Efficacy of Two Sonic Toothbrushes in Reducing Extrinsic Tooth Stain

NCT05202093 | Completed Results

• 1 other identifier: Whitening sonic toothbrush
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

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.

Conditions

Tooth Bleaching

Keywords

Controlled Clinical Trial; Electric Toothbrush

Outcome Measures

Primary Outcomes (6)

• 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).

  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

Study Arms (3)

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

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

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

Device: Oral B manual toothbrush

Interventions

Oral B manual toothbrush DEVICE

Use Oral B manual toothbrush to brush teeth twice a day for 8 weeks

Manual toothbrush

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

the Oclean Digital Visual toothbrush (2.16 N·cm torque)

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

the Oclean Sonic Electric toothbrush (1.96 N·cm torque)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Hongchun Liu

Guangzhou, Guangdong, 510055, China

Location

Results Point of Contact

• Title: Dr. Hongchun Liu
• Organization: Sun Yat-sen University

hongchun_liu@vip.sina.com

86-13826189071

Study Officials

• Hongchun Liu

  Guanghua School of Stomatology, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 7, 2022
• First Posted: January 21, 2022
• Study Start: March 5, 2022
• Primary Completion: July 15, 2022
• Study Completion: July 15, 2022
• Last Updated: December 22, 2025
• Results First Posted: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)