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NCT Number: NCT05271890

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

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.

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Key information

Conditions

Periodontitis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Mouth Diseases Musculoskeletal Diseases Periodontal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pisa

Pisa, 56126, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Immediate non-surgical periodontal treatment and oral hygiene instructions

Procedure

Primary outcomes

  1. Disease Activity Score 28 (DAS-28)

    Time frame: 90 days

    Variation of DAS-28 90 days after periodontal treatment

Secondary outcomes

  1. Erythrocyte Sedimentation Rate (ESR)

    Time frame: 90 days

    Variation of ESR 90 days after periodontal treatment

  2. C-Reactive Protein (CRP)

    Time frame: 90 days

    Variation of CRP 90 days after periodontal treatment

  3. Interleuchin-6 concentration (IL-6)

    Time frame: 90 days

    Variation of IL-6 90 days after periodontal treatment

  4. Oral Health Related Quality of Life (OHRQoL)

    Time frame: 90 days

    Variation of OHRQoL 90 days after periodontal treatment

Sponsors and collaborators

Lead sponsor

University of Pisa

Other

Registry information

Important dates

Study start
2014
Primary completion
2018
Study completion
2019
First posted
Mar 9, 2022
Registry last updated
May 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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