Immunoregulation of Periodontal Diseases
1 other identifier
interventional
50
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2015
1 active site
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
CompletedFirst Posted
Study publicly available on registry
October 2, 2015
CompletedStudy Start
First participant enrolled
December 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedJuly 7, 2016
July 1, 2016
9 months
August 31, 2015
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
EXPERIMENTALblood samples will be done for patients suffering of periodontal diseases
healthy volunteers
ACTIVE COMPARATORblood samples will be done for healthy volunteers
Interventions
blood samples will be done for patients patients suffering of periodontal diseases and healthy volunteers
Eligibility Criteria
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Virgine MONNET CORTI
Assistance Publique Hopitaux De Marseille
Central Study Contacts
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