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Efficacy of Two Sonic Toothbrushes in Reducing Extrinsic Tooth Stain

NCT ID: NCT05202093

Last Updated: 2025-12-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-05

Study Completion Date

2022-07-15

Brief Summary

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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.

Detailed Description

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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

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Tooth Bleaching

Keywords

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Controlled Clinical Trial Electric Toothbrush

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

Use the 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

Group Type ACTIVE_COMPARATOR

Oral B manual toothbrush

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Oral B manual toothbrush

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

Intervention Type DEVICE

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Liu Hongchun

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hongchun Liu

Role: PRINCIPAL_INVESTIGATOR

Guanghua School of Stomatology, Sun Yat-sen University

Locations

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Hongchun Liu

Guangzhou, Guangdong, China

Site Status

Countries

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China

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

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Other Identifiers

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Whitening sonic toothbrush

Identifier Type: -

Identifier Source: org_study_id