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Evaluation of Toothbrush Bristles in Plaque Reduction

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ClinicalTrials.gov Identifier: NCT04681885
Recruitment Status : Completed
First Posted : December 23, 2020
Last Update Posted : October 1, 2021
Sponsor:
Information provided by (Responsible Party):
Sunstar Americas

Study Description
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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.


Condition or disease Intervention/treatment Phase
Plaque, Dental Gingivitis Device: Tapered bristles A Device: Tapered bristles B Device: End rounded bristles Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Device Feasibility
Official Title: Evaluation of Toothbrush Bristles in Plaque Reduction
Actual Study Start Date : June 30, 2021
Actual Primary Completion Date : September 17, 2021
Actual Study Completion Date : September 17, 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: Tapered bristles A Device: Tapered bristles A
Subjects use the toothbrush two times daily with a fluoride toothpaste for 2 minutes with instructed brushing method for one week .

Device: Tapered bristles B
Subjects use the toothbrush two times daily with a fluoride toothpaste for 2 minutes with instructed brushing method for one week.

Device: End rounded bristles
Subjects use the toothbrush two times daily with a fluoride toothpaste for 2 minutes with instructed brushing method for one week.
Active Comparator: Tapered bristles B Device: Tapered bristles A
Subjects use the toothbrush two times daily with a fluoride toothpaste for 2 minutes with instructed brushing method for one week .

Device: Tapered bristles B
Subjects use the toothbrush two times daily with a fluoride toothpaste for 2 minutes with instructed brushing method for one week.

Device: End rounded bristles
Subjects use the toothbrush two times daily with a fluoride toothpaste for 2 minutes with instructed brushing method for one week.
Active Comparator: End rounded bristles Device: Tapered bristles A
Subjects use the toothbrush two times daily with a fluoride toothpaste for 2 minutes with instructed brushing method for one week .

Device: Tapered bristles B
Subjects use the toothbrush two times daily with a fluoride toothpaste for 2 minutes with instructed brushing method for one week.

Device: End rounded bristles
Subjects use the toothbrush two times daily with a fluoride toothpaste for 2 minutes with instructed brushing method for one week.


Outcome Measures
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Primary Outcome Measures :
  1. Change of plaque index after one-time brushing [ Time Frame: Baseline ]
    Change of plaque index (Navy Pl) for interdental area after one-time brushing in a whole mouth.

  2. Change of plaque area after one-time brushing [ Time Frame: Baseline ]
    Change of digitally measured interdental plaque area on non-molar teeth after one-time brushing by image analysis.


Secondary Outcome Measures :
  1. Change of plaque index at 7 days [ Time Frame: Baseline, 7 days ]
    Change of plaque index (Navy PI) for interdental area in a whole mouth at 7 days of test product use.

  2. Change of plaque area at 7 days [ Time Frame: Baseline, 7 days ]
    Change of digitally measured interdental plaque area on non-molar teeth at 7 days of test product use .


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04681885


Locations
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United States, Tennessee
The University of Tennessee Health Science Center
Memphis, Tennessee, United States, 38163
Sponsors and Collaborators
Sunstar Americas
Investigators
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Principal Investigator: Franklin Garcia-Godoy, DDS, PhD The University of Tennessee Health Science Center
More Information
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Responsible Party: Sunstar Americas
ClinicalTrials.gov Identifier: NCT04681885    
Other Study ID Numbers: CLP-2020-06-01-1
First Posted: December 23, 2020    Key Record Dates
Last Update Posted: October 1, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gingivitis
Dental Plaque
Infections
Gingival Diseases
Periodontal Diseases
 Mouth Diseases
Stomatognathic Diseases
Dental Deposits
Tooth Diseases