Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00541060
Recruitment Status : Completed
First Posted : October 8, 2007
Last Update Posted : December 20, 2010
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris

Brief Summary:
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 or disease Intervention/treatment Phase
Dental Caries Genetic: mutation Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 390 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : October 2007
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   2 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00541060


Locations
Layout table for location information
France
Hopital Bretonneau
Paris, France, 75018
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Layout table for investigator information
Study Director: Catherine Miller, MCU-PH Assistance Publique - Hôpitaux de Paris
Layout table for additonal information
Responsible Party: Aurélie GUIMFACK, Department of Clinical Research of developpement
ClinicalTrials.gov Identifier: NCT00541060    
Other Study ID Numbers: P061009
First Posted: October 8, 2007    Key Record Dates
Last Update Posted: December 20, 2010
Last Verified: November 2010
Keywords provided by Assistance Publique - Hôpitaux de Paris:
caries susceptibility,enamel matrix,candidate genes,mutation
Additional relevant MeSH terms:
Layout table for MeSH terms
Dental Caries
Disease Susceptibility
Genetic Predisposition to Disease
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Disease Attributes
Pathologic Processes