Immunoregulation of Periodontal Disease | NCT00702429

Studies
Immunoregulation of Periodontal Disease

NCT00702429

Sponsor

Assistance Publique Hopitaux De Marseille

Status

Completed

Last Update Posted

Aug 28, 2014Estimated

Enrollment

23Actual

Phase

Not Applicable

Conditions

Periodontal Disease

Interventions

Blood sampling
Blood sampling

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2008

Primary Completion Date

Jul 2010Actual

Completion Date

Jul 2010Actual

First Submitted Date

Jun 18, 2008

First Submission Date that Met QC Criteria

Jun 19, 2008

First Posted Date

Jun 20, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 27, 2014

Last Update Posted Date

Aug 28, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Our design is to test in hospital practice a selection of immune parameters that could assess the pathophysiology and progression of periodontal lesions.

Detailed Description

These parameters will be measured in 25 healthy volunteers and 25 moderate-to severe periodontal disese patients. Phagocytes will be tested phenotypically and functionally, both ex vivo and in vitro.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

23Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Patients achieve of parodontopathies	Other: Blood sampling
2	Placebo Comparator	Patients without parodontales diseases	Other: Blood sampling

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood sampling	Other	Analysis of the PNN, analysis of the monocytes	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of positive cells and intensity of expression for the molecules of surface studied there cytometric in stream		24 months

Secondary Outcomes

Measure	Description	Time Frame
Rate of secretion of cytokines and the other substances		24 months
Detection and quantification of ARN messengers		24 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Persons appearing spontaneously at the consultation of parodontologie for parodontale disease,
persons agreeing to undergo a sampling of blood intended for the search

Exclusion Criteria:

Presence of a chronic or pointed pathology,
an age 18-year-old subordinate or 65-year-old superior,
pregnant women,

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joana VITTE, MD	Assistance Publique des Hôpitaux de Marseille	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hopital de la Conception- Laboratoire d'Immunologie		Marseille		13274	France

Condition Browse Module

MeSH Terms

ID	Term
D010510	Periodontal Diseases

Ancestor Terms

ID	Term
D009059	Mouth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided