DMFT Index, ICDAS Score, Dental Plaque Index, Communication, Prevention, Dentist, OrthodontistDENTMINNCT06905067
Assessment of Oral Health in Minors Incarcerated at Fleury Merogis: Retrospective Observational Study
An observational study of DMFT Index, ICDAS Score, Dental Plaque Index, Communication, Prevention, Dentist, Orthodontist, run by Centre Hospitalier Sud Francilien at 1 site in France.
Trial summary
The goal of this study is to assess the oral health of males juveniles incarcerated at Fleury-Mérogis over a given period. The goal is also to understand the needs of these patients and improve their care in prison while raising awareness about oral health to achieve lasting results. Read more about this study
- Who is it for?
- Ages Up to 17 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- DMFT Index, ICDAS Score, Dental Plaque Index, Communication, Prevention, Dentist, Orthodontist
- What is being tested?
- questionnaire and dental clinical examination
- How many people
- 73 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jun 2025to 8 Jul 2025
- 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 Up to 17 years
- Men only
- Healthy volunteers accepted
- Child
Study population: male minors incarcerated in Fleury-Mérogis over the study period (between June 2024 and December 2024)
Who may be able to join
- Male minor patients incarcerated at the Fleury-Mérogis Prison between June 2024 and December 2024
- Patients who have had a dental check-up
Who cannot join
- Patients and/or those with parental authority who have been informed and have objected to the use of their data.- Female patients and/or those with parental authority over the newborn who have objected to the use of their data.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this study is to assess the oral health of males juveniles incarcerated at Fleury-Mérogis over a given period.
The goal is also to understand the needs of these patients and improve their care in prison while raising awareness about oral health to achieve lasting results.
Read more
Hypothesis: Incarcerated juveniles often grew up in precarious conditions. Is their DMFT (decayed, missing, filled permanent teeth) index higher than the "standard" juvenile population? Public interest: Understanding the needs of these juvenile patients, public health data.
By comparing our results to those of the "standard" population (non-incarcerated minors) through a literature review regarding the DMFT index in these patients, we will determine whether incarcerated juvenile patients represent a population at risk of developing oral pathologies. Oral disease prevention for these patients to raise awareness of the importance of oral hygiene and follow-up dental appointments outside of the prison system. The earlier these patients are educated, the greater the chance they will develop better habits throughout their lives.
Read the detailed description
This is a retrospective observational study in which we will collect data from the first dental consultation between June 2024 and December 2024.
The primary objective is to assess the oral health of minors incarcerated at Fleury-Mérogis using the primary outcome measure, the DMFT index.
77 male minors are included in the study. Data will be collected retrospectively by the research team from their medical records.
The data will be collected by the research team in a pseudo-anonymized form in an electronic CRF (case report form) and then analyzed by the biostatistician at the Clinical Research Unit of the Centre Hospitalier Sud Francilien.
- Conditions
- DMFT Index, ICDAS Score, Dental Plaque Index, Communication, Prevention, Dentist, Orthodontist
- Being tested
- questionnaire and dental clinical examination
- Keywords
- dental caries, DMF index, oral health, oral hygiene, humans, adolescent, jails, prisoners, young adult, male, prevalence, france, epidemiology, retrospective studies, observational studies as topic
- Medical subject headings
- Communication, Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire and dental clinical examinationOther
Assessment of the DMFT index
| Study group | Role | What they receive |
|---|---|---|
| Minors incarcerated in fleury-Merogis prison | male minors incarcerated in fleury merogis prison for a period between June and December 2024. Receives: Other: questionnaire and dental clinical examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decayed missing filled permanent teeth index (DMFT
Number of decayed, missing and filled permanent teeth
Measured: at day 0
Secondary outcomes (3)
Frequency of brushing and presence of absence of snacking
Assess oral hygiene and dietary habits
Measured: at day 0
NRS scale
NRS (numeric rating scale) : A score of 0 means no pain, and 10 means the worst pain you have ever felt.
Measured: at day 0
Presence of oral pathology defined by a DMFT index > 0
Assess oral pathologies in incarcerated minors
Measured: at day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start6 Jun 2025
- Primary completion8 Jul 2025
- Study completion8 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DMFT Index, ICDAS Score, Dental Plaque Index, Communication, Prevention, Dentist, OrthodontistStudies 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
- Retrospective
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Sud Francilien
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dominique ORPHELIN, MD, Principal investigator, Centre Hospitalier Sud Francilien
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06905067
- Sponsor's protocol ID
- 2025/0007
- Acronym
- DENTMIN
- Status last verified
- Aug 2025
- First submitted
- 25 Mar 2025
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Oral Health in Minors Incarcerated at Fleury Merogis: Retrospective Observational Study
- ClinicalTrials.gov ID
- NCT06905067
- Acronym / sponsor ID
- DENTMIN / 2025/0007
- Conditions
- DMFT Index, ICDAS Score, Dental Plaque Index, Communication, Prevention, Dentist, Orthodontist
- Keywords
- dental caries, DMF index, oral health, oral hygiene, humans, adolescent, jails, prisoners
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Centre Hospitalier Sud FrancilienUniversity, hospital or other
- Study start
- 6 Jun 2025 (actual)
- Primary completion
- 8 Jul 2025 (actual)
- Study completion
- 8 Jul 2025 (actual)
- First posted
- 1 Apr 2025 (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 goal of this study is to assess the oral health of males juveniles incarcerated at Fleury-Mérogis over a given period.
The goal is also to understand the needs of these patients and improve their care in prison while raising awareness about oral health to achieve lasting results.
Hypothesis: Incarcerated juveniles often grew up in precarious conditions. Is their DMFT (decayed, missing, filled permanent teeth) index higher than the "standard" juvenile population? Public interest: Understanding the needs of these juvenile patients, public health data.
By comparing our results to those of the "standard" population (non-incarcerated minors) through a literature review regarding the DMFT index in these patients, we will determine whether incarcerated juvenile patients represent a population at risk of developing oral pathologies. Oral disease prevention for these patients to raise awareness of the importance of oral hygiene and follow-up dental appointments outside of the prison system. The earlier these patients are educated, the greater the chance they will develop better habits throughout their lives.
Detailed description
This is a retrospective observational study in which we will collect data from the first dental consultation between June 2024 and December 2024.
The primary objective is to assess the oral health of minors incarcerated at Fleury-Mérogis using the primary outcome measure, the DMFT index.
77 male minors are included in the study. Data will be collected retrospectively by the research team from their medical records.
The data will be collected by the research team in a pseudo-anonymized form in an electronic CRF (case report form) and then analyzed by the biostatistician at the Clinical Research Unit of the Centre Hospitalier Sud Francilien.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Minors incarcerated in fleury-Merogis prison | – | Other: questionnaire and dental clinical examinationmale minors incarcerated in fleury merogis prison for a period between June and December 2024. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- male minors incarcerated in Fleury-Mérogis over the study period (between June 2024 and December 2024)
Key inclusion criteria (2 listed)
- Male minor patients incarcerated at the Fleury-Mérogis Prison between June 2024 and December 2024
- Patients who have had a dental check-up
Key exclusion criteria (1 listed)
- Patients and/or those with parental authority who have been informed and have objected to the use of their data.- Female patients and/or those with parental authority over the newborn who have objected to the use of their data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaire and dental clinical examinationAssessment of the DMFT index | Other | Minors incarcerated in fleury-Merogis prison |
Primary outcome
Decayed missing filled permanent teeth index (DMFT
Time frame: at day 0
Number of decayed, missing and filled permanent teeth
3 secondary outcomes
Frequency of brushing and presence of absence of snacking
Time frame: at day 0
NRS scale
Time frame: at day 0
Presence of oral pathology defined by a DMFT index > 0
Time frame: at day 0
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 14 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Dominique ORPHELIN, MD principal investigator
Centre Hospitalier Sud Francilien
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 DMFT Index, ICDAS Score, Dental Plaque Index, Communication, Prevention, Dentist, Orthodontist, run by Centre Hospitalier Sud Francilien 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: finished, as of the sponsor's last update on 14 Aug 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?
Decayed missing filled permanent teeth index (DMFT (time frame: at day 0). 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 14 Aug 2025.