Study of Factors of Genetic Susceptibility Associated to Severe Caries Phenotype (Cariogene)
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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 |
- 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 ]
- 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 |
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
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 Tooth Demineralization |
Tooth Diseases Stomatognathic Diseases Disease Attributes Pathologic Processes |
ClinicalTrials.gov processed this record on June 18, 2013