Caries
Conditions
Brief summary
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.
Interventions
DRUG1100 ppm SnF2
Each subject will be assigned to this treatment during the fifth period for this crossover study.
DRUG1100 ppm as MFP
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
DRUG0 ppm F
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
DRUG250 ppm F as MFP
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
Sponsors
Procter and Gamble
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Masking description
Fifth leg of the study will not be randomized, participants will remain blinded but all will use the same product.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* Be between 18 and 85 years of age; * Provide written informed consent prior to participation and be given a signed copy of the informed consent form; * Be in general good health as determined by the Investigator based on a review of the health history/update for participation in the trial; * Be wearing a removable mandibular partial denture with sufficient room in one posterior buccal flange area to accommodate two 4 mm round enamel specimens and room on the same side to accommodate two 4 mm round specimens in the buccal surface of two posterior denture teeth; * Be willing and capable of wearing their removable partial denture 24 hours a day for four (4), three-week treatment periods; * Be willing to allow study personnel to drill specimen sites (as described in #iv) in their mandibular partial denture; * Be in good medical and dental health with no active caries or periodontal disease (NOTE: subjects presenting at screening with caries may continue in the study if their carious lesions are restored prior to beginning treatment 1); * Have a salivary flow rate in the range of normal values (unstimulated whole saliva flow rate ≥ 0.2 mL/min; gum base stimulated whole saliva flow rate ≥ 0.8 mL/min).
Exclusion criteria
* Currently being pregnant, intending to become pregnant during the study period, or breast feeding; * Currently having any medical condition that could be expected to interfere with the subject's safety during the study period; * Currently taking antibiotics or having taken antibiotics in the two weeks prior to beginning treatment 1; * Having participated in another clinical study or receipt of an investigational drug within 30 days of beginning treatment 1; or * Taking fluoride supplements, required to use a fluoride mouth rinse, or have received a professional fluoride treatment in the two weeks preceding specimen placement; * Currently taking or have ever taken bisphosphonate drugs (e.g., Fosamax, Actonel and Boniva) for the treatment of osteoporosis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Enamel Fluoride Uptake (EFU) | Evaluations will occur after 21 days of product use | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Enamel Fluoride Uptake (EFU) | Evaluations will occur after 7 days of product use | 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. |
| Percent Surface Microhardness (SMH) | Evaluations will occur after 7 days of product use | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 3 |
| 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. | 4 |
| 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. | 4 |
| 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. | 4 |
| Total | 15 |
Baseline characteristics
| Characteristic | 0 Ppm MFP, 250 Ppm MFP, 1100 Ppm MFP, 2800 Ppm MFP, 1100 Ppm SnF2 | 2800 Ppm MFP, 1100 Ppm MFP, 250 Ppm MFP, 0 Ppm MFP, 1100 Ppm SnF2 | 1100 Ppm MFP, 0 Ppm MFP, 2800 Ppm MFP, 250 Ppm MFP, 1100 Ppm SnF2 | 250 Ppm MFP, 2800 Ppm MFP, 0 Ppm MFP, 1100 Ppm MFP, 1100 Ppm SnF2 | Total |
|---|---|---|---|---|---|
| Age, Continuous | 69.7 years STANDARD_DEVIATION 8.33 | 76.3 years STANDARD_DEVIATION 9.32 | 69.7 years STANDARD_DEVIATION 9.5 | 72.5 years STANDARD_DEVIATION 4.51 | 72.2 years STANDARD_DEVIATION 7.75 |
| Race and Ethnicity Not Collected | — | — | — | — | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 4 Participants | 3 Participants | 2 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 2 Participants | 0 Participants | 1 Participants | 2 Participants | 5 Participants |
| Region of Enrollment United States | 3 participants | 4 participants | 4 participants | 4 participants | 15 participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 4 Participants | 2 Participants | 9 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 0 Participants | 2 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 14 | 0 / 13 | 0 / 14 | 0 / 13 |
| other Total, other adverse events | 3 / 14 | 2 / 14 | 2 / 13 | 5 / 14 | 0 / 13 |
| serious Total, serious adverse events | 0 / 14 | 0 / 14 | 0 / 13 | 0 / 14 | 0 / 13 |
Outcome results
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.
Time frame: Evaluations will occur after 21 days of product use
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 0 Ppm F (Placebo, Negative Control) | Enamel Fluoride Uptake (EFU) | 2.28 μg F/cm^2 | Standard Error 0.709 |
| 250 Ppm F as MFP (Dose-response Control) | Enamel Fluoride Uptake (EFU) | 4.51 μg F/cm^2 | Standard Error 0.709 |
| 1100 Ppm F as MFP (Reference) | Enamel Fluoride Uptake (EFU) | 8.78 μg F/cm^2 | Standard Error 0.736 |
| 2800 Ppm F as MFP (Dose-response Control) | Enamel Fluoride Uptake (EFU) | 14.05 μg F/cm^2 | Standard Error 0.709 |
| 1100 Ppm SnF2 | Enamel Fluoride Uptake (EFU) | 7.43 μg F/cm^2 | Standard Error 0.423 |
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.
Time frame: Evaluations will occur after 14 days of product use
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 0 Ppm F (Placebo, Negative Control) | Enamel Fluoride Uptake (EFU) | 3.86 μg F/cm^2 | Standard Error 1.141 |
| 250 Ppm F as MFP (Dose-response Control) | Enamel Fluoride Uptake (EFU) | 7.23 μg F/cm^2 | Standard Error 1.141 |
| 1100 Ppm F as MFP (Reference) | Enamel Fluoride Uptake (EFU) | 11.53 μg F/cm^2 | Standard Error 1.185 |
| 2800 Ppm F as MFP (Dose-response Control) | Enamel Fluoride Uptake (EFU) | 18.92 μg F/cm^2 | Standard Error 1.141 |
| 1100 Ppm SnF2 | Enamel Fluoride Uptake (EFU) | 12.65 μg F/cm^2 | Standard Error 1.215 |
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.
Time frame: Evaluations will occur after 7 days of product use
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 0 Ppm F (Placebo, Negative Control) | Enamel Fluoride Uptake (EFU) | 3.13 μg F/cm^2 | Standard Error 0.881 |
| 250 Ppm F as MFP (Dose-response Control) | Enamel Fluoride Uptake (EFU) | 5.20 μg F/cm^2 | Standard Error 0.882 |
| 1100 Ppm F as MFP (Reference) | Enamel Fluoride Uptake (EFU) | 8.20 μg F/cm^2 | Standard Error 0.916 |
| 2800 Ppm F as MFP (Dose-response Control) | Enamel Fluoride Uptake (EFU) | 13.52 μg F/cm^2 | Standard Error 0.85 |
| 1100 Ppm SnF2 | Enamel Fluoride Uptake (EFU) | 9.11 μg F/cm^2 | Standard Error 0.67 |
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.
Time frame: Evaluations will occur after 21 days of product use
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 0 Ppm F (Placebo, Negative Control) | Percent Surface Microhardness (SMH) | 4.76 Percent SMH Recovery | Standard Error 4.921 |
| 250 Ppm F as MFP (Dose-response Control) | Percent Surface Microhardness (SMH) | 11.14 Percent SMH Recovery | Standard Error 4.921 |
| 1100 Ppm F as MFP (Reference) | Percent Surface Microhardness (SMH) | 17.51 Percent SMH Recovery | Standard Error 5.068 |
| 2800 Ppm F as MFP (Dose-response Control) | Percent Surface Microhardness (SMH) | 33.38 Percent SMH Recovery | Standard Error 4.921 |
| 1100 Ppm SnF2 | Percent Surface Microhardness (SMH) | 17.91 Percent SMH Recovery | Standard Error 3.108 |
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.
Time frame: Evaluations will occur after 7 days of product use
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 0 Ppm F (Placebo, Negative Control) | Percent Surface Microhardness (SMH) | 15.92 Percent SMH Recovery | Standard Error 3.259 |
| 250 Ppm F as MFP (Dose-response Control) | Percent Surface Microhardness (SMH) | 22.50 Percent SMH Recovery | Standard Error 3.264 |
| 1100 Ppm F as MFP (Reference) | Percent Surface Microhardness (SMH) | 22.42 Percent SMH Recovery | Standard Error 3.36 |
| 2800 Ppm F as MFP (Dose-response Control) | Percent Surface Microhardness (SMH) | 35.61 Percent SMH Recovery | Standard Error 3.16 |
| 1100 Ppm SnF2 | Percent Surface Microhardness (SMH) | 26.32 Percent SMH Recovery | Standard Error 4.605 |
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.
Time frame: Evaluations will occur after 14 days of product use
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 0 Ppm F (Placebo, Negative Control) | Percent Surface Microhardness (SMH) | 10.49 Percent SMH Recovery | Standard Error 4.258 |
| 250 Ppm F as MFP (Dose-response Control) | Percent Surface Microhardness (SMH) | 18.62 Percent SMH Recovery | Standard Error 4.258 |
| 1100 Ppm F as MFP (Reference) | Percent Surface Microhardness (SMH) | 24.76 Percent SMH Recovery | Standard Error 4.369 |
| 2800 Ppm F as MFP (Dose-response Control) | Percent Surface Microhardness (SMH) | 38.08 Percent SMH Recovery | Standard Error 4.258 |
| 1100 Ppm SnF2 | Percent Surface Microhardness (SMH) | 28.28 Percent SMH Recovery | Standard Error 4.562 |