com|
|Contact: Jean-Noël VERGNES, MD||6 98 000 314. ext +firstname.lastname@example.org|
|CHU de Bordeaux||Recruiting|
|Bordeaux, France, 33000|
|Contact: Elise ARRIVE, MD 6 62 83 66 58 ext +33 email@example.com|
|Pôle Odontologie Hôpital Purpan - Pavillon Rayer||Recruiting|
|Toulouse, France, 31059|
|Contact: Paul MONSARRAT, MD 188.8.131.52.55 ext +33 firstname.lastname@example.org|
|Contact: Jean-Noël VERGNES, MD 6 98 000 314. ext +33 email@example.com|
|Principal Investigator:||Paul MONSARRAT, MD||Faculté de chirurgie dentaire - Toulouse|