Immunoregulation of Periodontal Diseases

NCT ID: NCT02567019

Last Updated: 2016-07-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2016-12-31

Brief Summary

Periodontal diseases are a group of diseases that affect 15% of the population and in the absence of treatment causes tooth loss. Periodontal lesions are characterized mainly by strong inflammation and hyper-vascularization. Search in blood cells and inflammatory markers attempts to explain the etiological-pathogenetic mechanisms. Innate immunity can be assessed by qualitative and quantitative analysis of blood phagocytes, natural killer cells, complement, proteins of inflammation and cytokines. Current data from the literature on this subject give contradictory results and the comparison of studies are difficult because the diversity of the populations studied, evaluated cells and the methods used. The aim of the study was to evaluate the innate immunity of patients with periodontal disease and compare it with a group of patients without periodontal disease.

Detailed Description

Periodontal diseases are a group of diseases that affect 15% of the population and in the absence of treatment causes tooth loss. Periodontal lesions are characterized mainly by strong inflammation and hyper-vascularization. Search in blood cells and inflammatory markers attempts to explain the etiological-pathogenetic mechanisms. Innate immunity can be assessed by qualitative and quantitative analysis of blood phagocytes, natural killer cells, complement, proteins of inflammation and cytokines. Current data from the literature on this subject give contradictory results and the comparison of studies are difficult because the diversity of the populations studied, evaluated cells and the methods used. The aim of the study was to evaluate the innate immunity of patients with periodontal disease and compare it with a group of patients without periodontal disease. The previous conclusions of study focused on the difference in the general immunological parameters in healthy patients and patients suffering from periodontal disease, current advances in immunology have helped to develop new markers on functional status of blood phagocytes all through their anti-microbial action. The adhesion, migration, phagocytosis and bactericidal capacity are assessed and quantified using recognized tests and practiced regularly in analytical laboratory. The identification of altered immunological parameters in patients with periodontal disease would better understand the natural history of these diseases and may lead to new diagnostic criteria, prognostic and therapeutic.

In practice, the project brings together immunological skills (functional analysis of cells and membrane markers) and dental (patient selection and diagnosis of periodontal disease) for further testing applicable to many patients likely to develop periodontal disease.

Conditions

Parodontosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

periodontal diseases

blood samples will be done for patients suffering of periodontal diseases

Group Type: EXPERIMENTAL

blood samples

Intervention Type: OTHER

blood samples will be done for patients patients suffering of periodontal diseases and healthy volunteers

healthy volunteers

blood samples will be done for healthy volunteers

Group Type: ACTIVE_COMPARATOR

blood samples

Intervention Type: OTHER

blood samples will be done for patients patients suffering of periodontal diseases and healthy volunteers

Interventions

blood samples

blood samples will be done for patients patients suffering of periodontal diseases and healthy volunteers

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

For periodontal subjects

• At least present 20 teeth on the dental arches
• Presence of periodontal deep pockets = 4 mm measured by means of a periodontal probe increased in millimeters and raised on at least 30 % of the dental surfaces (proximal, vestibular and Palatine or lingual) present teeth on the dental arches.

For healthy volunteers : absence of periodontal deep pockets

Exclusion Criteria

• pathologies or treatments whom could affect the immunological parameters for the both arms

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Virgine MONNET CORTI

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique Hopitaux De Marseille

Locations

Assistance Publique Hopitaux de Marseille

Marseille, , France

Site Status: RECRUITING

Countries

France

Central Contacts

virginie MONNET CORTI

Role: CONTACT

vmonnet-corti@ap-hm.fr

Alexandra GIULIANI

Role: CONTACT

agiuliani@ap-hm.fr

0491382870

Facility Contacts

Virginie MONNET CORTI

Role: primary

vmonnet-corti@ap-hm.fr

Alexandra GIULIANI

Role: backup

agiuliani@ap-hm.fr

0491382870

Other Identifiers

2015-A00882-47

Identifier Type: -

Identifier Source: org_study_id