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

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: Completed
• Conditions: Dental Cavity
• Intervention / Treatment: Other: Dental cavity evaluation; Biological: Saliva sampling; Biological: Plaque sampling

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: Observational
• Enrollment (Actual): 56

Contacts and Locations

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 Cedex 9, France, 30029
    • CHRU de Nîmes - Hôpital Universitaire Carémeau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Bacterial profile	Bacterial profiles will be constructed using saliva and plaque samples.	Baseline (day 0)
ICDAS assessment	Dental caries will be assessed using the ICDAS (International Caries Detection and Assessment System) system	Baseline (day 0)

Secondary Outcome Measures

Outcome Measure	Time Frame
Studies were stopped during high school? yes/no	baseline (Day 0)
Does the patient have at least five fillings? yes/no	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	baseline (day 0)
Within the last 12 months, the patient has had dental care or tooth removal following the carious lesion? yes/no	baseline (day 0)
Yesterday, did the patient eat at least three snacks (or sugary or carbonated drinks) between meals? yes/no	Baseline (day 0)
Yesterday, did the patient brush his/her teeth fewer than 2 times? yes/no	baseline (day 0)
The patient has at least one carious lesion restricted to the enamel? yes/no	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)	baseline (day 0)
The patient has at least one carious lesion attacking the dentin or pulp. yes/no	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)	baseline (day 0)

Other Outcome Measures

Outcome Measure	Time Frame
Age	baseline (day 0)
Profession (or parents' professions)	baseline (day 0)
Sex	baseline (day 0)

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Hervé Léon, MD, Centre Hospitalier Universitaire de Nîmes

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2016
• Primary Completion (Actual): March 8, 2017
• Study Completion (Actual): March 8, 2017

Study Registration Dates

• First Submitted: February 4, 2014
• First Submitted That Met QC Criteria: February 4, 2014
• First Posted (Estimate): February 5, 2014

Study Record Updates

• Last Update Posted (Actual): August 12, 2020
• Last Update Submitted That Met QC Criteria: August 11, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Bacteria; hygiene; microbial community
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: AOI/2012/LH; 2013-A01213-42 (Other Identifier: RCB number)