Toothbrush Bristle Types for Gum Disease

Overseen By Senior Clinical Research Coordinator, Bachelor of Science

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: State University of New York at Buffalo

Disqualifiers: Oral pathology, Chronic disease, Orthodontic treatment, Smoking, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Marcelle Nascimento, DDS, MS, PhD

Principal Investigator

State University of New York at Buffalo

Are You a Good Fit for This Trial?

This trial is for individuals with gum disease or periodontal conditions. Participants should be willing to use a specific type of toothbrush at home as directed by the study. There are no specified exclusion criteria provided, but typically those with other significant dental issues may not qualify.

Inclusion Criteria

Must have read, understood and signed an informed consent prior to being entered into the study

I am between 18 and 70 years old.

Must have average Plaque Index of greater than 2 at screening

Exclusion Criteria

I am not currently undergoing or need major dental or orthodontic work.

Pregnancy

Currently using bleaching trays

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants use assigned toothbrush (either tapered or end-rounded bristles) at home

4 weeks

Baseline, Week 2, Week 4 (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Evaluation of Toothbrush Bristles

Trial Overview

The study is examining the effectiveness of two types of toothbrush bristles: end-rounded and tapered. It aims to see which one better reduces plaque, improves gum-tooth attachment, decreases bleeding on probing, and minimizes irritation.

How Is the Trial Designed?

Group I: Product B Experimental Treatment 1 Intervention

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

Group II: Product A Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

State University of New York at Buffalo

Lead Sponsor

Trials

279

Recruited

52,600+