InfectionDIASNCT03864952
Infectious Agents Exposure : Archiving in Dental Plaque
An observational study of Infection and Dental Calculus, run by University Hospital, Brest at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection, Dental Calculus
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 4 Mar 2019to 4 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients reffering to the Hospital university of Brest (France) 3 to 12 months before the study
Who may be able to join
- three months before, having been infected with a documented pathogen
- this infection must have been clinically obvious
- the patient must have dental calculus
Who cannot join
- to be under 18 years old
- to be incapable to consenting
- a tartar removal since the infection
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHRU de Brest
Brest, 29609
Luc de Saint-Martin, +33 298 347 341, luc.desaintmartin@chu-brest.fr
Sophie Vallet, MD, PhD
About this study
Official title: Dental Plaque and Infectious Agents Story)
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.
Read the 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.
- Conditions
- Infection, Dental Calculus
- Keywords
- Infection, genomic, dental calculus
- Medical subject headings
- Infections, Dental Calculus
What is being measured
The primary outcome is the main question the study is designed to answer.
successful detection of pathogen
detection of infectious agent
Measured: 3 to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2019
- Study start4 Mar 2019
- Primary completion4 Sep 2019 (estimated)
- Study completion4 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luc de Saint-Martin, MD, Ph, Study director, University Hopsital of Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03864952
- Sponsor's protocol ID
- 29BRC18.0131 (DIAS study)
- Acronym
- DIAS
- Status last verified
- Mar 2019
- First submitted
- 5 Mar 2019
- Last updated
- 6 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dental Plaque and Infectious Agents Story)
- ClinicalTrials.gov ID
- NCT03864952
- Acronym / sponsor ID
- DIAS / 29BRC18.0131 (DIAS study)
- Conditions
- Infection, Dental Calculus
- Keywords
- Infection, genomic, dental calculus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 4 Mar 2019 (actual)
- Primary completion
- 4 Sep 2019 (estimated)
- Study completion
- 4 Sep 2019 (estimated)
- First posted
- 6 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients reffering to the Hospital university of Brest (France) 3 to 12 months before the study
Key inclusion criteria (3 listed)
- three months before, having been infected with a documented pathogen
- this infection must have been clinically obvious
- the patient must have dental calculus
Key exclusion criteria (3 listed)
- to be under 18 years old
- to be incapable to consenting
- a tartar removal since the infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
successful detection of pathogen
Time frame: 3 to 12 months
detection of infectious agent
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luc de Saint-Martin, MD, Ph study director
University Hopsital of Brest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infection and Dental Calculus, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luc de Saint-Martin, MD, PhD (+33 298 347 341, luc.desaintmartin@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
successful detection of pathogen (time frame: 3 to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2019.