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

April 12, 2022 updated by: Liu Hongchun, Sun Yat-sen University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

135

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510055

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lobene Stain Index of Stain Extent Scores 4 Weeks After Toothbrush Use
Time Frame: 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
Time Frame: 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 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
Time Frame: 4 weeks after toothbrush 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
Time Frame: 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
Time Frame: 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 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
Time Frame: 8 weeks after toothbrush use
A composite score is calculated for each subject by averaging the product of the intensity and extent scores.
8 weeks after toothbrush use

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Collaborators

Shenzhen Yunding Information Technology Co., Ltd.

Investigators

  • Principal Investigator: Hongchun Liu, Guanghua School of Stomatology, Sun Yat-Sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2022

Primary Completion (Anticipated)

August 1, 2022

Study Completion (Anticipated)

August 1, 2022

Study Registration Dates

First Submitted

January 7, 2022

First Submitted That Met QC Criteria

January 7, 2022

First Posted (Actual)

January 21, 2022

Study Record Updates

Last Update Posted (Actual)

April 14, 2022

Last Update Submitted That Met QC Criteria

April 12, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Whitening electric toothbrush

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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