Tooth DecayPRECA-6NCT03817437
Correlation Study Between Socio-economical Deprivation and Oral Health in Children of 9 Years of Age
An observational study of Tooth Decay and Missing Tooth/Teeth, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Retrospective, observational cohort study. Objectives : To search for correlations between socio-economical deprivation and oral health in french children of 9 years of age. To study the annual use of oral and dental care of children from 6 to 9 years of age depending on their geographical and socio-economical… Read more about this study
- Who is it for?
- Ages 6 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Decay, Missing Tooth/Teeth
- How many people
- 600,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2019to 1 Jun 2020
- 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 6 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Patients born in 2008
Who may be able to join
- Being born in 2008
- Being covered by the mandatory french national health insurance plan without discontinuity between 2014 and 2017
- Living in France without discontinuity between 2014 and 2017
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation Study Between Socio-economical Deprivation and Oral Health in in French Children of 9 Years of Age in 2017. A Nationwide Database Retrospective Observational Cohort Study
Retrospective, observational cohort study.
Objectives :
To search for correlations between socio-economical deprivation and oral health in french children of 9 years of age.
To study the annual use of oral and dental care of children from 6 to 9 years of age depending on their geographical and socio-economical environment, and the medical demography ; To identify and study the share of the cohort not using oral and dental care, and the socio-economical and geographical factors implicated in this non-use of care.
The study will use data from the french nationwide healthcare systems database (SNDS) and data from the french national institute of statistics and economic studies (INSEE).
- Conditions
- Tooth Decay, Missing Tooth/Teeth
- Keywords
- Oral health, Odontology, Epidemiology, Public health, Deprivation
- Medical subject headings
- Dental Caries, Anodontia
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlations (odds-ratios) between several socio-economical indicators and oral care use
Correlations (odds-ratios) between several socio-economical indicators and oral care use
Measured: 36 months
Secondary outcomes (1)
Mean numbers of several types of oral cares depending on the patients geographical and socio-economical environment
Mean numbers of several types of oral cares depending on the patients geographical and socio-economical environment, and the medical demography
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2019
- Study start1 Jan 2019
- Primary completion30 Apr 2019
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth DecayStudies 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
- Retrospective
- Enrolment
- 600,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume BOUREL, MsC, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03817437
- Sponsor's protocol ID
- RECHMPL18_0401
- Acronym
- PRECA-6
- Status last verified
- Jun 2020
- First submitted
- 23 Jan 2019
- 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
- Correlation Study Between Socio-economical Deprivation and Oral Health in in French Children of 9 Years of Age in 2017. A Nationwide Database Retrospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT03817437
- Acronym / sponsor ID
- PRECA-6 / RECHMPL18_0401
- Conditions
- Tooth Decay, Missing Tooth/Teeth
- Keywords
- Oral health, Odontology, Epidemiology, Public health, Deprivation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600,000 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 25 Jan 2019 (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.
Retrospective, observational cohort study.
Objectives :
To search for correlations between socio-economical deprivation and oral health in french children of 9 years of age.
To study the annual use of oral and dental care of children from 6 to 9 years of age depending on their geographical and socio-economical environment, and the medical demography ; To identify and study the share of the cohort not using oral and dental care, and the socio-economical and geographical factors implicated in this non-use of care.
The study will use data from the french nationwide healthcare systems database (SNDS) and data from the french national institute of statistics and economic studies (INSEE).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Patients born in 2008
Key inclusion criteria (3 listed)
- Being born in 2008
- Being covered by the mandatory french national health insurance plan without discontinuity between 2014 and 2017
- Living in France without discontinuity between 2014 and 2017
Key exclusion criteria (1 listed)
- None
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
Correlations (odds-ratios) between several socio-economical indicators and oral care use
Time frame: 36 months
Correlations (odds-ratios) between several socio-economical indicators and oral care use
1 secondary outcome
Mean numbers of several types of oral cares depending on the patients geographical and socio-economical environment
Time frame: 36 months
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 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.
Guillaume BOUREL, MsC 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 Tooth Decay and Missing Tooth/Teeth, 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 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?
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?
Correlations (odds-ratios) between several socio-economical indicators and oral care use (time frame: 36 months). 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.