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

Completed

• Conditions: Dental Cavity
• Interventions: Other: Dental cavity evaluation; Biological: Saliva sampling; Biological: Plaque sampling

• Registration Number: NCT02056262
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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.

Study Timeline

• Study First Submitted: 2014-02-04
• Study First Submitted QC: 2014-02-04
• Study First Posted: 2014-02-05
• Study Start: 2016-03-15
• Primary Completion: 2017-03-08
• Study Completion: 2017-03-08
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-11
• Last Update Posted: 2020-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
17 - 45 years of age	Saliva sampling	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
3 to 16 years of age	Plaque sampling	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
17 - 45 years of age	Dental cavity evaluation	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
3 to 16 years of age	Dental cavity evaluation	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
3 to 16 years of age	Saliva sampling	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
17 - 45 years of age	Plaque sampling	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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)
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)
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)
Studies were stopped during high school? 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)

Trial Locations

Locations (3)

CHRU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 9, France

CHRU de Montpellier - Hôpital La Colombière; 🇫🇷 Montpellier, France

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