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Clinical Trials/NCT01806974
NCT01806974
Terminated
Phase 4

Multicenter, Prospective Study, on the Consequences of Anti-interleukin 6 Immunotherapy Treatment for Rheumatoid Arthritis on: - Healthy and Pathological Periodontium - The Level of Expression of Some Markers of Inflammation and Periodontal Pathogenic Bacteria in Periodontal Sulci and Periodontal Pockets

Nantes University Hospital2 sites in 1 country16 target enrollmentDecember 2012

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Rheumatoid Arthritis
Sponsor
Nantes University Hospital
Enrollment
16
Locations
2
Primary Endpoint
Clinical attachment level
Status
Terminated
Last Updated
10 years ago

Overview

Brief Summary

Rheumatoid arthritis and periodontitis are two inflammatory diseases that share many pathophysiological similarities as some inflammatory mediators like TNF-alpha, IL-1, Il-6, Il-17, Il-12 et Il-17, RANK-L, or OPG The most severe or progressive forms of rheumatoid arthritis require in 10-30% of cases, the use of biotherapies such as anti-TNF-alpha, anti CD-20 and anti-lL-6. All these treatments results in, among other things, an increased risk of infection, both viral and bacterial.

These new biotherapies could have an impact on periodontal status

  • either by favouring sub gingival colonization of root surfaces by periodontal pathogenic bacteria and initiate periodontitis or exacerbate pre-existing periodontitis,
  • or a positive modulation of the host response by inhibiting bone resorption of the alveolar process.

To date, very few studies have been conducted on this subject which is really a translational research, involving several medical specialties.

Registry
clinicaltrials.gov
Start Date
December 2012
End Date
June 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • patient over 18 years presenting a rheumatoid arthritis and for which an anti IL6 biotherapy treatment is prescribed.
  • At least 18 permanent teeth in the mouth at least 3 teeth with a healthy periodontal status
  • Having expressed their written free and informed consent

Exclusion Criteria

  • Hypersensitivity to any of the following components : tocilizumab, saccharose, polysorbate 80, phosphate disodique dodécahydrate, phosphate monosodique dehydrate
  • Severe or active infections
  • Systemic Pathology affecting the immune system including Sjögren's syndrome
  • Surgery in the previous month
  • HIV positive
  • Alcoholic
  • Toxicoman
  • Antibiotic treatment in the last 2 months
  • Legally protected patients

Outcomes

Primary Outcomes

Clinical attachment level

Time Frame: 6 month

Gain or loss obtained by periodontal probing.

Secondary Outcomes

  • Quantification of periodontopathogenic germs(6 month)
  • Quantification of inflammation markers in the gingival fluid(6 month)
  • Detection of periodontopathogenic germs(6 month)
  • Assessment of inflammation(6 month)
  • Assessment of oral hygiene level(6 month)
  • Detection of inflammation markers in the gingival fluid(6 month)

Study Sites (2)

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