Back to resultsEvaluation of Toothbrush Bristles in Plaque Reduction
Primary Purpose
Plaque, Dental, Gingivitis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tapered bristles A
Tapered bristles B
End rounded bristles
Sponsored by
About this trial
This is an interventional device feasibility trial for Plaque, Dental
Eligibility Criteria
Inclusion Criteria: Individuals may be included in the study if they meet all of the following inclusion criteria:
- Must have read, understood and signed an informed consent prior to being entered into the study
- Must be 18 to 70 years of age, male or female
- Have at least 20 natural or restored teeth
- Must have average Plaque Index of Ramfjord teeth at baseline greater than 2(Quigley and Hein) at screening
- Agree not to have a dental prophylaxis or any other elective, non-emergency dental procedures (other than those provided during the study) any time during the study
- Agree to refrain from regular oral hygiene regimen for 24 hours and eating for 4 hours before the appointment in the study
- Agree to abstain from the use of any dental products other than those provided in the study
- Agree to comply with the conditions and schedule of the study
Exclusion Criteria: Individuals are not eligible for participation in this study if any of the following are noted:
- Physical limitations or restrictions that might preclude normal tooth brushing
- Evidence of gross oral pathology
- Presence of severe gingivitis with 30 or more sites showing bleeding on probing
- Evidence of major soft tissue lesions or trauma at the baseline visit as determined by the Investigator/Examiner
- Chronic disease with concomitant oral manifestations
- Subjects who are currently undergoing, or require, extensive dental work, orthodontic treatment or periodontal surgery or orthodontic treatment in the preceding 3 months
- Currently using bleaching trays
- Eating disorders
- Recent history of substance abuse
- Smoking >10 cigarettes/day
- Participation in other clinical studies within 14 days of screening
Sites / Locations
- The University of Tennessee Health Science Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Tapered bristles A
Tapered bristles B
End rounded bristles
Arm Description
Outcomes
Primary Outcome Measures
Change of plaque index after one-time brushing
Change of plaque index (Navy Pl) for interdental area after one-time brushing in a whole mouth.
Change of plaque area after one-time brushing
Change of digitally measured interdental plaque area on non-molar teeth after one-time brushing by image analysis.
Secondary Outcome Measures
Change of plaque index at 7 days
Change of plaque index (Navy PI) for interdental area in a whole mouth at 7 days of test product use.
Change of plaque area at 7 days
Change of digitally measured interdental plaque area on non-molar teeth at 7 days of test product use .
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04681885
Brief Title
Evaluation of Toothbrush Bristles in Plaque Reduction
Official Title
Evaluation of Toothbrush Bristles in Plaque Reduction
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
June 30, 2021 (Actual)
Primary Completion Date
September 17, 2021 (Actual)
Study Completion Date
September 17, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunstar Americas
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this cross-over clinical research is to evaluate the cleaning efficacy of toothbrushes tufted with two types of tapered bristles and end rounded bristles in removal of interdental plaque with clinical measurement (Plaque Index) and objective measurement (digitally measured plaque area). This study will demonstrate the influence by a type of processing bristles on removal of interdental plaque and determine an agreement between the different evaluation methods.
This is a randomized evaluator-masked crossover study with 10 subjects. Subjects will be randomly allocated to three test groups. Subjects will use the assigned toothbrush at baseline appointment and two times a day for a week. Plaque Index and plaque area will be assessed before/after one time use at baseline and Day 7. Subjects will be assigned to another toothbrush after one week wash-out period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque, Dental, Gingivitis
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tapered bristles A
Arm Type
Experimental
Arm Title
Tapered bristles B
Arm Type
Active Comparator
Arm Title
End rounded bristles
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Tapered bristles A
Intervention Description
Subjects use the toothbrush two times daily with a fluoride toothpaste for 2 minutes with instructed brushing method for one week .
Intervention Type
Device
Intervention Name(s)
Tapered bristles B
Intervention Description
Subjects use the toothbrush two times daily with a fluoride toothpaste for 2 minutes with instructed brushing method for one week.
Intervention Type
Device
Intervention Name(s)
End rounded bristles
Intervention Description
Subjects use the toothbrush two times daily with a fluoride toothpaste for 2 minutes with instructed brushing method for one week.
Primary Outcome Measure Information:
Title
Change of plaque index after one-time brushing
Description
Change of plaque index (Navy Pl) for interdental area after one-time brushing in a whole mouth.
Time Frame
Baseline
Title
Change of plaque area after one-time brushing
Description
Change of digitally measured interdental plaque area on non-molar teeth after one-time brushing by image analysis.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Change of plaque index at 7 days
Description
Change of plaque index (Navy PI) for interdental area in a whole mouth at 7 days of test product use.
Time Frame
Baseline, 7 days
Title
Change of plaque area at 7 days
Description
Change of digitally measured interdental plaque area on non-molar teeth at 7 days of test product use .
Time Frame
Baseline, 7 days
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: Individuals may be included in the study if they meet all of the following inclusion criteria:
Must have read, understood and signed an informed consent prior to being entered into the study
Must be 18 to 70 years of age, male or female
Have at least 20 natural or restored teeth
Must have average Plaque Index of Ramfjord teeth at baseline greater than 2(Quigley and Hein) at screening
Agree not to have a dental prophylaxis or any other elective, non-emergency dental procedures (other than those provided during the study) any time during the study
Agree to refrain from regular oral hygiene regimen for 24 hours and eating for 4 hours before the appointment in the study
Agree to abstain from the use of any dental products other than those provided in the study
Agree to comply with the conditions and schedule of the study
Exclusion Criteria: Individuals are not eligible for participation in this study if any of the following are noted:
Physical limitations or restrictions that might preclude normal tooth brushing
Evidence of gross oral pathology
Presence of severe gingivitis with 30 or more sites showing bleeding on probing
Evidence of major soft tissue lesions or trauma at the baseline visit as determined by the Investigator/Examiner
Chronic disease with concomitant oral manifestations
Subjects who are currently undergoing, or require, extensive dental work, orthodontic treatment or periodontal surgery or orthodontic treatment in the preceding 3 months
Currently using bleaching trays
Eating disorders
Recent history of substance abuse
Smoking >10 cigarettes/day
Participation in other clinical studies within 14 days of screening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franklin Garcia-Godoy, DDS, PhD
Organizational Affiliation
The University of Tennessee Health Science Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Tennessee Health Science Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States
12. IPD Sharing Statement
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Evaluation of Toothbrush Bristles in Plaque Reduction
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