Dental CavityCaries SpeciesNCT02056262
Pathogenic Species and Genotypes of Bacterial Diversity in Relation to the Severity of Dental Caries
An observational study of Dental Cavity, run by Centre Hospitalier Universitaire de Nīmes at 3 sites in France.
Trial summary
The primary objective of this study is to estimate the distribution of pathogenic species and genotypes of bacterial diversity in 7 stages ICDAS (International Caries Detection and Assessment System) corresponding to the severity of dental caries among patients aged 3-45 years consulting in the Dentistry Departments… Read more about this study
- Who is it for?
- Ages 3 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Cavity
- What is being tested?
- Dental cavity evaluation, Saliva sampling and Plaque sampling
- How many people
- 56 participants
- Where
- 3 sitesFrance
- Study dates
- 15 Mar 2016to 8 Mar 2017
- Phase
- Observational
- 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 3 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Volunteers aged 3 to 45 who come in to the hospital for a dental consultation. Patients are recruted according to age in order to form two groups: 1/2 of participants will be between 3 and 16 years of age; the other half of participants will be between 17 and 45 years of age.
Who may be able to join
- Volunteers aged 3 to 45 who come in to the hospital for a dental consultation
- Minors must have parental permission
- The patient must have given his/her informed and signed consent
Who cannot join
- The patient is participating in another study
- The patient is in an exclusion period determined by a previous study
- The patient is pregnant, or breastfeeding
- The patient has been on antibiotics within the past two months
- Smokers
- Teeth under current care
Show all 9Show fewer
- Parodontopathy
- Use of a mouthwash within the last week
- Insufficient numbers of healthy and/or teeth with carious lesions for carrying out the study
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHRU de Montpellier - Centre de Soins, d'Enseignement et de Recherche Dentaires
Montpellier, 34295
CHRU de Montpellier - Hôpital La Colombière
Montpellier, 34295
CHRU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, 30029
About this study
Official title: Prevalence and Identification of Pathogenic Species and Genotypes of Bacterial Diversity in Relation to the Severity of Dental Caries
The primary objective of this study is to estimate the distribution of pathogenic species and genotypes of bacterial diversity in 7 stages ICDAS (International Caries Detection and Assessment System) corresponding to the severity of dental caries among patients aged 3-45 years consulting in the Dentistry Departments of the Nîmes University Hospital and the Montpellier University Hospital.
Read the detailed description
Secondary objectives include:
- Compare the distribution of bacterial species in relation to stages of severity of caries
- Compare the results from plaque with those of saliva samples.
- Conditions
- Dental Cavity
- Being tested
- Dental cavity evaluation, Saliva sampling, Plaque sampling
- Keywords
- Bacteria, microbial community, hygiene
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental cavity evaluationOther
The dental cavities present will be evaluated using the ICDAS (International Caries Detection and Assessment System).
Saliva samplingBiological
A saliva sample will be harvested.
Plaque samplingBiological
Plaque samples from a healthy tooth and a tooth with a cavity will be harvested.
| Study group | Role | What they receive |
|---|---|---|
| 3 to 16 years of age | Volunteers of 3 to 16 years of age, coming in to the hospital for a dental consultation. See inclusion/exclusion criteria.
Intervention: Dental cavity evaluation Intervention: Saliva sampling Intervention: Plaque sampling Receives: Other: Dental cavity evaluation; Biological: Saliva sampling; Biological: Plaque sampling | |
| 17 - 45 years of age | Volunteers of 17 to 45 years of age, coming in to the hospital for a dental consultation. See inclusion/exclusion criteria.
Intervention: Dental cavity evaluation Intervention: Saliva sampling Intervention: Plaque sampling Receives: Other: Dental cavity evaluation; Biological: Saliva sampling; Biological: Plaque sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial profile
Bacterial profiles will be constructed using saliva and plaque samples.
Measured: Baseline (day 0)
ICDAS assessment
Dental caries will be assessed using the ICDAS (International Caries Detection and Assessment System) system
Measured: Baseline (day 0)
Secondary outcomes (10)
Studies were stopped during high school? yes/no
Measured: baseline (Day 0)
Does the patient have at least five fillings? yes/no
Measured: Baseline (day 0)
Does the patient have at least one filling and one missing tooth on the anterior sector following the carious lesion? yes/no
Measured: baseline (day 0)
Within the last 12 months, the patient has had dental care or tooth removal following the carious lesion? yes/no
Measured: baseline (day 0)
Yesterday, did the patient eat at least three snacks (or sugary or carbonated drinks) between meals? yes/no
Measured: Baseline (day 0)
Yesterday, did the patient brush his/her teeth fewer than 2 times? yes/no
Measured: baseline (day 0)
The patient has at least one carious lesion restricted to the enamel? yes/no
Measured: baseline (day 0)
The patient has at least one carious lesion restricted to the enamel on an anterior tooth or involving the smooth surface on a posterior tooth (yes/no)
Measured: baseline (day 0)
The patient has at least one carious lesion attacking the dentin or pulp. yes/no
Measured: baseline (day 0)
The patient has at least one carious lesion reaching dentin or pulp on an anterior tooth or on the smooth surface of a posterior tooth (yes/no)
Measured: baseline (day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2014 (estimated)
- Study start15 Mar 2016
- Primary completion8 Mar 2017
- Study completion8 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CavityStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hervé Léon, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02056262
- Sponsor's protocol ID
- AOI/2012/LH
- Other IDs
- 2013-A01213-42
- Acronym
- Caries Species
- Status last verified
- Aug 2020
- First submitted
- 4 Feb 2014
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Identification of Pathogenic Species and Genotypes of Bacterial Diversity in Relation to the Severity of Dental Caries
- ClinicalTrials.gov ID
- NCT02056262
- Acronym / sponsor ID
- Caries Species / AOI/2012/LH
- Conditions
- Dental Cavity
- Keywords
- Bacteria, microbial community, hygiene
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 15 Mar 2016 (actual)
- Primary completion
- 8 Mar 2017 (actual)
- Study completion
- 8 Mar 2017 (actual)
- First posted
- 5 Feb 2014 (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.
The primary objective of this study is to estimate the distribution of pathogenic species and genotypes of bacterial diversity in 7 stages ICDAS (International Caries Detection and Assessment System) corresponding to the severity of dental caries among patients aged 3-45 years consulting in the Dentistry Departments of the Nîmes University Hospital and the Montpellier University Hospital.
Detailed description
Secondary objectives include:
- Compare the distribution of bacterial species in relation to stages of severity of caries
- Compare the results from plaque with those of saliva samples.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3 to 16 years of age | – | Other: Dental cavity evaluation, Biological: Saliva sampling, Biological: Plaque samplingVolunteers of 3 to 16 years of age, coming in to the hospital for a dental consultation. See inclusion/exclusion criteria. Intervention: Dental cavity evaluation Intervention: Saliva sampling Intervention: Plaque sampling |
| 17 - 45 years of age | – | Other: Dental cavity evaluation, Biological: Saliva sampling, Biological: Plaque samplingVolunteers of 17 to 45 years of age, coming in to the hospital for a dental consultation. See inclusion/exclusion criteria. Intervention: Dental cavity evaluation Intervention: Saliva sampling Intervention: Plaque sampling |
Who may qualify
- Ages
- 3 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Volunteers aged 3 to 45 who come in to the hospital for a dental consultation. Patients are recruted according to age in order to form two groups: 1/2 of participants will be between 3 and 16 years of age; the other half of participants will be between 17 and 45 years of age.
Key inclusion criteria (3 listed)
- Volunteers aged 3 to 45 who come in to the hospital for a dental consultation
- Minors must have parental permission
- The patient must have given his/her informed and signed consent
Key exclusion criteria (9 listed)
- The patient is participating in another study
- The patient is in an exclusion period determined by a previous study
- The patient is pregnant, or breastfeeding
- The patient has been on antibiotics within the past two months
- Smokers
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 |
|---|---|---|
| Dental cavity evaluationThe dental cavities present will be evaluated using the ICDAS (International Caries Detection and Assessment System). | Other | 17 - 45 years of age, 3 to 16 years of age |
| Saliva samplingA saliva sample will be harvested. | Biological | 17 - 45 years of age, 3 to 16 years of age |
| Plaque samplingPlaque samples from a healthy tooth and a tooth with a cavity will be harvested. | Biological | 17 - 45 years of age, 3 to 16 years of age |
Primary outcome
Bacterial profile
Time frame: Baseline (day 0)
Bacterial profiles will be constructed using saliva and plaque samples.
ICDAS assessment
Time frame: Baseline (day 0)
Dental caries will be assessed using the ICDAS (International Caries Detection and Assessment System) system
10 secondary outcomes
Studies were stopped during high school? yes/no
Time frame: baseline (Day 0)
Does the patient have at least five fillings? yes/no
Time frame: Baseline (day 0)
Does the patient have at least one filling and one missing tooth on the anterior sector following the carious lesion? yes/no
Time frame: baseline (day 0)
Within the last 12 months, the patient has had dental care or tooth removal following the carious lesion? yes/no
Time frame: baseline (day 0)
Yesterday, did the patient eat at least three snacks (or sugary or carbonated drinks) between meals? yes/no
Time frame: Baseline (day 0)
Yesterday, did the patient brush his/her teeth fewer than 2 times? yes/no
Time frame: baseline (day 0)
The patient has at least one carious lesion restricted to the enamel? yes/no
Time frame: baseline (day 0)
The patient has at least one carious lesion restricted to the enamel on an anterior tooth or involving the smooth surface on a posterior tooth (yes/no)
Time frame: baseline (day 0)
The patient has at least one carious lesion attacking the dentin or pulp. yes/no
Time frame: baseline (day 0)
The patient has at least one carious lesion reaching dentin or pulp on an anterior tooth or on the smooth surface of a posterior tooth (yes/no)
Time frame: baseline (day 0)
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 30 Jun 2026.
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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.
Hervé Léon, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Cavity, run by Centre Hospitalier Universitaire de Nīmes at 3 sites 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 3 inclusion and 9 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 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. 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?
Bacterial profile (time frame: Baseline (day 0)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jun 2026.