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

Not Applicable
Conditions
Tooth Bleaching
Interventions
Device: Oral B manual toothbrush
Device: Oclean electric toothbrush B
Device: Oclean electric toothbrush A
Registration Number
NCT05202093
Lead Sponsor
Sun Yat-sen University
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
135
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

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Manual toothbrushOral B manual toothbrushUse Oral B manual toothbrush to brush teeth twice daily for 8 weeks
Electric toothbrush BOclean electric toothbrush BUse Oclean electric toothbrush B to brush teeth twice daily for 8 week
Electric toothbrush AOclean electric toothbrush AUse Oclean electric toothbrush A to brush teeth twice daily for 8 weeks
Primary Outcome Measures
NameTimeMethod
Lobene Stain Index of Stain Composite Scores 4 Weeks After Dentifrice Use4 weeks after toothbrush use

A composite score is calculated for each subject by averaging the product of the intensity and extent scores.

Lobene Stain Index of Stain Area Scores 4 Weeks After Dentifrice Use4 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 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.

Lobene Stain Index of Stain Extent Scores 4 Weeks After Toothbrush Use4 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).

Lobene Stain Index of Stain Extent Scores 8 Weeks After Toothbrush Use8 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).

Lobene Stain Index of Stain Composite Scores 8 Weeks After Dentifrice Use8 weeks after toothbrush use

A composite score is calculated for each subject by averaging the product of the intensity and extent scores.

Lobene Stain Index of Stain Area Scores 8 Weeks After Dentifrice Use8 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 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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Hongchun Liu

🇨🇳

Guangzhou, Guangdong, China

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