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

May 17, 2022 updated by: Filippo Graziani, DDS MClinDent PhD, University of Pisa
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Pisa, Italy, 56126
        • University of Pisa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Procedure: Immediate non-surgical periodontal treatment and oral hygiene instructions
NO_INTERVENTION: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pisa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 25, 2014

Primary Completion (ACTUAL)

December 1, 2018

Study Completion (ACTUAL)

February 1, 2019

Study Registration Dates

First Submitted

February 27, 2022

First Submitted That Met QC Criteria

February 27, 2022

First Posted (ACTUAL)

March 9, 2022

Study Record Updates

Last Update Posted (ACTUAL)

May 24, 2022

Last Update Submitted That Met QC Criteria

May 17, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Perioreuma

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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