Outcomes of Periodontal Therapy in Rheumatoid Arthritis (OPERA)

• Register: ISRCTN
• Last refreshed on: 24 February 2020
• Main ID: ISRCTN52833273
• Date of registration: 05/06/2014
• Prospective Registration: No
• Primary sponsor: University of Birmingham (UK)
• Public title: Outcomes of Periodontal Therapy in Rheumatoid Arthritis (OPERA)
• Scientific title: Outcomes of Periodontal Therapy in Rheumatoid Arthritis (OPERA)
• Date of first enrolment: 01/04/2013
• Target sample size: 60
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN52833273
• Study type: Interventional
• Study design: Randomised; Interventional; Design type: Not specified, Treatment (Treatment)
• Phase: Not Applicable

Countries of recruitment

United Kingdom

Contacts

• Name: Thomas Dietrich

Key inclusion & exclusion criteria

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


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

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

Intervention(s)

Periodontal Therapy, Intensive periodontal therapy administered by a Dental Hygienist; Study Entry : Registration and One or More Randomisations

Primary Outcome(s)

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

Secondary Outcome(s)

Not provided at time of registration

Secondary ID(s)

11940

Source(s) of Monetary Support

NIHR Research for Patient Benefit (RfPB); Grant Codes: PB-PG-0609-19100

Ethics review

Status:
Approval date:
Contact:

11/WM/0235

Results

• Results available: Yes
• Date Completed: 31/03/2015