Outcomes of Periodontal Therapy in Rheumatoid Arthritis (OPERA)

Not Applicable

Completed

• Conditions: Topic: Musculoskeletal disorders, Oral and dental health; Subtopic: Musculoskeletal (all Subtopics), Oral and dental health; Disease: Inflammatory Arthritis; Musculoskeletal Diseases

• Registration Number: ISRCTN52833273
• Lead Sponsor: niversity of Birmingham (UK)

Brief Summary

2020 results in https://www.ncbi.nlm.nih.gov/pubmed/31009578 (added 27/01/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-06-05
• Study Completion: 2015-03-31
• Last Update Posted: 24 February 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Able and willing to give written informed consent and comply with the requirements of the study protocol
2. Age 18+ years
3. Patients with rheumatoid arthritis (RA) diagnosed according to the revised 1987 ACR criteria for the classification of RA
4. DAS28 score =3.2
5. DAS28 score >5.1 only if patient on biologics or patient unwilling to take biologics
6. Treatment with DMARD for = 3 months and stable dose for = 2 months OR patient refusing to use DMARD
7. Generalized moderate to severe chronic periodontitis as evidenced by pocketing with clinical attachment loss (CAL>=4 mm on at least 2 non-adjacent teeth AND cumulative probing depth >=40mm). The threshold based on CAL is consistent with a recently proposed case definition. Cumulative pocket depth is the sum of the deepest probing depths of at least 4mm on each tooth. The proposed threshold ensures a minimum number of teeth with deep periodontal pockets, e.g., a patient who has 8 teeth with 5mm pockets would meet this criterion.

Exclusion Criteria

1. Rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA (including but not limited to vasculitis, pulmonary fibrosis or Felty?s syndrome). Secondary Sjögren?s syndrome or secondary limited cutaneous vasculitis with RA is permitted.
2. History of, or current, inflammatory joint disease other than RA (including, but not limited to, gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy) or other systemic autoimmune disorder (including, but not limited to, systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, mixed connective tissue disease or any overlap syndrome).
3. Diagnosis of juvenile idiopathic arthritis (JIA) or juvenile rheumatoid arthritis (JRA) and/or RA before age 16.
4. Any surgical procedure, including bone/joint surgery/synovectomy (including joint fusion or replacement) within 12 weeks prior to baseline or planned during study
5. Significant concomitant disease, which would preclude patient participation in the investigators? opinion.
6. intra-articular or parenteral glucocorticoids within 4 weeks prior to baseline
7. any dental condition that would preclude, in the investigator?s opinion, articipation in the trial (including but not limited to restorations impairing oral hygiene or instrumentation, need for extractions or extensive restorative work)
8. periodontal treatment (surgical or nonsurgical, excluding supragingival cleanings) within 12 months prior to baseline
9. previous participation in a CTIMP within the past 4 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Outcome evaluations will include measures of RA disease activity and disability, periodontal measure

Secondary Outcome Measures

Name	Time	Method
ot provided at time of registration