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

Not Applicable

Completed

• Conditions: Periodontitis; Arthritis, Rheumatoid
• Interventions: Procedure: Immediate non-surgical periodontal treatment and oral hygiene instructions

• Registration Number: NCT05271890
• Lead Sponsor: University of Pisa

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08-25
• Primary Completion: 2018-12
• Study Completion: 2019-02
• Study First Submitted: 2022-02-27
• Study First Submitted QC: 2022-02-27
• Study First Posted: 2022-03-09
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-17
• Last Update Posted: 2022-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immediate periodontal treatment	Immediate non-surgical periodontal treatment and oral hygiene instructions	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.

Primary Outcome Measures

Name	Time	Method
Disease Activity Score 28 (DAS-28)	90 days	Variation of DAS-28 90 days after periodontal treatment

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Pisa; 🇮🇹 Pisa, Italy