Infectious Agents Exposure : Archiving in Dental Plaque | NCT03864952

Studies
Infectious Agents Exposure : Archiving in Dental Plaque

NCT03864952

Sponsor

University Hospital, Brest

Status

Unknown status

Last Update Posted

Mar 6, 2019Actual

Enrollment

15Estimated

Phase

Not provided

Conditions

Infection
Dental Calculus

Interventions

Not provided

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

Mar 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 4, 2019Actual

Primary Completion Date

Sep 4, 2019Estimated

Completion Date

Sep 4, 2019Estimated

First Submitted Date

Mar 5, 2019

First Submission Date that Met QC Criteria

Mar 5, 2019

First Posted Date

Mar 6, 2019Actual

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

Mar 5, 2019

Last Update Posted Date

Mar 6, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

We are studying the possibility of using dental calculus as a reservoir for the genes of an infectious agent that has infected the patient in previous months; as it is done to highlight climate change in ice samples.

Detailed Description

From a sample of people who have had a microbiologically well-documented infection, we will study the possibility after genomic amplification to find, three to 12 months after genetic sequences of the infectious agent in the dental calculus of the person. The people will be recruited according to a large panel of infectious agent (gram + and gram bacterium, mycobacteria, parasite, fungus, DNA, RNA or retrovirus) and, of course, the presence of dental calculus.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

15Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
successful detection of pathogen	detection of infectious agent	3 to 12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

three months before, having been infected with a documented pathogen
this infection must have been clinically obvious
the patient must have dental calculus

Exclusion Criteria:

to be under 18 years old
to be incapable to consenting
a tartar removal since the infection

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients reffering to the Hospital university of Brest (France) 3 to 12 months before the study

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Luc de Saint-Martin, MD, PhD	Contact	+33 298 347 341		luc.desaintmartin@chu-brest.fr
Sophie Vallet, MD, PhD	Contact	+33 298 145 097		sophie.vallet@chu-brest.fr

Overall Officials

Name	Affiliation	Role
Luc de Saint-Martin, MD, Ph	University Hopsital of Brest	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHRU de Brest	Recruiting	Brest		29609	France

Condition Browse Module

MeSH Terms

ID	Term
D007239	Infections
D003728	Dental Calculus

Ancestor Terms

ID	Term
D003741	Dental Deposits
D014076	Tooth Diseases
D009057	Stomatognathic Diseases
D002137	Calculi

Browse Leaves

Not provided

Browse Branches

Not provided