Caries Risk Assessment in Children and Adolescents in the Alpes Maritimes (France)
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| First Received Date ICMJE | April 22, 2008 | ||||||||
| Last Updated Date | January 23, 2013 | ||||||||
| Start Date ICMJE | June 2007 | ||||||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
dental decay [ Time Frame: every year ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01372436 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Caries Risk Assessment in Children and Adolescents in the Alpes Maritimes (France) | ||||||||
| Official Title ICMJE | Caries Risk Assessment in Children and Adolescents in the Alpes Maritimes (France) | ||||||||
| Brief 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 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). |
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| 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:
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) |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Probability Sample | ||||||||
| Study Population | Children in primary or high-schools |
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| Condition ICMJE | Children in School | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 678 | ||||||||
| Estimated Completion Date | June 2013 | ||||||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria: - Enrolled in 1rst or 5th year (CP ou 6ème) at the beginning of the study Exclusion criteria:
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| Gender | Both | ||||||||
| Ages | 5 Years to 18 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | France | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01372436 | ||||||||
| Other Study ID Numbers ICMJE | ARPSPBD2 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Centre Hospitalier Universitaire de Nice | ||||||||
| Study Sponsor ICMJE | Centre Hospitalier Universitaire de Nice | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Centre Hospitalier Universitaire de Nice | ||||||||
| Verification Date | April 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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