Evaluation of Toothbrush Bristles

March 5, 2026 updated by: Marcelle Nascimento, State University of New York at Buffalo

Evaluation of Toothbrush Bristles in Reduction of Plaque, Inflammation, Bleeding, and Abrasion: A Comparative Study of Tapered vs. End-Rounded Bristles

The goal of this randomized clinical trial is to investigate two different types of toothbrush bristles.

The main questions it aims to answer are the effects of two different bristle types on:

  • how much plaque is on the teeth
  • how deep the space is between gums and teeth
  • how much gum and bone are attached to the teeth
  • whether the gums bleed when checked
  • if the gums get scratched or irritated

Researchers will compare toothbrushes with tapered bristles to those with regular round bristles.

Participants will be randomly assigned toothbrush A or B to use at home during the study.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

70

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

  • Name: Senior Clinical Research Coordinator, Bachelor of Science
  • Phone Number: 716-829-6397
  • Email: sgerlach@buffalo.edu

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14214
        • Recruiting
        • SUNY Buffalo School of Dental Medicine
        • Contact:
          • Senior Clinical Research Coordinator, Bachelor of Science
          • Phone Number: 716-829-6397
          • Email: sgerlach@buffalo.edu
        • Principal Investigator:
          • Marcelle Nascimento, DDS, MS, PhD

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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, not including implants.
  • Must have average Plaque Index of greater than 2 at screening.
  • Must have more than 20% of pockets with bleeding on probing at screening.
  • Agree not to have a dental prophylaxis or any other elective, non-emergency dental procedures 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:

  • Physical limitations or restrictions that might preclude normal tooth brushing.
  • Evidence of gross oral pathology
  • Periodontal probing pocket depths (PPD) ≥ 5mm.
  • Evidence of major soft tissue lesions or trauma at the baseline visit as determined by the 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
  • Pregnancy

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Product A
Product A: Double Tapered J-hook bristles (GUM® Technique® Deep Clean Toothbrush, 525 TPA1)
Other: Toothbrush with tapered bristles
Toothbrush with tapered bristles
Other: Product B
End rounded bristles: (GUM® Technique® Deep Clean Toothbrush, 525 TPA1)
Other: Toothbrush with end-rounded bristles
Toothbrush with end-rounded bristles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rustogi Modified Navy Plaque Index
Time Frame: Baseline, Week 2 and Week 4
Measured before and after on-site brushing to compare the frequency of plaque presence before and after brushing, as well as cumulative effects of brushing over 2 and 4 weeks. Plaque index is recorded as "1", meaning plaque is present or "0", meaning no plaque is present.
Baseline, Week 2 and Week 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gingival Abrasion Score
Time Frame: Baseline, Week 2, and Week 4
Measured before and after on-site brushing and categorized based on abrasion size (small, medium, large) to assess the one-time brushing effects as well as the cumulative effects of brushing over 2 and 4 weeks. Abrasion sizes are measured in millimeters and categorized as small (≤2 mm), medium (3-5 mm), and large (>5 mm). Measurements between 2 and 3 mm are assigned a score of small or medium according to nearest mm mark. Higher scores indicate a worse outcome than a low score, or no score (no abrasion).
Baseline, Week 2, and Week 4

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bleeding on Probing
Time Frame: Baseline, Week 2, Week 4
Measured before and after on-site brushing to assess the one-time brushing effects as well as the cumulative effects of brushing over 2 and 4 weeks.
Baseline, Week 2, Week 4
Periodontal Probing Depth and Clinical Attachment Loss
Time Frame: Baseline, Week 2 and Week 4
PPD and CAL will be determined at six sites per tooth (mesio-facial, mid facial, disto-facial, disto-lingual, mid lingual, and mesio-lingual) to assess changes over 4 week study period.
Baseline, Week 2 and Week 4

Collaborators and Investigators

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

Sponsor

State University of New York at Buffalo

Investigators

  • Principal Investigator: Marcelle Nascimento, DDS, MS, PhD, State University of New York at Buffalo

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)

October 21, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

August 31, 2026

Study Registration Dates

First Submitted

December 1, 2025

First Submitted That Met QC Criteria

December 18, 2025

First Posted (Actual)

December 26, 2025

Study Record Updates

Last Update Posted (Actual)

March 9, 2026

Last Update Submitted That Met QC Criteria

March 5, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00009358

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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