Rheumatoid Arthritis and Treatment of Periodontitis: a Randomized Clinical Trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Pisa
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Disease Activity Score 28 (DAS-28)
Study Overview
Brief Summary
Periodontitis is an infectious disease defined by bacteria-mediated inflammation of the supporting tissues of the teeth that if left untreated may ultimately lead to the destruction of the attachment apparatus, culminating in tooth loss. Rheumatoid arthritis is a chronic destructive inflammatory disease characterized by autoantibodies and the accumulation and persistence of an inflammatory infiltrate in the synovial membrane that leads to synovitis and the destruction of the joint architecture. The objective of this study was to evaluate the possible beneficial additional value of non-surgical periodontal therapy on systemic markers of inflammation and clinical and serological parameters of rheumatoid arthritis.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Triple (Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subjects affected by rheumatoid arthritis with a stable therapeutic regimen for at least 3 months preceding the study participation
- •Subjects with at least 15 teeth
- •Subjects affected by severe generalized periodontitis that had undergone no periodontal treatment in the 6 months preceding the study participation
Exclusion Criteria
- •Age younger than 18 years
- •Pregnancy or breastfeeding
- •Edentulism
- •Diagnosis of other autoimmune pathologies, liver disease, diabetes, early/juvenile arthritis or syndromes associated with RA
Arms & Interventions
Immediate periodontal treatment
Subjects assigned to this group were receiving non-surgical periodontal treatment as well as oral hygiene instructions immediately after their inclusion. All subjects were undergone full periodontal and rheumatologic clinical examinations both at baseline and 90 days after the completion of the treatment. Blood collection for the analysis of the serum concentration of CRP, ESR, Fibrinogen, IL-6 and TNF-α was also performed at baseline and 90 days after periodontal treatment.
Intervention: Immediate non-surgical periodontal treatment and oral hygiene instructions (Procedure)
Delayed periodontal treatment
Subjects assigned to this group were receiving non-surgical periodontal treatment 90 days after baseline evaluation. All subjects were undergone full periodontal and rheumatologic clinical examinations both at baseline and 90 days after. Blood collection for the analysis of the serum concentration of CRP, ESR, Fibrinogen, IL-6 and TNF-α was also performed at baseline and 90 days after.
Outcomes
Primary Outcomes
Disease Activity Score 28 (DAS-28)
Time Frame: 90 days
Variation of DAS-28 90 days after periodontal treatment
Secondary Outcomes
- C-Reactive Protein (CRP)(90 days)
- Interleuchin-6 concentration (IL-6)(90 days)
- Oral Health Related Quality of Life (OHRQoL)(90 days)
- Erythrocyte Sedimentation Rate (ESR)(90 days)
Investigators
Filippo Graziani, DDS MClinDent PhD
FULL PROFESSOR
University of Pisa