Dental PlaqueNCT04119583
Efficacy of an U-shape Automatic Electric Toothbrush in Plaque Removal
A study testing U-shape Automatic Electric Toothbrush, Usual home toothbrushing procedure and Conventional Electric Toothbrush in people with Dental Plaque and Toothbrushing, run by University of Florence at 1 site in Italy.
Trial summary
Over time, many different types of manual and electric toothbrushes have been produced. A systematic review has shown that some electric toothbrushes are more effective at removing bacterial plaque than manual toothbrushes. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Plaque, Toothbrushing
- What is being tested?
- U-shape Automatic Electric Toothbrush, Usual home toothbrushing procedure and Conventional Electric Toothbrush
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteItaly
- Study dates
- 20 Jan 2020to 14 Feb 2020
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 and 30 years;
- no fixed orthodontic equipment;
- presence of at least 20 teeth;
- Full mouth plaque score (FMPS) above 40%.
Who cannot join
- Subjects with manual disabilities to perform normal oral hygiene maneuvers;
- Subjects allergic to silicone
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of an U-shape Automatic Electric Toothbrush in Plaque Removal: a Crossover Randomized Study
Over time, many different types of manual and electric toothbrushes have been produced. A systematic review has shown that some electric toothbrushes are more effective at removing bacterial plaque than manual toothbrushes. A new U-shaped electric toothbrush with silicone bristles has recently been produced that has a fully automatic and simultaneous action on both arches. However, its efficacy in removing bacterial plaque is not clear at the moment, as no randomized study has been published on this type of toothbrush.
The aim of this study is to compare the efficacy in terms of bacterial plaque removal in a single use of a new automatic U-shaped electric toothbrush, compared with the usual home toothbrushing procedure, a conventional electric toothbrush, and negative control (no toothbrushing) in a group of volunteer students of the School of Dentistry of the University of Florence, Italy.
Read more
Primary endpoint will be the difference in "full mouth plaque score" between before and after brushing. Secondary endpoints will be feeling of "clean mouth" evaluated on a VAS (Visual Analogue Scale) scale from 0 to 10 where 0 indicates no feeling of clean mouth and 10 maximum feeling of clean mouth.
This study will be a monocentric, randomized, controlled, superiority, cross-over study, with blind examiner and 4 therapies (U-shaped electric toothbrush, usual home toothbrushing procedure, conventional electric toothbrush, no toothbrushing), carried out in a single session with an interval of one week between the 4 therapies.
Study population will be students of the School of Dentistry who are healthy volunteers. Number of patients to be enrolled: 22. Inclusion criteria: age between 18 and 30 years; no fixed orthodontic appliance; presence of at least 20 teeth; Full mouth plaque score (FMPS) above 40%.
Exclusion criteria: subjects with manual disabilities to perform normal oral hygiene maneuvers; subjects allergic to silicone.
- Conditions
- Dental Plaque, Toothbrushing
- Being tested
- U-shape Automatic Electric Toothbrush, Usual home toothbrushing procedure, Conventional Electric Toothbrush
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
U-shape Automatic Electric ToothbrushDevice
The U-shape Automatic Electric Toothbrush will be applied for 30-45 seconds on the teeth of both arches without the use of toothpaste.
Usual home toothbrushing procedureOther
Usual home toothbrushing procedure either with manual or electric toothbrush without the use of toothpaste.
Conventional Electric ToothbrushOther
The Conventional Electric Toothbrush will be applied for 2 minutes on the teeth of both arches without the use of toothpaste.
| Study group | Role | What they receive |
|---|---|---|
| U-shape Automatic Electric Toothbrush | Experimental | Not described Receives: Device: U-shape Automatic Electric Toothbrush |
| Usual home toothbrushing procedure | Active comparator | Not described Receives: Other: Usual home toothbrushing procedure |
| No toothbrushing | No intervention | Not described |
| Conventional Electric Toothbrush | Active comparator | Not described Receives: Other: Conventional Electric Toothbrush |
What is being measured
The primary outcome is the main question the study is designed to answer.
Full mouth plaque score
Percentage of sites that presents with plaque on the total of the sites examined (6 sites per tooth).
Measured: Difference between pre- and post-brushing (time frame 10-15 minutes)
Secondary outcomes (1)
Feeling of "clean mouth"
Visual analogue scale from 0 to 10 where 0 indicates no feeling of clean mouth and 10 maximum feeling of clean mouth
Measured: Post-brushing (time frame 1-2 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study start20 Jan 2020
- Primary completion14 Feb 2020
- Study completion14 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental PlaqueStudies 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
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florence
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lorenzo Franchi, University of Florence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04119583
- Sponsor's protocol ID
- IUFET1
- Status last verified
- Mar 2020
- First submitted
- 3 Oct 2019
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an U-shape Automatic Electric Toothbrush in Plaque Removal: a Crossover Randomized Study
- ClinicalTrials.gov ID
- NCT04119583
- Acronym / sponsor ID
- IUFET1
- Conditions
- Dental Plaque, Toothbrushing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of FlorenceUniversity, hospital or other
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 14 Feb 2020 (actual)
- Study completion
- 14 Feb 2020 (actual)
- First posted
- 8 Oct 2019 (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.
Over time, many different types of manual and electric toothbrushes have been produced. A systematic review has shown that some electric toothbrushes are more effective at removing bacterial plaque than manual toothbrushes. A new U-shaped electric toothbrush with silicone bristles has recently been produced that has a fully automatic and simultaneous action on both arches. However, its efficacy in removing bacterial plaque is not clear at the moment, as no randomized study has been published on this type of toothbrush.
The aim of this study is to compare the efficacy in terms of bacterial plaque removal in a single use of a new automatic U-shaped electric toothbrush, compared with the usual home toothbrushing procedure, a conventional electric toothbrush, and negative control (no toothbrushing) in a group of volunteer students of the School of Dentistry of the University of Florence, Italy.
Primary endpoint will be the difference in "full mouth plaque score" between before and after brushing. Secondary endpoints will be feeling of "clean mouth" evaluated on a VAS (Visual Analogue Scale) scale from 0 to 10 where 0 indicates no feeling of clean mouth and 10 maximum feeling of clean mouth.
This study will be a monocentric, randomized, controlled, superiority, cross-over study, with blind examiner and 4 therapies (U-shaped electric toothbrush, usual home toothbrushing procedure, conventional electric toothbrush, no toothbrushing), carried out in a single session with an interval of one week between the 4 therapies.
Study population will be students of the School of Dentistry who are healthy volunteers. Number of patients to be enrolled: 22. Inclusion criteria: age between 18 and 30 years; no fixed orthodontic appliance; presence of at least 20 teeth; Full mouth plaque score (FMPS) above 40%.
Exclusion criteria: subjects with manual disabilities to perform normal oral hygiene maneuvers; subjects allergic to silicone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| U-shape Automatic Electric Toothbrush | Experimental | Device: U-shape Automatic Electric Toothbrush |
| Usual home toothbrushing procedure | Active comparator | Other: Usual home toothbrushing procedure |
| No toothbrushing | No intervention | – |
| Conventional Electric Toothbrush | Active comparator | Other: Conventional Electric Toothbrush |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age between 18 and 30 years;
- no fixed orthodontic equipment;
- presence of at least 20 teeth;
- Full mouth plaque score (FMPS) above 40%.
Key exclusion criteria (2 listed)
- Subjects with manual disabilities to perform normal oral hygiene maneuvers;
- Subjects allergic to silicone
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 |
|---|---|---|
| U-shape Automatic Electric ToothbrushThe U-shape Automatic Electric Toothbrush will be applied for 30-45 seconds on the teeth of both arches without the use of toothpaste. | Device | U-shape Automatic Electric Toothbrush |
| Usual home toothbrushing procedureUsual home toothbrushing procedure either with manual or electric toothbrush without the use of toothpaste. | Other | Usual home toothbrushing procedure |
| Conventional Electric ToothbrushThe Conventional Electric Toothbrush will be applied for 2 minutes on the teeth of both arches without the use of toothpaste. | Other | Conventional Electric Toothbrush |
Primary outcome
Full mouth plaque score
Time frame: Difference between pre- and post-brushing (time frame 10-15 minutes)
Percentage of sites that presents with plaque on the total of the sites examined (6 sites per tooth).
1 secondary outcome
Feeling of "clean mouth"
Time frame: Post-brushing (time frame 1-2 minutes)
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 24 Mar 2020.
- Individual participant dataSharing planned: Undecided
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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 U-shape Automatic Electric Toothbrush, Usual home toothbrushing procedure and Conventional Electric Toothbrush in people with Dental Plaque and Toothbrushing, run by University of Florence at 1 site in Italy.
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 4 inclusion and 2 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 24 Mar 2020. 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 Italy. 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?
Full mouth plaque score (time frame: Difference between pre- and post-brushing (time frame 10-15 minutes)). 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 24 Mar 2020.