Evaluation of Toothbrush Bristles in Plaque Reduction

July 19, 2024 updated by: Sunstar Americas

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

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 Locations

  • United States
    • Tennessee
      • Memphis, Tennessee, United States, 38163
        • The University of Tennessee Health Science Center

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

Yes

Description

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

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: Device Feasibility
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tapered bristles A
Test toothbrush with tapered bristle
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
Test toothbrush with tapered bristle
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
Conventionla toothbrush with end rounded bristle
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Navy Plaque Index (Navy Pl) After One-time Brushing
Time Frame: Pre-intervention at baseline and after one-time brushing for 2 minutes at baseline
Change of Navy Plaque Index (Navy Pl) after one-time brushing in a whole mouth. The Navy Plaque Index (PI) can be either 0 (plaque is not present) or 1 (plaque is present). Each tooth is partitioned into 9 areas, and the PI is evaluated for teeth numbered 2-15 and 18-31, totaling 28 teeth. Both buccal (B) and lingual (L) sides of each tooth are assessed. The PI value of each person ranges from 0 to 504 (28 teeth × 9 areas × 2 sides). Baseline value is calculated by averaging PI values of 10 subjects before brushing. Post-brushing value is calculated by averaging PI values of 10 subjects after a one-time brushing for 2 minutes
Pre-intervention at baseline and after one-time brushing for 2 minutes at baseline
Change of Digitally Measured Interdental Plaque Area After One-time Brushing
Time Frame: Pre-intervention at baseline and after one-time brushing for 2 minutes at baseline
Change of digitally measured interdental plaque area on non-molar teeth, facial/buccal aspect after one-time brushing by image analysis.
Pre-intervention at baseline and after one-time brushing for 2 minutes at baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Navy Plaque Index (Navy PI) After 7-day Brushing
Time Frame: Pre-intervention at baseline and after 7- day brushing at baseline
Change of Navy Plaque Index (Navy Pl) after 7-day brushing in a whole mouth. The Navy Plaque Index (PI) can be either 0 (plaque is not present) or 1 (plaque is present). Each tooth is partitioned into 9 areas, and the PI is evaluated for teeth numbered 2-15 and 18-31, totaling 28 teeth. Both buccal (B) and lingual (L) sides of each tooth are assessed. The PI value of each person ranges from 0 to 504 (28 teeth × 9 areas × 2 sides). Baseline value is calculated by averaging PI values of 10 subjects before brushing. 7-day value is calculated by averaging PI values of 10 subjects after 7-day brushing.
Pre-intervention at baseline and after 7- day brushing at baseline
Change of Digitally Measured Interdental Plaque Area After 7-day Brushing
Time Frame: Pre-intervention at baseline and after 7-day brushing at baseline
Change of digitally measured interdental plaque area on non-molar teeth, facial/buccal aspect after 7- day brushing by image analysis.
Pre-intervention at baseline and after 7-day brushing at baseline

Collaborators and Investigators

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

Sponsor

Sunstar Americas

Investigators

  • Principal Investigator: Franklin Garcia-Godoy, DDS, PhD, The University of Tennessee Health Science Center

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)

June 30, 2021

Primary Completion (Actual)

September 17, 2021

Study Completion (Actual)

September 17, 2021

Study Registration Dates

First Submitted

December 18, 2020

First Submitted That Met QC Criteria

December 18, 2020

First Posted (Actual)

December 23, 2020

Study Record Updates

Last Update Posted (Actual)

October 15, 2024

Last Update Submitted That Met QC Criteria

July 19, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLP-2020-06-01-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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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