Healthy Clinical Trial
— BACTERIBOfficial title:
Impact of Interdental Brushing on the Evolution of Supra-gingival Bacterial Flora in Healthy Subjects Aged 18 to 35 Years (BACTERIB)
NCT number | NCT03714295 |
Other study ID # | BACTERIB |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 1, 2015 |
Est. completion date | July 1, 2015 |
Verified date | October 2018 |
Source | Claude Bernard University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Completed |
Enrollment | 25 |
Est. completion date | July 1, 2015 |
Est. primary completion date | April 15, 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 35 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
France | University Lyon | Lyon |
Lead Sponsor | Collaborator |
---|---|
Claude Bernard University |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 |
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