Trial record 10 of 140 for:    Open Studies | "Aggression"

Analysis of Osteoimmune Interactions Linking Inflammation and Bone Destruction in Aggressive Periodontitis (PAG)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Centre Hospitalier Universitaire de Nice
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT01993368
First received: November 15, 2013
Last updated: January 29, 2014
Last verified: January 2014
  Purpose

Periodontitis are inflammatory diseases characterized by the destruction of the tooth-supporting bone due to increased bone resorption by osteoclasts (OCLs). Two forms are described: chronic periodontitis (CP) and aggressive periodontitis (AP) that differ by the severity and rapidity of bone loss, much more important for AP than CP. In both forms, the link with uncontrolled activation of the immune system is largely admitted. Despite the physiopathology of CP is fairly well studied, very few data are available regarding AP. The investigators aim is to understand the severity of AP by analyzing the proportion and action of immune and mesnchymal cells potentially involved in bone destruction, on biopsies of periodontal granulation tissue (surgical waste) and blood. Three groups of 20 patients will be included: affected with AP, CP or controls (necessitating an extraction of wisdom teeth).


Condition Intervention
Aggressive Periodontitis
Chronic Periodontitis
Other: flow cytometry

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Analysis of Osteoimmune Interactions Linking Inflammation and Bone Destruction in Aggressive Periodontitis

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:
  • proportion of lymphocytes, myeloid and mesenchymal populations in the samples [ Time Frame: At the surgery time ] [ Designated as safety issue: No ]
    determined by flow cytometry


Estimated Enrollment: 60
Study Start Date: November 2013
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
chronic periodontitis
biopsy of periodontal granulation tissue (surgical waste)
Other: flow cytometry

These populations will be identified by different combinations of antibodies to identify:

  • T cell subsets (CD45, CD3, CD4, CD8, CD45RA, CD69, CD28, TCRαβ, TCRγδ, CD197, CD25, FoxP3), B cells (CD45, CD19, HLA-DR, IgA), cells NK (CD45, CD3, CD56).
  • Monocyte subsets (CD45, CD11b, CD14, CD16, CD1c, HLA-DR)
  • Mesenchymal stromal cells (CD45, HLA-ABC, CD105, CD90, CD73)
Other Name: proportion of lymphocytes, myeloid and mesenchymal populations in the samples, as determined by flow cytometry.
aggressive periodontitis (AP)
biopsy of periodontal granulation tissue (surgical waste)
Other: flow cytometry

These populations will be identified by different combinations of antibodies to identify:

  • T cell subsets (CD45, CD3, CD4, CD8, CD45RA, CD69, CD28, TCRαβ, TCRγδ, CD197, CD25, FoxP3), B cells (CD45, CD19, HLA-DR, IgA), cells NK (CD45, CD3, CD56).
  • Monocyte subsets (CD45, CD11b, CD14, CD16, CD1c, HLA-DR)
  • Mesenchymal stromal cells (CD45, HLA-ABC, CD105, CD90, CD73)
Other Name: proportion of lymphocytes, myeloid and mesenchymal populations in the samples, as determined by flow cytometry.
controls
necessitating an extraction of wisdom teeth
Other: flow cytometry

These populations will be identified by different combinations of antibodies to identify:

  • T cell subsets (CD45, CD3, CD4, CD8, CD45RA, CD69, CD28, TCRαβ, TCRγδ, CD197, CD25, FoxP3), B cells (CD45, CD19, HLA-DR, IgA), cells NK (CD45, CD3, CD56).
  • Monocyte subsets (CD45, CD11b, CD14, CD16, CD1c, HLA-DR)
  • Mesenchymal stromal cells (CD45, HLA-ABC, CD105, CD90, CD73)
Other Name: proportion of lymphocytes, myeloid and mesenchymal populations in the samples, as determined by flow cytometry.

Detailed Description:

Context: Periodontitis are inflammatory diseases affecting the periodontium and characterized by the destruction of the tooth-supporting bone due to increased bone resorption by osteoclasts (OCLs). Two forms are described: chronic periodontitis (CP) and aggressive periodontitis (AP) that differ by the severity and rapidity of bone loss, much more important for AP than CP. In both forms, the link with uncontrolled activation of the immune system is largely admitted. But despite the physiopathology of CP is fairly well studied, very few data are available regarding AP. Based on the investigators previous studies, their hypothesis to explain this severity is the existence of a vicious circle involving immune cells, mesenchymal cells and OCLs, that would maintain and amplify inflammation and bone loss.

Study: this is a transversal, interventional and single-center study. It includes 3 groups of 20 patients: affected with AP, CP or controls (necessitating an extraction of wisdom teeth).

Aims: the investigators will compare the proportion of immune and mesenchymal cells in the 3 groups of patients to identify the populations potentially involved in bone destruction. The investigators will compare in vitro their capacity to induce OCL differentiation in order to determine their role in bone loss. The investigators will also compare the capacity of OCLs and mesenchymal cells to activate T cells, in order to determine their role in inflammation.

Methodology: patients will be recruited in the department of periodontology, CHU of Nice. After signing the informed consent, a biopsy of periodontal granulation tissue (surgical waste) will be collected during the usual treatment of these diseases, as well as a blood sample. Then, patients will leave the study. Cells from the biopsies will be analyzed by flow cytometry to determine the proportion of lymphocytic, monocytic and mesenchymal cells. In vitro, their capacity to induce OCL differentiation or to activate T cells will be determined. From the blood samples, OCLs will be generated to study their capacity to activate T cells.

Chronology of consultations and examinations: 3 visits are planned: (1) a routine visit corresponding to the usual treatment of the patient during which it is proposed to participate in the study, (2) a visit to obtaining consent, clinical examination, criteria verification and (3) a visit corresponding to the usual treatment in which will be collected tissue biopsies and blood.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • Inclusion criterias for agressive periodontits

    • Young patients not suffering of any médical conditions
    • Small amount of calculus detected
    • Pocket depth >5mm
    • Alveolar Bone loss >50%
  • Inclusion criterias for chronic periodontitis

    • Evident presence of calculus above or under the gingiva
    • Pocket depth >5mm
  • Inclusion criterias for control patients :

    • Young patients in need of impacted wisdom teeth removal
    • And not suffering of chronic or agressive periodontitis
  • Exclusion criterias :

    • Patients with blood disorder
    • Patients presenting with liver, kidney, or vascular disorder, and /or psychiatric disorder
    • Patients who have allergies
    • Patients taking biphosphonates, anticoagulant drugs, or anticonvulsivant
    • Patients who have had a cancer of the mouth, and/or treated by radiotherapy
    • Patients who have taken anti-inflammatory drugs, and/or anti-cancer drugs, and/or immuno-suppresive drugs in the past 6 months
    • Patients who have had a periodontal treatment in the past 12 months
    • Pregnant Women
    • Patients juged difficult to follow by the investigator
    • Vulnerable patients
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01993368

Contacts
Contact: Jérôme SURMENIAN, PhD surmenian.j@chu-nice.fr

Locations
France
Odontology Department, Nice Unversity Hospital Recruiting
Nice, France, 06000
Contact: jérôme SURMENIAN, PhD       surmenian.j@chu-nice.fr   
Principal Investigator: Jerôme SURMENIAN, PhD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
Principal Investigator: Jérôme SURMENIAN, MD Odontology Department, NIce University Hospital
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT01993368     History of Changes
Other Study ID Numbers: 13-PP-07
Study First Received: November 15, 2013
Last Updated: January 29, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
France: Committee for the Protection of Personnes

Keywords provided by Centre Hospitalier Universitaire de Nice:
wisdom teeth extraction

Additional relevant MeSH terms:
Aggression
Inflammation
Periodontitis
Aggressive Periodontitis
Chronic Periodontitis
Behavioral Symptoms
Pathologic Processes
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on July 23, 2014