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| ID | Type | Description | Link |
|---|---|---|---|
| RH02437 | Other Identifier | GSK |
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This study will evaluate the effect of experimental sodium fluoride-silica dentifrice formulations, with and without zinc, on remineralization of enamel in situ. Following the remineralization phase, the acid resistance of the new mineral formed will be assessed. Fluoride uptake during the remineralization phase will also be measured.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sodium fluoride (1426 ppm) | Experimental | Non-zinc, 1426ppm fluoride as sodium fluoride in a silica gel base |
|
| Sodium fluoride (1150 ppm) | Experimental | Non-zinc, 1150ppm fluoride as sodium fluoride in a silica gel base |
|
| Sodium fluoride (250 ppm) | Experimental | Non-zinc, 250ppm fluoride as sodium fluoride in a silica gel base |
|
| Sodium fluoride (1426 ppm) + zinc base A | Experimental | Zinc base A, 1426ppm fluoride as sodium fluoride in a silica gel base |
|
| Sodium fluoride (1426 ppm) + zinc base B | Experimental | Zinc base B, 1426ppm fluoride as sodium fluoride in a silica gel base |
|
| Fluoride (0 ppm) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium fluoride (1426 ppm) | Drug | Non-zinc, 1426ppm fluoride as sodium fluoride in a silica gel base |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Surface Microhardness Recovery (% SMHR) | Changes in the mineral content of the four centrally-located enamel specimens were evaluated using the Surface Microhardness (SMH) Test. The SMH was measured using a Wilson 2100 Hardness Tester. The baseline SMH was determined prior to the in vitro acid challenge. SMH was determined again after the in vitro acid challenge, after the in situ remineralization test, and again after the second in vitro acid challenge. The extent of remineralization was calculated as the % recovery in SMH using the equation: % SMHR= [(D1-R)/(D1-B)]*100 Where B = indentation length (μm) of sound enamel at baseline; D1 = indentation length (μm) after first acid challenge; R = indentation length (μm) after in situ remineralization. | Baseline to 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Enamel Fluoride Uptake | The microdrill enamel biopsy technique was used to analyze the fluoride uptake by enamel. Each enamel specimen was mounted on the long axis of a drill attached to a microdrill and drilled to a depth of approximately 100 micrometer (μm) through the entire lesion (four cores per specimen). The enamel powder pooled from four drilling sample was then immediately analyzed for fluoride content using fluoride specific electrode and pH/ion meter. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores and expressed as microgram per square centimeter (μg/cm^2). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Indianapolis | Indiana | 46202 | United States |
A total of 64 participants were screened and 62 were randomized.
Participants were recruited at one clinical study site in the USA.
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| ID | Title | Description |
|---|---|---|
| FG000 | Overall Participants | Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 seconds (sec) to create dentifrice slurry. Then swished the slurry around the palatal appliance for 1 minute (min) and 35 sec. Next, they expectorated the slurry, rinsed with 15 milliliter (mL) of tap water for 10 sec and expectorated. There was a 2 day washout period before each treatment period when participants used a non-fluoridated dentifrice.
|
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Non-zinc, 0ppm fluoride in a silica gel base |
|
| Sodium fluoride (1150 ppm) | Drug | Non-zinc, 1150ppm fluoride as sodium fluoride in a silica gel base |
|
| Sodium fluoride (250 ppm) | Drug | Non-zinc, 250ppm fluoride as sodium fluoride in a silica gel base |
|
| Sodium fluoride (1426 ppm) + zinc base A | Drug | Zinc base A, 1426ppm fluoride as sodium fluoride in a silica gel base |
|
| Sodium fluoride (1426 ppm) + zinc base B | Drug | Zinc base B, 1426ppm fluoride as sodium fluoride in a silica gel base |
|
| Fluoride (0 ppm) | Drug | Non-zinc, 0ppm fluoride in a silica gel base |
|
| Baseline to 4 hours |
| Percentage Net Acid Resistance (% NAR) | Changes in the mineral content of the four centrally-located enamel specimens were evaluated using the SMH Test. The SMH was measured using a Wilson 2100 Hardness Tester. The baseline SMH was measured prior to the in vitro acid challenge. SMH was measured again after the in vitro acid challenge, after the in situ remineralization test, and again after the second in vitro acid challenge. The % NAR was calculated using the equation: % NAR= [(D1-D2)/(D1-B)]*100 where B= Indentation length (μm) of sound enamel at baseline; D1= Indentation length (μm) after first acid challenge and D2= Indentation length (μm) after second acid challenge. | Baseline to 4 hours |
| Percentage Comparative Acid Resistance (% CAR) | Changes in the mineral content of the four centrally-located enamel specimens were evaluated using the SMH Test. The SMH was measured using a Wilson 2100 Hardness Tester. The baseline SMH was measured prior to the in vitro acid challenge. SMH was measured again after the in vitro acid challenge, after the in situ remineralization test, and again after the second in vitro acid challenge. The % CAR was calculated using the equation: % CAR= [(D2-R)/(D1-B)]*100 where B= Indentation length (μm) of sound enamel at baseline; R= Indentation length (μm) of enamel after in situ remineralization; D1= Indentation length (μm) after first acid challenge; D2= Indentation length (μm) after second acid challenge. | Baseline to 4 hours |
| Sodium Fluoride (1150 Ppm) |
|
| Sodium Fluoride (0 Ppm) |
|
| Sodium Fluoride (1426 Ppm) + Zinc Base A |
|
| Sodium Fluoride (250 Ppm) |
|
| Sodium Fluoride (1426 Ppm) |
|
| Sodium Fluoride (1426 Ppm) + Zinc Base B |
|
| COMPLETED |
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| NOT COMPLETED |
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All randomized participants were evaluated for baseline characteristics
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| ID | Title | Description |
|---|---|---|
| BG000 | All Randomized Participants | All randomized participants were evaluated for baseline characteristics |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Percentage Surface Microhardness Recovery (% SMHR) | Changes in the mineral content of the four centrally-located enamel specimens were evaluated using the Surface Microhardness (SMH) Test. The SMH was measured using a Wilson 2100 Hardness Tester. The baseline SMH was determined prior to the in vitro acid challenge. SMH was determined again after the in vitro acid challenge, after the in situ remineralization test, and again after the second in vitro acid challenge. The extent of remineralization was calculated as the % recovery in SMH using the equation: % SMHR= [(D1-R)/(D1-B)]*100 Where B = indentation length (μm) of sound enamel at baseline; D1 = indentation length (μm) after first acid challenge; R = indentation length (μm) after in situ remineralization. | The primary population for the efficacy analysis was the Per Protocol (PP) population, including participants with a protocol violation affecting some (but not all) of the efficacy assessments. However, data from assessments when a violation occurred were excluded. | Posted | Least Squares Mean | Standard Error | Percentage of SMHR | Baseline to 4 hours |
|
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| Secondary | Enamel Fluoride Uptake | The microdrill enamel biopsy technique was used to analyze the fluoride uptake by enamel. Each enamel specimen was mounted on the long axis of a drill attached to a microdrill and drilled to a depth of approximately 100 micrometer (μm) through the entire lesion (four cores per specimen). The enamel powder pooled from four drilling sample was then immediately analyzed for fluoride content using fluoride specific electrode and pH/ion meter. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores and expressed as microgram per square centimeter (μg/cm^2). | The main population for the secondary efficacy analysis was the PP population, including participants with a protocol violation affecting some (but not all) of the efficacy assessments. However, data from assessments when a violation occurred were excluded. | Posted | Least Squares Mean | Standard Error | microgram per square centimeter(μg/cm^2) | Baseline to 4 hours |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage Net Acid Resistance (% NAR) | Changes in the mineral content of the four centrally-located enamel specimens were evaluated using the SMH Test. The SMH was measured using a Wilson 2100 Hardness Tester. The baseline SMH was measured prior to the in vitro acid challenge. SMH was measured again after the in vitro acid challenge, after the in situ remineralization test, and again after the second in vitro acid challenge. The % NAR was calculated using the equation: % NAR= [(D1-D2)/(D1-B)]*100 where B= Indentation length (μm) of sound enamel at baseline; D1= Indentation length (μm) after first acid challenge and D2= Indentation length (μm) after second acid challenge. | The main population for the secondary efficacy analysis was the PP population, including participants with a protocol violation affecting some (but not all) of the efficacy assessments. However, data from assessments when a violation occurred were excluded. | Posted | Least Squares Mean | Standard Error | Percentage of NAR | Baseline to 4 hours |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage Comparative Acid Resistance (% CAR) | Changes in the mineral content of the four centrally-located enamel specimens were evaluated using the SMH Test. The SMH was measured using a Wilson 2100 Hardness Tester. The baseline SMH was measured prior to the in vitro acid challenge. SMH was measured again after the in vitro acid challenge, after the in situ remineralization test, and again after the second in vitro acid challenge. The % CAR was calculated using the equation: % CAR= [(D2-R)/(D1-B)]*100 where B= Indentation length (μm) of sound enamel at baseline; R= Indentation length (μm) of enamel after in situ remineralization; D1= Indentation length (μm) after first acid challenge; D2= Indentation length (μm) after second acid challenge. | The main population for the secondary efficacy analysis was the PP population, including participants with a protocol violation affecting some (but not all) of the efficacy assessments. However, data from assessments when a violation occurred were excluded. | Posted | Least Squares Mean | Standard Error | Percentage of CAR | Baseline to 4 hours |
|
Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
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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 | Sodium Fluoride (1426 Ppm) | Non-zinc, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice. | 0 | 59 | 3 | 59 | ||
| EG001 | Sodium Fluoride (1150 Ppm) | Non-zinc, 1150ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice. | 0 | 57 | 1 | 57 | ||
| EG002 | Sodium Fluoride (250 Ppm) | Non-zinc, 250ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice. | 0 | 55 | 5 | 55 | ||
| EG003 | Sodium Fluoride (1426 Ppm) + Zinc Base A | Zinc base A, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice. | 0 | 58 | 1 | 58 | ||
| EG004 | Sodium Fluoride (1426 Ppm) + Zinc Base B | Zinc base B, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice. | 1 | 60 | 4 | 60 | ||
| EG005 | Sodium Fluoride (0 Ppm) | Non-zinc, 0ppm fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice. | 0 | 59 | 5 | 59 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oral Mucosal Erythema | Gastrointestinal disorders |
| |||
| Abdominal Discomfort | Gastrointestinal disorders |
| |||
| Parotid Gland Enlargement | Gastrointestinal disorders |
| |||
| Nasopharyngitis | Infections and infestations |
| |||
| Lymph gland infection | Infections and infestations |
| |||
| Meniscus injury | Injury, poisoning and procedural complications |
| |||
| Thermal burn | Injury, poisoning and procedural complications |
| |||
| Headache | Nervous system disorders |
| |||
| Paraesthesia | Nervous system disorders |
| |||
| Palpitations | Cardiac disorders |
| |||
| Motion sickness | Ear and labyrinth disorders |
| |||
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders |
| |||
| Dysmenorrhoea | Reproductive system and breast disorders |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D012969 | Sodium Fluoride |
| D005459 | Fluorides |
| ID | Term |
|---|---|
| D006858 | Hydrofluoric Acid |
| D017611 | Fluorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D002327 | Cariostatic Agents |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
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| OG004 | Sodium Fluoride (1426 Ppm) + Zinc Base B | Zinc base B, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice. |
| OG005 | Sodium Fluoride (0 Ppm) | Non-zinc, 0ppm fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice. |
Quadratic contrasts were fitted in order to establish whether there was a dose-response relationship. Quadratic contrasts are for experimental dentifrice: non-zinc treatments. |
| ANOVA |
Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect. |
| 0.2274 |
| 95 |
| No |
| Superiority or Other |
| ANOVA | Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect. | 0.5950 | Mean Difference (Net) | 0.68 | 2-Sided | 95 | -1.84 | 3.20 | Difference was calculated as Sodium fluoride (1426 ppm) minus Sodium fluoride (1150 ppm) such that a positive difference favors Sodium fluoride (1426 ppm). | No | Superiority or Other |
| ANOVA | Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect. | 0.0002 | Mean Difference (Net) | 4.93 | 2-Sided | 95 | 2.38 | 7.48 | Difference was calculated as Sodium fluoride (1426 ppm) minus Sodium fluoride (250 ppm) such that a positive difference favors Sodium fluoride (1426 ppm). | No | Superiority or Other |
| ANOVA | Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect. | 0.0013 | Mean Difference (Net) | 4.25 | 2-Sided | 95 | 1.68 | 6.82 | Difference was calculated as Sodium fluoride (1150 ppm) minus Sodium fluoride (250 ppm) such that a positive difference favors Sodium fluoride (1150 ppm). | No | Superiority or Other |
| ANOVA | Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect. | <0.0001 | Mean Difference (Net) | 7.71 | 2-Sided | 95 | 5.20 | 10.21 | Difference was calculated as Sodium fluoride (1426 ppm) minus Sodium fluoride (0 ppm) such that a positive difference favors Sodium fluoride (1426 ppm). | No | Superiority or Other |
| ANOVA | Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect. | <0.0001 | Mean Difference (Net) | 7.03 | 2-Sided | 95 | 4.51 | 9.55 | Difference was calculated as Sodium fluoride (1150 ppm) minus Sodium fluoride (0 ppm) such that a positive difference favors Sodium fluoride (1150 ppm). | No | Superiority or Other |
| ANOVA | Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect. | 0.0325 | Mean Difference (Net) | 2.78 | 2-Sided | 95 | 0.23 | 5.32 | Difference was calculated as Sodium fluoride (250 ppm) minus Sodium fluoride (0 ppm) such that a positive difference favors Sodium fluoride (250 ppm). | No | Superiority or Other |
| ANOVA | Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect. | 0.0920 | Mean Difference (Net) | -2.16 | 2-Sided | 95 | -4.67 | 0.35 | Difference was calculated as 'Sodium fluoride (1426 ppm) + zinc base A' minus Sodium fluoride (0 ppm) such that a positive difference favors 'Sodium fluoride (1426 ppm) + zinc base A'. | No | Superiority or Other |
| ANOVA | Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect. | 0.2185 | Mean Difference (Net) | -1.56 | 2-Sided | 95 | -4.04 | 0.93 | Difference was calculated as 'Sodium fluoride (1426 ppm) + zinc base B' minus Sodium fluoride (0 ppm) such that a positive difference favors 'Sodium fluoride (1426 ppm) + zinc base B'. | No | Superiority or Other |
| ANOVA | Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect. | <0.0001 | Mean Difference (Net) | 9.87 | 2-Sided | 95 | 7.36 | 12.37 | Difference was calculated as Sodium fluoride (1426 ppm) minus 'Sodium fluoride (1426 ppm) + zinc base A' such that a positive difference favors Sodium fluoride (1426 ppm). | No | Superiority or Other |
| ANOVA | Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect. | <0.0001 | Mean Difference (Net) | 9.26 | 2-Sided | 95 | 6.77 | 11.75 | Difference was calculated as Sodium fluoride (1426 ppm) minus 'Sodium fluoride (1426ppm) + zinc base B' such that a positive difference favors Sodium fluoride (1426 ppm). | No | Superiority or Other |
| Sodium Fluoride (1150 Ppm) |
Non-zinc, 1150ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice. |
| OG002 | Sodium Fluoride (250 Ppm) | Non-zinc, 250ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice. |
| OG003 | Sodium Fluoride (1426 Ppm) + Zinc Base A | Zinc base A, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice. |
| OG004 | Sodium Fluoride (1426 Ppm) + Zinc Base B | Zinc base B, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice. |
| OG005 | Sodium Fluoride (0 Ppm) | Non-zinc, 0ppm fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice. |
|
|
| OG001 |
| Sodium Fluoride (1150 Ppm) |
Non-zinc, 1150ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice. |
| OG002 | Sodium Fluoride (250 Ppm) | Non-zinc, 250ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice. |
| OG003 | Sodium Fluoride (1426 Ppm) + Zinc Base A | Zinc base A, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice. |
| OG004 | Sodium Fluoride (1426 Ppm) + Zinc Base B | Zinc base B, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice. |
| OG005 | Sodium Fluoride (0 Ppm) | Non-zinc, 0ppm fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice. |
|
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| OG001 | Sodium Fluoride (1150 Ppm) | Non-zinc, 1150ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice. |
| OG002 | Sodium Fluoride (250 Ppm) | Non-zinc, 250ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice. |
| OG003 | Sodium Fluoride (1426 Ppm) + Zinc Base A | Zinc base A, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice. |
| OG004 | Sodium Fluoride (1426 Ppm) + Zinc Base B | Zinc base B, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice. |
| OG005 | Sodium Fluoride (0 Ppm) | Sodium fluoride (0 ppm) Non-zinc, 0ppm fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice. |
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