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

Primary Purpose

Periodontitis, Arthritis, Rheumatoid

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Immediate non-surgical periodontal treatment and oral hygiene instructions
Sponsored by
University of Pisa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Periodontitis focused on measuring Periodontitis, Rheumatoid arthritis, Treatment of periodontitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Pisa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Immediate periodontal treatment

Delayed periodontal treatment

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 27, 2022
Last Updated
May 17, 2022
Sponsor
University of Pisa
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1. Study Identification

Unique Protocol Identification Number
NCT05271890
Brief Title
Rheumatoid Arthritis and Treatment of Periodontitis: a Randomized Clinical Trial.
Official Title
Rheumatoid Arthritis and Treatment of Periodontitis: a Randomized Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
August 25, 2014 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
February 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pisa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Arthritis, Rheumatoid
Keywords
Periodontitis, Rheumatoid arthritis, Treatment of periodontitis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediate periodontal treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Delayed periodontal treatment
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Immediate non-surgical periodontal treatment and oral hygiene instructions
Primary Outcome Measure Information:
Title
Disease Activity Score 28 (DAS-28)
Description
Variation of DAS-28 90 days after periodontal treatment
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Erythrocyte Sedimentation Rate (ESR)
Description
Variation of ESR 90 days after periodontal treatment
Time Frame
90 days
Title
C-Reactive Protein (CRP)
Description
Variation of CRP 90 days after periodontal treatment
Time Frame
90 days
Title
Interleuchin-6 concentration (IL-6)
Description
Variation of IL-6 90 days after periodontal treatment
Time Frame
90 days
Title
Oral Health Related Quality of Life (OHRQoL)
Description
Variation of OHRQoL 90 days after periodontal treatment
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University of Pisa
City
Pisa
ZIP/Postal Code
56126
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

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

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