Tooth BleachingNCT05202093
Efficacy of Two Sonic Toothbrushes in Reducing Extrinsic Tooth Stain
A study testing the Oclean Digital Visual toothbrush (2.16 N·cm torque), Oral B manual toothbrush and the Oclean Sonic Electric toothbrush (1.96 N·cm torque) in people with Tooth Bleaching, run by Sun Yat-sen University at 1 site in China.
Trial summary
The objective of the present study was to compare the effects of reduction of extrinsic stains between 2 commercially available Oclean sonic toothbrushes in comparison with an Oral-B manual toothbrush. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Bleaching
- What is being tested?
- the Oclean Digital Visual toothbrush (2.16 N·cm torque), Oral B manual toothbrush and the Oclean Sonic Electric toothbrush (1.96 N·cm torque)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteChina
- Study dates
- 5 Mar 2022to 15 Jul 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
The inclusion criteria were: 1) aged 18-70 years; 2) good general health; 3) ability to attend all scheduled visits over the 8-week study period; 4) possession of more than 20 natural permanent teeth, excluding third molars, which are free of crowns or extensive restorative materials; 5) at least 12 anterior teeth suitable for scoring (i.e., free of crowns, veneers, large restorations, trauma, or non-vital pulp); 6) a whole-mouth mean Lobene stain composite score greater than 1.
Exclusion criteria included: 1) severe oral or systemic diseases; 2) advanced periodontal diseases; 3) pregnancy or lactation; 4) dental fluorosis or tetracycline staining; 5) orthodontic appliances or partial removable dentures; 6) participation in other clinical trials; 7) professional prophylaxis within 3 months or tooth whitening within 6 months; and 8) known allergy to study products.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Two Sonic Toothbrushes in Reducing Extrinsic Tooth Stain: An 8-week Randomized Clinical Trial
The objective of the present study was to compare the effects of reduction of extrinsic stains between 2 commercially available Oclean sonic toothbrushes in comparison with an Oral-B manual toothbrush.
Read the detailed description
Extrinsic tooth stain, especially on anterior teeth, is a common aesthetic issue that affect smile and self-confidence. Epidemiological studies show that dissatisfaction with tooth color impacts approximately 20% to 60% of various population groups. In a Chinese urban sample, 52.6% reported dissatisfaction with tooth color. Patients often express a desire to achieve whiter teeth, as it improves smile aesthetics, attractiveness and quality of life. It also promotes overall oral health and well-being.
Mechanical tooth cleaning through brushing remains the most effective approach for daily oral hygiene, effectively removing plaque and stain to maintain oral health, irrespective of the use of dentifrice. The effectiveness of manual toothbrush is predominantly influenced by users' brushing habits and their compliance with professional recommendations.
The electric toothbrush was first introduced in Switzerland in 1954. It was designed to simulate and enhance manual brushing motions, thereby potentially offering an improved cleaning experience. Modern electric toothbrushes feature integrated timers, pressure sensors, multiple brushing modes, and Bluetooth-enabled apps to enhance brushing duration and quality. The Oclean Digital Visual toothbrush and Oclean Sonic Electric toothbrush, developed by a Shenzhen-based Chinese company, exemplify these innovations. Both sonic toothbrushes feature silent motor technology to reduce noise, avoid resonant frequencies to lessen facial discomfort, and provide real-time pressure feedback to prevent excessive brushing force. Together, these enhancements ensure a quieter, smoother, and more comfortable brushing experience. While both models share core manufacturing parameters, the Oclean Digital Visual toothbrush provides a higher driving torque (2.16 N.cm) than the Oclean Sonic Electric toothbrush (1.96 N.cm).
- Conditions
- Tooth Bleaching
- Being tested
- the Oclean Digital Visual toothbrush (2.16 N·cm torque), Oral B manual toothbrush, the Oclean Sonic Electric toothbrush (1.96 N·cm torque)
- Keywords
- Controlled Clinical Trial, Electric Toothbrush
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the Oclean Digital Visual toothbrush (2.16 N·cm torque)Device
Use the Oclean Digital Visual toothbrush (2.16 N·cm torque) to brush teeth twice a day for 8 weeks
Oral B manual toothbrushDevice
Use Oral B manual toothbrush to brush teeth twice a day for 8 weeks
the Oclean Sonic Electric toothbrush (1.96 N·cm torque)Device
Use the Oclean Sonic Electric toothbrush (1.96 N·cm torque) to brush teeth twice a day for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| the Oclean Digital Visual toothbrush (2.16 N·cm torque) | Experimental | Use the Oclean Digital Visual toothbrush (2.16 N·cm torque) to brush teeth twice daily for 8 weeks Receives: Device: the Oclean Digital Visual toothbrush (2.16 N·cm torque) |
| the Oclean Sonic Electric toothbrush (1.96 N·cm torque) | Experimental | Use the Oclean Sonic Electric toothbrush (1.96 N·cm torque) to brush teeth twice daily for 8 week Receives: Device: the Oclean Sonic Electric toothbrush (1.96 N·cm torque) |
| Manual toothbrush | Active comparator | Use Oral-B manual toothbrush to brush teeth twice daily for 8 weeks Receives: Device: Oral B manual toothbrush |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lobene Stain Index of Stain Intensity Scores 4 Weeks After Toothbrush Use
Tooth stain of the anterior teeth was measured using the Lobene Stain Index. The index assesses the area and intensity of extrinsic tooth stain on the facial and lingual surfaces of the lower anterior teeth and the facial surfaces of the upper anterior teeth. Each evaluated tooth surface was divided into two anatomical regions: body and gingival. For each region, stain intensity was rated on a 0-3 ordinal scale with the following criteria: 0 = No stain; 1 = Light stain (yellow to light brown or gray); 2 = Moderate stain (medium brown); 3 = Heavy stain (dark brown to black).
Each region(body and gingival) has a score range of 0-3 (minimum = 0, maximum = 3).
The mean Lobene stain intensity score was determined by summing the scores from all assessed regions of the tooth surfaces and dividing by the total number of regions evaluated.
Higher scores (both subscale and mean score) indicate a worse outcome (i.e., more severe extrinsic tooth stain).
Measured: 4 weeks after toothbrush use
Lobene Stain Index of Stain Area Scores 4 Weeks After Toothbrush Use
Tooth stain of the anterior teeth was measured using the Lobene Stain Index. The index assesses the area and intensity of extrinsic tooth stain on the facial and lingual surfaces of the lower anterior teeth and the facial surfaces of the upper anterior teeth. Each evaluated tooth surface was divided into two anatomical regions: body and gingival. For each region, the stain area score were assessed using 0-3 scale. 0= no stain detected; 1= stain covering up to 1/3 of the region; 2= stain covering >1/3 to 2/3 of the region; 3=stain covering >2/3 of the region.
Each region (body and gingival) has a score range of 0-3 (minimum = 0, maximum = 3).
The mean Lobene stain area score was determined by summing the scores from all assessed regions of the tooth surfaces and dividing by the total number of regions evaluated.
Higher scores (both subscale and mean score) indicate a worse outcome (i.e., more severe extrinsic tooth stain).
Measured: 4 weeks after toothbrush use
Lobene Stain Index of Stain Composite Scores 4 Weeks After Toothbrush Use
Tooth stain of the anterior teeth was measured using the Lobene Stain Index. The index assesses the area and intensity of extrinsic tooth stain on the facial and lingual surfaces of the lower anterior teeth and the facial surfaces of the upper anterior teeth. Each evaluated tooth surface was divided into two anatomical regions: body and gingival. For each region, a composite score is calculated by averaging the product of the intensity and extent scores.
Each region (body and gingival) has a score range of 0-9 (minimum = 0, maximum = 9).
The mean Lobene stain composite score was determined by summing the scores from all assessed regions of the tooth surfaces and dividing by the total number of regions evaluated.
Higher scores (both subscale and mean score) indicate a worse outcome (i.e., more severe extrinsic tooth stain).
Measured: 4 weeks after toothbrush use
Lobene Stain Index of Stain Intensity Scores 8 Weeks After Toothbrush Use
Tooth stain of the anterior teeth was measured using the Lobene Stain Index. The index assesses the area and intensity of extrinsic tooth stain on the facial and lingual surfaces of the lower anterior teeth and the facial surfaces of the upper anterior teeth. Each evaluated tooth surface was divided into two anatomical regions: body and gingival. For each region, stain intensity was rated on a 0-3 ordinal scale with the following criteria: 0 = No stain; 1 = Light stain (yellow to light brown or gray); 2 = Moderate stain (medium brown); 3 = Heavy stain (dark brown to black).
Each region(body and gingival) has a score range of 0-3 (minimum = 0, maximum = 3).
The mean Lobene stain intensity score was determined by summing the scores from all assessed regions of the tooth surfaces and dividing by the total number of regions evaluated.
Higher scores (both subscale and mean score) indicate a worse outcome (i.e., more severe extrinsic tooth stain).
Measured: 8 weeks after toothbrush use
Lobene Stain Index of Stain Area Scores 8 Weeks After Toothbrush Use
Tooth stain of the anterior teeth was measured using the Lobene Stain Index. The index assesses the area and intensity of extrinsic tooth stain on the facial and lingual surfaces of the lower anterior teeth and the facial surfaces of the upper anterior teeth. Each evaluated tooth surface was divided into two anatomical regions: body and gingival. For each region, the stain area score were assessed using 0-3 scale. 0= no stain detected; 1= stain covering up to 1/3 of the region; 2= stain covering >1/3 to 2/3 of the region; 3=stain covering >2/3 of the region.
Each region (body and gingival) has a score range of 0-3 (minimum = 0, maximum = 3).
The mean Lobene stain area score was determined by summing the scores from all assessed regions of the tooth surfaces and dividing by the total number of regions evaluated.
Higher scores (both subscale and mean score) indicate a worse outcome (i.e., more severe extrinsic tooth stain).
Measured: 8 weeks after toothbrush use
Lobene Stain Index of Stain Composite Scores 8 Weeks After Toothbrush Use
Tooth stain of the anterior teeth was measured using the Lobene Stain Index. The index assesses the area and intensity of extrinsic tooth stain on the facial and lingual surfaces of the lower anterior teeth and the facial surfaces of the upper anterior teeth. Each evaluated tooth surface was divided into two anatomical regions: body and gingival. For each region, a composite score is calculated by averaging the product of the intensity and extent scores.
Each region (body and gingival) has a score range of 0-9 (minimum = 0, maximum = 9).
The mean Lobene stain composite score was determined by summing the scores from all assessed regions of the tooth surfaces and dividing by the total number of regions evaluated.
Higher scores (both subscale and mean score) indicate a worse outcome (i.e., more severe extrinsic tooth stain).
Measured: 8 weeks after toothbrush use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start5 Mar 2022
- Primary completion15 Jul 2022
- Study completion15 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Tooth BleachingStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Hongchun, Hospital of Stomatology, Sun Yat-Sen University
- Investigators
- Hongchun Liu, Principal investigator, Guanghua School of Stomatology, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05202093
- Sponsor's protocol ID
- Whitening sonic toothbrush
- Status last verified
- Dec 2025
- First submitted
- 7 Jan 2022
- Last updated
- 22 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Two Sonic Toothbrushes in Reducing Extrinsic Tooth Stain: An 8-week Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05202093
- Acronym / sponsor ID
- Whitening sonic toothbrush
- Conditions
- Tooth Bleaching
- Keywords
- Controlled Clinical Trial, Electric Toothbrush
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 5 Mar 2022 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 21 Jan 2022 (actual)
- Results
- Posted 22 Dec 2025
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 the present study was to compare the effects of reduction of extrinsic stains between 2 commercially available Oclean sonic toothbrushes in comparison with an Oral-B manual toothbrush.
Detailed description
Extrinsic tooth stain, especially on anterior teeth, is a common aesthetic issue that affect smile and self-confidence. Epidemiological studies show that dissatisfaction with tooth color impacts approximately 20% to 60% of various population groups. In a Chinese urban sample, 52.6% reported dissatisfaction with tooth color. Patients often express a desire to achieve whiter teeth, as it improves smile aesthetics, attractiveness and quality of life. It also promotes overall oral health and well-being.
Mechanical tooth cleaning through brushing remains the most effective approach for daily oral hygiene, effectively removing plaque and stain to maintain oral health, irrespective of the use of dentifrice. The effectiveness of manual toothbrush is predominantly influenced by users' brushing habits and their compliance with professional recommendations.
The electric toothbrush was first introduced in Switzerland in 1954. It was designed to simulate and enhance manual brushing motions, thereby potentially offering an improved cleaning experience. Modern electric toothbrushes feature integrated timers, pressure sensors, multiple brushing modes, and Bluetooth-enabled apps to enhance brushing duration and quality. The Oclean Digital Visual toothbrush and Oclean Sonic Electric toothbrush, developed by a Shenzhen-based Chinese company, exemplify these innovations. Both sonic toothbrushes feature silent motor technology to reduce noise, avoid resonant frequencies to lessen facial discomfort, and provide real-time pressure feedback to prevent excessive brushing force. Together, these enhancements ensure a quieter, smoother, and more comfortable brushing experience. While both models share core manufacturing parameters, the Oclean Digital Visual toothbrush provides a higher driving torque (2.16 N.cm) than the Oclean Sonic Electric toothbrush (1.96 N.cm).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| the Oclean Digital Visual toothbrush (2.16 N·cm torque) | Experimental | Device: the Oclean Digital Visual toothbrush (2.16 N·cm torque)Use the Oclean Digital Visual toothbrush (2.16 N·cm torque) to brush teeth twice daily for 8 weeks |
| the Oclean Sonic Electric toothbrush (1.96 N·cm torque) | Experimental | Device: the Oclean Sonic Electric toothbrush (1.96 N·cm torque)Use the Oclean Sonic Electric toothbrush (1.96 N·cm torque) to brush teeth twice daily for 8 week |
| Manual toothbrush | Active comparator | Device: Oral B manual toothbrushUse Oral-B manual toothbrush to brush teeth twice daily for 8 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| the Oclean Digital Visual toothbrush (2.16 N·cm torque)Use the Oclean Digital Visual toothbrush (2.16 N·cm torque) to brush teeth twice a day for 8 weeks | Device | the Oclean Digital Visual toothbrush (2.16 N·cm torque) |
| Oral B manual toothbrushUse Oral B manual toothbrush to brush teeth twice a day for 8 weeks | Device | Manual toothbrush |
| the Oclean Sonic Electric toothbrush (1.96 N·cm torque)Use the Oclean Sonic Electric toothbrush (1.96 N·cm torque) to brush teeth twice a day for 8 weeks | Device | the Oclean Sonic Electric toothbrush (1.96 N·cm torque) |
Primary outcome
Lobene Stain Index of Stain Intensity Scores 4 Weeks After Toothbrush Use
Time frame: 4 weeks after toothbrush use
Tooth stain of the anterior teeth was measured using the Lobene Stain Index. The index assesses the area and intensity of extrinsic tooth stain on the facial and lingual surfaces of the lower anterior teeth and the facial surfaces of the upper anterior teeth. Each evaluated tooth surface was divided into two anatomical regions: body and gingival. For each region, stain intensity was rated on a 0-3 ordinal scale with the following criteria: 0 = No stain; 1 = Light stain (yellow to light brown or gray); 2 = Moderate stain (medium brown); 3 = Heavy stain (dark brown to black). Each region(body and gingival) has a score range of 0-3 (minimum = 0, maximum = 3). The mean Lobene stain intensity score was determined by summing the scores from all assessed regions of the tooth surfaces and dividing by the total number of regions evaluated. Higher scores (both subscale and mean score) indicate a worse outcome (i.e., more severe extrinsic tooth stain).
Lobene Stain Index of Stain Area Scores 4 Weeks After Toothbrush Use
Time frame: 4 weeks after toothbrush use
Tooth stain of the anterior teeth was measured using the Lobene Stain Index. The index assesses the area and intensity of extrinsic tooth stain on the facial and lingual surfaces of the lower anterior teeth and the facial surfaces of the upper anterior teeth. Each evaluated tooth surface was divided into two anatomical regions: body and gingival. For each region, the stain area score were assessed using 0-3 scale. 0= no stain detected; 1= stain covering up to 1/3 of the region; 2= stain covering >1/3 to 2/3 of the region; 3=stain covering >2/3 of the region. Each region (body and gingival) has a score range of 0-3 (minimum = 0, maximum = 3). The mean Lobene stain area score was determined by summing the scores from all assessed regions of the tooth surfaces and dividing by the total number of regions evaluated. Higher scores (both subscale and mean score) indicate a worse outcome (i.e., more severe extrinsic tooth stain).
Lobene Stain Index of Stain Composite Scores 4 Weeks After Toothbrush Use
Time frame: 4 weeks after toothbrush use
Tooth stain of the anterior teeth was measured using the Lobene Stain Index. The index assesses the area and intensity of extrinsic tooth stain on the facial and lingual surfaces of the lower anterior teeth and the facial surfaces of the upper anterior teeth. Each evaluated tooth surface was divided into two anatomical regions: body and gingival. For each region, a composite score is calculated by averaging the product of the intensity and extent scores. Each region (body and gingival) has a score range of 0-9 (minimum = 0, maximum = 9). The mean Lobene stain composite score was determined by summing the scores from all assessed regions of the tooth surfaces and dividing by the total number of regions evaluated. Higher scores (both subscale and mean score) indicate a worse outcome (i.e., more severe extrinsic tooth stain).
Lobene Stain Index of Stain Intensity Scores 8 Weeks After Toothbrush Use
Time frame: 8 weeks after toothbrush use
Tooth stain of the anterior teeth was measured using the Lobene Stain Index. The index assesses the area and intensity of extrinsic tooth stain on the facial and lingual surfaces of the lower anterior teeth and the facial surfaces of the upper anterior teeth. Each evaluated tooth surface was divided into two anatomical regions: body and gingival. For each region, stain intensity was rated on a 0-3 ordinal scale with the following criteria: 0 = No stain; 1 = Light stain (yellow to light brown or gray); 2 = Moderate stain (medium brown); 3 = Heavy stain (dark brown to black). Each region(body and gingival) has a score range of 0-3 (minimum = 0, maximum = 3). The mean Lobene stain intensity score was determined by summing the scores from all assessed regions of the tooth surfaces and dividing by the total number of regions evaluated. Higher scores (both subscale and mean score) indicate a worse outcome (i.e., more severe extrinsic tooth stain).
Lobene Stain Index of Stain Area Scores 8 Weeks After Toothbrush Use
Time frame: 8 weeks after toothbrush use
Tooth stain of the anterior teeth was measured using the Lobene Stain Index. The index assesses the area and intensity of extrinsic tooth stain on the facial and lingual surfaces of the lower anterior teeth and the facial surfaces of the upper anterior teeth. Each evaluated tooth surface was divided into two anatomical regions: body and gingival. For each region, the stain area score were assessed using 0-3 scale. 0= no stain detected; 1= stain covering up to 1/3 of the region; 2= stain covering >1/3 to 2/3 of the region; 3=stain covering >2/3 of the region. Each region (body and gingival) has a score range of 0-3 (minimum = 0, maximum = 3). The mean Lobene stain area score was determined by summing the scores from all assessed regions of the tooth surfaces and dividing by the total number of regions evaluated. Higher scores (both subscale and mean score) indicate a worse outcome (i.e., more severe extrinsic tooth stain).
Lobene Stain Index of Stain Composite Scores 8 Weeks After Toothbrush Use
Time frame: 8 weeks after toothbrush use
Tooth stain of the anterior teeth was measured using the Lobene Stain Index. The index assesses the area and intensity of extrinsic tooth stain on the facial and lingual surfaces of the lower anterior teeth and the facial surfaces of the upper anterior teeth. Each evaluated tooth surface was divided into two anatomical regions: body and gingival. For each region, a composite score is calculated by averaging the product of the intensity and extent scores. Each region (body and gingival) has a score range of 0-9 (minimum = 0, maximum = 9). The mean Lobene stain composite score was determined by summing the scores from all assessed regions of the tooth surfaces and dividing by the total number of regions evaluated. Higher scores (both subscale and mean score) indicate a worse outcome (i.e., more severe extrinsic tooth stain).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Hongchun Liu principal investigator
Guanghua School of Stomatology, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the Oclean Digital Visual toothbrush (2.16 N·cm torque), Oral B manual toothbrush and the Oclean Sonic Electric toothbrush (1.96 N·cm torque) in people with Tooth Bleaching, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 22 Dec 2025. 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 China. 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?
Yes. Results are posted in the registry (first posted 22 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Lobene Stain Index of Stain Intensity Scores 4 Weeks After Toothbrush Use (time frame: 4 weeks after toothbrush use). The study lists 6 primary outcomes in all. 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 22 Dec 2025.