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Trial record 6 of 1235 for:    tooth decay

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

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ClinicalTrials.gov Identifier: NCT02056262
Recruitment Status : Unknown
Verified March 2016 by Centre Hospitalier Universitaire de Nīmes.
Recruitment status was:  Recruiting
First Posted : February 5, 2014
Last Update Posted : February 1, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Dental Cavity 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.

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Study Type : Observational
Estimated Enrollment : 56 participants
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
Actual Study Start Date : March 15, 2016
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay

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.




Primary Outcome Measures :
  1. Bacterial profile [ Time Frame: Baseline (day 0) ]
    Bacterial profiles will be constructed using saliva and plaque samples.

  2. ICDAS assessment [ Time Frame: Baseline (day 0) ]
    Dental caries will be assessed using the ICDAS (International Caries Detection and Assessment System) system


Secondary Outcome Measures :
  1. Studies were stopped during high school? yes/no [ Time Frame: baseline (Day 0) ]
  2. Does the patient have at least five fillings? yes/no [ Time Frame: Baseline (day 0) ]
  3. 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) ]
  4. 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) ]
  5. Yesterday, did the patient eat at least three snacks (or sugary or carbonated drinks) between meals? yes/no [ Time Frame: Baseline (day 0) ]
  6. Yesterday, did the patient brush his/her teeth fewer than 2 times? yes/no [ Time Frame: baseline (day 0) ]
  7. The patient has at least one carious lesion restricted to the enamel? yes/no [ Time Frame: baseline (day 0) ]
  8. 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) ]
  9. The patient has at least one carious lesion attacking the dentin or pulp. yes/no [ Time Frame: baseline (day 0) ]
  10. 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) ]

Other Outcome Measures:
  1. Profession (or parents' professions) [ Time Frame: baseline (day 0) ]
  2. Age [ Time Frame: baseline (day 0) ]
  3. Sex [ Time Frame: baseline (day 0) ]

Biospecimen Retention:   Samples With DNA
Plaque and saliva samples; DNA analysis is aimed at describing microbial communities.


Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02056262


Contacts
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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
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France
CHRU de Montpellier - Centre de Soins, d'Enseignement et de Recherche Dentaires 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 Not yet recruiting
Montpellier, France, 34295
Sub-Investigator: Estelle Jumas-Bilak, MD, PhD         
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
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Principal Investigator: Hervé Léon, MD Centre Hospitalier Universitaire de Nîmes

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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT02056262     History of Changes
Other Study ID Numbers: AOI/2012/LH
2013-A01213-42 ( Other Identifier: RCB number )
First Posted: February 5, 2014    Key Record Dates
Last Update Posted: February 1, 2017
Last Verified: March 2016
Keywords provided by Centre Hospitalier Universitaire de Nīmes:
Bacteria
microbial community
hygiene
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases