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Clinical Trials/NCT03700840
NCT03700840UnknownNot Applicable

Interdental Microbiota According to the Caries Risk Factors Among Adolescents Aged 15 to 17 Years.

Université Montpellier2 sites in 1 country50 target enrollmentStarted: November 1, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
50
Locations
2
Primary Endpoint
Quantification of bacteria in the interdental plaque

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
15 Years to 17 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Clinical examination and sample

Other

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: Interdental brushes (Device)

Outcomes

Primary Outcomes

Quantification of bacteria in the interdental plaque

Time Frame: through study completion, an average of 1 year

Interdental sampling with a brush

Secondary Outcomes

  • Distribution of bacteria according to different factors(through study completion, an average of 1 year)

Investigators

Sponsor
Université Montpellier
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Paul TRAMINI

Ph.D. (department of public health)

Université Montpellier

Study Sites (2)

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