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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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)
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.

China1 site
  • Hongchun Liu

    Guangzhou, Guangdong, 510055

Other trials in China

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 groups in NCT05202093
Study groupRoleWhat they receive
the Oclean Digital Visual toothbrush (2.16 N·cm torque)ExperimentalUse 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)ExperimentalUse 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 toothbrushActive comparatorUse 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.

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  1. First posted21 Jan 2022
  2. Study start5 Mar 2022
  3. Primary completion15 Jul 2022
  4. Study completion15 Jul 2022

Resources

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)
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
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

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