HealthyBACTERIBNCT03714295
Impact of Interdental Brushing on the Evolution of Supra-gingival Bacterial Flora (BACTERIB)
An observational study of Healthy, run by Claude Bernard University at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Use of interdental brushes
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2015to 1 Jul 2015
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: - Subjects aged from 18 to 35 years in good health
Who may be able to join
- 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.
Who cannot join
- 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 ,
Show all 10Show fewer
- patients at risk for infectious endocarditis,
- patients unable to answer questions,
- non-cooperative patients,
- patients requiring geographic mobility compromising evaluation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- Use of interdental brushes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of interdental brushesOther
No intervention they just use interdental brushes as it should be done routinely
| Study group | Role | What they receive |
|---|---|---|
| Use of interdental brushes | The group use interdental brushes one time each day and wash teeth with a classical brush two times a day Receives: Other: Use of interdental brushes | |
| No use of interdental brushes | The group wash teeth with a classical brush two times a day Receives: Other: Use of interdental brushes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (1)
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2018
- Study start1 Apr 2015
- Primary completion15 Apr 2015
- Study completion1 Jul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Claude Bernard University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Denis Bourgeois, Claude Bernard University
- Investigators
- Denis Bourgeois, Pr, Study director, University Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03714295
- Sponsor's protocol ID
- BACTERIB
- Acronym
- BACTERIB
- Status last verified
- Oct 2018
- First submitted
- 15 Oct 2018
- Last updated
- 22 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Interdental Brushing on the Evolution of Supra-gingival Bacterial Flora in Healthy Subjects Aged 18 to 35 Years (BACTERIB)
- ClinicalTrials.gov ID
- NCT03714295
- Acronym / sponsor ID
- BACTERIB / BACTERIB
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Claude Bernard UniversityUniversity, hospital or other
- Study start
- 1 Apr 2015 (actual)
- Primary completion
- 15 Apr 2015 (actual)
- Study completion
- 1 Jul 2015 (actual)
- First posted
- 22 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Use of interdental brushes | – | Other: Use of interdental brushesThe group use interdental brushes one time each day and wash teeth with a classical brush two times a day |
| No use of interdental brushes | – | Other: Use of interdental brushesThe group wash teeth with a classical brush two times a day |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- - Subjects aged from 18 to 35 years in good health
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of interdental brushesNo intervention they just use interdental brushes as it should be done routinely | Other | No use of interdental brushes, Use of interdental brushes |
Primary outcome
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.
1 secondary outcome
Enumeration of periodontal pathogens in interdental microbiota of young adults using or not interdental brushes by real-time PCR
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denis Bourgeois, Pr study director
University Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Claude Bernard University at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enumeration of periodontal pathogens in interdental microbiota (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2018.