Tooth Erosion
Conditions
Keywords
enamel erosion, tooth remineralization, tooth erosion
Brief summary
An in situ model will be used to evaluate and compare enamel remineralization of bovine enamel specimens.
Interventions
DRUGSodium fluoride
Test fluoride toothpaste and test fluoride mouth rinse
United Kingdom marketed fluoride toothpaste
DRUGSterile water
Sterile water rinse
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* An intact maxillary dental arch suitable for the retention of the palatal appliance and an intact mandibular dental arch - subjects may have fixed bridges replacing missing teeth * No current active caries or periodontal disease that may compromise the study or the health of the subjects * A gum base stimulated whole saliva flow rate greater than or equal to 0.8 mL/minute and an unstimulated whole saliva flow rate greater than or equal to 0.2 mL/minute
Exclusion criteria
* Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adjusted Mean Percent Net Erosion Resistance (NER) of Enamel Specimens Exposed to Test Dentifrice + Test MR Relative to: 1) Test Dentifrice+ Sterile Water Rinse 2) Reference Dentifrice+ Sterile Water Rinse 3) Placebo Dentifrice+ Sterile Water Rinse | Baseline, 4 hours post treatment in each treatment period | Enamel specimens were exposed to dietary erosive challenge and set of five indentations within each specimen was measured. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine NER which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent NER was calculated by formula: \[(E1-E2)/ (E1-B)\]\*100. Smaller the negative NER, better is treatment regimen in imparting resistance to enamel. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adjusted Mean Percentage Surface Microhardness (SMH) Recovery of Enamel Specimens Exposed to Test Dentifrice + Test MR Relative to: 1)Test Dentifrice+Sterile Water Rinse 2)Reference Dentifrice+Sterile Water Rinse 3)Placebo Dentifrice+ Sterile Water Rinse | Baseline, 4 hours post treatment in each treatment period. | SMH test was used to assess mineralization status of enamel specimens using a 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 while decrease in the indentation length represents rehardening of enamel surface. Percent SMH recovery was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: \[(E1-R)/ (E1-B)\]\*100. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adjusted Mean Percent NER of Enamel Specimens Exposed to a Treatment Regimen of Placebo Dentifrice + Test MR Relative to: 1) Test Dentifrice +Test MR 2) Test Dentifrice + Sterile Water Rinse 3) Reference Dentifrice +Sterile Water Rinse | Baseline, 4 hours post treatment in each treatment period | Enamel specimens were exposed to dietary erosive challenge and set of five indentations within each specimen was measured. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine NER which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent NER was calculated by formula: \[(E1-E2)/ (E1-B)\]\*100. Smaller the negative NER, better is treatment regimen in imparting resistance to enamel. |
| Adjusted Mean Percentage SMH Recovery of Enamel Specimens Exposed to Test Dentifrice + Test MR Relative to Following Treatment Regimens: 1) Test Dentifrice +Test MR 2) Test Dentifrice + Sterile Water 3) Reference Dentifrice +Sterile Water | Baseline, 4 hours post treatment in each treatment period | SMH test was used to assess mineralization status of enamel specimens using a 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 while decrease in the indentation length represents rehardening of enamel surface. Percent SMH recovery was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: \[(E1-R)/ (E1-B)\]\*100. |
| Adjusted Mean Percent NER of Enamel Specimens Exposed to Test Dentifrice +Sterile Water Rinse and Reference Dentifrice +Sterile Water Rinse | Baseline, 4 hours post treatment in each treatment period | Enamel specimens were exposed to dietary erosive challenge and set of five indentations within each specimen was measured. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine NER which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent NER was calculated by formula: \[(E1-E2)/ (E1-B)\]\*100. Smaller the negative NER, better is treatment regimen in imparting resistance to enamel. |
| Adjusted Mean Percent SMH Recovery of Enamel Specimens Exposed to Test Dentifrice +Sterile Water Rinse and Reference Dentifrice +Sterile Water Rinse | Baseline, 4 hours post treatment in each treatment period | SMH test was used to assess mineralization status of enamel specimens using a 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 while decrease in the indentation length represents rehardening of enamel surface. Percent SMH recovery was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: \[(E1-R)/ (E1-B)\]\*100. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited at the clinical site.
Pre-assignment details
Two days, prior to each treatment visit ,participants used a fluoride- free dentifrice twice daily to avoid any carry over effect.
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants All randomized participants were included for baseline evaluation. | 36 |
| Total | 36 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Continuous | 37.0 Years STANDARD_DEVIATION 12.9 |
| Region of Enrollment United States | 36 Participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 17 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 | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 36 | 1 / 36 | 2 / 36 | 1 / 36 | 0 / 36 |
| serious Total, serious adverse events | 0 / 36 | 0 / 36 | 0 / 36 | 0 / 36 | 0 / 36 |
Outcome results
Primary
Adjusted Mean Percent Net Erosion Resistance (NER) of Enamel Specimens Exposed to Test Dentifrice + Test MR Relative to: 1) Test Dentifrice+ Sterile Water Rinse 2) Reference Dentifrice+ Sterile Water Rinse 3) Placebo Dentifrice+ Sterile Water Rinse
Enamel specimens were exposed to dietary erosive challenge and set of five indentations within each specimen was measured. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine NER which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent NER was calculated by formula: \[(E1-E2)/ (E1-B)\]\*100. Smaller the negative NER, better is treatment regimen in imparting resistance to enamel.
Time frame: Baseline, 4 hours post treatment in each treatment period
Population: Per protocol (PP) population: All randomized subjects who received at least one dose of the study treatments and had no major protocol deviations were included in analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Test Dentifrice + Test MR | Adjusted Mean Percent Net Erosion Resistance (NER) of Enamel Specimens Exposed to Test Dentifrice + Test MR Relative to: 1) Test Dentifrice+ Sterile Water Rinse 2) Reference Dentifrice+ Sterile Water Rinse 3) Placebo Dentifrice+ Sterile Water Rinse | -2.88 Percent NER | Standard Error 2.155 |
| Test Dentifrice + Sterile Water Rinse | Adjusted Mean Percent Net Erosion Resistance (NER) of Enamel Specimens Exposed to Test Dentifrice + Test MR Relative to: 1) Test Dentifrice+ Sterile Water Rinse 2) Reference Dentifrice+ Sterile Water Rinse 3) Placebo Dentifrice+ Sterile Water Rinse | -14.54 Percent NER | Standard Error 2.155 |
| Reference Dentifrice + Sterile Water Rinse | Adjusted Mean Percent Net Erosion Resistance (NER) of Enamel Specimens Exposed to Test Dentifrice + Test MR Relative to: 1) Test Dentifrice+ Sterile Water Rinse 2) Reference Dentifrice+ Sterile Water Rinse 3) Placebo Dentifrice+ Sterile Water Rinse | -29.48 Percent NER | Standard Error 2.155 |
| Placebo Dentifrice + Sterile Water Rinse | Adjusted Mean Percent Net Erosion Resistance (NER) of Enamel Specimens Exposed to Test Dentifrice + Test MR Relative to: 1) Test Dentifrice+ Sterile Water Rinse 2) Reference Dentifrice+ Sterile Water Rinse 3) Placebo Dentifrice+ Sterile Water Rinse | -40.05 Percent NER | Standard Error 2.155 |
Comparison: Null hypothesis considered population means for the test dentifrice+ test MR treatment regimen and test dentifrice + sterile water rinse treatment regimen to be equal with respect to percent NER. Statistical tests were 2-sided with a significance level of 0.05.p-value: <0.000195% CI: [7.09, 16.24]ANOVA
Comparison: Null hypothesis considered population means for the test dentifrice+ test MR treatment regimen and reference dentifrice + sterile water rinse treatment regimen to be equal with respect to percent NER. Statistical tests were 2-sided with a significance level of 0.05.p-value: <0.000195% CI: [22.02, 31.18]ANOVA
Comparison: Null hypothesis considered population means for the test dentifrice+ test MR treatment regimen and placebo dentifrice + sterile water rinse treatment regimen to be equal with respect to percent NER. Statistical tests were 2-sided with a significance level of 0.05.p-value: <0.000195% CI: [32.59, 41.74]ANOVA
Secondary
Adjusted Mean Percentage Surface Microhardness (SMH) Recovery of Enamel Specimens Exposed to Test Dentifrice + Test MR Relative to: 1)Test Dentifrice+Sterile Water Rinse 2)Reference Dentifrice+Sterile Water Rinse 3)Placebo Dentifrice+ Sterile Water Rinse
SMH test was used to assess mineralization status of enamel specimens using a 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 while decrease in the indentation length represents rehardening of enamel surface. Percent SMH recovery was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: \[(E1-R)/ (E1-B)\]\*100.
Time frame: Baseline, 4 hours post treatment in each treatment period.
Population: PP population: All randomized participants who received at least one dose of the study treatments and had no major protocol deviations were included in analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Test Dentifrice + Test MR | Adjusted Mean Percentage Surface Microhardness (SMH) Recovery of Enamel Specimens Exposed to Test Dentifrice + Test MR Relative to: 1)Test Dentifrice+Sterile Water Rinse 2)Reference Dentifrice+Sterile Water Rinse 3)Placebo Dentifrice+ Sterile Water Rinse | 42.14 Percent SMH | Standard Error 1.399 |
| Test Dentifrice + Sterile Water Rinse | Adjusted Mean Percentage Surface Microhardness (SMH) Recovery of Enamel Specimens Exposed to Test Dentifrice + Test MR Relative to: 1)Test Dentifrice+Sterile Water Rinse 2)Reference Dentifrice+Sterile Water Rinse 3)Placebo Dentifrice+ Sterile Water Rinse | 38.02 Percent SMH | Standard Error 1.399 |
| Reference Dentifrice + Sterile Water Rinse | Adjusted Mean Percentage Surface Microhardness (SMH) Recovery of Enamel Specimens Exposed to Test Dentifrice + Test MR Relative to: 1)Test Dentifrice+Sterile Water Rinse 2)Reference Dentifrice+Sterile Water Rinse 3)Placebo Dentifrice+ Sterile Water Rinse | 30.88 Percent SMH | Standard Error 1.399 |
| Placebo Dentifrice + Sterile Water Rinse | Adjusted Mean Percentage Surface Microhardness (SMH) Recovery of Enamel Specimens Exposed to Test Dentifrice + Test MR Relative to: 1)Test Dentifrice+Sterile Water Rinse 2)Reference Dentifrice+Sterile Water Rinse 3)Placebo Dentifrice+ Sterile Water Rinse | 30.57 Percent SMH | Standard Error 1.399 |
Comparison: Null hypothesis considered population means for the test dentifrice+ test MR treatment regimen and test dentifrice + Sterile water rinse to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.p-value: 0.008395% CI: [1.07, 7.15]ANOVA
Comparison: Null hypothesis considered population means for the test dentifrice+ test MR treatment regimen and reference dentifrice + Sterile water rinse treatment regimen to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.p-value: <0.000195% CI: [8.22, 14.29]ANOVA
Comparison: Null hypothesis considered population means for the test dentifrice+ test MR treatment regimen and placebo dentifrice + Sterile water rinse treatment regimen to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.p-value: <0.000195% CI: [8.53, 14.6]ANOVA
Other Pre-specified
Adjusted Mean Percentage SMH Recovery of Enamel Specimens Exposed to Test Dentifrice + Test MR Relative to Following Treatment Regimens: 1) Test Dentifrice +Test MR 2) Test Dentifrice + Sterile Water 3) Reference Dentifrice +Sterile Water
SMH test was used to assess mineralization status of enamel specimens using a 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 while decrease in the indentation length represents rehardening of enamel surface. Percent SMH recovery was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: \[(E1-R)/ (E1-B)\]\*100.
Time frame: Baseline, 4 hours post treatment in each treatment period
Population: PP population: All randomized participants who received at least one dose of the study treatments and had no major protocol deviations were included in analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Test Dentifrice + Test MR | Adjusted Mean Percentage SMH Recovery of Enamel Specimens Exposed to Test Dentifrice + Test MR Relative to Following Treatment Regimens: 1) Test Dentifrice +Test MR 2) Test Dentifrice + Sterile Water 3) Reference Dentifrice +Sterile Water | 37.75 Percent SMH | Standard Error 1.399 |
| Test Dentifrice + Sterile Water Rinse | Adjusted Mean Percentage SMH Recovery of Enamel Specimens Exposed to Test Dentifrice + Test MR Relative to Following Treatment Regimens: 1) Test Dentifrice +Test MR 2) Test Dentifrice + Sterile Water 3) Reference Dentifrice +Sterile Water | 42.14 Percent SMH | Standard Error 1.399 |
| Reference Dentifrice + Sterile Water Rinse | Adjusted Mean Percentage SMH Recovery of Enamel Specimens Exposed to Test Dentifrice + Test MR Relative to Following Treatment Regimens: 1) Test Dentifrice +Test MR 2) Test Dentifrice + Sterile Water 3) Reference Dentifrice +Sterile Water | 38.02 Percent SMH | Standard Error 1.399 |
| Placebo Dentifrice + Sterile Water Rinse | Adjusted Mean Percentage SMH Recovery of Enamel Specimens Exposed to Test Dentifrice + Test MR Relative to Following Treatment Regimens: 1) Test Dentifrice +Test MR 2) Test Dentifrice + Sterile Water 3) Reference Dentifrice +Sterile Water | 30.88 Percent SMH | Standard Error 1.399 |
| Placebo Dentifrice + Sterile Water Rinse | Adjusted Mean Percentage SMH Recovery of Enamel Specimens Exposed to Test Dentifrice + Test MR Relative to Following Treatment Regimens: 1) Test Dentifrice +Test MR 2) Test Dentifrice + Sterile Water 3) Reference Dentifrice +Sterile Water | 30.57 Percent SMH | Standard Error 1.399 |
Comparison: Null hypothesis considered population means for the Placebo dentifrice+ Test MR treatment regimen and Test dentifrice + Test MR to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.p-value: 0.004995% CI: [-7.43, -1.35]ANOVA
Comparison: Null hypothesis considered population means for the Placebo dentifrice+ test MR treatment regimen and test dentifrice + sterile water rinse to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.p-value: 0.857195% CI: [-3.31, 2.76]ANOVA
Comparison: Null hypothesis considered population means for the Placebo Dentifrice + Test MR treatment regimen and Reference Dentifrice + Sterile water rinse to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.p-value: <0.000195% CI: [3.83, 9.9]ANOVA
Comparison: Null hypothesis considered population means for the Placebo Dentifrice + Test MR treatment regimen and Placebo dentifrice + Sterile water rinse to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.p-value: <0.000195% CI: [4.14, 10.21]ANOVA
Other Pre-specified
Adjusted Mean Percent NER of Enamel Specimens Exposed to a Treatment Regimen of Placebo Dentifrice + Test MR Relative to: 1) Test Dentifrice +Test MR 2) Test Dentifrice + Sterile Water Rinse 3) Reference Dentifrice +Sterile Water Rinse
Enamel specimens were exposed to dietary erosive challenge and set of five indentations within each specimen was measured. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine NER which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent NER was calculated by formula: \[(E1-E2)/ (E1-B)\]\*100. Smaller the negative NER, better is treatment regimen in imparting resistance to enamel.
Time frame: Baseline, 4 hours post treatment in each treatment period
Population: PP population: All randomized subjects who received at least one dose of the study treatments and had no major protocol deviations were included in analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Test Dentifrice + Test MR | Adjusted Mean Percent NER of Enamel Specimens Exposed to a Treatment Regimen of Placebo Dentifrice + Test MR Relative to: 1) Test Dentifrice +Test MR 2) Test Dentifrice + Sterile Water Rinse 3) Reference Dentifrice +Sterile Water Rinse | -3.76 Percent NER | Standard Error 2.155 |
| Test Dentifrice + Sterile Water Rinse | Adjusted Mean Percent NER of Enamel Specimens Exposed to a Treatment Regimen of Placebo Dentifrice + Test MR Relative to: 1) Test Dentifrice +Test MR 2) Test Dentifrice + Sterile Water Rinse 3) Reference Dentifrice +Sterile Water Rinse | -2.88 Percent NER | Standard Error 2.155 |
| Reference Dentifrice + Sterile Water Rinse | Adjusted Mean Percent NER of Enamel Specimens Exposed to a Treatment Regimen of Placebo Dentifrice + Test MR Relative to: 1) Test Dentifrice +Test MR 2) Test Dentifrice + Sterile Water Rinse 3) Reference Dentifrice +Sterile Water Rinse | -14.54 Percent NER | Standard Error 2.155 |
| Placebo Dentifrice + Sterile Water Rinse | Adjusted Mean Percent NER of Enamel Specimens Exposed to a Treatment Regimen of Placebo Dentifrice + Test MR Relative to: 1) Test Dentifrice +Test MR 2) Test Dentifrice + Sterile Water Rinse 3) Reference Dentifrice +Sterile Water Rinse | -29.48 Percent NER | Standard Error 2.155 |
| Placebo Dentifrice + Sterile Water Rinse | Adjusted Mean Percent NER of Enamel Specimens Exposed to a Treatment Regimen of Placebo Dentifrice + Test MR Relative to: 1) Test Dentifrice +Test MR 2) Test Dentifrice + Sterile Water Rinse 3) Reference Dentifrice +Sterile Water Rinse | -40.05 Percent NER | Standard Error 2.155 |
Comparison: Null hypothesis considered population means for the Placebo Dentifrice + Test MR and Test dentifrice+ Test MR treatment regimen treatment regimen to be equal with respect to percent NER. Statistical tests were 2-sided with a significance level of 0.05.p-value: 0.704195% CI: [-5.46, 3.69]ANOVA
Comparison: Null hypothesis considered population means for the Placebo dentifrice+ test MR treatment regimen and test dentifrice + sterile water rinse treatment regimen to be equal with respect to percent NER. Statistical tests were 2-sided with a significance level of 0.05.p-value: <0.000195% CI: [6.21, 15.36]ANOVA
Comparison: Null hypothesis considered population means for the Placebo dentifrice+ Test MR treatment regimen and Reference dentifrice + sterile water rinse treatment regimen to be equal with respect to percent NER. Statistical tests were 2-sided with a significance level of 0.05.p-value: <0.000195% CI: [21.14, 30.29]ANOVA
Comparison: Null hypothesis considered population means for the Placebo dentifrice+ test MR treatment regimen and Placebo dentifrice + sterile water rinse treatment regimen to be equal with respect to percent NER. Statistical tests were 2-sided with a significance level of 0.05.p-value: <0.000195% CI: [31.71, 40.86]ANOVA
Other Pre-specified
Adjusted Mean Percent NER of Enamel Specimens Exposed to Test Dentifrice +Sterile Water Rinse and Reference Dentifrice +Sterile Water Rinse
Enamel specimens were exposed to dietary erosive challenge and set of five indentations within each specimen was measured. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine NER which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent NER was calculated by formula: \[(E1-E2)/ (E1-B)\]\*100. Smaller the negative NER, better is treatment regimen in imparting resistance to enamel.
Time frame: Baseline, 4 hours post treatment in each treatment period
Population: PP population: All randomized subjects who received at least one dose of the study treatments and had no major protocol deviations were included in analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Test Dentifrice + Test MR | Adjusted Mean Percent NER of Enamel Specimens Exposed to Test Dentifrice +Sterile Water Rinse and Reference Dentifrice +Sterile Water Rinse | -2.88 Percent NER | Standard Error 2.155 |
| Test Dentifrice + Sterile Water Rinse | Adjusted Mean Percent NER of Enamel Specimens Exposed to Test Dentifrice +Sterile Water Rinse and Reference Dentifrice +Sterile Water Rinse | -29.48 Percent NER | Standard Error 2.155 |
Comparison: Null hypothesis considered population means for the Test Dentifrice + Sterile water rinse treatment regimen andReference Dentifrice + Sterile water rinse treatment regimen to be equal with respect to percent NER. Statistical tests were 2-sided with a significance level of 0.05.95% CI: [10.36, 19.51]ANOVA
Other Pre-specified
Adjusted Mean Percent SMH Recovery of Enamel Specimens Exposed to Test Dentifrice +Sterile Water Rinse and Reference Dentifrice +Sterile Water Rinse
SMH test was used to assess mineralization status of enamel specimens using a 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 while decrease in the indentation length represents rehardening of enamel surface. Percent SMH recovery was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: \[(E1-R)/ (E1-B)\]\*100.
Time frame: Baseline, 4 hours post treatment in each treatment period
Population: PP population: All randomized subjects who received at least one dose of the study treatments and had no major protocol deviations were included in analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Test Dentifrice + Test MR | Adjusted Mean Percent SMH Recovery of Enamel Specimens Exposed to Test Dentifrice +Sterile Water Rinse and Reference Dentifrice +Sterile Water Rinse | 38.02 Percent SMH | Standard Error 1.399 |
| Test Dentifrice + Sterile Water Rinse | Adjusted Mean Percent SMH Recovery of Enamel Specimens Exposed to Test Dentifrice +Sterile Water Rinse and Reference Dentifrice +Sterile Water Rinse | 30.88 Percent SMH | Standard Error 1.399 |
Comparison: Null hypothesis considered population means for the Test Dentifrice + Sterile water rinse treatment regimen and Reference Dentifrice + Sterile water rinse to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.p-value: <0.000195% CI: [4.11, 10.18]ANOVA