Therapeutic Management of Periodontitis and Clinical Manifestations of Rheumatoid Arthritis (ESPERA)

Efficacy of Therapeutic Management of Periodontitis on the Clinical Manifestations of Rheumatoid Arthritis: the Randomized, Controlled ESPERA Trial.

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.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis; Periodontitis
• Intervention / Treatment: Procedure: Periodontal treatment

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33000
    • CHU de Bordeaux
  • Toulouse, France, 31059
    • Pôle Odontologie Hôpital Purpan - Pavillon Rayer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluation of parodontitis therapeutic care as assessed by variation in DAS28 score	Day 15 and day 90

Secondary Outcome Measures

Outcome Measure	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
Evaluation of parodontitis therapeutic care as assessed by variation in GOHAI score	Day 15 and day 90

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Paul MONSARRAT, MD, Faculté de chirurgie dentaire - Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2010
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: July 10, 2015
• First Submitted That Met QC Criteria: May 17, 2016
• First Posted (Estimate): May 20, 2016

Study Record Updates

• Last Update Posted (Actual): December 3, 2018
• Last Update Submitted That Met QC Criteria: November 29, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Arthritis; Arthritis, Rheumatoid; Periodontitis
• Other Study ID Numbers: 10 046 08; 2010-A01193-36 (Registry Identifier: National Agency of Drug Safety and Health Products)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No