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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Manual toothbrush | Active Comparator | Use Oral-B manual toothbrush to brush teeth twice daily for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | 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). |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Hongchun Liu | Guanghua School of Stomatology, Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hongchun Liu | Guangzhou | Guangdong | 510055 | China |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 Oclean electric toothbrush A: Use the Oclean Digital Visual toothbrush (2.16 N·cm torque)to brush teeth twice a day for 8 weeks |
| FG001 | 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 Oclean electric toothbrush B: Usethe Oclean Sonic Electric toothbrush (1.96 N·cm torque) to brush teeth twice a day for 8 weeks |
| FG002 | Manual Toothbrush | Use Oral-B manual toothbrush to brush teeth twice daily for 8 weeks Oral-B manual toothbrush: Use Oral B manual toothbrush to brush teeth twice a day for 8 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 Oclean 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Mean | Standard Deviation | score on a scale | 4 weeks after toothbrush use |
|
8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 Oclean electric toothbrush A: Use the Oclean Digital Visual toothbrush (2.16 N·cm torque) to brush teeth twice a day for 8 weeks |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Hongchun Liu | Sun Yat-sen University | 86-13826189071 | hongchun_liu@vip.sina.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 18, 2022 | Nov 20, 2025 | Prot_SAP_000.pdf |
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| Oral B manual toothbrush | Device | 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 |
|
| 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). | 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). | 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). | 8 weeks after toothbrush use |
| 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 Oclean 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 |
| BG002 | Manual Toothbrush | Use Oral-B manual toothbrush to brush teeth twice daily for 8 weeks Oral-B manual toothbrush: Use Oral B manual toothbrush to brush teeth twice a day for 8 weeks |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Lobene Stain Index of Stain Intensity Scores | Each tooth surface was divided into two regions: body and gingival. For each region, tooth stain intensity was rated on a 0-3 ordinal scale (minimum = 0, maximum = 3),using the Lobene Stain Index: 0 = No stain; 1 = Light stain (yellow to light brown or gray); 2 = Moderate stain (medium brown); 3 = Heavy stain (dark brown to black). The mean Lobene stain intensity score was calculated by summing the scores from all assessed regions of the tooth surfaces and dividing by the total number of regions. Higher scores indicate a worse outcome (i.e., more severe extrinsic tooth stain). | Mean | Standard Deviation | score on a scale |
|
| Lobene Stain Index of Stain Area Scores | Each tooth surface was divided into two regions: body and gingival. For each region, tooth stain area was rated on a 0-3 ordinal scale (minimum = 0, maximum = 3), using the Lobene Stain Index: 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. The mean Lobene stain area score was calculated by summing the scores from all assessed regions of the tooth surfaces and dividing by the total number of regions. Higher scores indicate a worse outcome (i.e., more severe extrinsic tooth stain). | Mean | Standard Deviation | score on a scale |
|
| Lobene Stain Index of Stain Composite Scores | Each tooth surface was divided into two regions: body and gingival. For each region, a composite score is calculated by averaging the product of the intensity and extent scores. Each subscale (body and gingival) has a 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 indicate a worse outcome (i.e., more severe extrinsic tooth stain). | Mean | Standard Deviation | score on a scale |
|
| OG000 |
| 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 Digital Visual toothbrush (2.16 N·cm torque) : Use Oclean electric toothbrush A to brush teeth twice a day for 8 weeks |
| OG001 | 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 the Oclean Sonic Electric toothbrush (1.96 N·cm torque): Use Oclean electric toothbrush B to brush teeth twice a day for 8 weeks |
| OG002 | Manual Toothbrush | Use Oral-B manual toothbrush to brush teeth twice daily for 8 weeks Oral B manual toothbrush: Use Oral B manual toothbrush to brush teeth twice a day for 8 weeks |
|
|
| Primary | 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). | Posted | Mean | Standard Deviation | score on a scale | 4 weeks after toothbrush use |
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| Primary | 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). | Posted | Mean | Standard Deviation | score on a scale | 4 weeks after toothbrush use |
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|
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| Primary | 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). | Posted | Mean | Standard Deviation | score on a scale | 8 weeks after toothbrush use |
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| Primary | 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). | Posted | Mean | Standard Deviation | score on a scale | 8 weeks after toothbrush use |
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| Primary | 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). | Posted | Mean | Standard Deviation | score on a scale | 8 weeks after toothbrush use |
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| 0 |
| 43 |
| 0 |
| 43 |
| 0 |
| 43 |
| EG001 | 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 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 | 0 | 42 | 0 | 42 | 0 | 42 |
| EG002 | Manual Toothbrush | Use Oral-B manual toothbrush to brush teeth twice daily for 8 weeks Oral-B manual toothbrush: Use Oral B manual toothbrush to brush teeth twice a day for 8 weeks | 0 | 41 | 0 | 41 | 0 | 41 |
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