Study of Factors of Genetic Susceptibility Associated to Severe Caries Phenotype
Cariogene
1 other identifier
interventional
390
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2007
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 4, 2007
CompletedFirst Posted
Study publicly available on registry
October 8, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedMarch 4, 2026
March 1, 2026
2.1 years
October 4, 2007
March 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (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.
6 months
Study Arms (2)
A
ACTIVE COMPARATOR250 young patients presenting several carious lesions
B
PLACEBO COMPARATOR160 young adults totally caries free
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hopital Bretonneau
Paris, 75018, France
Related Publications (1)
Gasse B, Grabar S, Lafont AG, Quinquis L, Opsahl Vital S, Davit-Beal T, Moulis E, Chabadel O, Hennequin M, Courson F, Droz D, Vaysse F, Laboux O, Tassery H, Al-Hashimi N, Boillot A, Carel JC, Treluyer JM, Jeanpierre M, Beldjord C, Sire JY, Chaussain C. Common SNPs of AmelogeninX (AMELX) and dental caries susceptibility. J Dent Res. 2013 May;92(5):418-24. doi: 10.1177/0022034513482941. Epub 2013 Mar 22.
PMID: 23525533RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Catherine Miller, MCU-PH
Assistance Publique - Hôpitaux de Paris
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 4, 2007
First Posted
October 8, 2007
Study Start
October 1, 2007
Primary Completion
November 1, 2009
Study Completion
November 1, 2009
Last Updated
March 4, 2026
Record last verified: 2026-03