Dental CariesNCT04795258
Oral Health Assessment of Children in CP Class
An observational study of Dental Caries, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Few oral exams are performed on 6-year-olds (key age for carious disease). This project aims to increase the number of oral check-ups for 6-year-olds in fragile areas (REP/REP+ areas). Read more about this study
- Who is it for?
- Ages 5 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- How many people
- 671 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2021to 1 Mar 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 5 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: first-grade student enrolled in a school in a zone REP/REP+
Who may be able to join
- Be a first-grade student enrolled in a school in a zone REP/REP+
- Have a parental permission
- Good understanding of the French language
Who cannot join
- lack of parental permission
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral Health Assessment of Children in CP Class in REP/REP+ Areas in the Department of Hérault
Few oral exams are performed on 6-year-olds (key age for carious disease). This project aims to increase the number of oral check-ups for 6-year-olds in fragile areas (REP/REP+ areas).
- Conditions
- Dental Caries
- Keywords
- Oral hygiene, Public Health, Children, Prevention
- Medical subject headings
- Dental Caries
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of decay on each tooth present in the mouth
Presence of decay on each tooth present in the mouth
Measured: 1 day
Presence of care on each tooth present in the mouth
Presence of care on each tooth present in the mouth
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start1 Jan 2021
- Primary completion30 Jan 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- 671 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Camille INQUIMBERT, PhD, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04795258
- Sponsor's protocol ID
- RECHMPL21_0116
- Status last verified
- Mar 2021
- First submitted
- 9 Mar 2021
- Last updated
- 18 Mar 2021
- 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 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Health Assessment of Children in CP Class in REP/REP+ Areas in the Department of Hérault
- ClinicalTrials.gov ID
- NCT04795258
- Acronym / sponsor ID
- RECHMPL21_0116
- Conditions
- Dental Caries
- Keywords
- Oral hygiene, Public Health, Children, Prevention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 671 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 12 Mar 2021 (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.
Few oral exams are performed on 6-year-olds (key age for carious disease). This project aims to increase the number of oral check-ups for 6-year-olds in fragile areas (REP/REP+ areas).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- first-grade student enrolled in a school in a zone REP/REP+
Key inclusion criteria (3 listed)
- Be a first-grade student enrolled in a school in a zone REP/REP+
- Have a parental permission
- Good understanding of the French language
Key exclusion criteria (1 listed)
- lack of parental permission
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
Presence of decay on each tooth present in the mouth
Time frame: 1 day
Presence of decay on each tooth present in the mouth
Presence of care on each tooth present in the mouth
Time frame: 1 day
Presence of care on each tooth present in the mouth
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 18 Mar 2021.
- 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.
Camille INQUIMBERT, PhD study director
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 Dental Caries, 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 3 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 18 Mar 2021. 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?
Presence of decay on each tooth present in the mouth (time frame: 1 day). The study lists 2 primary outcomes in all. 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 18 Mar 2021.