Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02056262
Other study ID # AOI/2012/LH
Secondary ID 2013-A01213-42
Status Completed
Phase
First received
Last updated
Start date March 15, 2016
Est. completion date March 8, 2017

Study information

Verified date August 2020
Source Centre Hospitalier Universitaire de Nimes
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 56
Est. completion date March 8, 2017
Est. primary completion date March 8, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Years to 45 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
France CHRU de Montpellier - Centre de Soins, d'Enseignement et de Recherche Dentaires Montpellier
France CHRU de Montpellier - Hôpital La Colombière Montpellier
France CHRU de Nîmes - Hôpital Universitaire Carémeau Nîmes Cedex 9

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Other Profession (or parents' professions) baseline (day 0)
Other Age baseline (day 0)
Other Sex baseline (day 0)
Primary Bacterial profile Bacterial profiles will be constructed using saliva and plaque samples. Baseline (day 0)
Primary ICDAS assessment Dental caries will be assessed using the ICDAS (International Caries Detection and Assessment System) system Baseline (day 0)
Secondary Studies were stopped during high school? yes/no baseline (Day 0)
Secondary Does the patient have at least five fillings? yes/no Baseline (day 0)
Secondary 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)
Secondary Within the last 12 months, the patient has had dental care or tooth removal following the carious lesion? yes/no baseline (day 0)
Secondary Yesterday, did the patient eat at least three snacks (or sugary or carbonated drinks) between meals? yes/no Baseline (day 0)
Secondary Yesterday, did the patient brush his/her teeth fewer than 2 times? yes/no baseline (day 0)
Secondary The patient has at least one carious lesion restricted to the enamel? yes/no baseline (day 0)
Secondary 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)
Secondary The patient has at least one carious lesion attacking the dentin or pulp. yes/no baseline (day 0)
Secondary 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)