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

December 2, 2025 updated by: University Hospital, Toulouse

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: Day 15 and day 90
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
Time Frame: Day 15 and day 90
Day 15 and day 90
Evaluation of parodontitis therapeutic care as assessed by variation in HAQ score
Time Frame: Day 15 and day 90
Day 15 and day 90
Evaluation of parodontitis therapeutic care as assessed by variation in GOHAI score
Time Frame: Day 15 and day 90
Day 15 and day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Paul MONSARRAT, MD, Faculté de chirurgie dentaire - Toulouse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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 (Estimated)

May 20, 2016

Study Record Updates

Last Update Posted (Estimated)

December 10, 2025

Last Update Submitted That Met QC Criteria

December 2, 2025

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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