NCT03700840

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 9, 2018

Completed
23 days until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

November 7, 2018

Status Verified

November 1, 2018

Enrollment Period

2 months

First QC Date

October 2, 2018

Last Update Submit

November 6, 2018

Conditions

Dental CariesGingivitis

Keywords

Oral biofilmMicrobiotaAdolescentDental carie

Outcome Measures

Primary Outcomes (1)

  • Quantification of bacteria in the interdental plaque

    Interdental sampling with a brush

    through study completion, an average of 1 year

Secondary Outcomes (1)

  • Distribution of bacteria according to different factors

    through study completion, an average of 1 year

Study Arms (1)

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.

Device: Interdental brushes

Interventions

Interdental brushesDEVICE

interdental brush at 4 sites and PCR analysis

Clinical examination and sample

Eligibility Criteria

Age15 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TRAMINI

Montpellier, 34080, France

RECRUITING

MeSH Terms

Conditions

Dental CariesGingivitis

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic DiseasesInfectionsGingival DiseasesPeriodontal DiseasesMouth Diseases

Study Officials

  • Paul TRAMINI, PhD

    paul.tramini@orange.fr

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul TRAMINI, PhD

CONTACT

+33671876718paul.tramini@orange.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D. (department of public health)

Study Record Dates

First Submitted

October 2, 2018

First Posted

October 9, 2018

Study Start

November 1, 2018

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

November 7, 2018

Record last verified: 2018-11

Locations

FR(1)