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Clinical Trials/NCT02056262
NCT02056262
Completed
Not Applicable

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

Centre Hospitalier Universitaire de Nīmes3 sites in 1 country56 target enrollmentMarch 15, 2016
ConditionsDental Cavity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dental Cavity
Sponsor
Centre Hospitalier Universitaire de Nīmes
Enrollment
56
Locations
3
Primary Endpoint
Bacterial profile
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 15, 2016
End Date
March 8, 2017
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Centre Hospitalier Universitaire de Nīmes
Responsible Party
Sponsor

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
  • 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

Outcomes

Primary Outcomes

Bacterial profile

Time Frame: Baseline (day 0)

Bacterial profiles will be constructed using saliva and plaque samples.

ICDAS assessment

Time Frame: Baseline (day 0)

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

Secondary Outcomes

  • Within the last 12 months, the patient has had dental care or tooth removal following the carious lesion? 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))
  • Does the patient have at least five fillings? 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))
  • 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))
  • Studies were stopped during high school? yes/no(baseline (Day 0))

Study Sites (3)

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