Study of Factors of Genetic Susceptibility Associated to Severe Caries Phenotype

Dental Caries Clinical Trial

— Cariogene  

Official title:

Study of Factors of Genetic Susceptibility Associated to Severe Caries Phenotype in Young Patients. First Approach by Systematic Screening of Candidate Genes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00541060
• Other study ID #: P061009
• Status: Completed
• Phase: N/A
• First received: October 4, 2007
• Last updated: December 17, 2010
• Start date: October 2007
• Est. completion date: November 2009

Study information

• Verified date: November 2010
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 390
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Years to 30 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Dental Caries
• Disease Susceptibility
• Genetic Predisposition to Disease

Intervention

Genetic:
• mutation
a mutation of a gene coding

Locations

Country	Name	City	State
France	Hopital Bretonneau	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the finding of a mutation on the candidates genes not resulting in an amelogenesis imperfecta phenotype but associated to a severe caries phenotype		baseline, 6 months	No
Secondary	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.		6 months	No