Outcomes of periodontal therapy in rheumatoid arthritis. Methodological considerations

OBJECTIVES: To describe the methodology for a feasibility clinical trial about the periodontal treatment of patients with rheumatoid arthritis (RA) METHODS: Inclusion criteria: Rheumatoid disease activity score (DAS28) ≥3.2; Stable RA treatment ≥2 months; Cumulative periodontal probing depth ≥40mm; CAL≥4mm on ≥2 non‐adjacent teeth. Exclusion criteria: other rheumatic autoimmune diseases; other inflammatory joint disease; any surgical procedure involving joints 12 weeks prior baseline or during follow‐up. Pilot randomized controlled trial (RCT) with intervention and delayed intervention group. Patients in each group (30) continue with their RA therapy. Intervention arm receives non‐surgical, intensive periodontal treatment ‐root scaling and root surface debridement (RSD). Patients in control arm (delayed treatment) receive oral hygiene instructions. Follow‐up at 3 months and 6 months from baseline. In case of probing depth ≥2mm from baseline, site‐specific rescue treatment is provided. Endpoints: Change in periodontal status (measured by full mouth probing) and quality of life (validated questionnaires). Change in rheumatoid disease activity score (DAS28) and musculoskeletal ultrasound (grey‐scale and power‐doppler). Qualitative data from interviews and focus groups about the views of RA patients on oral/periodontal health and the connections with RA. Feasibility data about patient’s compliance, drop‐out rate and reasons for these, gathered through qualitative interviews. RESULTS: Recruitment commenced in March 2014. Updated results about the study will be presented at the IADR meeting. CONCLUSIONS: There are several methodological, logistic and ethical challenges for an RCT to assess the efficacy of an add‐on periodontal treatment for patients with RA. This pilot study provides feasibility data for a larger RCT that aims to assess the effects of periodontal therapy on rheumatoid status of patients with RA.