Effect of periodontal treatment on the clinical parameters of patients with rheumatoid arthritis: study protocol of the randomized, controlled ESPERA trial

Abstract

BackgroundRheumatoid arthritis (RA) is a chronic inflammatory disorder that leads to joint damage, deformity, and pain. It affects approximately 1% of adults in developed countries. Periodontitis is a chronic oral infection, caused by inflammatory reactions to gram-negative anaerobic bacteria, and affecting about 35 to 50% of adults. If left untreated, periodontitis can lead to tooth loss. A significant association has been shown to exist between periodontitis and RA in observational studies. Some intervention studies have suggested that periodontal treatment can reduce serum inflammatory biomarkers such as C-reactive protein, or erythrocyte sedimentation rate. We hypothesize that periodontitis could be an aggravating factor in patients with RA, and that its treatment would improve RA outcomes. The aim of this clinical trial is to assess the effect of periodontal treatment on the biological and clinical parameters of patients with RA.Methods/designThe ESPERA (Experimental Study of Periodontitis and Rheumatoid Arthritis) study is an open-label, randomized, controlled trial. Subjects with both RA and periodontitis will be recruited at two university hospitals in southwestern France. In total, 40 subjects will be randomized into two arms (intervention and control groups), and will be followed up for 3 months. Intervention will consist of full-mouth supra-gingival and sub-gingival non-surgical scaling and root planing, followed by systemic antibiotic therapy, local antiseptics, and oral hygiene instructions. After the 3-month follow-up period, the same intervention will be applied to the subjects randomized to the control group.The primary outcome will be change of in Disease Activity Score in 28 Joints (DAS28) at the end of the follow-up period. Secondary outcomes will be the percentages of subjects with 20%, 50%, and 70% improvement in disease according to the American College of Rheumatology criteria. Health-related quality of life assessments (the Health Assessment Questionnaire and the Geriatric Oral Health Assessment Index) will also be compared between the two groups.DiscussionEvidence-based management of potential aggravating factors in subjects with active RA could be of clinical importance, yet there are few randomized controlled trials on the effect of periodontal treatment on the clinical parameters of RA. The ESPERA trial is designed to determine if non-surgical periodontal treatment could improve clinical outcomes in patients with active RA, and the quality of life of these patients.Trial registrationThe ESPERA Trial was registered in Current Controlled Trials [ISRCTN79186420] on 2012/03/20. The trial started recruiting on 2012/03/06.

The effects of periodontal therapy on gingival crevicular fluid matrix metalloproteinase‐8, interleukin‐6 and prostaglandin E2 levels in patients with rheumatoid arthritis

“…A recent systematic review concluded that non‐surgical periodontal therapy in patients with RA with periodontal disease could result in reductions of ESR, without a significant effect on the RF or CRP levels . Non‐surgical mechanical therapy followed by systemic antibiotics led to improved clinical outcomes in patients with active RA . As mentioned above, the systemic characteristics of the included patients (baseline DAS28 scores, duration and type of drug therapy in patients with RA), as well as the severity of periodontitis, could explain the discrepancy with the studies that reported systemic improvements after periodontal therapy.…”

The microbiome in autoimmune diseases

“…Also, polysaccharide A produced by B. fragilis binds TLR‐2 on the surface of lymphocytes and DCs. It thus promotes the maturation of CD4 + lymphocytes into T reg lymphocytes and the production of anti‐inflammatory cytokines such as IL‐10 . Rogier et al .…”

Does Treatment of Periodontal Disease Influence Systemic Disease?

“…110 More recent treatment studies confirm these findings, with a significant decrease in TNF-a levels. [119][120][121] Improvement in signs and symptoms of RA occurred, regardless of whether the RA patients were under anti-TNF-a treatment. 117 Anti-TNF-a RA treatment had no effect on the periodontal health without periodontal therapy.…”