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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by Centre Hospitalier Universitaire de Nīmes
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT02056262
First received: February 4, 2014
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Dental Cavity
Other: Dental cavity evaluation
Biological: Saliva sampling
Biological: Plaque sampling

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Prevalence and Identification of Pathogenic Species and Genotypes of Bacterial Diversity in Relation to the Severity of Dental Caries

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • Bacterial profile [ Time Frame: Baseline (day 0) ] [ Designated as safety issue: No ]
    Bacterial profiles will be constructed using saliva and plaque samples.

  • ICDAS assessment [ Time Frame: Baseline (day 0) ] [ Designated as safety issue: No ]
    Dental caries will be assessed using the ICDAS (International Caries Detection and Assessment System) system


Secondary Outcome Measures:
  • Studies were stopped during high school? yes/no [ Time Frame: baseline (Day 0) ] [ Designated as safety issue: No ]
  • Does the patient have at least five fillings? yes/no [ Time Frame: Baseline (day 0) ] [ Designated as safety issue: No ]
  • Does the patient have at least one filling and one missing tooth on the anterior sector following the carious lesion? yes/no [ Time Frame: baseline (day 0) ] [ Designated as safety issue: No ]
  • Within the last 12 months, the patient has had dental care or tooth removal following the carious lesion? yes/no [ Time Frame: baseline (day 0) ] [ Designated as safety issue: No ]
  • Yesterday, did the patient eat at least three snacks (or sugary or carbonated drinks) between meals? yes/no [ Time Frame: Baseline (day 0) ] [ Designated as safety issue: No ]
  • Yesterday, did the patient brush his/her teeth fewer than 2 times? yes/no [ Time Frame: baseline (day 0) ] [ Designated as safety issue: No ]
  • The patient has at least one carious lesion restricted to the enamel? yes/no [ Time Frame: baseline (day 0) ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: baseline (day 0) ] [ Designated as safety issue: No ]
  • The patient has at least one carious lesion attacking the dentin or pulp. yes/no [ Time Frame: baseline (day 0) ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: baseline (day 0) ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Profession (or parents' professions) [ Time Frame: baseline (day 0) ] [ Designated as safety issue: No ]
  • Age [ Time Frame: baseline (day 0) ] [ Designated as safety issue: No ]
  • Sex [ Time Frame: baseline (day 0) ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

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


Estimated Enrollment: 56
Study Start Date: December 2014
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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

Ages Eligible for Study:   3 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02056262

Contacts
Contact: Hervé Léon, MD +33.(0)4.66.68.68.54 herve.leon@chu-nimes.fr
Contact: Carey Suehs, PhD +33.(0)4.66.68.67.88 carey.suehs@chu-nimes.fr

Locations
France
CHRU de Montpellier - Centre de Soins, d'Enseignement et de Recherche Dentaires Not yet recruiting
Montpellier, France, 34295
Sub-Investigator: Jean-Christophe Chazel, MD, PhD         
Sub-Investigator: Pierre Michailesco, MD, PhD         
Sub-Investigator: Estelle Moulis, MD, PhD         
Sub-Investigator: Paul Tramini, MD, PhD         
Sub-Investigator: Jean Valcarcel, MD, PhD         
Sub-Investigator: Paula Vintan, MD         
CHRU de Montpellier - Hôpital La Colombière Active, not recruiting
Montpellier, France, 34295
CHRU de Nîmes - Hôpital Universitaire Carémeau Not yet recruiting
Nîmes Cedex 9, France, 30029
Principal Investigator: Hervé Léon, MD         
Sub-Investigator: Jean-Albert Triay, MD         
Sub-Investigator: Bernard Delarbre, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Hervé Léon, MD Centre Hospitalier Universitaire de Nîmes
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT02056262     History of Changes
Other Study ID Numbers: AOI/2012/LH, 2013-A01213-42
Study First Received: February 4, 2014
Last Updated: March 3, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
France: Committee for the Protection of Personnes

Keywords provided by Centre Hospitalier Universitaire de Nīmes:
Bacteria
microbial community
hygiene

Additional relevant MeSH terms:
Dental Caries
Stomatognathic Diseases
Tooth Demineralization
Tooth Diseases

ClinicalTrials.gov processed this record on October 23, 2014