ToothbrushingtimebrushNCT00877019
Time Dependent Professional Toothbrushing Study
A study testing Sonicare elite medium brush head, Sonicare elite mini brushhead and GABA Elmex sensitive extra soft toothbrush in people with Toothbrushing, run by University of Erlangen-Nürnberg Medical School.
Trial summary
Aim: The study was designed to test the time dependent efficacy in plaque removal of four toothbrushes: one electric toothbrush, the Philips Sonicare Elite with long (A) and short (B) brushing head and two manual brushes, the Gaba Sensitve (C), and the ADA reference brush (D) and. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Toothbrushing
- What is being tested?
- Sonicare elite medium brush head, Sonicare elite mini brushhead and GABA Elmex sensitive extra soft toothbrush
- Type of treatment
- Medical device
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Aug 2007to Dec 2007
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- at least 24 evaluable teeth in the mouth
Who cannot join
- systemic disease
- regular drugs or actual antibiotics
- orthodontic banding or retention wires
- oral lesions or sites with a probing pocket depth X5 mm
About this study
Official title: Time Dependent Professional Toothbrushing Study Comparing Sonicare With Manual Toothbrushes
Aim:
The study was designed to test the time dependent efficacy in plaque removal of four toothbrushes: one electric toothbrush, the Philips Sonicare Elite with long (A) and short (B) brushing head and two manual brushes, the Gaba Sensitve (C), and the ADA reference brush (D) and.
Read more
Materials and Methods:
The study was a single-blind, randomized clinical timer study consisting of four identical experiments testing each brush in one quadrant. The distribution of the quadrants and brushes was randomized so that always all brushes were used within one participant. The teeth were brushed by a dental hygienist for 10, 20, 30, 45, 60 und 90 seconds per quadrant. No toothpaste was used throughout this study. The plaque assessment (Tureskey modified QHI) was done after each time interval blinded on six sites per tooth by a separate investigator. Ninety subjects participated in the study and received a professional prophylaxis prior to the experiment. They were requested to refrain from brushing their teeth for 48 hours prior to the experiment.
- Conditions
- Toothbrushing
- Being tested
- Sonicare elite medium brush head, Sonicare elite mini brushhead, GABA Elmex sensitive extra soft toothbrush, ADA reference toothbrush
- Keywords
- sonic brushes, time effectiveness, brush head design, ADA-toothbrush, professional brushing, time dependence, efficacy, toothbrush
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sonicare elite medium brush headDevice
Sonicare elite mini brushheadDevice
GABA Elmex sensitive extra soft toothbrushDevice
ADA reference toothbrushDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2009 (estimated)
- Study startAug 2007
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ToothbrushingStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00877019
- Sponsor's protocol ID
- 001
- Acronym
- timebrush
- Status last verified
- Dec 2020
- First submitted
- 6 Apr 2009
- Last updated
- 14 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time Dependent Professional Toothbrushing Study Comparing Sonicare With Manual Toothbrushes
- ClinicalTrials.gov ID
- NCT00877019
- Acronym / sponsor ID
- timebrush / 001
- Conditions
- Toothbrushing
- Keywords
- sonic brushes, time effectiveness, brush head design, ADA-toothbrush, professional brushing, time dependence, efficacy, toothbrush
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 7 Apr 2009 (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.
Aim:
The study was designed to test the time dependent efficacy in plaque removal of four toothbrushes: one electric toothbrush, the Philips Sonicare Elite with long (A) and short (B) brushing head and two manual brushes, the Gaba Sensitve (C), and the ADA reference brush (D) and.
Materials and Methods:
The study was a single-blind, randomized clinical timer study consisting of four identical experiments testing each brush in one quadrant. The distribution of the quadrants and brushes was randomized so that always all brushes were used within one participant. The teeth were brushed by a dental hygienist for 10, 20, 30, 45, 60 und 90 seconds per quadrant. No toothpaste was used throughout this study. The plaque assessment (Tureskey modified QHI) was done after each time interval blinded on six sites per tooth by a separate investigator. Ninety subjects participated in the study and received a professional prophylaxis prior to the experiment. They were requested to refrain from brushing their teeth for 48 hours prior to the experiment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Single blind (investigator)
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- at least 24 evaluable teeth in the mouth
Key exclusion criteria (4 listed)
- systemic disease
- regular drugs or actual antibiotics
- orthodontic banding or retention wires
- oral lesions or sites with a probing pocket depth X5 mm
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 |
|---|---|---|
| Sonicare elite medium brush head | Device | – |
| Sonicare elite mini brushhead | Device | – |
| GABA Elmex sensitive extra soft toothbrush | Device | – |
| ADA reference toothbrush | Device | – |
Primary outcome
Not reported in the source record.
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 14 Dec 2020.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Sonicare elite medium brush head, Sonicare elite mini brushhead and GABA Elmex sensitive extra soft toothbrush in people with Toothbrushing, run by University of Erlangen-Nürnberg Medical School.
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 1 inclusion and 4 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 14 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
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.
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 14 Dec 2020.