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

NCT ID: NCT05271890

Last Updated: 2022-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-25
• Study Completion Date: 2019-02-28

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.

Conditions

Periodontitis; Arthritis, Rheumatoid

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Immediate non-surgical periodontal treatment and oral hygiene instructions

Intervention Type: 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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Immediate non-surgical periodontal treatment and oral hygiene instructions

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pisa

OTHER

Sponsor Role: lead

Responsible Party

Filippo Graziani, DDS MClinDent PhD

FULL PROFESSOR

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Pisa

Pisa, , Italy

Countries

Italy

Other Identifiers

Perioreuma

Identifier Type: -

Identifier Source: org_study_id