NCT01372436

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
678

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2007

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 22, 2008

Completed
3.1 years until next milestone

First Posted

Study publicly available on registry

June 14, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

July 24, 2018

Status Verified

June 1, 2018

Enrollment Period

6 years

First QC Date

April 22, 2008

Last Update Submit

July 23, 2018

Conditions

Keywords

dental decayDMFTIndividual Caries RiskRisk factors

Outcome Measures

Primary Outcomes (1)

  • dental decay

    every year

Study Arms (2)

1

children in high-school

2

children in primary school

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Children in primary or high-schools

You may qualify if:

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

You may not qualify if:

  • Planning to change school or high school in the 4 years
  • Refusing dental examination
  • Refusing to chew the piece of paraffine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Service d'Odontologie - Hôpital St Roch

Nice, 06000, France

Location

Haute Autorité de Santé

Saint-Denis, 93218, France

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Michèle Muller Bolla, Pr

    Odontologie - CHU de Nice

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2008

First Posted

June 14, 2011

Study Start

June 1, 2007

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

July 24, 2018

Record last verified: 2018-06

Locations