Evaluation of Toothbrush Bristles

NCT07306026 | Recruiting

• 1 other identifier: STUDY00009358
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Rustogi Modified Navy Plaque Index

  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 Outcomes (1)

• Gingival Abrasion Score

  Baseline, Week 2, and Week 4

Other Outcomes (2)

• Bleeding on Probing

  Baseline, Week 2, Week 4

• Periodontal Probing Depth and Clinical Attachment Loss

  Baseline, Week 2 and Week 4

Study Arms (2)

Product A

OTHER

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

Other: Toothbrush with tapered bristles

Product B

OTHER

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

Other: Toothbrush with end-rounded bristles

Interventions

Toothbrush with tapered bristles OTHER

Toothbrush with tapered bristles

Product A

Toothbrush with end-rounded bristles OTHER

Toothbrush with end-rounded bristles

Product B

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• State University of New York at Buffalo: lead

Study Sites (1)

SUNY Buffalo School of Dental Medicine

Buffalo, New York, 14214, United States

RECRUITING

MeSH Terms

Conditions

Gingivitis; Periodontal Diseases

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Marcelle Nascimento, DDS, MS, PhD

  State University of New York at Buffalo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Senior Clinical Research Coordinator, Bachelor of Science

CONTACT

716-829-6397; sgerlach@buffalo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Dean for Clinical Research

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 26, 2025
• Study Start: October 21, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: March 9, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)