search
Back to results

Interdental Microbiota Among Adolescents (MIARC)

Primary Purpose

Dental Caries, Gingivitis

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Interdental brushes
Sponsored by
Université Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Caries focused on measuring Oral biofilm, Microbiota, Adolescent, Dental carie

Eligibility Criteria

15 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • presence of teeth 15-16-25-26-35-36-45-46
  • At least of 22 teeth
  • Good understanding of the French language
  • One of the parents accepts the terms of the study and signs the written informed consent
  • In good general health, without clinical abnormality and medical history
  • Periodontal pocket greater than or equal to 3mm at interdental sites 15-16, 25-26, 35-36, 45-46

Exclusion Criteria:

  • Smoking patient
  • Patient with pathologies, orthodontic appliance
  • Patient having taken antibiotics in the last 3 months
  • Patient regularly using interdental brushes and / or dental floss and / or mouthwash
  • Patient at risk for infectious endocarditis
  • Patient unable to answer questions, non-cooperative

Sites / Locations

  • TRAMINIRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Clinical examination and sample

Arm Description

Cross-sectional observational study Measure of 6 indices: "Bleeding on Intergental Brush Index" (BOIB) Gingivitis Score (GI) Plaque index score (PI) ICDAS Salivary test Individual caries risk assessment Determination of interdental brushes adapted to each interdental site Recovery of the interdental brush passed through the 4 sites (between 15-16, 25-26, 35-36, 45-46) on which the interdental biofilm was fixed during the passage in the interdental space. The interdental brush is immediately put in a sterile tube and then sent in dry ice to maintain the integrity of the genetic material. Quantitative PCR experiments will be performed and a qualitative and quantitative analysis of the interdental flora will be made.

Outcomes

Primary Outcome Measures

Quantification of bacteria in the interdental plaque
Interdental sampling with a brush

Secondary Outcome Measures

Distribution of bacteria according to different factors
Distribution of bacteria according to the level of caries risk, the salivary risk and other indices assessed during the clinical examination

Full Information

First Posted
October 2, 2018
Last Updated
November 6, 2018
Sponsor
Université Montpellier
Collaborators
University of Lyon
search

1. Study Identification

Unique Protocol Identification Number
NCT03700840
Brief Title
Interdental Microbiota Among Adolescents
Acronym
MIARC
Official Title
Interdental Microbiota According to the Caries Risk Factors Among Adolescents Aged 15 to 17 Years.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 2018 (Anticipated)
Primary Completion Date
December 31, 2018 (Anticipated)
Study Completion Date
December 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université Montpellier
Collaborators
University of Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Adolescence remains a period during which tooth decay is still very active. There are few epidemiological studies in adolescents, and the majority of them were young people aged 15 and under. Early studies have characterized the interdental periodontal microbiota in healthy adults but, to our knowledge, no studies have analyzed the caries interdental microbiota in young people between 15 and 17 years of age. The main objective of this study is to describe the interdental microbiota in adolescents by a quantitative detection system using real-time PCR methodology. It will quantify 26 major interdental pathogens. The secondary objective is to analyse the distribution of these bacteria according to the level of caries risk and salivary risk. Fifty Caucasian adolescents were recruited for this cross sectional study.
Detailed Description
Fifty Caucasian subjects were recruited from a pool of first-time volunteers who were referred to the Department of Public Health of the Faculty of Dentistry at the University of Montpellier, France. Written informed consent was obtained from all enrolled individuals in accordance with the Declaration of Helsinki. The study protocol was reviewed and approved by the Committee for the protection of persons (CPP) and by the National Commission of Informatics and Liberties, France. Standardized clinical monitoring was performed 3 weeks before microbiological monitoring. The subjects were submitted to a medical/dental anamnesis, and information regarding their age, gender, and smoking status was obtained. The clinical examination was performed by trained and calibrated dentist. Clinical measurements were taken at six sites per tooth (mesio-buccal, buccal, disto-buccal, disto-lingual, lingual, and mesio-lingual) on all teeth, with the exception of the third molars, as previously described. The full-mouth clinical measurements included International Caries Detection and Assessment System (ICDAS), Caries Bleeding on interdental brushing index (BOIB), Gingival Index (GI), Plaque Index (PI) and Hygiene Index (HI), which were recorded on a dental chair, using a smooth probe, plane mirror and a surgical lamp. Clinical assessments of the interdental spaces were performed using an IAP CURAPROX© colorimetric probe and registered the diameter of all the interproximal spaces of four pairs of teeth (premolar-molar). At the end of the examination visit, the participants were instructed to brush their teeth 3 h before the sampling visit and not to drink, eat or practice oral hygiene during this period. In a group of 10 individuals who did not participate in this study, pairs of examinations were conducted in each individual, with a 1-h interval between them. Intraclass correlation coefficients for ICDAS, GI, PI, HI and BOIB were calculated at the site level. The intra- and inter-examiner coefficients for PI and HI ranged between 0.80 and 0.85, and between 0.75 and 0.85 for ICDAS. For all subjects, the same four interdental sites (15-16, 25-26, 35-36, and 45-46) were assessed (total 200 sites). The appropriate prime interdental brushes were selected based on the clinical assessment of the interdental spaces. With an alpha error of 5%, a power of 80%, an intraclass correlation coefficient of 0.8, a mean difference of bacteria counts between the 2 caries risk groups of 1,300,000, a total of 200 sites (which means 50 subjects) will be necessary. Qualitative variables will be described by frequencies or percentages and quantitative variables by means and standard deviations. A Shapiro-Wilks test will be used to test the normality of the data. The comparison between the 2 caries risk groups will be achieved by a McNemar test for the qualitative variables and a Student test or a paired Wilcoxon test for the quantitative variables, depending on the normality of these variables. The "clinical" questionnaire data completed by the dentist will be captured on a paper form provided at the beginning of the study. The forms thus recovered will be entered using a software to form the database. Paper forms will be archived with the study documents. The bacteriological data obtained will be returned with the T envelope to the scientific manager and registered in the software. The database created with the answers of "clinical" questionnaires and the results of the bacteriological analysis will be identified by order number and no surname data will be recorded on the electronic file thus created. At the end of the study, a report with the statistical tables and conclusions will be published for analysis and discussion of the data by the scientific committee and the project managers. Scientific publications will be written. The data is the property of the administrative manager of the study, no personal data will be released. Apart from the report and scientific publications, no data sharing is planned.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries, Gingivitis
Keywords
Oral biofilm, Microbiota, Adolescent, Dental carie

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Clinical examination and sample
Arm Type
Other
Arm Description
Cross-sectional observational study Measure of 6 indices: "Bleeding on Intergental Brush Index" (BOIB) Gingivitis Score (GI) Plaque index score (PI) ICDAS Salivary test Individual caries risk assessment Determination of interdental brushes adapted to each interdental site Recovery of the interdental brush passed through the 4 sites (between 15-16, 25-26, 35-36, 45-46) on which the interdental biofilm was fixed during the passage in the interdental space. The interdental brush is immediately put in a sterile tube and then sent in dry ice to maintain the integrity of the genetic material. Quantitative PCR experiments will be performed and a qualitative and quantitative analysis of the interdental flora will be made.
Intervention Type
Device
Intervention Name(s)
Interdental brushes
Intervention Description
interdental brush at 4 sites and PCR analysis
Primary Outcome Measure Information:
Title
Quantification of bacteria in the interdental plaque
Description
Interdental sampling with a brush
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Distribution of bacteria according to different factors
Description
Distribution of bacteria according to the level of caries risk, the salivary risk and other indices assessed during the clinical examination
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: presence of teeth 15-16-25-26-35-36-45-46 At least of 22 teeth Good understanding of the French language One of the parents accepts the terms of the study and signs the written informed consent In good general health, without clinical abnormality and medical history Periodontal pocket greater than or equal to 3mm at interdental sites 15-16, 25-26, 35-36, 45-46 Exclusion Criteria: Smoking patient Patient with pathologies, orthodontic appliance Patient having taken antibiotics in the last 3 months Patient regularly using interdental brushes and / or dental floss and / or mouthwash Patient at risk for infectious endocarditis Patient unable to answer questions, non-cooperative
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paul TRAMINI, PhD
Phone
+33671876718
Email
paul.tramini@orange.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul TRAMINI, PhD
Organizational Affiliation
paul.tramini@orange.fr
Official's Role
Principal Investigator
Facility Information:
Facility Name
TRAMINI
City
Montpellier
ZIP/Postal Code
34080
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul TRAMINI
Phone
+33 6 71 87 67 18
Email
paul.tramini@orange.fr

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Interdental Microbiota Among Adolescents

We'll reach out to this number within 24 hrs