Dental PlaqueE-TOOTHNCT06358482
Electric Toothbrush Efficacy in Preventing Dental Plaque Development
A study testing oscillating toothbrush and standard manual toothbrush in people with Dental Plaque and Calculus, Dental, run by Riccardo Polosa at 1 site in Italy.
Trial summary
The present study will be the first to compared dental plaque quantitation between an oscillating-rotating electric toothbrush and a manual toothbrush with a new QLF technology. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Plaque, Calculus, Dental
- What is being tested?
- oscillating toothbrush and standard manual toothbrush
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 30 Jan 2023to 29 Apr 2024
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy adult (aged 18-50 years)
- non-smokers
- without clinical signs of periodontitis with at least 10 natural anterior teeth in total (cuspid to cuspid and lower and upper jaw).
Who cannot join
- significant oral soft tissue pathology or any type of gingival overgrowth other than plaque-induced gingivitis,
- with fixed and removable orthodontic appliances or removable dentures,
- with any other medical condition that, in the opinion of the principal investigator, would jeopardize the participant's safety or diminish the validity of study results
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Electric Toothbrush Efficacy in Preventing Dental Plaque Development: A RCT Using QLF Technology
The present study will be the first to compared dental plaque quantitation between an oscillating-rotating electric toothbrush and a manual toothbrush with a new QLF technology.
Read the detailed description
This is a randomized controlled trial of 12-weeks duration designed to assess whether a new commercially available oscillating-rotating electric toothbrush can objectively improve dental plaque parameters obtained via light induced fluorescence (QLF) technology. The study will be conducted in a dental clinic in Italy
- Conditions
- Dental Plaque, Calculus, Dental
- Being tested
- oscillating toothbrush, standard manual toothbrush
- Medical subject headings
- Dental Plaque, Dental Calculus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oscillating toothbrushBehavioural
oscillating toothbrush
standard manual toothbrushBehavioural
standard manual toothbrush
| Study group | Role | What they receive |
|---|---|---|
| A Digital | Experimental | oscillating-rotating electric toothbrush group Receives: Behavioral: oscillating toothbrush |
| B Manual | Active comparator | manual toothbrush group Receives: Behavioral: standard manual toothbrush |
What is being measured
The primary outcome is the main question the study is designed to answer.
fluorescence intensity of at least 30% (ΔR30)
- the percentage of the total tooth surface showing an increase in the fluorescence intensity of at least 30% (ΔR30) - this indicates the total area of mature dental plaque detected,
Measured: 120 DAYS
the fluorescence intensity of at least 120% (ΔR120)
- the percentage of the total tooth surface showing an increase in the fluorescence intensity of at least 120% (ΔR120) - this reveals just areas of greater level of plaque thickness/maturation (i.e. calculus/tartar) within the total area of mature dental plaque detected.
Measured: 120 DAYS
Secondary outcomes (1)
oral hygiene (SOH) scoring, The score can be from 0, 1, .. to 5. A SOH value of 0 indicates no plaque, and 5 is the maximum and stands for maximum plaque teeth coverage an is the worst state.
- the simple oral hygiene (SOH) scoring - this score is calculated by the proprietary software and provides an estimate of the degree of gingival inflammation.
Measured: 120 DAYS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start30 Jan 2023
- Primary completion29 Apr 2024
- Study completion29 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riccardo Polosa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Riccardo Polosa, University of Catania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06358482
- Sponsor's protocol ID
- ORAL1
- Acronym
- E-TOOTH
- Status last verified
- May 2024
- First submitted
- 5 Apr 2024
- Last updated
- 17 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Di Stefano A, Gangi D, La Rosa GRM, Isola G, Fala V, Amaliya A, Kowalski J, Chapple I, Weglarz J, Del Giovane C, Pellegrino MN, Pacino SA, Polosa R. Electric vs Manual Toothbrushing Effects on QLF-Assessed Plaque in Smokers and Non-Smokers: A 24-Week RCT. Int Dent J. 2026 Jul 2;76(5):109716. doi: 10.1016/j.identj.2026.109716. Online ahead of print.
PubMed 42391887
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electric Toothbrush Efficacy in Preventing Dental Plaque Development: A RCT Using QLF Technology
- ClinicalTrials.gov ID
- NCT06358482
- Acronym / sponsor ID
- E-TOOTH / ORAL1
- Conditions
- Dental Plaque, Calculus, Dental
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Riccardo PolosaUniversity, hospital or other
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 29 Apr 2024 (actual)
- Study completion
- 29 Apr 2024 (actual)
- First posted
- 10 Apr 2024 (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 present study will be the first to compared dental plaque quantitation between an oscillating-rotating electric toothbrush and a manual toothbrush with a new QLF technology.
Detailed description
This is a randomized controlled trial of 12-weeks duration designed to assess whether a new commercially available oscillating-rotating electric toothbrush can objectively improve dental plaque parameters obtained via light induced fluorescence (QLF) technology. The study will be conducted in a dental clinic in Italy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A Digital | Experimental | Behavioral: oscillating toothbrushoscillating-rotating electric toothbrush group |
| B Manual | Active comparator | Behavioral: standard manual toothbrushmanual toothbrush group |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- healthy adult (aged 18-50 years)
- non-smokers
- without clinical signs of periodontitis with at least 10 natural anterior teeth in total (cuspid to cuspid and lower and upper jaw).
Key exclusion criteria (3 listed)
- significant oral soft tissue pathology or any type of gingival overgrowth other than plaque-induced gingivitis,
- with fixed and removable orthodontic appliances or removable dentures,
- with any other medical condition that, in the opinion of the principal investigator, would jeopardize the participant's safety or diminish the validity of study results
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 |
|---|---|---|
| oscillating toothbrushoscillating toothbrush | Behavioural | A Digital |
| standard manual toothbrushstandard manual toothbrush | Behavioural | B Manual |
Primary outcome
fluorescence intensity of at least 30% (ΔR30)
Time frame: 120 DAYS
1) the percentage of the total tooth surface showing an increase in the fluorescence intensity of at least 30% (ΔR30) - this indicates the total area of mature dental plaque detected,
the fluorescence intensity of at least 120% (ΔR120)
Time frame: 120 DAYS
2) the percentage of the total tooth surface showing an increase in the fluorescence intensity of at least 120% (ΔR120) - this reveals just areas of greater level of plaque thickness/maturation (i.e. calculus/tartar) within the total area of mature dental plaque detected.
1 secondary outcome
oral hygiene (SOH) scoring, The score can be from 0, 1, .. to 5. A SOH value of 0 indicates no plaque, and 5 is the maximum and stands for maximum plaque teeth coverage an is the worst state.
Time frame: 120 DAYS
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 17 May 2024.
- Derived from this study: PubMed 42391887Di Stefano A, Gangi D, La Rosa GRM, Isola G, Fala V, Amaliya A, Kowalski J, Chapple I, Weglarz J, Del Giovane C, Pellegrino MN, Pacino SA, Polosa R. Electric vs Manual Toothbrushing Effects on QLF-Assessed Plaque in Smokers and Non-Smokers: A 24-Week RCT. Int Dent J. 2026 Jul 2;76(5):109716. doi: 10.1016/j.identj.2026.109716. Online ahead of print.
- Individual participant dataSharing planned: No
Related trials for Dental Plaque
Not yet recruiting
Effect of Xylitol- Versus Erythritol-Sweetened Mints on Plaque ATP-Bioluminescence Readings
Dental Caries, Dental Plaque
Not yet recruitingObservational study
Plaque and Bleeding on Probing Around Implants Supporting Fixed Full-Arch Dental Prostheses
Peri-Implant Health
Not yet recruiting
Effectiveness of Oil Pulling Using Oils in Comparison With Mouthwash for Gingivitis
Gingivitis
Not yet recruiting
Individualized Management of Plaque-Related Gingival Inflammation in Routine Dental Practice
Plaque-Induced Gingivitis
Recruiting
The Study to Evaluate the Plaque Control and Anti-Gingivitis Efficacy of a Toothpaste in Chinese Population
Dental Plaque, Gingivitis
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 oscillating toothbrush and standard manual toothbrush in people with Dental Plaque and Calculus, Dental, run by Riccardo Polosa 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 3 inclusion and 3 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 17 May 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 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?
fluorescence intensity of at least 30% (ΔR30) (time frame: 120 DAYS). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06358482, which also lists 1 linked publication.
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 17 May 2024.