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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
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Brief Summary:

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Immediate Periodontal treatment group Procedure: Periodontal treatment
  • Mechanical debridement (scaling, root planning, subgingival curettage)
  • Antimicrobial therapy (systematically administered: amoxicillin or clindamycin).
  • Antiseptic mouthrinses, gel or dentifrice
  • Oral hygiene instructions (to educate and motivate patients to control the accumulation of plaque and calculus)

Active Comparator: Delayed Periodontal treatment Group Procedure: Periodontal treatment
  • Mechanical debridement (scaling, root planning, subgingival curettage)
  • Antimicrobial therapy (systematically administered: amoxicillin or clindamycin).
  • Antiseptic mouthrinses, gel or dentifrice
  • Oral hygiene instructions (to educate and motivate patients to control the accumulation of plaque and calculus)




Primary Outcome Measures :
  1. Evaluation of parodontitis therapeutic care as assessed by variation in DAS28 score [ Time Frame: Day 15 and day 90 ]

Secondary Outcome Measures :
  1. Evaluation of parodontitis therapeutic care as assessed by variation in ACR 20 score [ Time Frame: Day 15 and day 90 ]
  2. Evaluation of parodontitis therapeutic care as assessed by variation in HAQ score [ Time Frame: Day 15 and day 90 ]
  3. Evaluation of parodontitis therapeutic care as assessed by variation in GOHAI score [ Time Frame: Day 15 and day 90 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA:

  • rheumatoid arthritis diagnosed for at least one year
  • DAS28 score between 3.2 and 5.1
  • no change to medication, dosage or formulation in RA treatment during the 3 months preceding the screening visit
  • subject available for all study visits over three months in the Dental Care Departments (V1 to V4)
  • subjects with at least six natural teeth with root
  • subject with periodontitis, defined by the presence of one site with periodontal probing depth ≥ 4 mm and clinical attachment level ≥ 3 mm on at least 4 teeth.
  • subject has given his informed consent: 1 week cooling-off period

EXCLUSION CRITERIA:

  • subject will not qualify for enrolment if he presents at least one of the following: acute oral infection, acute oral pain (including pulpitis), suspicious oral mucosal lesion, severe oral inflammation unrelated to periodontal conditions, or need for immediate tooth extractions
  • have a planned hospitalization within 4 months after the screening visit
  • subject suffering from one or more known infectious diseases (HIV, hepatitis, infectious mononucleosis),
  • subject suffering from known clinically significant renal disease (creatinine clearance <60 ml/min), or liver disease,
  • unbalanced diabetes
  • have a known risk of endocarditis,
  • have a permanent pacemaker,
  • subject taking antithrombotic treatment,
  • subject having severe difficulties in understanding written and spoken French
  • for females: are pregnant or intending to become pregnant, or lactating
  • subject suffering from a chronic disorder that requires chronic or intermittent use of antibiotics,
  • subject having known hypersensitivity to chlorhexidine gluconate
  • are participating in another intervention study
  • have known contraindications to both amoxicillin and clindamycin
  • have known contraindications to dental local anesthetic.

Information from the National Library of Medicine

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


Contacts
Contact: Paul MONSARRAT, MD 6.98.47.53.55 ext +33 paul.monsarrat@gmail.com
Contact: Jean-Noël VERGNES, MD 6 98 000 314. ext +33 vergnes.jn@chu-toulouse.fr

Locations
France
CHU de Bordeaux Recruiting
Bordeaux, France, 33000
Contact: Elise ARRIVE, MD    6 62 83 66 58 ext +33    elise.arrive@isped.u-bordeaux2.fr   
Pôle Odontologie Hôpital Purpan - Pavillon Rayer Recruiting
Toulouse, France, 31059
Contact: Paul MONSARRAT, MD    6.98.47.53.55 ext +33    paul.monsarrat@gmail.com   
Contact: Jean-Noël VERGNES, MD    6 98 000 314. ext +33    vergnes.jn@chu-toulouse.fr   
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: Paul MONSARRAT, MD Faculté de chirurgie dentaire - Toulouse

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02779179     History of Changes
Other Study ID Numbers: 10 046 08
2010-A01193-36 ( Registry Identifier: National Agency of Drug Safety and Health Products )
First Posted: May 20, 2016    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Arthritis
Arthritis, Rheumatoid
Periodontitis