NCT02567019

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 2, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

July 7, 2016

Status Verified

July 1, 2016

Enrollment Period

9 months

First QC Date

August 31, 2015

Last Update Submit

July 6, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • % phagocytes cells of blood

    Identification of altered immunological parameters in patients with periodontal disease

    1 year

Study Arms (2)

periodontal diseases

EXPERIMENTAL

blood samples will be done for patients suffering of periodontal diseases

Other: blood samples

healthy volunteers

ACTIVE COMPARATOR

blood samples will be done for healthy volunteers

Other: blood samples

Interventions

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

healthy volunteersperiodontal diseases

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13005, France

RECRUITING

MeSH Terms

Conditions

Periodontal Diseases

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Virgine MONNET CORTI

    Assistance Publique Hopitaux De Marseille

    PRINCIPAL INVESTIGATOR

Central Study Contacts

virginie MONNET CORTI

CONTACT

Alexandra GIULIANI

CONTACT

Study Design

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

Study Record Dates

First Submitted

August 31, 2015

First Posted

October 2, 2015

Study Start

December 1, 2015

Primary Completion

September 1, 2016

Study Completion

December 1, 2016

Last Updated

July 7, 2016

Record last verified: 2016-07

Locations