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

NCT02056262 | Completed

• 2 other identifiers: AOI/2012/LH2013-A01213-42
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 3

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.

Conditions

Dental Cavity

Keywords

Bacteria; microbial community; hygiene

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• 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)

Other Outcomes (3)

• Profession (or parents' professions)

  baseline (day 0)

• Age

  baseline (day 0)

• Sex

  baseline (day 0)

Study Arms (2)

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; 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

Other: Dental cavity evaluation; Biological: Saliva sampling; Biological: Plaque sampling

Interventions

Dental cavity evaluation OTHER

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

17 - 45 years of age; 3 to 16 years of age

Saliva sampling BIOLOGICAL

A saliva sample will be harvested.

17 - 45 years of age; 3 to 16 years of age

Plaque sampling BIOLOGICAL

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

17 - 45 years of age; 3 to 16 years of age

Eligibility Criteria

• Age: 3 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• The patient is participating in another 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (3)

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

Montpellier, 34295, France

Location

CHRU de Montpellier - Hôpital La Colombière

Montpellier, 34295, France

Location

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plaque and saliva samples; DNA analysis is aimed at describing microbial communities.

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Hervé Léon, MD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2014
• First Posted: February 5, 2014
• Study Start: March 15, 2016
• Primary Completion: March 8, 2017
• Study Completion: March 8, 2017
• Last Updated: August 12, 2020

Record last verified: 2020-08

Locations

FR (3)