Healthy SubjectsBROSCYLNCT01950988
Effectiveness of a Novel Concept for a Manual Toothbrush Broscyl®
A study testing Manual toothbrush reference, Measure of the dental plaque and Manual toothbrush Broscyl® in people with Healthy Subjects, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
The aim is to determine the efficacy and the satisfaction/adaptability of the manual Broscyl® toothbrush as compared with a standard " soft " manual toothbrush ADA (American Dental Association) reference using the modified Stillman brushing technique, in children, adults and elderly persons, after 3 months of daily… Read more about this study
- Who is it for?
- Ages 8 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Manual toothbrush reference, Measure of the dental plaque and Manual toothbrush Broscyl®
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteFrance
- Study dates
- 16 Jul 2013to 8 Jun 2016
- Phase
- Interventional
- 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 8 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Children attending school aged between 8 and 15 years
- OR adults aged from 18 to 45 years
- OR elderly persons aged more than 65 years old
- Presenting at least one incisive, one canine, one premolar and one molar in each quadrant
- Able to brush their own teeth at least twice a day
- Persons who have provided written informed consent
- Persons covered by the national health insurance agency
Who cannot join
- Persons with acute periodontal disease
- Persons in a period of postsurgical healing
- Persons with an acute oral pain syndrome
- Persons undergoing orthodontic treatment with a fixed brace
- Persons not covered by the national health insurance agency
- Pregnant women
- The use of adjuvants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness and Satisfaction-adaptability of a Novel Concept for a Manual Toothbrush Broscyl®: Randomised Clinical Trial in Children, Adults and Elderly People
The aim is to determine the efficacy and the satisfaction/adaptability of the manual Broscyl® toothbrush as compared with a standard " soft " manual toothbrush ADA (American Dental Association) reference using the modified Stillman brushing technique, in children, adults and elderly persons, after 3 months of daily use.
- Conditions
- Healthy Subjects
- Being tested
- Manual toothbrush reference, Measure of the dental plaque, Manual toothbrush Broscyl®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual toothbrush referenceDevice
Measure of the dental plaqueProcedure or surgery
Manual toothbrush Broscyl®Device
| Study group | Role | What they receive |
|---|---|---|
| Children | Other | Not described Receives: Device: Manual toothbrush reference; Procedure: Measure of the dental plaque; Device: Manual toothbrush Broscyl® |
| Adults | Other | Not described Receives: Device: Manual toothbrush reference; Procedure: Measure of the dental plaque; Device: Manual toothbrush Broscyl® |
| Elderly people | Other | Not described Receives: Device: Manual toothbrush reference; Procedure: Measure of the dental plaque; Device: Manual toothbrush Broscyl® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the dental plaque index
Measured: up to 3 months
Secondary outcomes (1)
Patient satisfaction
self-completed questionnaire
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2013 (estimated)
- Study start16 Jul 2013
- Primary completion8 Jun 2016
- Study completion8 Jun 2016
Why it stopped: Lack of inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01950988
- Sponsor's protocol ID
- ZWETYENGA PHRC IR 2011
- Acronym
- BROSCYL
- Status last verified
- Feb 2024
- First submitted
- 27 Aug 2013
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Satisfaction-adaptability of a Novel Concept for a Manual Toothbrush Broscyl®: Randomised Clinical Trial in Children, Adults and Elderly People
- ClinicalTrials.gov ID
- NCT01950988
- Acronym / sponsor ID
- BROSCYL / ZWETYENGA PHRC IR 2011
- Conditions
- Healthy Subjects
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of inclusion
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 16 Jul 2013 (actual)
- Primary completion
- 8 Jun 2016 (actual)
- Study completion
- 8 Jun 2016 (actual)
- First posted
- 26 Sep 2013 (estimated)
- 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.
The aim is to determine the efficacy and the satisfaction/adaptability of the manual Broscyl® toothbrush as compared with a standard " soft " manual toothbrush ADA (American Dental Association) reference using the modified Stillman brushing technique, in children, adults and elderly persons, after 3 months of daily use.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Children | Other | Device: Manual toothbrush reference, Procedure: Measure of the dental plaque, Device: Manual toothbrush Broscyl® |
| Adults | Other | Device: Manual toothbrush reference, Procedure: Measure of the dental plaque, Device: Manual toothbrush Broscyl® |
| Elderly people | Other | Device: Manual toothbrush reference, Procedure: Measure of the dental plaque, Device: Manual toothbrush Broscyl® |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Children attending school aged between 8 and 15 years
- OR adults aged from 18 to 45 years
- OR elderly persons aged more than 65 years old
- Presenting at least one incisive, one canine, one premolar and one molar in each quadrant
- Able to brush their own teeth at least twice a day
Key exclusion criteria (7 listed)
- Persons with acute periodontal disease
- Persons in a period of postsurgical healing
- Persons with an acute oral pain syndrome
- Persons undergoing orthodontic treatment with a fixed brace
- Persons not covered by the national health insurance agency
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 |
|---|---|---|
| Manual toothbrush reference | Device | Adults, Children, Elderly people |
| Measure of the dental plaque | Procedure or surgery | Adults, Children, Elderly people |
| Manual toothbrush Broscyl® | Device | Adults, Children, Elderly people |
Primary outcome
Measurement of the dental plaque index
Time frame: up to 3 months
1 secondary outcome
Patient satisfaction
Time frame: up to 3 months
Results and safety
The study was stopped early (reason given: Lack of inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual toothbrush reference, Measure of the dental plaque and Manual toothbrush Broscyl® in people with Healthy Subjects, run by Centre Hospitalier Universitaire Dijon 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 7 inclusion and 7 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: stopped early, as of the sponsor's last update on 28 Feb 2024. 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 was stopped early (reason given: Lack of inclusion). Results are not available in the source record.
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?
Measurement of the dental plaque index (time frame: up to 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 28 Feb 2024.