Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
70 participants
INTERVENTIONAL
2025-10-21
2026-08-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Product A
Product A: Double Tapered J-hook bristles (GUM® Technique® Deep Clean Toothbrush, 525 TPA1)
Toothbrush with tapered bristles
Toothbrush with tapered bristles
Product B
End rounded bristles: (GUM® Technique® Deep Clean Toothbrush, 525 TPA1)
Toothbrush with end-rounded bristles
Toothbrush with end-rounded bristles
Interventions
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Toothbrush with tapered bristles
Toothbrush with tapered bristles
Toothbrush with end-rounded bristles
Toothbrush with end-rounded bristles
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
Yes
Sponsors
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State University of New York at Buffalo
OTHER
Responsible Party
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Marcelle Nascimento
Assistant Dean for Clinical Research
Principal Investigators
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Marcelle Nascimento, DDS, MS, PhD
Role: PRINCIPAL_INVESTIGATOR
State University of New York at Buffalo
Locations
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SUNY Buffalo School of Dental Medicine
Buffalo, New York, United States
Countries
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Central Contacts
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Senior Clinical Research Coordinator, Bachelor of Science
Role: CONTACT
Phone: 716-829-6397
Email: [email protected]
Facility Contacts
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Senior Clinical Research Coordinator, Bachelor of Science
Role: primary
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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STUDY00009358
Identifier Type: -
Identifier Source: org_study_id