Children in SchoolNCT01372436
Caries Risk Assessment in Children and Adolescents in the Alpes Maritimes (France)
An observational study of Children in School, run by Centre Hospitalier Universitaire de Nice at 2 sites in France.
Trial summary
Identification of caries high risk subjects. Studying the relevance and the distribution of caries risk factors as defined by the HAS, and the part played by the zone of schooling (priority education area or not) Studying the interest of bacteriological tests using the technique of real-time PCR and the laser… Read more about this study
- Who is it for?
- Ages 5 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Children in School
- How many people
- 678 participants
- Where
- 2 sitesFrance
- Study dates
- Jun 2007to Jun 2013
- 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 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Children in primary or high-schools
Who may be able to join
- Enrolled in 1rst or 5th year (CP ou 6ème) at the beginning of the study
Who cannot join
- Planning to change school or high school in the 4 years
- Refusing dental examination
- Refusing to chew the piece of paraffine
Trial locations and contacts
2 sites in 1 country.
France2 sites
Service d'Odontologie - Hôpital St Roch
Nice, 06000
Haute Autorité de Santé
Saint-Denis, 93218
About this study
Identification of caries high risk subjects. Studying the relevance and the distribution of caries risk factors as defined by the HAS, and the part played by the zone of schooling (priority education area or not) Studying the interest of bacteriological tests using the technique of real-time PCR and the laser fluorescence device in the caries risk assessment Thanks to a prospective cohort study conducted over a period of 4 years on a representative sample of pupils and students chosen at random from the 360 primary schools and 89 high schools in the Alpes Maritimes (678 subjects).
Read the detailed description
Main goal: Reducing social inequalities in dental health in the Alpes-Maritimes with the identification of high-risk subjects in order to implement effective preventive actions focused on people likely to benefit most from such actions.
Carrying out a prospective representative cohort, in schools, over a period of 4 years has the following objectives:
- To study the pattern of risk factors for tooth decay, as defined by the HAS, in the representative studied sample, and particularly to assess the part played by the zone of schooling (priority education area (low socio-economic) (PEA) or not).
- To evaluate, in a representative French sample, the relevance of the caries risk (CR) factors defined by the HAS based on an analysis of the foreign literature.
- To evaluate the interest of bacteriological tests using the technique of real-time PCR (Cario-analysis ®, Pierre Fabre Oral Care) in the assessment of CR, once the other risk factors are taken into account.
- To study the interest of using a laser fluorescence device (Diagnodent ® Pen, Kavo) compared to clinical examination alone, in the detection of caries which are difficult to diagnose(approximal caries or small enamel lesions) and its impact on the caries risk assessment.
Study Type: prospective cohort study. Population study: This study is conducted in 360 primary schools and 89 high-schools in the Alpes Maritimes (randomized study). They are divided into two strata (priority education area or not). Within each stratum and for each level of education (primary schools and high schools), schools are chosen at random on the corresponding list until the number of children needed in both the 1rst grade and the 5th grade is reached.
Pupils are followed by the investigators. Subjects Number: 678 (339 in 1rst grade and 339 in 5th grade proportionally divided into non-PEA and PEA).
Duration of follow-up: 4 years Frequency of visits: annual visits Oral health screening - clinical examination (probe and mirror) and with the new laser fluorescence device (DIAGNOdent ® pen, Kavo). Salivary Tests: bacteriological in real-time PCR (Cario-analysis ® Oral Care Pierre Fabre) and CRT Buffer ® Ivoclar Vivadent) Statistical analyses - Descriptive analyses and logistic regression models (dependent variable is the high caries risk (when CAODM36-CAODJ0 > or = 4)
- Conditions
- Children in School
- Keywords
- dental decay, DMFT, Individual Caries Risk, Risk factors
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | children in high-school | |
| 2 | children in primary school |
What is being measured
The primary outcome is the main question the study is designed to answer.
dental decay
Measured: every year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2011 (estimated)
- Study startJun 2007
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children in SchoolStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- 678 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michèle Muller Bolla, Pr, Principal investigator, Odontologie - CHU de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01372436
- Sponsor's protocol ID
- ARPSPBD2
- Status last verified
- Jun 2018
- First submitted
- 22 Apr 2008
- Last updated
- 24 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caries Risk Assessment in Children and Adolescents in the Alpes Maritimes (France)
- ClinicalTrials.gov ID
- NCT01372436
- Acronym / sponsor ID
- ARPSPBD2
- Conditions
- Children in School
- Keywords
- dental decay, DMFT, Individual Caries Risk, Risk factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 678 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Jun 2007 (actual)
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 14 Jun 2011 (estimated)
- 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.
Identification of caries high risk subjects. Studying the relevance and the distribution of caries risk factors as defined by the HAS, and the part played by the zone of schooling (priority education area or not) Studying the interest of bacteriological tests using the technique of real-time PCR and the laser fluorescence device in the caries risk assessment Thanks to a prospective cohort study conducted over a period of 4 years on a representative sample of pupils and students chosen at random from the 360 primary schools and 89 high schools in the Alpes Maritimes (678 subjects).
Detailed description
Main goal: Reducing social inequalities in dental health in the Alpes-Maritimes with the identification of high-risk subjects in order to implement effective preventive actions focused on people likely to benefit most from such actions.
Carrying out a prospective representative cohort, in schools, over a period of 4 years has the following objectives:
- To study the pattern of risk factors for tooth decay, as defined by the HAS, in the representative studied sample, and particularly to assess the part played by the zone of schooling (priority education area (low socio-economic) (PEA) or not).
- To evaluate, in a representative French sample, the relevance of the caries risk (CR) factors defined by the HAS based on an analysis of the foreign literature.
- To evaluate the interest of bacteriological tests using the technique of real-time PCR (Cario-analysis ®, Pierre Fabre Oral Care) in the assessment of CR, once the other risk factors are taken into account.
- To study the interest of using a laser fluorescence device (Diagnodent ® Pen, Kavo) compared to clinical examination alone, in the detection of caries which are difficult to diagnose(approximal caries or small enamel lesions) and its impact on the caries risk assessment.
Study Type: prospective cohort study. Population study: This study is conducted in 360 primary schools and 89 high-schools in the Alpes Maritimes (randomized study). They are divided into two strata (priority education area or not). Within each stratum and for each level of education (primary schools and high schools), schools are chosen at random on the corresponding list until the number of children needed in both the 1rst grade and the 5th grade is reached.
Pupils are followed by the investigators. Subjects Number: 678 (339 in 1rst grade and 339 in 5th grade proportionally divided into non-PEA and PEA).
Duration of follow-up: 4 years Frequency of visits: annual visits Oral health screening - clinical examination (probe and mirror) and with the new laser fluorescence device (DIAGNOdent ® pen, Kavo). Salivary Tests: bacteriological in real-time PCR (Cario-analysis ® Oral Care Pierre Fabre) and CRT Buffer ® Ivoclar Vivadent) Statistical analyses - Descriptive analyses and logistic regression models (dependent variable is the high caries risk (when CAODM36-CAODJ0 > or = 4)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –children in high-school |
| 2 | – | –children in primary school |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Children in primary or high-schools
Key inclusion criteria (1 listed)
- Enrolled in 1rst or 5th year (CP ou 6ème) at the beginning of the study
Key exclusion criteria (3 listed)
- Planning to change school or high school in the 4 years
- Refusing dental examination
- Refusing to chew the piece of paraffine
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
dental decay
Time frame: every year
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 24 Jul 2018.
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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.
Michèle Muller Bolla, Pr principal investigator
Odontologie - CHU de Nice
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Children in School, run by Centre Hospitalier Universitaire de Nice at 2 sites 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 1 inclusion and 3 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 24 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
dental decay (time frame: every year). 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 24 Jul 2018.