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

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05271890
• Other study ID #: Perioreuma
• Status: Completed
• Phase: N/A
• Start date: August 25, 2014
• Est. completion date: February 2019

Study information

• Verified date: May 2022
• Source: University of Pisa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Periodontitis

Intervention

Procedure:
• Immediate non-surgical periodontal treatment and oral hygiene instructions

Locations

Country	Name	City	State
Italy	University of Pisa	Pisa

Sponsors (1)

Lead Sponsor	Collaborator
University of Pisa

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease Activity Score 28 (DAS-28)	Variation of DAS-28 90 days after periodontal treatment	90 days
Secondary	Erythrocyte Sedimentation Rate (ESR)	Variation of ESR 90 days after periodontal treatment	90 days
Secondary	C-Reactive Protein (CRP)	Variation of CRP 90 days after periodontal treatment	90 days
Secondary	Interleuchin-6 concentration (IL-6)	Variation of IL-6 90 days after periodontal treatment	90 days
Secondary	Oral Health Related Quality of Life (OHRQoL)	Variation of OHRQoL 90 days after periodontal treatment	90 days