CClinicalTrials.gg
Status unknownNCT02567019Updated Jul 7, 2016

Immunoregulation of Periodontal Diseases

An interventional study of blood samples in Parodontosis, sponsored by Assistance Publique Hopitaux De Marseille. Status unknown at 1 site in France. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-07-07.

Sponsored by Assistance Publique Hopitaux De Marseille · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Jul 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Parodontosis

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03

In context

Periodontal Diseases

830 studies on the registry are indexed under Periodontal Diseases; 189 are open to participants now.

This study's planned enrollment of 50 is above the median of 45 across 530 interventional studies indexed under Periodontal Diseases.

Browse Periodontal Diseases studies →

Lead sponsor

Assistance Publique Hopitaux De Marseille is the lead sponsor of 686 studies on the registry; 148 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    periodontal diseases

    blood samples will be done for patients suffering of periodontal diseases

    Other: blood samples

  • Active comparator
    healthy volunteers

    blood samples will be done for healthy volunteers

    Other: blood samples

Interventions

  • Otherblood samples

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

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What researchers measure

Primary outcomes

  1. % phagocytes cells of blood

    Identification of altered immunological parameters in patients with periodontal disease

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 7, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02567019
Lead sponsor
Assistance Publique Hopitaux De Marseille
Responsible party
Sponsor
First posted
Oct 2, 2015
Start date
Dec 2015
Primary completion
Sep 2016 (estimated)
Completion
Dec 2016 (estimated)
Last update
Jul 7, 2016

Study contacts

virginie MONNET CORTI
Contact
vmonnet-corti@ap-hm.fr
Alexandra GIULIANI
Contact
agiuliani@ap-hm.fr
0491382870
Virgine MONNET CORTI
principal investigator · Assistance Publique Hopitaux De Marseille

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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