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An in situ model will be used to evaluate and compare enamel remineralization of bovine enamel specimens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Dentifrice + Test Mouth Rinse (MR) | Experimental | Test fluoride dentifrice and test fluoride MR |
|
| Test Dentifrice + Sterile Water Rinse | Experimental | Test fluoride dentifrice and sterile water rinse |
|
| Placebo Dentifrice + Test MR | Experimental | Placebo dentifrice and test fluoride rinse |
|
| Reference Dentifrice + Sterile Water Rinse | Active Comparator | Marketed fluoride dentifrice with sterile water rinse |
|
| Placebo Dentifrice + Sterile Water Rinse | Placebo Comparator | Placebo dentifrice and sterile water rinse |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium fluoride | Drug | Test fluoride toothpaste and test fluoride mouth rinse |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 4 hours post treatment in each treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University School of Dentistry | Indianapolis | Indiana | 46202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21256403 | Background | Maggio B, Guibert RG, Mason SC, Karwal R, Rees GD, Kelly S, Zero DT. Evaluation of mouthrinse and dentifrice regimens in an in situ erosion remineralisation model. J Dent. 2010 Nov;38 Suppl 3:S37-44. doi: 10.1016/S0300-5712(11)70007-0. |
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Two days, prior to each treatment visit ,participants used a fluoride- free dentifrice twice daily to avoid any carry over effect.
Participants were recruited at the clinical site.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Dentifrice + Test Mouth Rinse (MR) | Participants were administered with treatment regimen comprising of test sodium fluoride (NaF) dentifrice [containing 1450 parts per million (ppm) fluoride (F) as NaF and potassium nitrate (KNO3)] and test NaF (450ppmF) MR. The treatment regimen included application of 1.5 gram (g) test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of test MR for one minute. |
| FG001 | Test Dentifrice + Sterile Water Rinse | Participants were administered with treatment regimen comprising of test NaF Dentifrice (1450ppmF) and placebo sterile water rinse. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create a dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute. |
| FG002 | Reference Dentifrice + Sterile Water Rinse | Participants were administered with treatment regimen comprising of reference sodium monofluorophosphate (NaMFP)/ NaF dentifrice (1450ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g reference dentifrice to a wet study toothbrush, brushing for 25 seconds to create a dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute. |
| FG003 | Placebo Dentifrice + Sterile Water Rinse | Participants were administered with treatment regimen comprising of placebo dentifrice (0ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g placebo dentifrice to a wet study toothbrush, brushing for 25 seconds to create a dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute. |
| FG004 | Placebo Dentifrice + Test MR | Participants were administered with treatment regimen comprising of placebo dentifrice (0ppmF) and test MR containing NaF (450ppmF). The treatment regimen included application of 1.5g placebo dentifrice to a wet study toothbrush, brushing for 25 seconds to create a dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of test MR for one minute. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period I |
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| Period II |
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| Period III |
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| Period IV |
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| Period V |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | All randomized participants were included for baseline evaluation. |
| 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 | 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. | 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. | Posted | Least Squares Mean | Standard Error | Percent NER | Baseline, 4 hours post treatment in each treatment period |
|
All AEs encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.
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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 | Test Dentifrice + Test MR | Participants were administered with treatment regimen comprising of test NaF dentifrice [containing 1450ppmF as NaF and KNO3] and test NaF (450ppmF) MR. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create a dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of test MR for one minute. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gingival Erythema | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D014077 | Tooth Erosion |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D057085 | Tooth Wear |
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| ID | Term |
|---|---|
| D012969 | Sodium Fluoride |
| ID | Term |
|---|---|
| D005459 | Fluorides |
| D006858 | Hydrofluoric Acid |
| D017611 | Fluorine Compounds |
| D007287 | Inorganic Chemicals |
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| Sodium monoflurophosphate | Drug | United Kingdom marketed fluoride toothpaste |
|
| Sterile water | Drug | Sterile water rinse |
|
| Baseline, 4 hours post treatment in each treatment period. |
| Baseline, 4 hours post treatment in each treatment period |
| 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. | Baseline, 4 hours post treatment in each treatment period |
| 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. | Baseline, 4 hours post treatment in each treatment period |
| 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. | Baseline, 4 hours post treatment in each treatment period |
| COMPLETED |
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| NOT COMPLETED |
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| 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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| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | Participants |
|
| OG000 | Test Dentifrice + Test MR | Participants were administered with treatment regimen comprising of test NaF dentifrice [containing 1450ppmF as NaF and KNO3] and test NaF (450ppmF) MR. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create a dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of test MR for one minute. |
| OG001 | Test Dentifrice + Sterile Water Rinse | Participants were administered with treatment regimen comprising of test NaF Dentifrice (1450ppmF) and placebo sterile water rinse. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute. |
| OG002 | Reference Dentifrice + Sterile Water Rinse | Participants were administered with treatment regimen comprising of reference NaMFP/ NaF dentifrice (1450ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g reference dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute. |
| OG003 | Placebo Dentifrice + Sterile Water Rinse | Participants were administered with treatment regimen comprising of placebo dentifrice (0ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g placebo dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute. |
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| 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. | 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. | Posted | Least Squares Mean | Standard Error | Percent SMH | Baseline, 4 hours post treatment in each treatment period. |
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| 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. | 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. | Posted | Least Squares Mean | Standard Error | Percent NER | Baseline, 4 hours post treatment in each treatment period |
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| 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. | 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. | Posted | Least Squares Mean | Standard Error | Percent SMH | Baseline, 4 hours post treatment in each treatment period |
|
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| 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. | 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. | Posted | Least Squares Mean | Standard Error | Percent NER | Baseline, 4 hours post treatment in each treatment period |
|
|
|
|
| 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. | 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. | Posted | Least Squares Mean | Standard Error | Percent SMH | Baseline, 4 hours post treatment in each treatment period |
|
|
|
|
| 0 |
| 36 |
| 0 |
| 36 |
| EG001 | Test Dentifrice + Sterile Water Rinse | Participants were administered with treatment regimen comprising of test NaF Dentifrice (1450ppmF) and placebo sterile water rinse. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute. | 0 | 36 | 1 | 36 |
| EG002 | Reference Dentifrice + Sterile Water Rinse | Participants were administered with treatment regimen comprising of reference NaMFP/ NaF dentifrice (1450ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g reference dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute. | 0 | 36 | 2 | 36 |
| EG003 | Placebo Dentifrice + Test MR | Participants were administered with treatment regimen comprising of placebo dentifrice (0ppmF) and test MR containing NaF (450ppmF). The treatment regimen included application of 1.5g placebo dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of test MR for one minute. | 0 | 36 | 1 | 36 |
| EG004 | Placebo Dentifrice + Sterile Water Rinse | Participants were administered with treatment regimen comprising of placebo dentifrice (0ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g placebo dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute. | 0 | 36 | 0 | 36 |
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D017670 |
| Sodium Compounds |
| D002327 | Cariostatic Agents |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| No |
| Superiority or Other |
| 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. | ANOVA | ANOVA with factors for treatment, study period, and subject (random effect) | <0.0001 | No adjustments made for multiple comparisons as the primary comparison was pre-specified. | Adjusted Mean DIfference | 11.25 | 2-Sided | 95 | 8.22 | 14.29 | Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment. | No | Superiority or Other |
| 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. | ANOVA | ANOVA with factors for treatment, study period, and subject (random effect) | <0.0001 | No adjustments made for multiple comparisons as the primary comparison was pre-specified. | Adjusted Mean Difference | 11.56 | 2-Sided | 95 | 8.53 | 14.60 | Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment. | No | Superiority or Other |
| No |
| Superiority or Other |
| 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. | ANOVA | ANOVA with factors for treatment, study period, and subject (random effect). | <0.0001 | No adjustments made for multiple comparisons as the primary comparison was pre-specified. | Adjusted Mean Difference | 10.78 | 2-Sided | 95 | 6.21 | 15.36 | Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment. | No | Superiority or Other |
| 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. | ANOVA | ANOVA with factors for treatment, study period, and subject (random effect). | <0.0001 | No adjustments made for multiple comparisons as the primary comparison was pre-specified. | Adjusted Mean Difference | 25.72 | 2-Sided | 95 | 21.14 | 30.29 | Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| 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. | ANOVA | ANOVA with factors for treatment, study period, and subject (random effect). | <0.0001 | No adjustments made for multiple comparisons as the primary comparison was pre-specified. | Adjusted Mean Difference | 36.29 | 2-Sided | 95 | 31.71 | 40.86 | Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment. | No | Superiority or Other |
| No |
| Superiority or Other |
| 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. | ANOVA | ANOVA with factors for treatment, study period, and subject (random effect). | 0.8571 | No adjustments made for multiple comparisons as the primary comparison was pre-specified. | Adjusted Mean Difference | -0.28 | 2-Sided | 95 | -3.31 | 2.76 | Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| 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. | ANOVA | ANOVA with factors for treatment, study period, and subject (random effect). | <0.0001 | No adjustments made for multiple comparisons as the primary comparison was pre-specified. | Adjusted Mean Difference | 6.87 | 2-Sided | 95 | 3.83 | 9.90 | Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment. | No | Superiority or Other |
| 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. | ANOVA | ANOVA with factors for treatment, study period, and subject (random effect). | <0.0001 | No adjustments made for multiple comparisons as the primary comparison was pre-specified. | Adjusted Mean Difference | 7.17 | 2-Sided | 95 | 4.14 | 10.21 | Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| No |
| Superiority or Other |
| No |
| Superiority or Other |