Study of Factors of Genetic Susceptibility Associated to Severe Caries Phenotype (Cariogene)
Primary Purpose
Dental Caries
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
mutation
Sponsored by
About this trial
This is an interventional basic science trial for Dental Caries focused on measuring caries susceptibility,enamel matrix,candidate genes,mutation
Eligibility 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
Sites / Locations
- Hopital Bretonneau
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
A
B
Arm Description
250 young patients presenting several carious lesions
160 young adults totally caries free
Outcomes
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
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.
Full Information
NCT ID
NCT00541060
First Posted
October 4, 2007
Last Updated
December 17, 2010
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT00541060
Brief Title
Study of Factors of Genetic Susceptibility Associated to Severe Caries Phenotype
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
caries susceptibility,enamel matrix,candidate genes,mutation
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
390 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Description
250 young patients presenting several carious lesions
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
160 young adults totally caries free
Intervention Type
Genetic
Intervention Name(s)
mutation
Other Intervention Name(s)
a mutation of a gene coding
Intervention Description
a mutation of a gene coding
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Miller, MCU-PH
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Study Director
Facility Information:
Facility Name
Hopital Bretonneau
City
Paris
ZIP/Postal Code
75018
Country
France
12. IPD Sharing Statement
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Study of Factors of Genetic Susceptibility Associated to Severe Caries Phenotype
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