Caries
Conditions
Keywords
fluoride, in situ, remineralization, enamel, caries
Brief summary
This study is to evaluate the effect of fluoride dentifrices on enamel with artificial caries lesions in an in situ model
Detailed description
In situ models represent an acceptable approach for testing the anti-caries potential of fluoride products. This study is to evaluate the effect of fluoride dentifrice containing 1450 parts per million fluoride (ppm F) on enamel with artificial caries lesions in an in situ model. The study toothpaste containing sodium fluoride (NaF) and 0.4% carbopol will be compared to 4 other dentifrices. Comparator toothpastes include NaF toothpaste (1400 ppm F), NaF toothpaste (675 ppm F), sodium monofluorophosphate (NaMFP) and NaF toothpaste (1450 ppm F) and placebo toothpaste (0 ppm F).
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 78 Years
Healthy volunteers
Yes
Inclusion criteria
* Consent:Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form. * Age:Aged between 18 and 80 years. * Compliance:Understands and is willing, able and likely to comply with all study procedures and restrictions. * General Health:Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or physical examination. * Fluoride:Currently living in the Indianapolis, Indiana area and not taking fluoride supplements for medical reasons * Dentures: a)Currently wearing a removable mandibular partial denture with sufficient room in both posterior buccal flange areas to accommodate two enamel specimens on each side, four specimens in total - required dimensions 12 x 7 millimeter (mm) per side. b) Willing to have their denture modified to accommodate enamel test specimens and willing and capable of wearing their removable mandibular partial dentures 24 hours per day during the experimental periods * Dental health: Have no current active caries or periodontal disease that may compromise the study or the health of the subjects and all restorations in a good state of repair * Salivary flow:Have a salivary flow rate in the range of normal values (unstimulated whole saliva flow rate = 0.2 milliliter (mL)/minute; gum base stimulated whole saliva flow rate = 0.8 mL/minute)
Exclusion criteria
* Pregnancy: Women who are known to be pregnant or who are intending to become pregnant over the duration of the study. * Breast-feeding:Women who are breast-feeding. * Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients. * Antibiotics: Currently taking antibiotics or have taken antibiotics in the two weeks prior to the screening visit * Clinical Study/Experimental Medication: a) Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.b) Participation in another GSKCH investigational dental product study within 7 days of first study treatment c)Previous participation in this study. * Substance abuse: Recent history (within the last year) of alcohol or other substance abuse. * Personnel:a) A member of the site study staff living in same household.b)An employee of the sponsor. c) Any employee of any toothpaste manufacturer or their spouse or family member
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Surface Microhardness Recovery (%SMHR) of Sound Enamel Specimens Exposed to NaF Toothpaste (1450ppmF) and NaF Toothpaste (1400ppmF) | Baseline to 14 days | SMH test was used to assess mineral status of partially demineralized enamel specimens using Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening/demineralization while decrease in the indentation represents rehardening/ remineralization of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline(B); after intra-oral exposure(R) on Day 14; and after in-vitro demineralization(D) on Day 14 using formula \[(D-R)/(D-B)\]\*100. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage SMHR of Sound Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), NaF Toothpaste (1400ppmF), NaMFP/NaF Toothpaste (1450ppmF), NaF Toothpaste (675ppmF) and Placebo Toothpaste (0ppmF) | Baseline to 14 days | SMH test was used to assess mineral status of partially demineralized enamel specimens using Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening/demineralization while decrease in the indentation represents rehardening/ remineralization of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline(B); after intra-oral exposure(R) on Day 14; and after in-vitro demineralization(D) on Day 14 using formula \[(D-R)/(D-B)\]\*100. |
| Percentage SMHR of Demineralized Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), NaF Toothpaste (1400ppmF), NaF Toothpaste (675ppmF), NaMFP/NaF Toothpaste(1450ppmF) and Placebo Toothpaste (0ppmF) | Baseline to 14 days | SMH test was used to assess mineral status of partially demineralized enamel specimens using Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening/demineralization while decrease in the indentation represents rehardening/ remineralization of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline(B); after intra-oral exposure(R) on Day 14; and after in-vitro demineralization(D) on Day 14 using formula \[(D-R)/(D-B)\]\*100. |
| Enamel Fluoride Uptake (Sound Enamel Specimens) | Baseline to 14 days | Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on the amount of fluoride (F) divided by the area of the enamel cores. The difference between treatments was calculated with respect to fluoride uptake by enamel. |
| Enamel Fluoride Uptake (Demineralized Specimens) | Baseline to 14 days | Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on the amount of fluoride (F) divided by the area of the enamel cores. The difference between treatments was calculated with respect to fluoride uptake by enamel. |
Countries
United States
Participant flow
Pre-assignment details
Two days before the start of each treatment period, participants received a professional dental cleaning of their natural teeth, then brushed at home with the fluoride-free toothpaste.
Participants by arm
| Arm | Count |
|---|---|
| All Randomized Participants All randomized participants who received at least one of the treatment dentifrices during the study and had at least one safety assessment after using the treatment dentifrice. | 57 |
| Total | 57 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Period 1 | Other Reason | 0 | 0 | 0 | 0 | 1 |
| Period 1 | Protocol Violation | 0 | 1 | 0 | 2 | 0 |
| Period 2 | Protocol Violation | 0 | 1 | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | All Randomized Participants |
|---|---|
| Age, Continuous | 65.5 years STANDARD_DEVIATION 10.32 |
| Region of Enrollment United States | 57 participants |
| Sex: Female, Male Female | 34 Participants |
| Sex: Female, Male Male | 23 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 | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 3 / 50 | 1 / 52 | 3 / 53 | 4 / 53 | 1 / 51 | 10 / 57 |
| serious Total, serious adverse events | 0 / 50 | 0 / 52 | 0 / 53 | 0 / 53 | 0 / 51 | 0 / 57 |
Outcome results
Primary
Percentage Surface Microhardness Recovery (%SMHR) of Sound Enamel Specimens Exposed to NaF Toothpaste (1450ppmF) and NaF Toothpaste (1400ppmF)
SMH test was used to assess mineral status of partially demineralized enamel specimens using Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening/demineralization while decrease in the indentation represents rehardening/ remineralization of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline(B); after intra-oral exposure(R) on Day 14; and after in-vitro demineralization(D) on Day 14 using formula \[(D-R)/(D-B)\]\*100.
Time frame: Baseline to 14 days
Population: Intent to Treat (ITT) population: All randomized participants who had at least one post baseline efficacy assessment. Missing data was not imputed. Due to drop outs there were differences in the number of participants (N) per treatment group.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| NaF Toothpaste (1450ppmF) | Percentage Surface Microhardness Recovery (%SMHR) of Sound Enamel Specimens Exposed to NaF Toothpaste (1450ppmF) and NaF Toothpaste (1400ppmF) | 28.31 Percentage SMHR | Standard Error 5.54 |
| NaF Toothpaste (1400ppmF) | Percentage Surface Microhardness Recovery (%SMHR) of Sound Enamel Specimens Exposed to NaF Toothpaste (1450ppmF) and NaF Toothpaste (1400ppmF) | 26.32 Percentage SMHR | Standard Error 5.51 |
Comparison: Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.p-value: 0.575795% CI: [-5, 8.97]ANOVA
Secondary
Enamel Fluoride Uptake (Demineralized Specimens)
Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on the amount of fluoride (F) divided by the area of the enamel cores. The difference between treatments was calculated with respect to fluoride uptake by enamel.
Time frame: Baseline to 14 days
Population: ITT population: All randomized participants with at least one post baseline efficacy assessment. Missing data was not imputed. Due to drop out there are differences in the number of participants analyzed per treatment group.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| NaF Toothpaste (1450ppmF) | Enamel Fluoride Uptake (Demineralized Specimens) | 2499.47 μg*F/cm^2 | Standard Error 133.46 |
| NaF Toothpaste (1400ppmF) | Enamel Fluoride Uptake (Demineralized Specimens) | 2513.37 μg*F/cm^2 | Standard Error 131.09 |
| NaMFP/NaF Toothpaste (1450ppmF) | Enamel Fluoride Uptake (Demineralized Specimens) | 1923.76 μg*F/cm^2 | Standard Error 129.91 |
| NaF Toothpaste (675ppmF) | Enamel Fluoride Uptake (Demineralized Specimens) | 1861.80 μg*F/cm^2 | Standard Error 129.78 |
| Placebo Toothpaste (0ppmF) | Enamel Fluoride Uptake (Demineralized Specimens) | 686.18 μg*F/cm^2 | Standard Error 132.2 |
Comparison: Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.p-value: 0.929395% CI: [-322.47, 294.66]ANOVA
Comparison: Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.p-value: 0.000395% CI: [268.24, 883.17]ANOVA
Comparison: Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.p-value: <0.000195% CI: [330.3, 945.03]ANOVA
Comparison: Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.p-value: <0.000195% CI: [1503.03, 2123.54]ANOVA
Comparison: Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.p-value: 0.000295% CI: [285.31, 893.92]ANOVA
Comparison: Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.p-value: <0.000195% CI: [346.44, 956.7]ANOVA
Comparison: Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.p-value: <0.000195% CI: [1519.78, 2134.6]ANOVA
Comparison: Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.p-value: 0.687495% CI: [-241.25, 365.17]ANOVA
Comparison: Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.p-value: <0.000195% CI: [931.46, 1543.7]ANOVA
Comparison: Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.p-value: <0.000195% CI: [869.15, 1482.1]ANOVA
Secondary
Enamel Fluoride Uptake (Sound Enamel Specimens)
Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on the amount of fluoride (F) divided by the area of the enamel cores. The difference between treatments was calculated with respect to fluoride uptake by enamel.
Time frame: Baseline to 14 days
Population: ITT population:. All randomized participants who had at least one post baseline efficacy assessment. Missing data was not imputed. Due to drop out there are differences in the number of participants analyzed per treatment group.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| NaF Toothpaste (1450ppmF) | Enamel Fluoride Uptake (Sound Enamel Specimens) | 648.06 micrograms (μg)*F/centimeters(cm)^2] | Standard Error 47.1 |
| NaF Toothpaste (1400ppmF) | Enamel Fluoride Uptake (Sound Enamel Specimens) | 650.07 micrograms (μg)*F/centimeters(cm)^2] | Standard Error 46.3 |
| NaMFP/NaF Toothpaste (1450ppmF) | Enamel Fluoride Uptake (Sound Enamel Specimens) | 541.16 micrograms (μg)*F/centimeters(cm)^2] | Standard Error 45.91 |
| NaF Toothpaste (675ppmF) | Enamel Fluoride Uptake (Sound Enamel Specimens) | 487.14 micrograms (μg)*F/centimeters(cm)^2] | Standard Error 45.86 |
| Placebo Toothpaste (0ppmF) | Enamel Fluoride Uptake (Sound Enamel Specimens) | 425.59 micrograms (μg)*F/centimeters(cm)^2] | Standard Error 46.67 |
Comparison: Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.p-value: 0.969795% CI: [-106.34, 102.32]ANOVA
Comparison: Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.p-value: 0.04495% CI: [2.92, 210.87]ANOVA
Comparison: Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.p-value: 0.002695% CI: [56.96, 264.88]ANOVA
Comparison: Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.p-value: <0.000195% CI: [117.58, 327.36]ANOVA
Comparison: Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.p-value: 0.038295% CI: [5.98, 211.83]ANOVA
Comparison: Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.p-value: 0.002195% CI: [59.68, 266.18]ANOVA
Comparison: Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.p-value: <0.000195% CI: [120.51, 328.46]ANOVA
Comparison: Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.p-value: 0.300395% CI: [-48.56, 156.61]ANOVA
Comparison: Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.p-value: 0.243295% CI: [-42.14, 165.24]ANOVA
Comparison: Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.p-value: 0.028995% CI: [12.02, 219.13]ANOVA
Secondary
Percentage SMHR of Demineralized Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), NaF Toothpaste (1400ppmF), NaF Toothpaste (675ppmF), NaMFP/NaF Toothpaste(1450ppmF) and Placebo Toothpaste (0ppmF)
SMH test was used to assess mineral status of partially demineralized enamel specimens using Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening/demineralization while decrease in the indentation represents rehardening/ remineralization of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline(B); after intra-oral exposure(R) on Day 14; and after in-vitro demineralization(D) on Day 14 using formula \[(D-R)/(D-B)\]\*100.
Time frame: Baseline to 14 days
Population: ITT population. All randomized participants who had at least one post baseline efficacy assessment. Missing data was not imputed. Due to drop out there were differences in the number of participants analyzed per treatment group.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| NaF Toothpaste (1450ppmF) | Percentage SMHR of Demineralized Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), NaF Toothpaste (1400ppmF), NaF Toothpaste (675ppmF), NaMFP/NaF Toothpaste(1450ppmF) and Placebo Toothpaste (0ppmF) | 34.62 Percentage SMHR | Standard Error 2.82 |
| NaF Toothpaste (1400ppmF) | Percentage SMHR of Demineralized Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), NaF Toothpaste (1400ppmF), NaF Toothpaste (675ppmF), NaMFP/NaF Toothpaste(1450ppmF) and Placebo Toothpaste (0ppmF) | 36.06 Percentage SMHR | Standard Error 2.79 |
| NaMFP/NaF Toothpaste (1450ppmF) | Percentage SMHR of Demineralized Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), NaF Toothpaste (1400ppmF), NaF Toothpaste (675ppmF), NaMFP/NaF Toothpaste(1450ppmF) and Placebo Toothpaste (0ppmF) | 31.12 Percentage SMHR | Standard Error 2.77 |
| NaF Toothpaste (675ppmF) | Percentage SMHR of Demineralized Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), NaF Toothpaste (1400ppmF), NaF Toothpaste (675ppmF), NaMFP/NaF Toothpaste(1450ppmF) and Placebo Toothpaste (0ppmF) | 27.15 Percentage SMHR | Standard Error 2.77 |
| Placebo Toothpaste (0ppmF) | Percentage SMHR of Demineralized Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), NaF Toothpaste (1400ppmF), NaF Toothpaste (675ppmF), NaMFP/NaF Toothpaste(1450ppmF) and Placebo Toothpaste (0ppmF) | 11.10 Percentage SMHR | Standard Error 2.8 |
Comparison: Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.p-value: 0.545195% CI: [-6.15, 3.26]ANOVA
Comparison: Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.p-value: 0.143395% CI: [-1.2, 8.19]ANOVA
Comparison: Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.p-value: 0.00295% CI: [2.78, 12.16]ANOVA
Comparison: Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.p-value: <0.000195% CI: [18.79, 28.25]ANOVA
Comparison: Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.p-value: 0.037395% CI: [0.29, 9.59]ANOVA
Comparison: Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.p-value: 0.000295% CI: [4.24, 13.59]ANOVA
Comparison: Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.p-value: <0.000195% CI: [20.27, 29.66]ANOVA
Comparison: Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.p-value: 0.092595% CI: [-0.66, 8.61]ANOVA
Comparison: Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.p-value: <0.000195% CI: [15.35, 24.7]ANOVA
Comparison: Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.p-value: <0.000195% CI: [11.36, 20.74]ANOVA
Secondary
Percentage SMHR of Sound Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), NaF Toothpaste (1400ppmF), NaMFP/NaF Toothpaste (1450ppmF), NaF Toothpaste (675ppmF) and Placebo Toothpaste (0ppmF)
SMH test was used to assess mineral status of partially demineralized enamel specimens using Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening/demineralization while decrease in the indentation represents rehardening/ remineralization of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline(B); after intra-oral exposure(R) on Day 14; and after in-vitro demineralization(D) on Day 14 using formula \[(D-R)/(D-B)\]\*100.
Time frame: Baseline to 14 days
Population: ITT population: All randomized participants who had at least one post baseline efficacy assessment. Missing data was not imputed. Due to drop out there were differences in the number of participants analyzed per treatment group.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| NaF Toothpaste (1450ppmF) | Percentage SMHR of Sound Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), NaF Toothpaste (1400ppmF), NaMFP/NaF Toothpaste (1450ppmF), NaF Toothpaste (675ppmF) and Placebo Toothpaste (0ppmF) | 28.31 Percentage SMHR | Standard Error 5.54 |
| NaF Toothpaste (1400ppmF) | Percentage SMHR of Sound Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), NaF Toothpaste (1400ppmF), NaMFP/NaF Toothpaste (1450ppmF), NaF Toothpaste (675ppmF) and Placebo Toothpaste (0ppmF) | 26.32 Percentage SMHR | Standard Error 5.51 |
| NaMFP/NaF Toothpaste (1450ppmF) | Percentage SMHR of Sound Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), NaF Toothpaste (1400ppmF), NaMFP/NaF Toothpaste (1450ppmF), NaF Toothpaste (675ppmF) and Placebo Toothpaste (0ppmF) | 26.13 Percentage SMHR | Standard Error 5.49 |
| NaF Toothpaste (675ppmF) | Percentage SMHR of Sound Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), NaF Toothpaste (1400ppmF), NaMFP/NaF Toothpaste (1450ppmF), NaF Toothpaste (675ppmF) and Placebo Toothpaste (0ppmF) | 25.52 Percentage SMHR | Standard Error 5.48 |
| Placebo Toothpaste (0ppmF) | Percentage SMHR of Sound Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), NaF Toothpaste (1400ppmF), NaMFP/NaF Toothpaste (1450ppmF), NaF Toothpaste (675ppmF) and Placebo Toothpaste (0ppmF) | 53.38 Percentage SMHR | Standard Error 5.52 |
Comparison: Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.p-value: 0.538795% CI: [-4.79, 9.14]ANOVA
Comparison: Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.p-value: 0.430695% CI: [-4.18, 9.77]ANOVA
Comparison: Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.p-value: <0.000195% CI: [-32.09, -18.06]ANOVA
Comparison: Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.p-value: 0.956795% CI: [-6.71, 7.09]ANOVA
Comparison: Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.p-value: 0.818895% CI: [-6.14, 7.76]ANOVA
Comparison: Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.p-value: <0.000195% CI: [-34.03, -20.08]ANOVA
Comparison: Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.p-value: 0.859995% CI: [-6.28, 7.51]ANOVA
Comparison: Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.p-value: <0.000195% CI: [-34.2, -20.3]ANOVA
Comparison: Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.p-value: <0.000195% CI: [-34.84, -20.89]ANOVA