- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06905067
Assessment of Oral Health in Minors Incarcerated at Fleury Merogis: Retrospective Observational Study (DENTMIN)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Corbeil-essonnes Cedex, France, 91106
- Centre Hospitalier Sud Francilien
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Male minor patients incarcerated at the Fleury-Mérogis Prison between June 2024 and December 2024
- Patients who have had a dental check-up
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Minors incarcerated in fleury-Merogis prison
male minors incarcerated in fleury merogis prison for a period between June and December 2024.
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Assessment of the DMFT index
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Decayed missing filled permanent teeth index (DMFT
Time Frame: at day 0
|
Number of decayed, missing and filled permanent teeth
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at day 0
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Frequency of brushing and presence of absence of snacking
Time Frame: at day 0
|
Assess oral hygiene and dietary habits
|
at day 0
|
|
NRS scale
Time Frame: at day 0
|
NRS (numeric rating scale) : A score of 0 means no pain, and 10 means the worst pain you have ever felt.
|
at day 0
|
|
Presence of oral pathology defined by a DMFT index > 0
Time Frame: at day 0
|
Assess oral pathologies in incarcerated minors
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at day 0
|
Collaborators and Investigators
Investigators
- Principal Investigator: Dominique ORPHELIN, MD, Centre Hospitalier Sud Francilien
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025/0007
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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