Clinical trial NCT02056262: Pathogenic Species and Genotypes of Bacterial Diversity in Relation to the Severity of Dental Caries
Official title: Prevalence and Identification of Pathogenic Species and Genotypes of Bacterial Diversity in Relation to the Severity of Dental Caries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Cavity
Keywords: Bacteria
microbial community
hygiene
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2014-02-05
Enrollment: 56
Sex: ALL
Minimum age (years): 3
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

Brief 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Bacterial profile
timeFrame: Baseline (day 0)
measure: ICDAS assessment
timeFrame: Baseline (day 0)
Secondary outcomes:
measure: Studies were stopped during high school? yes/no
timeFrame: baseline (Day 0)
measure: Does the patient have at least five fillings? yes/no
timeFrame: Baseline (day 0)
measure: Does the patient have at least one filling and one missing tooth on the anterior sector following the carious lesion? yes/no
timeFrame: baseline (day 0)
measure: Within the last 12 months, the patient has had dental care or tooth removal following the carious lesion? yes/no
timeFrame: baseline (day 0)
measure: Yesterday, did the patient eat at least three snacks (or sugary or carbonated drinks) between meals? yes/no
timeFrame: Baseline (day 0)
measure: Yesterday, did the patient brush his/her teeth fewer than 2 times? yes/no
timeFrame: baseline (day 0)
measure: The patient has at least one carious lesion restricted to the enamel? yes/no
timeFrame: baseline (day 0)
measure: 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)
timeFrame: baseline (day 0)
measure: The patient has at least one carious lesion attacking the dentin or pulp. yes/no
timeFrame: baseline (day 0)
measure: 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)
timeFrame: baseline (day 0)
Other outcomes:
measure: Profession (or parents' professions)
timeFrame: baseline (day 0)
measure: Age
timeFrame: baseline (day 0)
measure: Sex
timeFrame: baseline (day 0)
Locations:
city: Montpellier
country: France
facility: CHRU de Montpellier - Centre de Soins, d'Enseignement et de Recherche Dentaires
city: Montpellier
country: France
facility: CHRU de Montpellier - Hôpital La Colombière
city: Nîmes Cedex 9
country: France
facility: CHRU de Nîmes - Hôpital Universitaire Carémeau
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Hervé Léon, MD
role: PRINCIPAL_INVESTIGATOR
References: