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Chromogranin-A-Derived Peptides and Periodontitis in Diabetic Patients

Primary Purpose

Periodontitis and Diabetitis

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Gingival crevicular fluid samples (this procedure is added to the subject usual medical follow-up).

About this trial

This is an interventional diagnostic trial for Periodontitis and Diabetitis focused on measuring Periodontitis, Diabetes, Gingival crevicular fluid, GCF, Saliva, Chromogranin, Electrophorèse, Western Blot, RT-HPLC

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria:

Patients from 20 to 80 years old
A minimum of 10 teeth
Healthy volunteers or diabetic patients with or without periodontitis

Exclusion criteria:

a course of antibiotics
a fungicidal therapy
a corticotherapy
a hormone therapy
a pregnancy
persons under guardianship

Sites / Locations

Département de Parodontologie - Hôpital CivilRecruiting

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00399620

First Posted

November 14, 2006

Last Updated

January 9, 2009

Sponsor

University Hospital, Strasbourg, France

1. Study Identification

Unique Protocol Identification Number

NCT00399620

Brief Title

Chromogranin-A-Derived Peptides and Periodontitis in Diabetic Patients

Official Title

Chromogranin-A-Derived Peptides in the Gingival Crevicular Fluid and the Saliva of Diabetic Patients With or Without Periodontitis

Study Type

Interventional

2. Study Status

Record Verification Date

January 2009

Overall Recruitment Status

Unknown status

Study Start Date

March 2008 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

University Hospital, Strasbourg, France

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Periodontitis is a chronic disease of the supporting tissue of the teeth, characterized by bleeding and inflamed gingival, resorption of alveolar bone. This disease has a significant impact of the quality of life as the teeth become progressively mobile and may fall out spontaneously if no treatment is provided. Periodontal disease has been cited as the sixth complication of diabetes mellitus.Chromogranins / secretogranins are a family of proteins present in nervous endocrine and immune cells, released with catecholamines during stress situations. Chromogranin A (CGA) is the major member of this family.The aim of this study is to determine the level of CGA and its derived peptides in the gingival crevicular fluid (GCF) of health or diabetic patients with and without periodontitis.Then, we want to determine the antimicrobial activity of these peptides.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Periodontitis and Diabetitis

Keywords

Periodontitis, Diabetes, Gingival crevicular fluid, GCF, Saliva, Chromogranin, Electrophorèse, Western Blot, RT-HPLC

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Gingival crevicular fluid samples (this procedure is added to the subject usual medical follow-up).

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: Patients from 20 to 80 years old A minimum of 10 teeth Healthy volunteers or diabetic patients with or without periodontitis Exclusion criteria: a course of antibiotics a fungicidal therapy a corticotherapy a hormone therapy a pregnancy persons under guardianship

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Martine Soell, MD

Phone

33 6 74 86 67 36

martine.soell@chru-strasbourg.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Martine Soell, MD

Organizational Affiliation

Hôpitaux Universitaires de Strasbourg

Official's Role

Study Director

Facility Information:

Facility Name

Département de Parodontologie - Hôpital Civil

City

Strasbourg

ZIP/Postal Code

67091

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Martine Soell, MD

Phone

33.6.74.86.67.36

martine.soell@chru-strasbourg.fr

First Name & Middle Initial & Last Name & Degree

Martine Soell, MD

First Name & Middle Initial & Last Name & Degree

Frédéric Blickle, MD

12. IPD Sharing Statement

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Chromogranin-A-Derived Peptides and Periodontitis in Diabetic Patients

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