Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07306026

Evaluation of Toothbrush 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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SUNY Buffalo School of Dental Medicine

Buffalo, New York, 14214, United States

Location status: Recruiting

Location contact

Marcelle Nascimento, DDS, MS, PhD

PRINCIPAL_INVESTIGATOR

Senior Clinical Research Coordinator, Bachelor of Science

CONTACT

[email protected]

716-829-6397

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Toothbrush with tapered bristles

Other

Toothbrush with tapered bristles

Toothbrush with end-rounded bristles

Other

Toothbrush with end-rounded bristles

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

Other outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Senior Clinical Research Coordinator, Bachelor of Science

CONTACT

[email protected]

716-829-6397

Sponsors and collaborators

Lead sponsor

State University of New York at Buffalo

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 26, 2025
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.