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

NCT01993368 | Terminated

• 1 other identifier: 13-PP-07
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Aggressive Periodontitis; Chronic Periodontitis

Keywords

wisdom teeth extraction

Outcome Measures

Primary Outcomes (1)

• proportion of lymphocytes, myeloid and mesenchymal populations in the samples

  determined by flow cytometry

  At the surgery time

Study Arms (3)

chronic periodontitis

OTHER

biopsy of periodontal granulation tissue (surgical waste)

Other: flow cytometry

aggressive periodontitis (AP)

OTHER

biopsy of periodontal granulation tissue (surgical waste)

Other: flow cytometry

controls

OTHER

necessitating an extraction of wisdom teeth

Other: flow cytometry

Interventions

flow cytometry OTHER

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)

Also known as: proportion of lymphocytes, myeloid and mesenchymal populations in the samples, as determined by flow cytometry.

aggressive periodontitis (AP); chronic periodontitis; controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Young patients not suffering of any médical conditions
• Small amount of calculus detected
• Pocket depth \>5mm
• Alveolar Bone loss \>50%
• Evident presence of calculus above or under the gingiva
• Pocket depth \>5mm
• Young patients in need of impacted wisdom teeth removal
• And not suffering of chronic or agressive periodontitis

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

Odontology Department, Nice Unversity Hospital

Nice, 06000, France

Location

MeSH Terms

Conditions

Aggressive Periodontitis; Chronic Periodontitis

Interventions

Flow Cytometry

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cytophotometry; Fluorometry; Luminescent Measurements; Photometry; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Jérôme SURMENIAN, MD

  Odontology Department, NIce University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2013
• First Posted: November 25, 2013
• Study Start: November 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: February 7, 2018

Record last verified: 2018-02

Locations

FR (1)