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The primary objective of this study is to evaluate the effect of two experimental hops extract-containing dentifrices on gingivitis relative to a positive control 0.454% SnF2 dentifrice and a negative control dentifrice after 12 weeks of product use.
The participants will be enrolled and use their assigned treatment products for 12 weeks (~3 months).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Positive Control | Active Comparator | 0.454% stannous fluoride, 0.533% zinc citrate |
|
| Experimental #1 | Experimental | 0.243% NaF with 0.1% Hops, Humulus lupulus extract [0.045% hops β-acids] |
|
| Experimental #2 | Experimental | 0.243% NaF with 0.5% Hops, Humulus lupulus extract [0.225% hops β-acids] |
|
| Negative Control | Active Comparator | 0.76% Sodium Monofluorophosphate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stannous Fluoride Dentifrice | Drug | Each subject will be randomly assigned to one of four treatment products and will be asked to brush 2x a day (1 minute per brushing) for 12 weeks (~3 months). |
| Measure | Description | Time Frame |
|---|---|---|
| Number Bleeding Sites | 4 weeks (~1 month) and 12 weeks (~3 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Löe-Silness Gingivitis Evaluation | scored on a scale of 0-3; 0 Normal gingiva; 1 Mild inflammation - slight change in colour, slight edema. No bleeding on probing; 2 Moderate inflammation - redness, edema, and glazing. Bleeding on probing; 3 Severe inflammation - marked redness, edema. Ulceration. Tendency to spontaneous bleeding | 4 weeks (~1 month) and 12 weeks (~3 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| All Sum Research | All Sum Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| All Sum ResearchAll Sum Research Center Ltd. | Mississauga | Ontario | L5N 6J2 | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | Negative Control | 0.76% Sodium Monofluorophosphate |
| FG001 | Experimental #1 | 0.243% NaF with 0.1% Hops, Humulus lupulus extract [0.045% hops β-acids] |
| FG002 | Experimental #2 | 0.243% NaF with 0.5% Hops, Humulus lupulus extract [0.225% hops β-acids] |
| FG003 | Positive Control | 0.454% stannous fluoride, 0.533% zinc citrate |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Negative Control | 0.76% Sodium Monofluorophosphate Sodium monofluorophosphate dentifrice: Each subject will be randomly assigned to one of four treatment products and will be asked to brush 2x a day (1 minute per brushing) for 3 months. |
| BG001 | Experimental #1 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number Bleeding Sites | Number of Bleeding sites | Posted | Least Squares Mean | Standard Error | number of bleeding sites | 4 weeks (~1 month) and 12 weeks (~3 months) |
|
Data collected over 12 weeks (~3 months) of product use.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Positive Control | 0.454% stannous fluoride, 0.533% zinc citrate Stannous Fluoride Dentifrice: Each subject will be randomly assigned to one of four treatment products and will be asked to brush 2x a day (1 minute per brushing) for 12 weeks (~3 months). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| HEADACHE | Nervous system disorders | MedDRA (26.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Tao He | Procter & Gamble | 513-622-2159 | he.t@pg.com |
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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 | Feb 20, 2025 | Apr 27, 2026 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D005891 | Gingivitis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
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| Sodium Fluoride Dentifrice | Drug | Each subject will be randomly assigned to one of four treatment products and will be asked to brush 2x a day (1 minute per brushing) for 12 weeks (~3 months). |
|
| Sodium monofluorophosphate dentifrice | Drug | Each subject will be randomly assigned to one of four treatment products and will be asked to brush 2x a day (1 minute per brushing) for 12 weeks (~3 months). |
|
0.243% NaF with 0.1% Hops, Humulus lupulus extract [0.045% hops β-acids] Sodium Fluoride Dentifrice: Each subject will be randomly assigned to one of four treatment products and will be asked to brush 2x a day (1 minute per brushing) for 3 months. |
| BG002 | Experimental #2 | 0.243% NaF with 0.5% Hops, Humulus lupulus extract [0.225% hops β-acids] Sodium Fluoride Dentifrice: Each subject will be randomly assigned to one of four treatment products and will be asked to brush 2x a day (1 minute per brushing) for 3 months. |
| BG003 | Positive Control | 0.454% stannous fluoride, 0.533% zinc citrate Stannous Fluoride Dentifrice: Each subject will be randomly assigned to one of four treatment products and will be asked to brush 2x a day (1 minute per brushing) for 3 months. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Experimental #2 | 0.243% NaF with 0.5% Hops, Humulus lupulus extract [0.225% hops β-acids] Sodium Fluoride Dentifrice: Each subject will be randomly assigned to one of four treatment products and will be asked to brush 2x a day (1 minute per brushing) for 3 months. |
| OG003 | Positive Control | 0.454% stannous fluoride, 0.533% zinc citrate Stannous Fluoride Dentifrice: Each subject will be randomly assigned to one of four treatment products and will be asked to brush 2x a day (1 minute per brushing) for 3 months. |
|
|
| Secondary | Löe-Silness Gingivitis Evaluation | scored on a scale of 0-3; 0 Normal gingiva; 1 Mild inflammation - slight change in colour, slight edema. No bleeding on probing; 2 Moderate inflammation - redness, edema, and glazing. Bleeding on probing; 3 Severe inflammation - marked redness, edema. Ulceration. Tendency to spontaneous bleeding | Posted | Least Squares Mean | Standard Error | score on scale | 4 weeks (~1 month) and 12 weeks (~3 months) |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 2 |
| 30 |
| EG001 | Experimental #1 | 0.243% NaF with 0.1% Hops, Humulus lupulus extract [0.045% hops β-acids] Sodium Fluoride Dentifrice: Each subject will be randomly assigned to one of four treatment products and will be asked to brush 2x a day (1 minute per brushing) for 12 weeks (~3 months). | 0 | 30 | 0 | 30 | 0 | 30 |
| EG002 | Experimental #2 | 0.243% NaF with 0.5% Hops, Humulus lupulus extract [0.225% hops β-acids] Sodium Fluoride Dentifrice: Each subject will be randomly assigned to one of four treatment products and will be asked to brush 2x a day (1 minute per brushing) for 12 weeks (~3 months). | 0 | 30 | 0 | 30 | 0 | 30 |
| EG003 | Negative Control | 0.76% Sodium Monofluorophosphate Sodium monofluorophosphate dentifrice: Each subject will be randomly assigned to one of four treatment products and will be asked to brush 2x a day (1 minute per brushing) for 12 weeks (~3 months). | 0 | 30 | 0 | 30 | 0 | 30 |
The PI agrees not to publish the results of a study without the prior written consent of Sponsor.
| D009057 |
| Stomatognathic Diseases |
| 3 Months |
|