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The purpose of this study is to evaluate the fluoride dose response of different dentifrice fluoride concentrations - 0, 250, 1100 and 2800 ppm fluoride as sodium monofluorophosphate (MFP) and a fifth leg of 1100 ppm Stannous Fluoride (SnF2) using an in situ caries model.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Period 1 | Other | 0 ppm F (placebo, negative control), 250 ppm F as MFP (dose-response control), 1100 ppm F as MFP (reference), 2800 ppm F as MFP (dose-response control) |
|
| Period 2 | Other | 0 ppm F (placebo, negative control), 250 ppm F as MFP (dose-response control), 1100 ppm F as MFP (reference), 2800 ppm F as MFP (dose-response control) |
|
| Period 3 | Other | 0 ppm F (placebo, negative control), 250 ppm F as MFP (dose-response control), 1100 ppm F as MFP (reference), 2800 ppm F as MFP (dose-response control) |
|
| Period 4 | Other | 0 ppm F (placebo, negative control), 250 ppm F as MFP (dose-response control), 1100 ppm F as MFP (reference), 2800 ppm F as MFP (dose-response control) |
|
| Period 5 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0 ppm F | Drug | Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Enamel Fluoride Uptake (EFU) | The EFU test will evaluate the level of fluoride in partially demineralized enamel specimens via the microdrill enamel biopsy technique by [Sakkab et al., 1984]. The calculated scores will be measured in μg F/cm2. | Evaluations will occur after 21 days of product use |
| Measure | Description | Time Frame |
|---|---|---|
| Enamel Fluoride Uptake (EFU) | The EFU test will evaluate the level of fluoride in partially demineralized enamel specimens via the microdrill enamel biopsy technique by [Sakkab et al., 1984]. The calculated scores will be measured in μg F/cm2. | Evaluations will occur after 7 days of product use |
| Percent Surface Microhardness (SMH) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oral Health Research Institute | Indianapolis | Indiana | 46202 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 0 Ppm MFP, 250 Ppm MFP, 1100 Ppm MFP, 2800 Ppm MFP, 1100 Ppm SnF2 | This was a 4-way crossover design study. All participants were randomized to receive the following interventions in this order: 0, 250, 1100 and 2800 ppm fluoride as sodium monofluorophosphate (MFP) using an in situ caries model. Participants were additionally invited to participate in a fifth leg which contained 1100 ppm SnF2. |
| FG001 | 250 Ppm MFP, 2800 Ppm MFP, 0 Ppm MFP, 1100 Ppm MFP, 1100 Ppm SnF2 | This was a 4-way crossover design study. All participants were randomized to receive the following interventions in this order: 250, 2800, 0, and 1100 ppm fluoride as sodium monofluorophosphate (MFP) using an in situ caries model. Participants were additionally invited to participate in a fifth leg which contained 1100 ppm SnF2. |
| FG002 | 1100 Ppm MFP, 0 Ppm MFP, 2800 Ppm MFP, 250 Ppm MFP, 1100 Ppm SnF2 | This was a 4-way crossover design study. All participants were randomized to receive the following interventions in this order: 1100, 0, 2800 and 250 ppm fluoride as sodium monofluorophosphate (MFP) using an in situ caries model. Participants were additionally invited to participate in a fifth leg which contained 1100 ppm SnF2. |
| FG003 | 2800 Ppm MFP, 1100 Ppm MFP, 250 Ppm MFP, 0 Ppm MFP, 1100 Ppm SnF2 | This was a 4-way crossover design study. All participants were randomized to receive the following interventions in this order: 2800, 1100, 250 and 0 ppm fluoride as sodium monofluorophosphate (MFP) using an in situ caries model. Participants were additionally invited to participate in a fifth leg which contained 1100 ppm SnF2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Period 2 |
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| Period 3 |
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| Period 4 |
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| Period 5 |
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| ID | Title | Description |
|---|---|---|
| BG000 | 0 Ppm MFP, 250 Ppm MFP, 1100 Ppm MFP, 2800 Ppm MFP, 1100 Ppm SnF2 | This was a 4-way crossover design study. All participants were randomized to receive the following interventions in this order: 0, 250, 1100 and 2800 ppm fluoride as sodium monofluorophosphate (MFP) using an in situ caries model. Participants were additionally invited to participate in a fifth leg which contained 1100 ppm SnF2. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Enamel Fluoride Uptake (EFU) | The EFU test will evaluate the level of fluoride in partially demineralized enamel specimens via the microdrill enamel biopsy technique by [Sakkab et al., 1984]. The calculated scores will be measured in μg F/cm2. | Posted | Mean | Standard Error | μg F/cm^2 | Evaluations will occur after 21 days of product use |
|
Each participant was monitored throughout the whole study, up to 4 months.
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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 | 0 Ppm F (Placebo, Negative Control) | Each subject was randomly assigned to 0 ppm F dentifrice during one of the four periods for this crossover study. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coughing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Manager | Procter & Gamble | 513-622-2489 | peters.j.2@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 | May 19, 2021 | Mar 22, 2022 | Prot_SAP_000.pdf |
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Fifth leg of the study will not be randomized, participants will remain blinded but all will use the same product.
1100 ppm SnF2 toothpaste only |
|
| 250 ppm F as MFP | Drug | Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study. |
|
| 1100 ppm as MFP | Drug | Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study. |
|
| 2800 ppm F as MFP | Drug | Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study. |
|
| 1100 ppm SnF2 | Drug | Each subject will be assigned to this treatment during the fifth period for this crossover study. |
|
The SMH test will evaluate changes in the mineral status of partially demineralized enamel specimens through use of a Wilson 2100 Hardness Tester. These scores will be calculated as a percent. |
| Evaluations will occur after 7 days of product use |
| Enamel Fluoride Uptake (EFU) | The EFU test will evaluate the level of fluoride in partially demineralized enamel specimens via the microdrill enamel biopsy technique by [Sakkab et al., 1984]. The calculated scores will be measured in μg F/cm2. | Evaluations will occur after 14 days of product use |
| Percent Surface Microhardness (SMH) | The SMH test will evaluate changes in the mineral status of partially demineralized enamel specimens through use of a Wilson 2100 Hardness Tester. These scores will be calculated as a percent. | Evaluations will occur after 14 days of product use |
| Percent Surface Microhardness (SMH) | The SMH test will evaluate changes in the mineral status of partially demineralized enamel specimens through use of a Wilson 2100 Hardness Tester. These scores will be calculated as a percent. | Evaluations will occur after 21 days of product use |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| BG001 | 250 Ppm MFP, 2800 Ppm MFP, 0 Ppm MFP, 1100 Ppm MFP, 1100 Ppm SnF2 | This was a 4-way crossover design study. All participants were randomized to receive the following interventions in this order: 250, 2800, 0 and 1100 ppm fluoride as sodium monofluorophosphate (MFP) using an in situ caries model. Participants were additionally invited to participate in a fifth leg which contained 1100 ppm SnF2. |
| BG002 | 1100 Ppm MFP, 0 Ppm MFP, 2800 Ppm MFP, 250 Ppm MFP, 1100 Ppm SnF2 | This was a 4-way crossover design study. All participants were randomized to receive the following interventions in this order: 1100, 0, 2800 and 250 ppm fluoride as sodium monofluorophosphate (MFP) using an in situ caries model. Participants were additionally invited to participate in a fifth leg which contained 1100 ppm SnF2. |
| BG003 | 2800 Ppm MFP, 1100 Ppm MFP, 250 Ppm MFP, 0 Ppm MFP, 1100 Ppm SnF2 | This was a 4-way crossover design study. All participants were randomized to receive the following interventions in this order: 2800, 1100, 250 and 0 ppm fluoride as sodium monofluorophosphate (MFP) using an in situ caries model. Participants were additionally invited to participate in a fifth leg which contained 1100 ppm SnF2. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | 1100 Ppm F as MFP (Reference) | Each subject was randomly assigned to 1100 ppm F dentifrice during one of the four periods for this crossover study. |
| OG003 | 2800 Ppm F as MFP (Dose-response Control) | Each subject was randomly assigned to 2800 ppm F dentifrice during one of the four periods for this crossover study. |
| OG004 | 1100 Ppm SnF2 | Each subject was assigned to 1100 ppm SnF2 dentifrice during the fifth period for this study. |
|
|
| Secondary | Enamel Fluoride Uptake (EFU) | The EFU test will evaluate the level of fluoride in partially demineralized enamel specimens via the microdrill enamel biopsy technique by [Sakkab et al., 1984]. The calculated scores will be measured in μg F/cm2. | Posted | Mean | Standard Error | μg F/cm^2 | Evaluations will occur after 7 days of product use |
|
|
|
| Secondary | Percent Surface Microhardness (SMH) | The SMH test will evaluate changes in the mineral status of partially demineralized enamel specimens through use of a Wilson 2100 Hardness Tester. These scores will be calculated as a percent. | Posted | Mean | Standard Error | Percent SMH Recovery | Evaluations will occur after 7 days of product use |
|
|
|
| Secondary | Enamel Fluoride Uptake (EFU) | The EFU test will evaluate the level of fluoride in partially demineralized enamel specimens via the microdrill enamel biopsy technique by [Sakkab et al., 1984]. The calculated scores will be measured in μg F/cm2. | Posted | Mean | Standard Error | μg F/cm^2 | Evaluations will occur after 14 days of product use |
|
|
|
| Secondary | Percent Surface Microhardness (SMH) | The SMH test will evaluate changes in the mineral status of partially demineralized enamel specimens through use of a Wilson 2100 Hardness Tester. These scores will be calculated as a percent. | Posted | Mean | Standard Error | Percent SMH Recovery | Evaluations will occur after 14 days of product use |
|
|
|
| Secondary | Percent Surface Microhardness (SMH) | The SMH test will evaluate changes in the mineral status of partially demineralized enamel specimens through use of a Wilson 2100 Hardness Tester. These scores will be calculated as a percent. | Posted | Mean | Standard Error | Percent SMH Recovery | Evaluations will occur after 21 days of product use |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 3 |
| 14 |
| EG001 | 250 Ppm F as MFP (Dose-response Control) | Each subject was randomly assigned to 250 ppm F dentifrice during one of the four periods for this crossover study. | 0 | 14 | 0 | 14 | 2 | 14 |
| EG002 | 1100 Ppm F as MFP (Reference) | Each subject was randomly assigned to 1100 ppm F dentifrice during one of the four periods for this crossover study. | 0 | 13 | 0 | 13 | 2 | 13 |
| EG003 | 2800 Ppm F as MFP (Dose-response Control) | Each subject was randomly assigned to 2800 ppm F dentifrice during one of the four periods for this crossover study. | 0 | 14 | 0 | 14 | 5 | 14 |
| EG004 | 1100 Ppm SnF2 | Each subject was assigned to 1100 ppm SnF2 dentifrice during the fifth period for this study. | 0 | 13 | 0 | 13 | 0 | 13 |
| Irritation Mouth | Gastrointestinal disorders | Systematic Assessment |
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| Edentulous Ridge Erythmea | Gastrointestinal disorders | Systematic Assessment |
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| Vaginitis | Reproductive system and breast disorders | Systematic Assessment |
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| Tooth Broken | Gastrointestinal disorders | Systematic Assessment |
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| Neck Pain | Injury, poisoning and procedural complications | Systematic Assessment |
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| Renal Kidney Tumor | Renal and urinary disorders | Systematic Assessment |
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| Irritation Gum | Gastrointestinal disorders | Systematic Assessment |
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| Irritation Tongue | Gastrointestinal disorders | Systematic Assessment |
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| Lung Cancer | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Mouth Ulceration | Gastrointestinal disorders | Systematic Assessment |
|
PI should disclose plans to sponsor prior to public release.
| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
|