Pathogenic Species and Genotypes of Bacterial Diversity in Relation to the Severity of Dental Caries (Caries Species)

June 29, 2026 updated by: Centre Hospitalier Universitaire de Nīmes

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • CHRU de Montpellier - Centre de Soins, d'Enseignement et de Recherche Dentaires
      • Montpellier, France, 34295
        • CHRU de Montpellier - Hôpital La Colombière
      • Nîmes, France, 30029
        • CHRU de Nîmes - Hôpital Universitaire Carémeau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Parodontopathy
  • Use of a mouthwash within the last week
  • Insufficient numbers of healthy and/or teeth with carious lesions for carrying out the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Other: Dental cavity evaluation
The dental cavities present will be evaluated using the ICDAS (International Caries Detection and Assessment System).
Biological: Saliva sampling
A saliva sample will be harvested.
Biological: Plaque sampling
Plaque samples from a healthy tooth and a tooth with a cavity will be harvested.
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
Other: Dental cavity evaluation
The dental cavities present will be evaluated using the ICDAS (International Caries Detection and Assessment System).
Biological: Saliva sampling
A saliva sample will be harvested.
Biological: Plaque sampling
Plaque samples from a healthy tooth and a tooth with a cavity will be harvested.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Bacterial profile
Time Frame: Baseline (day 0)
Bacterial profiles will be constructed using saliva and plaque samples.
Baseline (day 0)
ICDAS assessment
Time Frame: Baseline (day 0)
Dental caries will be assessed using the ICDAS (International Caries Detection and Assessment System) system
Baseline (day 0)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Studies were stopped during high school? yes/no
Time Frame: baseline (Day 0)
baseline (Day 0)
Does the patient have at least five fillings? yes/no
Time Frame: Baseline (day 0)
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)
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)
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)
Baseline (day 0)
Yesterday, did the patient brush his/her teeth fewer than 2 times? yes/no
Time Frame: baseline (day 0)
baseline (day 0)
The patient has at least one carious lesion restricted to the enamel? yes/no
Time Frame: baseline (day 0)
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)
baseline (day 0)
The patient has at least one carious lesion attacking the dentin or pulp. yes/no
Time Frame: baseline (day 0)
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)
baseline (day 0)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Age
Time Frame: baseline (day 0)
baseline (day 0)
Profession (or parents' professions)
Time Frame: baseline (day 0)
baseline (day 0)
Sex
Time Frame: baseline (day 0)
baseline (day 0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Nīmes

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hervé Léon, MD, Centre Hospitalier Universitaire de Nîmes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 15, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 8, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 8, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 4, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2014

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 5, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 30, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AOI/2012/LH
  • 2013-A01213-42 (Other Identifier: RCB number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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