Impact of Interdental Brushing on the Evolution of Supra-gingival Bacterial Flora (BACTERIB) (BACTERIB)

Impact of Interdental Brushing on the Evolution of Supra-gingival Bacterial Flora in Healthy Subjects Aged 18 to 35 Years (BACTERIB)

In France, two-thirds of adults over 35 years of age have at least a periodontal disease. The etiology is the accumulation of dental plaque, especially in interdental spaces. The cleaning of interdental spaces is particularly complex. This accumulation of dental plaque is at the origin of a modification of the bacterial flora in favor of periodontopathogenic bacteria. These pathogens can induce within the periodontal tissues an immune and inflammatory reaction that cause tissue degradation. The majority of studies focus on people over 30 years of age with gingivitis or periodontitis. However, young adults, in whom the initial or even reversible stages of periodontal disease are the most frequent, should be the preferred target of preventive measures for this pathology.

The main objective of this study is to quantify, in healthy patients, the evolution of the supragingival bacterial flora, in the interdental spaces, following the daily passage of brushes with the adapted diameter and single passage. The secondary objective is to evaluate the qualitative change in the bacterial flora (proportions of periodontal bacteria / commensal bacteria) following the interdental cleaning.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Use of interdental brushes

• Study Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69008
    • University Lyon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

- Subjects aged from 18 to 35 years in good health

Description

Inclusion Criteria:

• having teeth at the 4 interdental sites studied (15-16, 25-26, 35-36, 45-46),
• reporting a minimum of two daily toothbrushes,
• having a good understanding of the French language,
• accepting the terms of the study and signing written informed consent,
• in good general health (opinion of the investigator) without significant clinical abnormality and medical history.

Exclusion Criteria:

• Smoking patients (daily consumption greater than or equal to 1 cigarette),
• patients with pathologies: diabetic, haemophilia, anticoagulant, platelet antiaggregant, pregnant and lactating women,
• patients with a history of periodontal treatments,
• patients with mandibular fixed orthodontic appliances and or maxillary, masticatory coefficient less than 80%,
• patients who have taken antibiotics in the past 3 months,
• patients using interdental brushes on a regular basis (more than once a week) in addition to brushing teeth or mouthwash ,
• patients at risk for infectious endocarditis,
• patients unable to answer questions,
• non-cooperative patients,
• patients requiring geographic mobility compromising evaluation.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Use of interdental brushes; The group use interdental brushes one time each day and wash teeth with a classical brush two times a day	Other: Use of interdental brushes; No intervention they just use interdental brushes as it should be done routinely
No use of interdental brushes; The group wash teeth with a classical brush two times a day	Other: Use of interdental brushes; No intervention they just use interdental brushes as it should be done routinely

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enumeration of periodontal pathogens in interdental microbiota	Quantitative RT-PCR analyses for A. viscosus, S.mitis, Streptococcus sp., V. parvula, A. odontolyticus, E. corrodens, C. sputigena, C. ochracea, C. concisus, A. actino a, A. actino b, S. sobrinus.- et des bactéries pardonthopathogènes - C. gracilis, C. rectus, P. intermedia, P. nigrescens, P. micros, F. nuc, P. gingivalis, T. forsythensis, T. denticola, S. mutans, and Lactobacillus spp. in the interdental microbiota.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enumeration of periodontal pathogens in interdental microbiota of young adults using or not interdental brushes by real-time PCR	Quantitative RT-PCR analyses for A. viscosus, S.mitis, Streptococcus sp., V. parvula, A. odontolyticus, E. corrodens, C. sputigena, C. ochracea, C. concisus, A. actino a, A. actino b, S. sobrinus.- et des bactéries pardonthopathogènes - C. gracilis, C. rectus, P. intermedia, P. nigrescens, P. micros, F. nuc, P. gingivalis, T. forsythensis, T. denticola, S. mutans, and Lactobacillus spp. in the interdental microbiota of young adults using or not interdental brushes.	3 months

Collaborators and Investigators

• Sponsor: Claude Bernard University
• Investigators: Study Director: Denis Bourgeois, Pr, University Lyon

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Actual): April 15, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: October 15, 2018
• First Submitted That Met QC Criteria: October 19, 2018
• First Posted (Actual): October 22, 2018

Study Record Updates

• Last Update Posted (Actual): October 22, 2018
• Last Update Submitted That Met QC Criteria: October 19, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: BACTERIB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No