Oral DiseaseDepiDentNCT03736070
Assessment of Routine Oral Screening Programs for New Prisoners
An observational study of Oral Disease, run by University Hospital, Montpellier at 1 site in France.
Trial summary
In 2018, 10 detention centers in France will start organisational programs to improve the quality of screening of oral diseases, relatively to French recommendations, among new prisoners in France. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Disease
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2018to 1 Dec 2021
- 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
- No healthy volunteers
- Adult, Older adult
Study population: New prisoners
Who may be able to join
- new prisoners
- fluent French language
Who cannot join
- adult guardianship
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Uhmontpellier
Montpellier, 34295
Claire M DUFLOS, MD, c-duflos@chu-montpellier.fr
About this study
Official title: Assessment of Routine Oral Screening Programs for New Prisoners in France
In 2018, 10 detention centers in France will start organisational programs to improve the quality of screening of oral diseases, relatively to French recommendations, among new prisoners in France. Our study aims 1) to assess the prevalence and nosology of oral diseases ; 2) to describe the care pathway of participants during their stay in the detention center where they were included ; 3) to assess the cost of care per patient, from a societal perspective, using a top-down method.
- Conditions
- Oral Disease
- Medical subject headings
- Mouth Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of the oral problems of people entering detention
Description of the oral problems of people entering detention : Any oral disease at inclusion (prevalence study)
Measured: 1 day
Secondary outcomes (1)
attending to consultations
attending to consultations : The rate of attended visits is defined as the number of visits attended by the patient, divided by the number of scheduled visits, during the prison stay of the participant.
Measured: The collection of data will end at the discharge of the participant, or at 6 months after inclusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2018
- Study start1 Mar 2018
- Primary completion1 May 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral DiseaseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- General Health Office, France
- Responsible party
- Sponsor
- Investigators
- Claire M DUFLOS, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03736070
- Sponsor's protocol ID
- RECHMPL18_0069
- Acronym
- DepiDent
- Status last verified
- Jun 2020
- First submitted
- 1 Feb 2018
- Last updated
- 5 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Routine Oral Screening Programs for New Prisoners in France
- ClinicalTrials.gov ID
- NCT03736070
- Acronym / sponsor ID
- DepiDent / RECHMPL18_0069
- Conditions
- Oral Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- General Health Office, France
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 May 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 8 Nov 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.
In 2018, 10 detention centers in France will start organisational programs to improve the quality of screening of oral diseases, relatively to French recommendations, among new prisoners in France. Our study aims 1) to assess the prevalence and nosology of oral diseases ; 2) to describe the care pathway of participants during their stay in the detention center where they were included ; 3) to assess the cost of care per patient, from a societal perspective, using a top-down method.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- New prisoners
Key inclusion criteria (2 listed)
- new prisoners
- fluent French language
Key exclusion criteria (1 listed)
- adult guardianship
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
Description of the oral problems of people entering detention
Time frame: 1 day
Description of the oral problems of people entering detention : Any oral disease at inclusion (prevalence study)
1 secondary outcome
attending to consultations
Time frame: The collection of data will end at the discharge of the participant, or at 6 months after inclusion.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2020.
- Individual participant dataSharing planned: Undecided. NC
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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.
Claire M DUFLOS principal investigator
University Hospital, Montpellier
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 Oral Disease, run by University Hospital, Montpellier 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 2 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: status not confirmed, as of the sponsor's last update on 5 Jun 2020. 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 Claire M DUFLOS, MD (467336407 ext. 33, c-duflos@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of the oral problems of people entering detention (time frame: 1 day). 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 5 Jun 2020.