Recruiting

Tapered & RoundEvaluation of Toothbrush Bristles

Sponsor:

State University of New York at Buffalo

Code:

NCT07306026

Conditions

Gingivitis and Periodontal Diseases

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Interventions

Toothbrush with tapered bristles

Toothbrush with end-rounded bristles

Study Details

Brief summary:

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.

Conditions

Gingivitis and Periodontal Diseases

Study ID

NCT07306026

Start date

Oct 21, 2025

Status verified date

Aug, 2026

Completion date

Nov 30, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

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 Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Product A

Product A: Double Tapered J-hook bristles (GUM® Technique® Deep Clean Toothbrush, 525 TPA1)

other: Product B

End rounded bristles: (GUM® Technique® Deep Clean Toothbrush, 525 TPA1)

Interventions

Toothbrush with tapered bristles

Toothbrush with end-rounded bristles

Primary outcome measure

Rustogi Modified Navy Plaque Index [ Time Frame: Baseline, Week 2 and Week 4 ]

Central Contacts and Locations

Central contacts

Senior Clinical Research Coordinator, Bachelor of Science

716-829-6397 sgerlach@buffalo.edu

Locations

SUNY Buffalo School of Dental Medicine

Recruiting

Buffalo, New York, United States, 14214

Contacts

Senior Clinical Research Coordinator, Bachelor of Science

716-829-6397 sgerlach@buffalo.edu

Principal Investigator:

Marcelle Nascimento, DDS, MS, PhD

More Information

Sponsor

State University of New York at Buffalo

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by State University of New York at Buffalo on 2026-08-20.