Outcomes of periodontal therapy in rheumatoid arthritis: The OPERA feasibility randomized trial

Abstract

Aim: Periodontitis is independently associated with rheumatoid arthritis (RA); however, there is limited data on whether periodontal treatment improves overall RA disease activity. We conducted a pilot feasibility randomized controlled clinical trial to test whether intensive periodontal therapy reduces RA disease activity in patients with active RA and periodontitis.

Materials and methods: The following inclusion criteria were applied: patients with RA and periodontitis, aged 18+, stable on treatment with disease-modifying anti-rheumatic drugs for ≥3 months, disease activity score (DAS28) ≥3.2, and DAS28 >5.1 only if patient unwilling to take biologics. Participants meeting the inclusion criteria were randomized to immediate intensive periodontal therapy or to delayed therapy (control group) administered by a dental hygienist in a secondary care setting. Data were collected at baseline and at 3 and 6 months of follow-up. Participants randomized to the control group (delayed therapy) received the standard of care for the duration of the trial, including oral hygiene instructions delivered by a dental hygienist, and the same periodontal therapy as the intervention group after study completion (i.e., 6 months after randomization). The periodontal inflammation surface area was calculated using clinical attachment loss (CAL), periodontal probing pocket depth, and bleeding on probing. Cumulative probing depth was also measured. We examined the effect of periodontal therapy on periodontal outcomes and on clinical markers of disease activity in RA, as measured by the DAS28-C-reactive protein score as well as musculo-skeletal ultrasound grey scale and power Doppler scores.

Results: A total of 649 patients with RA were invited to participate in the study. Of these, 296 (46%) consented to participate in the screening visit. A sample of 201 patients was assessed for eligibility, of whom 41 (20%) did not meet the RA inclusion criteria and 100 (50%) did not meet the periodontal disease criteria. Among the 60 (30%) eligible participants, 30 were randomized to immediate periodontal therapy and 30 were allocated to the control group. The loss to follow-up was 18% at the end of the trial. There were no major differences with regard to baseline characteristics between the groups. Periodontal therapy was associated with reduced periodontal inflamed surface area, cumulative probing depths, RA disease activity scores, and ultrasound scores over the course of the trial. There was no change in CAL.

Conclusions: Overall, the trial was feasible and acceptable to the study participants. Recruitment to and satisfactory retention in a randomized controlled trial on the effect of periodontal treatment on RA patients is possible, albeit challenging. In this feasibility study of patients with RA and periodontitis, periodontal treatment resulted in significant improvements in periodontal disease outcomes and overall RA disease activity, although complete resolution of periodontal inflammation was difficult to achieve in some cases.

Keywords: clinical trial; epidemiology; general health; periodontal diseases; therapy.

FIGURE 1

OPERA trial flow diagram. *A total of 353 (54%) patients with rheumatoid arthritis (RA) declined the invitation to participate in the study for a variety of reasons, including unwillingness to participate in trials (33%), other health priorities and comorbidities (24%), complete tooth loss (11%), self‐reported good dental health (4%), phobia of dentists (1%), lack of time due to work commitments (2.6%), language barriers (2.3%), and for undisclosed reasons (22%). PD, periodontal disease.

FIGURE 2

Periodontal disease measures. Periodontal inflammation surface area (PISA).

FIGURE 3

Rheumatoid arthritis disease activity measures

FIGURE 4

Rheumatoid arthritis disease activity score (DAS28)

FIGURE 5

Ultrasound disease activity measures. Ultrasound grey scale (USGS) and power Doppler (USPD) scores were obtained from all metacarpo‐phalangeal (MCP) joints and dorsal wrists on both sides. GSUS, greyscale ultrasound; binary GSUS, sum of greyscale data when converted to a binary variable, with joint involvement based on GS grade of at least 1; total ultrasound greyscale, sum of greyscale grades for all scanned joints; PDUS, power Doppler ultrasound; total USPD, sum of power Doppler grades for all scanned joints.