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

NCT ID: NCT03714295

Last Updated: 2018-10-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 25 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-04-01
• Study Completion Date: 2015-07-01

Brief Summary

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.

Conditions

Healthy

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Use of interdental brushes

The group use interdental brushes one time each day and wash teeth with a classical brush two times a day

Use of interdental brushes

Intervention Type: OTHER

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

Use of interdental brushes

Intervention Type: OTHER

No intervention they just use interdental brushes as it should be done routinely

Interventions

Use of interdental brushes

No intervention they just use interdental brushes as it should be done routinely

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Claude Bernard University

OTHER

Sponsor Role: lead

Responsible Party

Denis Bourgeois

Sponsor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Denis Bourgeois, Pr

Role: STUDY_DIRECTOR

University Lyon

Locations

University Lyon

Lyon, , France

Countries

France

Other Identifiers

BACTERIB

Identifier Type: -

Identifier Source: org_study_id