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

Primary Purpose

Tooth Bleaching

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Oclean electric toothbrush A
Oral B manual toothbrush
Oclean electric toothbrush B
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth Bleaching focused on measuring Controlled Clinical Trial, electric toothbrush

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Hongchun LiuRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Electric toothbrush A

Manual toothbrush

Electric toothbrush B

Arm Description

Use Oclean electric toothbrush A to brush teeth twice daily for 8 weeks

Use Oral B manual toothbrush to brush teeth twice daily for 8 weeks

Use Oclean electric toothbrush B to brush teeth twice daily for 8 week

Outcomes

Primary Outcome Measures

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).
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.
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.
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).
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.
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.

Secondary Outcome Measures

Full Information

First Posted
January 7, 2022
Last Updated
April 12, 2022
Sponsor
Sun Yat-sen University
Collaborators
Shenzhen Yunding Information Technology Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05202093
Brief Title
Eight Week Clinical Study to Investigate Reduction of Extrinsic Tooth Stain by Electric Toothbrush
Official Title
Eight Week Clinical Study to Investigate Reduction of Extrinsic Tooth Stain by Electric Toothbrush
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 3, 2022 (Actual)
Primary Completion Date
August 1, 2022 (Anticipated)
Study Completion Date
August 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
Collaborators
Shenzhen Yunding Information Technology Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Bleaching
Keywords
Controlled Clinical Trial, electric toothbrush

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
135 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Electric toothbrush A
Arm Type
Experimental
Arm Description
Use Oclean electric toothbrush A to brush teeth twice daily for 8 weeks
Arm Title
Manual toothbrush
Arm Type
Active Comparator
Arm Description
Use Oral B manual toothbrush to brush teeth twice daily for 8 weeks
Arm Title
Electric toothbrush B
Arm Type
Experimental
Arm Description
Use Oclean electric toothbrush B to brush teeth twice daily for 8 week
Intervention Type
Device
Intervention Name(s)
Oclean electric toothbrush A
Intervention Description
Use Oclean electric toothbrush to brush teeth twice a day for 8 weeks
Intervention Type
Device
Intervention Name(s)
Oral B manual toothbrush
Intervention Description
Use Oral B manual toothbrush to brush teeth twice a day for 8 weeks
Intervention Type
Device
Intervention Name(s)
Oclean electric toothbrush B
Intervention Description
Use Oclean electric toothbrush B to brush teeth twice a day for 8 weeks
Primary Outcome Measure Information:
Title
Lobene Stain Index of Stain Extent Scores 4 Weeks After Toothbrush Use
Description
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).
Time Frame
4 weeks after toothbrush use
Title
Lobene Stain Index of Stain Area Scores 4 Weeks After Dentifrice Use
Description
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.
Time Frame
4 weeks after toothbrush use
Title
Lobene Stain Index of Stain Composite Scores 4 Weeks After Dentifrice Use
Description
A composite score is calculated for each subject by averaging the product of the intensity and extent scores.
Time Frame
4 weeks after toothbrush use
Title
Lobene Stain Index of Stain Extent Scores 8 Weeks After Toothbrush Use
Description
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).
Time Frame
8 weeks after toothbrush use
Title
Lobene Stain Index of Stain Area Scores 8 Weeks After Dentifrice Use
Description
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.
Time Frame
8 weeks after toothbrush use
Title
Lobene Stain Index of Stain Composite Scores 8 Weeks After Dentifrice Use
Description
A composite score is calculated for each subject by averaging the product of the intensity and extent scores.
Time Frame
8 weeks after toothbrush use

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hongchun Liu, Ph.D.
Phone
86-13826189071
Email
hongchun_liu@vip.sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hongchun Liu
Organizational Affiliation
Guanghua School of Stomatology, Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hongchun Liu
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510055
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongchun Liu, Ph.D.
Phone
+8613826189071
Email
hongchun_liu@vip.sina.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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