B Cell Functions in Periodontitis (LBPARO)

July 10, 2019 updated by: University Hospital, Brest

Periodontitis and Inflammation : Biological and Clinical Approach of B Cell Role.

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.

Study Overview

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Brest, France, 29609
        • Recruiting
        • CHRU de Brest
        • Contact:
          • PERS Jacques-Olivier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Male or female from 18 to 75 years old before periodontal treatment

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Phenotype of B cells in the blood and gums
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: PERS Jacques-Olivier, University Hospital of Brest

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Anticipated)

September 1, 2020

Study Completion (Anticipated)

September 1, 2020

Study Registration Dates

First Submitted

July 12, 2016

First Submitted That Met QC Criteria

July 13, 2016

First Posted (Estimate)

July 14, 2016

Study Record Updates

Last Update Posted (Actual)

July 11, 2019

Last Update Submitted That Met QC Criteria

July 10, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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