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Completed

NCT Number: NCT05202093

Efficacy of Two Sonic Toothbrushes in Reducing Extrinsic Tooth Stain

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.

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Key information

Conditions

Tooth Bleaching

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hongchun Liu

Guangzhou, Guangdong, 510055, China

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

Primary outcomes

  1. Lobene Stain Index of Stain Intensity Scores 4 Weeks After Toothbrush Use

    Time frame: 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).

  2. Lobene Stain Index of Stain Area Scores 4 Weeks After Toothbrush Use

    Time frame: 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).

  3. Lobene Stain Index of Stain Composite Scores 4 Weeks After Toothbrush Use

    Time frame: 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. Lobene Stain Index of Stain Intensity Scores 8 Weeks After Toothbrush Use

    Time frame: 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).

  5. Lobene Stain Index of Stain Area Scores 8 Weeks After Toothbrush Use

    Time frame: 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).

  6. Lobene Stain Index of Stain Composite Scores 8 Weeks After Toothbrush Use

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

Efficacy of Two Sonic Toothbrushes in Reducing Extrinsic Tooth Stain: An 8-week Randomized Clinical Trial

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 21, 2022
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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