Gingivitis and Periodontal DiseasesNCT07306026
Evaluation of Toothbrush Bristles
A study testing Toothbrush with tapered bristles and Toothbrush with end-rounded bristles in people with Gingivitis and Periodontal Diseases, run by State University of New York at Buffalo at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis and Periodontal Diseases
- What is being tested?
- Toothbrush with tapered bristles and Toothbrush with end-rounded bristles
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Oct 2025to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
SUNY Buffalo School of Dental Medicine
Buffalo, New York, 14214
Senior Clinical Research Coordinator, Bachelor of Science, 716-829-6397, sgerlach@buffalo.edu
Marcelle Nascimento, DDS, MS, PhD
About this study
Official title: Evaluation of Toothbrush Bristles in Reduction of Plaque, Inflammation, Bleeding, and Abrasion: A Comparative Study of Tapered vs. End-Rounded Bristles
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
- Being tested
- Toothbrush with tapered bristles, Toothbrush with end-rounded bristles
- Medical subject headings
- Gingivitis, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toothbrush with tapered bristlesOther
Toothbrush with tapered bristles
Toothbrush with end-rounded bristlesOther
Toothbrush with end-rounded bristles
| Study group | Role | What they receive |
|---|---|---|
| Product A | Other | Product A: Double Tapered J-hook bristles (GUM® Technique® Deep Clean Toothbrush, 525 TPA1) Receives: Other: Toothbrush with tapered bristles |
| Product B | Other | End rounded bristles: (GUM® Technique® Deep Clean Toothbrush, 525 TPA1) Receives: Other: Toothbrush with end-rounded bristles |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Baseline, Week 2, and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start21 Oct 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingivitis and Periodontal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcelle Nascimento, State University of New York at Buffalo
- Investigators
- Marcelle Nascimento, DDS, MS, PhD, Principal investigator, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07306026
- Sponsor's protocol ID
- STUDY00009358
- Status last verified
- Aug 2026
- First submitted
- 1 Dec 2025
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Toothbrush Bristles in Reduction of Plaque, Inflammation, Bleeding, and Abrasion: A Comparative Study of Tapered vs. End-Rounded Bristles
- ClinicalTrials.gov ID
- NCT07306026
- Acronym / sponsor ID
- STUDY00009358
- Conditions
- Gingivitis and Periodontal Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 21 Oct 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 26 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Product A | Other | Other: Toothbrush with tapered bristlesProduct A: Double Tapered J-hook bristles (GUM® Technique® Deep Clean Toothbrush, 525 TPA1) |
| Product B | Other | Other: Toothbrush with end-rounded bristlesEnd rounded bristles: (GUM® Technique® Deep Clean Toothbrush, 525 TPA1) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Toothbrush with tapered bristlesToothbrush with tapered bristles | Other | Product A |
| Toothbrush with end-rounded bristlesToothbrush with end-rounded bristles | Other | Product B |
Primary outcome
Rustogi Modified Navy Plaque Index
Time frame: Baseline, Week 2 and Week 4
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.
1 secondary outcome
Gingival Abrasion Score
Time frame: Baseline, Week 2, and Week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Gingivitis and Periodontal Diseases
Not yet recruitingPhase 2
Efficacy of Thymus Vulgaris Mouthwash in the Management of Biofilm-Induced Gingivitis
Plaque-Induced Gingivitis
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Circadian Clock Proteins in Gingival Crevicular Fluid of Individuals With and Without Circadian Rhythm Disruption
Gingivitis, Circadian Rhythm Disruption
Not yet recruitingObservational study
Salivary and GCF Biomarkers in Periodontal Health, Gingivitis and Periodontitis
Periodontal Health, Gingivitis
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Alpha-Lipoic Acid as an Adjunct to Non-Surgical Periodontal Treatment in Gingivitis
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The Study to Evaluate the Plaque Control and Anti-Gingivitis Efficacy of a Toothpaste in Chinese Population
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marcelle Nascimento, DDS, MS, PhD principal investigator
State University of New York at Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Toothbrush with tapered bristles and Toothbrush with end-rounded bristles in people with Gingivitis and Periodontal Diseases, run by State University of New York at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Senior Clinical Research Coordinator, Bachelor of Science (716-829-6397, sgerlach@buffalo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rustogi Modified Navy Plaque Index (time frame: Baseline, Week 2 and Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.