Therapeutic Management of Periodontitis and Clinical Manifestations of Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

— ESPERA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02779179
• Other study ID #: 10 046 08
• Secondary ID: 2010-A01193-36
• Status: Completed
• Phase: N/A
• Start date: November 2010
• Est. completion date: November 2016

Study information

• Verified date: November 2018
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Periodontitis
• Rheumatoid Arthritis

Intervention

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)

Locations

Country	Name	City	State
France	CHU de Bordeaux	Bordeaux
France	Pôle Odontologie Hôpital Purpan - Pavillon Rayer	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of parodontitis therapeutic care as assessed by variation in DAS28 score		Day 15 and day 90
Secondary	Evaluation of parodontitis therapeutic care as assessed by variation in ACR 20 score		Day 15 and day 90
Secondary	Evaluation of parodontitis therapeutic care as assessed by variation in HAQ score		Day 15 and day 90
Secondary	Evaluation of parodontitis therapeutic care as assessed by variation in GOHAI score		Day 15 and day 90