ClinicalTrials.gg
RecruitingNCT07306026Updated Aug 20, 2026

Evaluation of Toothbrush Bristles

An interventional study of Toothbrush with tapered bristles and Toothbrush with end-rounded bristles in Gingivitis and Periodontal Diseases, sponsored by State University of New York at Buffalo. Recruiting at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-20.

Sponsored by State University of New York at Buffalo · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2025; still recruiting 1 year later.
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Gingivitis and Periodontal Diseases
03

In context

Gingivitis

631 studies on the registry are indexed under Gingivitis; 107 are open to participants now.

This study's planned enrollment of 70 is close to the median of 66 across 507 interventional studies indexed under Gingivitis.

Browse Gingivitis studies →

Lead sponsor

State University of New York at Buffalo is the lead sponsor of 294 studies on the registry; 63 are open to participants now.

Of its 19 completed or terminated interventional studies of FDA-regulated products, 15 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Must have read, understood and signed an 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

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
70 participants (estimated)

Study arms

  • Other
    Product A

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

    Other: Toothbrush with tapered bristles

  • Other
    Product B

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

    Other: Toothbrush with end-rounded bristles

Interventions

  • OtherToothbrush with tapered bristles

    Toothbrush with tapered bristles

  • OtherToothbrush with end-rounded bristles

    Toothbrush with end-rounded bristles

06

What researchers measure

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.

    Time frame: Baseline, Week 2 and Week 4

Secondary outcomes

  1. Gingival Abrasion Score

    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).

    Time frame: Baseline, Week 2, and Week 4

Other outcomes

  1. Bleeding on Probing

    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.

    Time frame: Baseline, Week 2, Week 4

  2. Periodontal Probing Depth and Clinical Attachment Loss

    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.

    Time frame: Baseline, Week 2 and Week 4

07

Study locations

1 of 1 sites recruiting
  • SUNY Buffalo School of Dental Medicine
    Buffalo, New York 14214, United States
    Recruiting
    • Senior Clinical Research Coordinator, Bachelor of Science · Contactsgerlach@buffalo.edu · 716-829-6397
    • Marcelle Nascimento, DDS, MS, PhD · Principal investigator
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2025 (actual). Primary completion is estimated for Sep 2026, 11 months after the start.

Of 204 non-industry interventional studies with no phase under Gingivitis, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 18. This study's planned 11 months is above that.

Counting every sponsor, half of 257 studies reached it within 7 months; a quarter within 3 and three quarters within 15.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 1, 2025
First posted
Dec 26, 2025
StartActual
Oct 21, 2025
Primary completionEst.
Sep 30, 2026
CompletionEst.
Nov 30, 2026
Last update
Aug 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07306026
Responsible party
Marcelle Nascimento (Assistant Dean for Clinical Research, State University of New York at Buffalo) — Principal investigator
First posted
Dec 26, 2025
Start date
Oct 21, 2025
Primary completion
Sep 30, 2026 (estimated)
Completion
Nov 30, 2026 (estimated)
Last update
Aug 20, 2026

Study contacts

Senior Clinical Research Coordinator, Bachelor of Science
Contact
sgerlach@buffalo.edu
716-829-6397
Marcelle Nascimento, DDS, MS, PhD
principal investigator · State University of New York at Buffalo

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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