Trial Outcomes & Findings for Efficacy of Two Sonic Toothbrushes in Reducing Extrinsic Tooth Stain (NCT NCT05202093)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

129 participants

Primary outcome timeframe

4 weeks after toothbrush use

Results posted on

2025-12-22

Participant Flow

Participant milestones

Participant milestones
Measure	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	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	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
Overall Study STARTED	43	43	43
Overall Study COMPLETED	43	42	41
Overall Study NOT COMPLETED	0	1	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy of Two Sonic Toothbrushes in Reducing Extrinsic Tooth Stain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	the Oclean Digital Visual Toothbrush (2.16 N·cm Torque) n=43 Participants 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	the Oclean Sonic Electric Toothbrush (1.96 N·cm Torque) n=42 Participants 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	Manual Toothbrush n=41 Participants 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	Total n=126 Participants Total of all reporting groups
Age, Continuous	43.02 years STANDARD_DEVIATION 8.87 • n=18 Participants	43.98 years STANDARD_DEVIATION 9.98 • n=102 Participants	44.15 years STANDARD_DEVIATION 8.28 • n=30 Participants	43.71 years STANDARD_DEVIATION 9.02 • n=37 Participants
Sex: Female, Male Female	26 Participants n=18 Participants	26 Participants n=102 Participants	24 Participants n=30 Participants	76 Participants n=37 Participants
Sex: Female, Male Male	17 Participants n=18 Participants	16 Participants n=102 Participants	17 Participants n=30 Participants	50 Participants n=37 Participants
Race/Ethnicity, Customized Han	43 Participants n=18 Participants	42 Participants n=102 Participants	41 Participants n=30 Participants	126 Participants n=37 Participants
Lobene Stain Index of Stain Intensity Scores	1.28 score on a scale STANDARD_DEVIATION 0.48 • n=18 Participants	1.28 score on a scale STANDARD_DEVIATION 0.57 • n=102 Participants	1.31 score on a scale STANDARD_DEVIATION 0.52 • n=30 Participants	1.29 score on a scale STANDARD_DEVIATION 0.52 • n=37 Participants
Lobene Stain Index of Stain Area Scores	1.1 score on a scale STANDARD_DEVIATION 0.35 • n=18 Participants	1.13 score on a scale STANDARD_DEVIATION 0.43 • n=102 Participants	1.14 score on a scale STANDARD_DEVIATION 0.39 • n=30 Participants	1.12 score on a scale STANDARD_DEVIATION 0.39 • n=37 Participants
Lobene Stain Index of Stain Composite Scores	2.4 score on a scale STANDARD_DEVIATION 1.03 • n=18 Participants	2.35 score on a scale STANDARD_DEVIATION 1.24 • n=102 Participants	2.37 score on a scale STANDARD_DEVIATION 1.16 • n=30 Participants	2.37 score on a scale STANDARD_DEVIATION 1.13 • n=37 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	the Oclean Digital Visual Toothbrush (2.16 N·cm Torque) n=43 Participants 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	the Oclean Sonic Electric Toothbrush (1.96 N·cm Torque) n=42 Participants 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	Manual Toothbrush n=41 Participants 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
Lobene Stain Index of Stain Intensity Scores 4 Weeks After Toothbrush Use	0.89 score on a scale Standard Deviation 0.48	0.88 score on a scale Standard Deviation 0.46	1.13 score on a scale Standard Deviation 0.55

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	the Oclean Digital Visual Toothbrush (2.16 N·cm Torque) n=43 Participants 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	the Oclean Sonic Electric Toothbrush (1.96 N·cm Torque) n=42 Participants 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	Manual Toothbrush n=41 Participants 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
Lobene Stain Index of Stain Area Scores 4 Weeks After Toothbrush Use	0.81 score on a scale Standard Deviation 0.37	0.81 score on a scale Standard Deviation 0.43	1.02 score on a scale Standard Deviation 0.43

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	the Oclean Digital Visual Toothbrush (2.16 N·cm Torque) n=43 Participants 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	the Oclean Sonic Electric Toothbrush (1.96 N·cm Torque) n=42 Participants 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	Manual Toothbrush n=41 Participants 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
Lobene Stain Index of Stain Composite Scores 4 Weeks After Toothbrush Use	1.54 score on a scale Standard Deviation 0.94	1.5 score on a scale Standard Deviation 0.96	2.05 score on a scale Standard Deviation 1.21

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	the Oclean Digital Visual Toothbrush (2.16 N·cm Torque) n=43 Participants 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	the Oclean Sonic Electric Toothbrush (1.96 N·cm Torque) n=42 Participants 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	Manual Toothbrush n=41 Participants 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
Lobene Stain Index of Stain Intensity Scores 8 Weeks After Toothbrush Use	0.78 score on a scale Standard Deviation 0.41	0.71 score on a scale Standard Deviation 0.4	1.01 score on a scale Standard Deviation 0.52

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	the Oclean Digital Visual Toothbrush (2.16 N·cm Torque) n=43 Participants 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	the Oclean Sonic Electric Toothbrush (1.96 N·cm Torque) n=42 Participants 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	Manual Toothbrush n=41 Participants 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
Lobene Stain Index of Stain Area Scores 8 Weeks After Toothbrush Use	0.75 score on a scale Standard Deviation 0.33	0.74 score on a scale Standard Deviation 0.42	0.94 score on a scale Standard Deviation 0.45

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	the Oclean Digital Visual Toothbrush (2.16 N·cm Torque) n=43 Participants 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	the Oclean Sonic Electric Toothbrush (1.96 N·cm Torque) n=42 Participants 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	Manual Toothbrush n=41 Participants 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
Lobene Stain Index of Stain Composite Scores 8 Weeks After Toothbrush Use	1.37 score on a scale Standard Deviation 0.87	1.27 score on a scale Standard Deviation 0.84	1.88 score on a scale Standard Deviation 1.21

Adverse Events

the Oclean Digital Visual Toothbrush (2.16 N·cm Torque)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

the Oclean Sonic Electric Toothbrush (1.96 N·cm Torque)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Manual Toothbrush

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Hongchun Liu

Sun Yat-sen University

Phone: 86-13826189071

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place