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

Sponsor
University of Pisa (Other)
Overall Status
Completed
CT.gov ID
NCT05271890
Collaborator
(none)
30
1
2
53.3
0.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Immediate non-surgical periodontal treatment and oral hygiene instructions
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Rheumatoid Arthritis and Treatment of Periodontitis: a Randomized Clinical Trial.
Actual Study Start Date :
Aug 25, 2014
Actual Primary Completion Date :
Dec 1, 2018
Actual Study Completion Date :
Feb 1, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Disease Activity Score 28 (DAS-28) [90 days]

    Variation of DAS-28 90 days after periodontal treatment

Secondary Outcome Measures

  1. Erythrocyte Sedimentation Rate (ESR) [90 days]

    Variation of ESR 90 days after periodontal treatment

  2. C-Reactive Protein (CRP) [90 days]

    Variation of CRP 90 days after periodontal treatment

  3. Interleuchin-6 concentration (IL-6) [90 days]

    Variation of IL-6 90 days after periodontal treatment

  4. Oral Health Related Quality of Life (OHRQoL) [90 days]

    Variation of OHRQoL 90 days after periodontal treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Pisa Pisa Italy 56126

Sponsors and Collaborators

  • University of Pisa

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Filippo Graziani, DDS MClinDent PhD, FULL PROFESSOR, University of Pisa
ClinicalTrials.gov Identifier:
NCT05271890
Other Study ID Numbers:
  • Perioreuma
First Posted:
Mar 9, 2022
Last Update Posted:
May 24, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Filippo Graziani, DDS MClinDent PhD, FULL PROFESSOR, University of Pisa
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 24, 2022