Caries Risk Assessment in Children and Adolescents in the Alpes Maritimes (France)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by Centre Hospitalier Universitaire de Nice.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT01372436
First received: April 22, 2008
Last updated: January 23, 2013
Last verified: April 2008
  Purpose

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).


Condition
Children in School

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Caries Risk Assessment in Children and Adolescents in the Alpes Maritimes (France)

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:
  • dental decay [ Time Frame: every year ] [ Designated as safety issue: No ]

Estimated Enrollment: 678
Study Start Date: June 2007
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
children in high-school
2
children in primary school

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)

  Eligibility

Ages Eligible for Study:   5 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Children in primary or high-schools

Criteria

Inclusion Criteria:

- Enrolled in 1rst or 5th year (CP ou 6ème) at the beginning of the study

Exclusion criteria:

  • Planning to change school or high school in the 4 years
  • Refusing dental examination
  • Refusing to chew the piece of paraffine
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01372436

Contacts
Contact: Michèle Muller Bolla, Pr muller@unice.fr
Contact: Laurence Lupi-Pegurier, PhD lupi@unice.fr

Locations
France
Service d'Odontologie - Hôpital St Roch Recruiting
Nice, France, 06000
Contact: Michèle MULLER BOLLA, Pr       muller@unice.fr   
Contact: Laurence Lupi-Pegurier, PhD       lupi@unice.fr   
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       p.martel@has-sante.fr   
Sub-Investigator: Philippe MARTEL, Dr         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
Principal Investigator: Michèle Muller Bolla, Pr Odontologie - CHU de Nice
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT01372436     History of Changes
Other Study ID Numbers: ARPSPBD2
Study First Received: April 22, 2008
Last Updated: January 23, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: French Data Protection Authority
France: Institutional Ethical Committee

Keywords provided by Centre Hospitalier Universitaire de Nice:
dental decay
DMFT
Individual Caries Risk
Risk factors

ClinicalTrials.gov processed this record on October 19, 2014