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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05202093
Other study ID # Whitening electric toothbrush
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 3, 2022
Est. completion date August 1, 2022

Study information

Verified date April 2022
Source Sun Yat-sen University
Contact Hongchun Liu, Ph.D.
Phone 86-13826189071
Email hongchun_liu@vip.sina.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of the present study was to compare the effects of reduction of extrinsic stains between a commercially available Oclean electric toothbrush and Oral B manual toothbrush.


Recruitment information / eligibility

Status Recruiting
Enrollment 135
Est. completion date August 1, 2022
Est. primary completion date August 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Aged between 18-70 years old - Good general health - Could attend the clinical examinations during the 4 week study period - Possessing >20 natural permanent teeth that were uncrowned or heavily filled with restorative materials, excluding third molars - Having a whole-mouth mean tooth stain score of more than 1.5 according to the Lobene index. Exclusion Criteria: - Severe oral diseases, chronic disease or allergic to the trial products - Advanced periodontal diseases - Females who are pregnant or lactating - Taking part in other clinical trials - Taking part in orthodontic treatment or wearing removable denture - Fluorosis or tetracycline teeth - Receiving prophylaxis during the previous 3 months or tooth whitening treatment during the past 6 months.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Oclean electric toothbrush A
Use Oclean electric toothbrush to brush teeth twice a day for 8 weeks
Oral B manual toothbrush
Use Oral B manual toothbrush to brush teeth twice a day for 8 weeks
Oclean electric toothbrush B
Use Oclean electric toothbrush B to brush teeth twice a day for 8 weeks

Locations

Country Name City State
China Hongchun Liu Guangzhou Guangdong

Sponsors (2)

Lead Sponsor Collaborator
Sun Yat-sen University Shenzhen Yunding Information Technology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Lobene Stain Index of Stain Extent Scores 4 Weeks After Toothbrush Use Tooth stain of the anterior teeth were measured using the Lobene Stain Index. The index measures the area and intensity of extrinsic tooth stain on the facial and lingual surfaces of the lower anterior teeth and facial surfaces of the upper anterior teeth. The tooth surfaces were divided into two parts: body and gingival. For each part, the stain intensity was assessed using 0-3 scale. 0= No stain; 1=Light stain(yellow to light brown or gray); 2=Moderate stain(medium brown); 3=Heavy stain(dark brown to black). 4 weeks after toothbrush use
Primary Lobene Stain Index of Stain Area Scores 4 Weeks After Dentifrice Use Tooth stain of the anterior teeth were measured using the Lobene Stain Index. The index measures the area and intensity of extrinsic tooth stain on the facial and lingual surfaces of the lower anterior teeth and facial surfaces of the upper anterior teeth. The tooth surfaces were divided into two parts: body and gingival. For each part, the stain area 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. 4 weeks after toothbrush use
Primary Lobene Stain Index of Stain Composite Scores 4 Weeks After Dentifrice Use A composite score is calculated for each subject by averaging the product of the intensity and extent scores. 4 weeks after toothbrush use
Primary Lobene Stain Index of Stain Extent Scores 8 Weeks After Toothbrush Use Tooth stain of the anterior teeth were measured using the Lobene Stain Index. The index measures the area and intensity of extrinsic tooth stain on the facial and lingual surfaces of the lower anterior teeth and facial surfaces of the upper anterior teeth. The tooth surfaces were divided into two parts: body and gingival. For each part, the stain intensity was assessed using 0-3 scale. 0= No stain; 1=Light stain(yellow to light brown or gray); 2=Moderate stain(medium brown); 3=Heavy stain(dark brown to black). 8 weeks after toothbrush use
Primary Lobene Stain Index of Stain Area Scores 8 Weeks After Dentifrice Use Tooth stain of the anterior teeth were measured using the Lobene Stain Index. The index measures the area and intensity of extrinsic tooth stain on the facial and lingual surfaces of the lower anterior teeth and facial surfaces of the upper anterior teeth. The tooth surfaces were divided into two parts: body and gingival. For each part, the stain area 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. 8 weeks after toothbrush use
Primary Lobene Stain Index of Stain Composite Scores 8 Weeks After Dentifrice Use A composite score is calculated for each subject by averaging the product of the intensity and extent scores. 8 weeks after toothbrush use
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