Environmental ExposureEXPOSOMESNCT03706196
Comparison of Environmental Factors Between the Areas of Over- and Under-incidence of Crohn's Disease in the Haut de France Region, by the Study of Dental Exposomes
An observational study of Environmental Exposure, run by University Hospital, Lille at 1 site in France.
Trial summary
the aim of this preliminary observational study is to compare external exposomes from 10 teeth issued through 10 subjects living in high incidence of crohn's disease area and 10 teeth issued through 10 subjects living in low incidence of crohn's disease area. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Environmental Exposure
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- 2 Apr 2019to 16 Jul 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: adults subjects living in high and low incidence of crohn's disease areas and needing a dental extraction for medical indication.
Who may be able to join
- adults subjects living in high and low incidence of crohn's disease areas and needing a dental extraction for medical indication
Who cannot join
- smokers during 10 last years
Trial locations and contacts
1 site in 1 country.
About this study
the aim of this preliminary observational study is to compare external exposomes from 10 teeth issued through 10 subjects living in high incidence of crohn's disease area and 10 teeth issued through 10 subjects living in low incidence of crohn's disease area.
- Conditions
- Environmental Exposure
- Keywords
- dental exposome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| high incidence crohn's disease area | subjects living in high incidence crohn's disease area coming in dentist for dental extraction linked to medical indication | |
| low incidence crohn's disease area | subjects living in low incidence crohn's disease area coming in dentist for dental extractionlinked to medical indication |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison of aluminum rate using metabolomic method in teeth between subjects living in high and low incidence crohn's disease areas.
Measured: Baseline: one session
Secondary outcomes (1)
comparison of environmental exposomes using metabolomic method in teeth between subjects living in high and low incidence crohn's disease areas.
Measured: Baseline: one session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2018
- Study start2 Apr 2019
- Primary completion16 Jul 2019
- Study completion16 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Environmental ExposureStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Corinne GOWER, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03706196
- Sponsor's protocol ID
- 2017_44
- Other IDs
- 2018-A00195-50
- Acronym
- EXPOSOMES
- Status last verified
- Dec 2025
- First submitted
- 11 Oct 2018
- Last updated
- 26 Dec 2025
- 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 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Environmental Factors Between the Areas of Over- and Under-incidence of Crohn's Disease in the Haut de France Region, by the Study of Dental Exposomes
- ClinicalTrials.gov ID
- NCT03706196
- Acronym / sponsor ID
- EXPOSOMES / 2017_44
- Conditions
- Environmental Exposure
- Keywords
- dental exposome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 2 Apr 2019 (actual)
- Primary completion
- 16 Jul 2019 (actual)
- Study completion
- 16 Jul 2019 (actual)
- First posted
- 15 Oct 2018 (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.
the aim of this preliminary observational study is to compare external exposomes from 10 teeth issued through 10 subjects living in high incidence of crohn's disease area and 10 teeth issued through 10 subjects living in low incidence of crohn's disease area.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high incidence crohn's disease area | – | –subjects living in high incidence crohn's disease area coming in dentist for dental extraction linked to medical indication |
| low incidence crohn's disease area | – | –subjects living in low incidence crohn's disease area coming in dentist for dental extractionlinked to medical indication |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- adults subjects living in high and low incidence of crohn's disease areas and needing a dental extraction for medical indication.
Key inclusion criteria (1 listed)
- adults subjects living in high and low incidence of crohn's disease areas and needing a dental extraction for medical indication
Key exclusion criteria (1 listed)
- smokers during 10 last years
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
comparison of aluminum rate using metabolomic method in teeth between subjects living in high and low incidence crohn's disease areas.
Time frame: Baseline: one session
1 secondary outcome
comparison of environmental exposomes using metabolomic method in teeth between subjects living in high and low incidence crohn's disease areas.
Time frame: Baseline: one session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
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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.
Corinne GOWER, MD,PhD principal investigator
University Hospital, Lille
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 Environmental Exposure, run by University Hospital, Lille 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 26 Dec 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison of aluminum rate using metabolomic method in teeth between subjects living in high and low incidence crohn's disease areas. (time frame: Baseline: one session). 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 26 Dec 2025.