Dental CariesCariogeneNCT00541060
Study of Factors of Genetic Susceptibility Associated to Severe Caries Phenotype
A study testing mutation in people with Dental Caries, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 2 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- mutation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 390 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2007to Nov 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- patients with systemic or enamel pathologies such as amelogenesis imperfecta
- osteogenesis imperfecta
- hypophosphatemia
- hypodermal dysplasia
- syndrome of Prader Willi
- Fluoroses
Show all 12Show fewer
- toxic enamel dysplasia
- pregnancy or breast-feeding
- HYPOSIALORRHEA
- immunodepression status
- chronicle diseases
- anorexia or bulimia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Factors of Genetic Susceptibility Associated to Severe Caries Phenotype in Young Patients. First Approach by Systematic Screening of Candidate Genes
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.
Read the 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.
- Conditions
- Dental Caries
- Being tested
- mutation
- Keywords
- caries susceptibility,enamel matrix,candidate genes,mutation
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mutationGenetic
Also called a mutation of a gene coding
a mutation of a gene coding
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | 250 young patients presenting several carious lesions Receives: Genetic: mutation |
| B | Placebo comparator | 160 young adults totally caries free Receives: Genetic: mutation |
What is being measured
The primary outcome is the main question the study is designed to answer.
the finding of a mutation on the candidates genes not resulting in an amelogenesis imperfecta phenotype but associated to a severe caries phenotype
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2007 (estimated)
- Study startOct 2007
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 390 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Catherine Miller, MCU-PH, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00541060
- Sponsor's protocol ID
- P061009
- Acronym
- Cariogene
- Status last verified
- Mar 2026
- First submitted
- 4 Oct 2007
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23525533
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Factors of Genetic Susceptibility Associated to Severe Caries Phenotype in Young Patients. First Approach by Systematic Screening of Candidate Genes
- ClinicalTrials.gov ID
- NCT00541060
- Acronym / sponsor ID
- Cariogene / P061009
- Conditions
- Dental Caries
- Keywords
- caries susceptibility,enamel matrix,candidate genes,mutation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 390 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- Oct 2007
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 8 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Genetic: mutation250 young patients presenting several carious lesions |
| B | Placebo comparator | Genetic: mutation160 young adults totally caries free |
Who may qualify
- Ages
- 2 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (12 listed)
- patients with systemic or enamel pathologies such as amelogenesis imperfecta
- osteogenesis imperfecta
- hypophosphatemia
- hypodermal dysplasia
- syndrome of Prader Willi
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mutationAlso: a mutation of a gene codinga mutation of a gene coding | Genetic | A, B |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Results publication: PubMed 23525533Gasse 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine Miller, MCU-PH study director
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mutation in people with Dental Caries, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00541060, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.