Eight Week Clinical Study to Investigate Reduction of Extrinsic Tooth Stain by Electric Toothbrush

Tooth Bleaching Clinical Trial

Official title:

Eight Week Clinical Study to Investigate Reduction of Extrinsic Tooth Stain by Electric Toothbrush

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05202093
• Other study ID #: Whitening electric toothbrush
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Tooth Bleaching
• Tooth Discoloration

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