Rheumatoid Arthritis and Treatment of Periodontitis: a Randomized Clinical Trial.

Study Overview
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Brief Summary
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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.

Official Title
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Rheumatoid Arthritis and Treatment of Periodontitis: a Randomized Clinical Trial.

Conditions
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Periodontitis, Arthritis, Rheumatoid

Intervention / Treatment
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* Procedure: Immediate non-surgical periodontal treatment and oral hygiene instructions


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate periodontal treatment<br>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. | Procedure: Immediate non-surgical periodontal treatment and oral hygiene instructions<br> <br> |
| No Intervention: Delayed periodontal treatment<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Activity Score 28 (DAS-28) | Variation of DAS-28 90 days after periodontal treatment | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Erythrocyte Sedimentation Rate (ESR) | Variation of ESR 90 days after periodontal treatment | 90 days | 
| C-Reactive Protein (CRP) | Variation of CRP 90 days after periodontal treatment | 90 days | 
| Interleuchin-6 concentration (IL-6) | Variation of IL-6 90 days after periodontal treatment | 90 days | 
| Oral Health Related Quality of Life (OHRQoL) | Variation of OHRQoL 90 days after periodontal treatment | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Periodontitis, Rheumatoid arthritis, Treatment of periodontitis