Caries Risk Assessment in Children and Adolescents in the Alpes Maritimes (France)
|ClinicalTrials.gov Identifier: NCT01372436|
Recruitment Status : Unknown
Verified April 2008 by Centre Hospitalier Universitaire de Nice.
Recruitment status was: Recruiting
First Posted : June 14, 2011
Last Update Posted : January 24, 2013
|Condition or disease|
|Children in School|
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 Type :||Observational|
|Estimated Enrollment :||678 participants|
|Official Title:||Caries Risk Assessment in Children and Adolescents in the Alpes Maritimes (France)|
|Study Start Date :||June 2007|
|Estimated Primary Completion Date :||June 2013|
|Estimated Study Completion Date :||June 2013|
children in high-school
children in primary school
- dental decay [ Time Frame: every year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01372436
|Contact: Michèle Muller Bolla, Prfirstname.lastname@example.org|
|Contact: Laurence Lupi-Pegurier, PhDemail@example.com|
|Service d'Odontologie - Hôpital St Roch||Recruiting|
|Nice, France, 06000|
|Contact: Michèle MULLER BOLLA, Pr firstname.lastname@example.org|
|Contact: Laurence Lupi-Pegurier, PhD email@example.com|
|Principal Investigator: Michèle Muller Bolla, Pr|
|Sub-Investigator: Laurence Lupi Pegurier, PhD|
|Sub-Investigator: Cybèle BORG-REAL, Dr|
|Sub-Investigator: Marc BOLLA, Pr|
|Haute Autorité de Santé||Recruiting|
|Saint Denis, France, 93218|
|Contact: Philippe MARTEL, Dr firstname.lastname@example.org|
|Sub-Investigator: Philippe MARTEL, Dr|
|Principal Investigator:||Michèle Muller Bolla, Pr||Odontologie - CHU de Nice|