Dental PlaqueNCT05594134
Efficacy of an Automatic Toothbrush
A study testing Automatic toothbrush with nylon bristle, Automatic toothbrush with silicone bristle and Manual toothbrush used for 2 minutes in people with Dental Plaque, run by University of Florence at 1 site in Italy.
Trial summary
The objective of this study is to compare the efficacy in terms of bacterial plaque removal, in a single use, of a new Y-shaped automatic electric toothbrush with nylon bristles, compared with the electric toothbrush of similar shape but with silicone bristles, with the manual toothbrush, and with a negative control… 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
- What is being tested?
- Automatic toothbrush with nylon bristle, Automatic toothbrush with silicone bristle and Manual toothbrush used for 2 minutes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteItaly
- Study dates
- 7 Nov 2022to 21 Dec 2022
- 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
- Absence of fixed orthodontic appliances
- Presence of at least 20 teeth
- Full mouth plaque score greater than 40%
- Having provided signed and dated informed consent.
Who cannot join
- Subjects with manual inability to perform normal oral hygiene maneuvers
- Subjects allergic to silicone or nylon.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of an Automatic Toothbrush With Nylon Bristles in Removing Dental Plaque: a Randomized Cross-over Study
The objective of this study is to compare the efficacy in terms of bacterial plaque removal, in a single use, of a new Y-shaped automatic electric toothbrush with nylon bristles, compared with the electric toothbrush of similar shape but with silicone bristles, with the manual toothbrush, and with a negative control (no brushing) in a group of volunteer students.
Primary endpoint: difference in "full mouth plaque score" between before and after brushing.
Read more
Secondary endpoint: sensation of "clean mouth" assessed on VAS scale from 0 to 10 where 0 indicates no sensation of clean mouth and 10 maximum sensation of clean mouth.
Single-center, randomized, controlled, superiority, cross-over, examiner-blinded study with 5 treatments (Y-shaped electric toothbrush with nylon bristles, similarly shaped electric toothbrush with silicone bristles, manual brushing for 45 seconds, manual brushing for 2 minutes, no brushing), carried out in a single session and spaced one week apart.
- Conditions
- Dental Plaque
- Being tested
- Automatic toothbrush with nylon bristle, Automatic toothbrush with silicone bristle, Manual toothbrush used for 2 minutes, Manual toothbrush used for 45 seconds
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automatic toothbrush with nylon bristleOther
The automatic toothbrush with nylon bristles will be used for 10 seconds per dental arch
Automatic toothbrush with silicone bristleOther
The automatic toothbrush with silicone bristles will be used for 10 seconds
Manual toothbrush used for 2 minutesOther
A conventional manual toothbrush will be used for 2 minutes
Manual toothbrush used for 45 secondsOther
A conventional manual toothbrush will be used for 45 seconds
| Study group | Role | What they receive |
|---|---|---|
| Automatic toothbrush with nylon bristles | Experimental | Not described Receives: Other: Automatic toothbrush with nylon bristle |
| Automatic toothbrush with silicone bristles | Active comparator | Not described Receives: Other: Automatic toothbrush with silicone bristle |
| Manual toothbrush used for 2 minutes | Active comparator | Not described Receives: Other: Manual toothbrush used for 2 minutes |
| Manual toothbrush used for 45 seconds | Active comparator | Not described Receives: Other: Manual toothbrush used for 45 seconds |
| No brushing | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in full mouth plaque score
Difference in full mouth plaque score between before and after brushing
Measured: 5 minutes
Secondary outcomes (1)
Perception of "clean mouth"
Sensation of "clean mouth" assessed on a visual analogue scale from 0 to 10 where 0 indicates no sensation of clean mouth and 10 maximum sensation of clean mouth
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2022
- Study start7 Nov 2022
- Primary completion21 Dec 2022
- Study completion21 Dec 2022
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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 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
- NCT05594134
- Sponsor's protocol ID
- IUFET2
- Status last verified
- Apr 2023
- First submitted
- 21 Oct 2022
- Last updated
- 18 Apr 2023
- 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 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an Automatic Toothbrush With Nylon Bristles in Removing Dental Plaque: a Randomized Cross-over Study
- ClinicalTrials.gov ID
- NCT05594134
- Acronym / sponsor ID
- IUFET2
- Conditions
- Dental Plaque
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of FlorenceUniversity, hospital or other
- Study start
- 7 Nov 2022 (actual)
- Primary completion
- 21 Dec 2022 (actual)
- Study completion
- 21 Dec 2022 (actual)
- First posted
- 26 Oct 2022 (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.
The objective of this study is to compare the efficacy in terms of bacterial plaque removal, in a single use, of a new Y-shaped automatic electric toothbrush with nylon bristles, compared with the electric toothbrush of similar shape but with silicone bristles, with the manual toothbrush, and with a negative control (no brushing) in a group of volunteer students.
Primary endpoint: difference in "full mouth plaque score" between before and after brushing.
Secondary endpoint: sensation of "clean mouth" assessed on VAS scale from 0 to 10 where 0 indicates no sensation of clean mouth and 10 maximum sensation of clean mouth.
Single-center, randomized, controlled, superiority, cross-over, examiner-blinded study with 5 treatments (Y-shaped electric toothbrush with nylon bristles, similarly shaped electric toothbrush with silicone bristles, manual brushing for 45 seconds, manual brushing for 2 minutes, no brushing), carried out in a single session and spaced one week apart.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Automatic toothbrush with nylon bristles | Experimental | Other: Automatic toothbrush with nylon bristle |
| Automatic toothbrush with silicone bristles | Active comparator | Other: Automatic toothbrush with silicone bristle |
| Manual toothbrush used for 2 minutes | Active comparator | Other: Manual toothbrush used for 2 minutes |
| Manual toothbrush used for 45 seconds | Active comparator | Other: Manual toothbrush used for 45 seconds |
| No brushing | No intervention | – |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Absence of fixed orthodontic appliances
- Presence of at least 20 teeth
- Full mouth plaque score greater than 40%
- Having provided signed and dated informed consent.
Key exclusion criteria (2 listed)
- Subjects with manual inability to perform normal oral hygiene maneuvers
- Subjects allergic to silicone or nylon.
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 |
|---|---|---|
| Automatic toothbrush with nylon bristleThe automatic toothbrush with nylon bristles will be used for 10 seconds per dental arch | Other | Automatic toothbrush with nylon bristles |
| Automatic toothbrush with silicone bristleThe automatic toothbrush with silicone bristles will be used for 10 seconds | Other | Automatic toothbrush with silicone bristles |
| Manual toothbrush used for 2 minutesA conventional manual toothbrush will be used for 2 minutes | Other | Manual toothbrush used for 2 minutes |
| Manual toothbrush used for 45 secondsA conventional manual toothbrush will be used for 45 seconds | Other | Manual toothbrush used for 45 seconds |
Primary outcome
Change in full mouth plaque score
Time frame: 5 minutes
Difference in full mouth plaque score between before and after brushing
1 secondary outcome
Perception of "clean mouth"
Time frame: 5 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 18 Apr 2023.
- 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.
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 Automatic toothbrush with nylon bristle, Automatic toothbrush with silicone bristle and Manual toothbrush used for 2 minutes in people with Dental Plaque, 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 18 Apr 2023. 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?
Change in full mouth plaque score (time frame: 5 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 18 Apr 2023.