Condition category
Musculoskeletal Diseases
Date applied
05/06/2014
Date assigned
05/06/2014
Last edited
06/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Thomas Dietrich

ORCID ID

Contact details

School Of Dentistry
St. Chads Queensway
Birmingham
B4 6NN
United Kingdom
t.dietrich@bham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

11940

Study information

Scientific title

Acronym

Outcomes of Periodontal Therapy in Rheumatoid Arthritis (OPERA)

Study hypothesis

Rheumatoid arthritis (RA) is common chronic inflammatory disease that is characterised by inflammation in the joints ultimately leading to joint destruction and consequently functional impairment and disability. In addition, patients with RA are more likely to develop cardiovascular diseases such as heart disease and stroke and are therefore at an increased risk of premature death.

Several studies now indicate that chronic periodontitis, a common inflammatory disease of the gums surrounding the teeth caused by bacteria in the mouth, can initiate and worsen inflammation in RA. A small number of small clinical studies in patients with RA have indicated that periodontal therapy aimed at eliminating gum infection can reduce joint and systemic inflammation in patients with RA. We therefore propose this clinical study to study the effects of an intensive periodontal therapy administered by a dental hygienist in a secondary care setting to patients with RA who also suffer from moderate to severe periodontitis.

We will measure the effect of this intervention on several clinical and blood measures of RA and RA activity as well as on overall and oral health related quality of life. We will also assess how easy or difficult it is to recruit patients into such a study and how easy and acceptable patients find participation and compliance with the periodontal therapy and the study procedures.

We plan to evaluate this intervention in a larger definitive study, provided that the proposed pilot study is successful and shows promising results. If successful, treatment of gum disease in patients with RA could be an inexpensive and safe, non-pharmacological
treatment with direct benefit for patients with RA in terms of RA severity and progression.

Ethics approval

11/WM/0235

Study design

Randomised; Interventional; Design type: Not specified, Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Intervention

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

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/04/2013

Overall trial end date

31/03/2015

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 60; UK Sample Size: 60

Participant 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

Recruitment start date

01/04/2013

Recruitment end date

31/03/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

School Of Dentistry , St. Chads Queensway
Birmingham
B4 6NN
United Kingdom

Sponsor information

Organisation

University of Birmingham (UK)

Sponsor details

Edgbaston
Birmingham
B15 2TT
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes