B Cell Functions in Periodontitis (LBPARO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02833285
Recruitment Status : Recruiting
First Posted : July 14, 2016
Last Update Posted : February 1, 2017
Information provided by (Responsible Party):
University Hospital, Brest

Brief Summary:

The inflammatory response involves many players from the immune response, including B lymphocytes. These cells are responsible for the synthesis of immunoglobulins in response to the presence of an antigen. They are characteristic of chronic inflammation. There are several subsets of B cells characterized by specific membrane markers. Once activated, these cells express many factors contributing to tissue destruction seen in periodontitis and particularly in osteoclastogenesis (receptor activator of nuclear factor kappa-B ligand, tumor necrosis factor, interleukin-6, macrophage inflammatory protein-1α and Monocyte Chemoattractant Protein-3).

During the establishment of a periodontal disease, an important inflammatory infiltrate is observed in the gum. This infiltrate is characterized by the presence of many B lymphocytes. B cell subsets in the blood and the gum of patients with periodontitis have been little studied. However, the number of autoreactive B cells (cluster of differentiation (CD)19+, CD5+) has been reported to be higher in the blood of patients with periodontal disease. In the gum, the rate of B and T cells increases with the level of inflammation and is correlated with the severity of the inflammatory process. Activation of B cells is a prerequisite for the progression of gingivitis to periodontitis. B cell distribution could then be an indicator of disease progression, but also allow to study the response to treatment.

The aim of this pilot study is to characterize B cell subsets in the blood and the gum of patients with periodontitis, according to disease activity. Analysis of B cells in the blood could highlight the association of a particular subpopulation with aggressive periodontal disease and evidence a particular biological profile of the host response. The investigators also wish to observe the evolution of this phenotype following an unconventional surgical therapy.

This study would better understand the pathogenesis of periodontal disease and refine the diagnosis, prognosis and treatment of periodontitis, and thus participate in the development of personalized medicine. Biological monitoring of therapeutic effects may be initiated and allow more effectively prevent recurrence.

Condition or disease
Chronic Periodontitis Aggressive Periodontitis

Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Periodontitis and Inflammation : Biological and Clinical Approach of B Cell Role.
Study Start Date : May 2015
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Primary Outcome Measures :
  1. Phenotype of B cells in the blood and gums [ Time Frame: 3 months ]

Biospecimen Retention:   Samples With DNA
gingiva biopsy gingival fluid blood

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Male or female from 18 to 75 years old before periodontal treatment

Inclusion Criteria:

  • Requiring periodontal surgery
  • In good health
  • Having signed consent

Exclusion Criteria:

  • Minor
  • Patient having taken antibiotics in the previous 3 months
  • Patients with systemic diseases including chronic inflammatory disease
  • Pregnancy
  • orthodontic treatment ongoing

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02833285

Contact: PERS Jacques-Olivier 02 98 32 33 84

CHRU de Brest Recruiting
Brest, France, 29609
Contact: PERS Jacques-Olivier         
Sponsors and Collaborators
University Hospital, Brest
Principal Investigator: PERS Jacques-Olivier University Hospital of Brest

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University Hospital, Brest Identifier: NCT02833285     History of Changes
Other Study ID Numbers: LBPARO
First Posted: July 14, 2016    Key Record Dates
Last Update Posted: February 1, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Chronic Periodontitis
Aggressive Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases