NCT03864952

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.

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
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2019

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 4, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 5, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 6, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 4, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 4, 2019

Completed
Last Updated

March 6, 2019

Status Verified

March 1, 2019

Enrollment Period

6 months

First QC Date

March 5, 2019

Last Update Submit

March 5, 2019

Conditions

InfectionDental Calculus

Keywords

Infectiongenomicdental calculus

Outcome Measures

Primary Outcomes (1)

  • successful detection of pathogen

    detection of infectious agent

    3 to 12 months

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Brest

Brest, 29609, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

dental calculus

MeSH Terms

Conditions

InfectionsDental Calculus

Condition Hierarchy (Ancestors)

Dental DepositsTooth DiseasesStomatognathic DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Luc de Saint-Martin, MD, Ph

    University Hopsital of Brest

    STUDY DIRECTOR

Central Study Contacts

Luc de Saint-Martin, MD, PhD

CONTACT

+33 298 347 341luc.desaintmartin@chu-brest.fr

Sophie Vallet, MD, PhD

CONTACT

+33 298 145 097sophie.vallet@chu-brest.fr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2019

First Posted

March 6, 2019

Study Start

March 4, 2019

Primary Completion

September 4, 2019

Study Completion

September 4, 2019

Last Updated

March 6, 2019

Record last verified: 2019-03

Locations

FR(1)