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Study of Factors of Genetic Susceptibility Associated to Severe Caries Phenotype (Cariogene)

This study has been completed.
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00541060
First received: October 4, 2007
Last updated: December 17, 2010
Last verified: November 2010
  Purpose

Alteration of the post- eruptive enamel microstructure due to a mutation of a gene coding for a matrix protein could increase the susceptibility of the enamel to caries after tooth eruption. To identify in young patients with severe caries incidence, the occurrence of mutations in several candidate genes which result in an alteration of the enamel microstructure that could explain the high caries susceptibility of the patient.


Condition Intervention
Dental Caries
Genetic: mutation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Study of Factors of Genetic Susceptibility Associated to Severe Caries Phenotype in Young Patients. First Approach by Systematic Screening of Candidate Genes

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • the finding of a mutation on the candidates genes not resulting in an amelogenesis imperfecta phenotype but associated to a severe caries phenotype [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • If a direct relation between a mutation and a severe caries phenotype was shown, all the classical approaches, prevention protocols and treatments of caries would need to be reconsidered. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 390
Study Start Date: October 2007
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
250 young patients presenting several carious lesions
Genetic: mutation
a mutation of a gene coding
Other Name: a mutation of a gene coding
Placebo Comparator: B
160 young adults totally caries free
Genetic: mutation
a mutation of a gene coding
Other Name: a mutation of a gene coding

Detailed Description:

Although its prevalence has decreased dramatically in European countries, dental caries remains a burden for the society and especially for certain groups of the population. For example, 80% of the carious lesions are diagnosed in about 20% of the children. For years, the aetiology of this disease has been mainly related to environmental factors but recent data support the possibility of a human genetic contribution. Alteration of the post- eruptive enamel microstructure due to a mutation of a gene coding for a matrix protein could increase the susceptibility of the enamel to caries after tooth eruption. The main objective of this study will be to identify in young patients with severe caries incidence, the occurrence of mutations in several candidate genes which result in an alteration of the enamel microstructure that could explain the high caries susceptibility of the patient. With this aim, we will carry out a case- control multicentre European study on 250 young patients presenting several carious lesions and 160 young adults totally caries free. Patients with systemic or enamel pathologies such as amelogenesis imperfecta will not be included in the study. The study will consist of 2 visits, 1: inclusion and genetic test based on a salivary sample and 2: after 6 months, communication of the genetic test result to the patient and his parents. The main evaluation criteria will be the finding of a mutation on the candidates genes not resulting in an amelogenesis imperfecta phenotype but associated to a severe caries phenotype. If a direct relation between a mutation and a severe caries phenotype was shown, all the classical approaches, prevention protocols and treatments of caries would need to be reconsidered.

  Eligibility

Ages Eligible for Study:   2 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients : presenting at least 3 active carious lesions aged 2 to 16 years old, written informed consent
  • Volunteers : young adults 18 to 30 years old totally caries free

Exclusion Criteria:

  • patients with systemic or enamel pathologies such as amelogenesis imperfecta
  • osteogenesis imperfecta
  • hypophosphatemia
  • hypodermal dysplasia
  • syndrome of Prader Willi
  • Fluoroses
  • toxic enamel dysplasia
  • pregnancy or breast-feeding
  • HYPOSIALORRHEA
  • immunodepression status
  • chronicle diseases
  • anorexia or bulimia
  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: NCT00541060

Locations
France
Hopital Bretonneau
Paris, France, 75018
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Study Director: Catherine Miller, MCU-PH AP-HP
  More Information

No publications provided

Responsible Party: Aurélie GUIMFACK, Department of Clinical Research of developpement
ClinicalTrials.gov Identifier: NCT00541060     History of Changes
Other Study ID Numbers: P061009
Study First Received: October 4, 2007
Last Updated: December 17, 2010
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
caries susceptibility,enamel matrix,candidate genes,mutation

Additional relevant MeSH terms:
Dental Caries
Disease Susceptibility
Genetic Predisposition to Disease
Disease Attributes
Pathologic Processes
Stomatognathic Diseases
Tooth Demineralization
Tooth Diseases

ClinicalTrials.gov processed this record on November 20, 2014