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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Product A | Other | Product A: Double Tapered J-hook bristles (GUM® Technique® Deep Clean Toothbrush, 525 TPA1) |
|
| Product B | Other | End rounded bristles: (GUM® Technique® Deep Clean Toothbrush, 525 TPA1) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Toothbrush with tapered bristles | Other | Toothbrush with tapered bristles |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 2, Week 4 |
| Periodontal Probing Depth and Clinical Attachment Loss |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Senior Clinical Research Coordinator, Bachelor of Science | Contact | 716-829-6397 | sgerlach@buffalo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Marcelle Nascimento, DDS, MS, PhD | State University of New York at Buffalo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SUNY Buffalo School of Dental Medicine | Recruiting | Buffalo | New York | 14214 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 14, 2025 | Nov 30, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005891 | Gingivitis |
| D010510 | Periodontal Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| Toothbrush with end-rounded bristles |
| Other |
Toothbrush with end-rounded bristles |
|
| Baseline, Week 2, and Week 4 |
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.
| Baseline, Week 2 and Week 4 |