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NCT Number: NCT02056262

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.

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Key information

Conditions

Dental Cavity Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

3 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU de Montpellier - Centre de Soins, d'Enseignement et de Recherche Dentaires, Montpellier, France

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dental cavity evaluation

Other

The dental cavities present will be evaluated using the ICDAS (International Caries Detection and Assessment System).

Saliva sampling

Biological

A saliva sample will be harvested.

Plaque sampling

Biological

Plaque samples from a healthy tooth and a tooth with a cavity will be harvested.

Primary outcomes

  1. Bacterial profile

    Time frame: Baseline (day 0)

    Bacterial profiles will be constructed using saliva and plaque samples.

  2. ICDAS assessment

    Time frame: Baseline (day 0)

    Dental caries will be assessed using the ICDAS (International Caries Detection and Assessment System) system

Secondary outcomes

  1. Studies were stopped during high school? yes/no

    Time frame: baseline (Day 0)

  2. Does the patient have at least five fillings? yes/no

    Time frame: Baseline (day 0)

  3. 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)

  4. 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)

  5. Yesterday, did the patient eat at least three snacks (or sugary or carbonated drinks) between meals? yes/no

    Time frame: Baseline (day 0)

  6. Yesterday, did the patient brush his/her teeth fewer than 2 times? yes/no

    Time frame: baseline (day 0)

  7. The patient has at least one carious lesion restricted to the enamel? yes/no

    Time frame: baseline (day 0)

  8. 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)

  9. The patient has at least one carious lesion attacking the dentin or pulp. yes/no

    Time frame: baseline (day 0)

  10. 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)

Other outcomes

  1. Profession (or parents' professions)

    Time frame: baseline (day 0)

  2. Age

    Time frame: baseline (day 0)

  3. Sex

    Time frame: baseline (day 0)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

Prevalence and Identification of Pathogenic Species and Genotypes of Bacterial Diversity in Relation to the Severity of Dental Caries

Acronym: Caries Species

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 5, 2014
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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