Tooth Bleaching
Conditions
Keywords
Controlled Clinical Trial, Electric Toothbrush
Brief 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.
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).
Interventions
DEVICEthe 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
DEVICEOral B manual toothbrush
Use Oral B manual toothbrush to brush teeth twice a day for 8 weeks
DEVICEthe 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
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lobene Stain Index of Stain Intensity Scores 4 Weeks After Toothbrush Use | 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 | 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 | 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 | 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 | 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 | 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). |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 43 |
| 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 | 42 |
| 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 | 41 |
| Total | 126 |
Baseline characteristics
| Characteristic | Manual Toothbrush | Total | the Oclean Digital Visual Toothbrush (2.16 N·cm Torque) | the Oclean Sonic Electric Toothbrush (1.96 N·cm Torque) |
|---|---|---|---|---|
| Age, Continuous | 44.15 years STANDARD_DEVIATION 8.28 | 43.71 years STANDARD_DEVIATION 9.02 | 43.02 years STANDARD_DEVIATION 8.87 | 43.98 years STANDARD_DEVIATION 9.98 |
| Lobene Stain Index of Stain Area Scores | 1.14 score on a scale STANDARD_DEVIATION 0.39 | 1.12 score on a scale STANDARD_DEVIATION 0.39 | 1.1 score on a scale STANDARD_DEVIATION 0.35 | 1.13 score on a scale STANDARD_DEVIATION 0.43 |
| Lobene Stain Index of Stain Composite Scores | 2.37 score on a scale STANDARD_DEVIATION 1.16 | 2.37 score on a scale STANDARD_DEVIATION 1.13 | 2.4 score on a scale STANDARD_DEVIATION 1.03 | 2.35 score on a scale STANDARD_DEVIATION 1.24 |
| Lobene Stain Index of Stain Intensity Scores | 1.31 score on a scale STANDARD_DEVIATION 0.52 | 1.29 score on a scale STANDARD_DEVIATION 0.52 | 1.28 score on a scale STANDARD_DEVIATION 0.48 | 1.28 score on a scale STANDARD_DEVIATION 0.57 |
| Race/Ethnicity, Customized Han | 41 Participants | 126 Participants | 43 Participants | 42 Participants |
| Sex: Female, Male Female | 24 Participants | 76 Participants | 26 Participants | 26 Participants |
| Sex: Female, Male Male | 17 Participants | 50 Participants | 17 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 43 | 0 / 42 | 0 / 41 |
| other Total, other adverse events | 0 / 43 | 0 / 42 | 0 / 41 |
| serious Total, serious adverse events | 0 / 43 | 0 / 42 | 0 / 41 |
Outcome results
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).
Time frame: 4 weeks after toothbrush use
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| the Oclean Digital Visual Toothbrush (2.16 N·cm Torque) | Lobene Stain Index of Stain Area Scores 4 Weeks After Toothbrush Use | 0.81 score on a scale | Standard Deviation 0.37 |
| the Oclean Sonic Electric Toothbrush (1.96 N·cm Torque) | Lobene Stain Index of Stain Area Scores 4 Weeks After Toothbrush Use | 0.81 score on a scale | Standard Deviation 0.43 |
| Manual Toothbrush | Lobene Stain Index of Stain Area Scores 4 Weeks After Toothbrush Use | 1.02 score on a scale | Standard Deviation 0.43 |
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).
Time frame: 8 weeks after toothbrush use
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| the Oclean Digital Visual Toothbrush (2.16 N·cm Torque) | Lobene Stain Index of Stain Area Scores 8 Weeks After Toothbrush Use | 0.75 score on a scale | Standard Deviation 0.33 |
| the Oclean Sonic Electric Toothbrush (1.96 N·cm Torque) | Lobene Stain Index of Stain Area Scores 8 Weeks After Toothbrush Use | 0.74 score on a scale | Standard Deviation 0.42 |
| Manual Toothbrush | Lobene Stain Index of Stain Area Scores 8 Weeks After Toothbrush Use | 0.94 score on a scale | Standard Deviation 0.45 |
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).
Time frame: 4 weeks after toothbrush use
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| the Oclean Digital Visual Toothbrush (2.16 N·cm Torque) | Lobene Stain Index of Stain Composite Scores 4 Weeks After Toothbrush Use | 1.54 score on a scale | Standard Deviation 0.94 |
| the Oclean Sonic Electric Toothbrush (1.96 N·cm Torque) | Lobene Stain Index of Stain Composite Scores 4 Weeks After Toothbrush Use | 1.5 score on a scale | Standard Deviation 0.96 |
| Manual Toothbrush | Lobene Stain Index of Stain Composite Scores 4 Weeks After Toothbrush Use | 2.05 score on a scale | Standard Deviation 1.21 |
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).
Time frame: 8 weeks after toothbrush use
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| the Oclean Digital Visual Toothbrush (2.16 N·cm Torque) | Lobene Stain Index of Stain Composite Scores 8 Weeks After Toothbrush Use | 1.37 score on a scale | Standard Deviation 0.87 |
| the Oclean Sonic Electric Toothbrush (1.96 N·cm Torque) | Lobene Stain Index of Stain Composite Scores 8 Weeks After Toothbrush Use | 1.27 score on a scale | Standard Deviation 0.84 |
| Manual Toothbrush | Lobene Stain Index of Stain Composite Scores 8 Weeks After Toothbrush Use | 1.88 score on a scale | Standard Deviation 1.21 |
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).
Time frame: 4 weeks after toothbrush use
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| the Oclean Digital Visual Toothbrush (2.16 N·cm Torque) | Lobene Stain Index of Stain Intensity Scores 4 Weeks After Toothbrush Use | 0.89 score on a scale | Standard Deviation 0.48 |
| the Oclean Sonic Electric Toothbrush (1.96 N·cm Torque) | Lobene Stain Index of Stain Intensity Scores 4 Weeks After Toothbrush Use | 0.88 score on a scale | Standard Deviation 0.46 |
| Manual Toothbrush | Lobene Stain Index of Stain Intensity Scores 4 Weeks After Toothbrush Use | 1.13 score on a scale | Standard Deviation 0.55 |
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).
Time frame: 8 weeks after toothbrush use
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| the Oclean Digital Visual Toothbrush (2.16 N·cm Torque) | Lobene Stain Index of Stain Intensity Scores 8 Weeks After Toothbrush Use | 0.78 score on a scale | Standard Deviation 0.41 |
| the Oclean Sonic Electric Toothbrush (1.96 N·cm Torque) | Lobene Stain Index of Stain Intensity Scores 8 Weeks After Toothbrush Use | 0.71 score on a scale | Standard Deviation 0.4 |
| Manual Toothbrush | Lobene Stain Index of Stain Intensity Scores 8 Weeks After Toothbrush Use | 1.01 score on a scale | Standard Deviation 0.52 |