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Completed

NCT Number: NCT03714295

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

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Key information

Conditions

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Lyon

Lyon, 69008, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Use of interdental brushes

Other

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

Primary outcomes

  1. Enumeration of periodontal pathogens in interdental microbiota

    Time frame: 3 months

    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.

Secondary outcomes

  1. Enumeration of periodontal pathogens in interdental microbiota of young adults using or not interdental brushes by real-time PCR

    Time frame: 3 months

    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.

Sponsors and collaborators

Lead sponsor

Claude Bernard University

Other

Registry information

Official study title

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

Acronym: BACTERIB

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Oct 22, 2018
Registry last updated
Oct 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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