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

Study Overview
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Brief Summary
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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.

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

Conditions
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Tooth Bleaching

Intervention / Treatment
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* Device: Oclean electric toothbrush A
* Device: Oral B manual toothbrush
* Device: Oclean electric toothbrush B


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electric toothbrush A<br>Use Oclean electric toothbrush A to brush teeth twice daily for 8 weeks | Device: Oclean electric toothbrush A<br>* Use Oclean electric toothbrush to brush teeth twice a day for 8 weeks<br>|
| Active Comparator: Manual toothbrush<br>Use Oral B manual toothbrush to brush teeth twice daily for 8 weeks | Device: Oral B manual toothbrush<br>* Use Oral B manual toothbrush to brush teeth twice a day for 8 weeks<br>|
| Experimental: Electric toothbrush B<br>Use Oclean electric toothbrush B to brush teeth twice daily for 8 week | Device: Oclean electric toothbrush B<br>* Use Oclean electric toothbrush B to brush teeth twice a day for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Controlled Clinical Trial, electric toothbrush