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An in situ model will be used to evaluate and compare enamel remineralization of human enamel specimens after single use of experimental children's toothpastes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluoride free toothpaste | Placebo Comparator | toothpaste with no fluoride |
|
| 1426ppm Fluoride Toothpaste | Experimental | Experimental toothpaste containing 1426 ppm Fluoride |
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| 1000 ppm Fluoride Toothpaste | Experimental | Experimental toothpaste containing 1000 ppm Fluoride |
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| 500 ppm Toothpaste | Experimental | Experimental toothpaste containing 500 ppm Fluoride |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluoride | Drug | Fluoride Toothpaste |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Surface Microhardness Recovery of Test Dentifrices Relative to Placebo Dentifrice | Surface microhardness recovery (SMHR) test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR 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 SMHR was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first demineralization challenge (D1) using formula: [(D1-R)/ (D1-B)]*100. | Baseline to 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| %SMHR of Enamel Specimens Exposed to Test Treatments | Surface microhardness recovery (SMHR) test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR 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 SMHR was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first demineralization challenge (D1) using formula: [(D1-R)/ (D1-B)]*100. |
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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 |
|---|---|---|---|---|---|---|
| Indiana University School of Dentistry | Indianapolis | Indiana | 46202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24283282 | Result | Newby EE, Martinez-Mier EA, Hara A, Lippert F, Kelly SA, Fleming N, Butler A, Bosma ML, Zero DT. A randomised clinical study to evaluate experimental children's toothpastes in an in-situ palatal caries model in children aged 11-14 years. Int Dent J. 2013 Dec;63 Suppl 2(Suppl 2):31-8. doi: 10.1111/idj.12073. |
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Of the 70 participants screened, 15 were not randomized into the study (12 did not meet study criteria and 3 withdrew the consent). A washout fluoride (F) toothpaste was used for a week prior treatment. In-situ appliances were prepared for participants to fit enamel specimens.
Participants were recruited at the clinical site.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sodium Fluoride(NaF) Toothpaste (1426parts Per Million(Ppm) F) | Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 grams (g) ± 0.1g of NaF toothpaste(1426 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided |
| FG001 | NaF Toothpaste (1000 Ppm F) | Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (1000 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided |
| FG002 | NaF Toothpaste (500 Ppm F) | Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (500 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided |
| FG003 | Placebo Toothpaste (0 Ppm F) | Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (0ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided |
| 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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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | All randomized participants who received atleast one dose of the study treatments |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Percentage Surface Microhardness Recovery of Test Dentifrices Relative to Placebo Dentifrice | Surface microhardness recovery (SMHR) test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR 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 SMHR was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first demineralization challenge (D1) using formula: [(D1-R)/ (D1-B)]*100. | Per Protocol (PP) Population: All randomized participants who received at least one study product, had one efficacy assessment and did not have any protocol violations deemed to affect efficacy. Missing enamel specimen values were imputed, by averaging over the available enamel specimens. | Posted | Mean | Standard Error | %SMHR | Baseline to 4 hours |
|
Baseline through 5 days post administration of last treatment
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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 | NaF Toothpaste (1426 Ppm F) | Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (1426 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D005459 | Fluorides |
| ID | Term |
|---|---|
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D007287 | Inorganic Chemicals |
| D006858 |
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| Placebo | Drug | Fluoride free toothpaste |
|
| Baseline to 4 hours |
| Percent Net Acid Resistance (%NAR) of Enamel Specimens | Changes in mineral content of enamel specimens exposed to dietary erosive challenge were determined by measuring the length of the indentations. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine NAR which compared the indentations values of sound enamel specimens at baseline (B), first demineralization challenge (D1) and second demineralization challenge (D2). Percent NAR was calculated by formula: [(D1-D2)/ (D1-B)]*100. | Baseline to 4 hours |
| Enamel Fluoride Uptake | Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on amount of F divided by volume of the enamel cores and expressed as micrograms (μg)* F/centimeters(cm)^2. Difference between treatments was calculated with respect to F uptake by enamel. | Baseline to 4 hours |
| COMPLETED |
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| NOT 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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| Race/Ethnicity, Customized | Number | Participants |
|
| OG000 |
| NaF Toothpaste (1426 Ppm F) |
Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (1426 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided |
| OG001 | NaF Toothpaste (1000 Ppm F) | Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (1000 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided |
| OG002 | NaF Toothpaste (500 Ppm F) | Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (500 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided |
| OG003 | Placebo Toothpaste (0 Ppm F) | Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (0ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided |
|
|
|
| Secondary | %SMHR of Enamel Specimens Exposed to Test Treatments | Surface microhardness recovery (SMHR) test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR 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 SMHR was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first demineralization challenge (D1) using formula: [(D1-R)/ (D1-B)]*100. | Per Protocol (PP) Population: All randomized participants who received at least one study product, had one efficacy assessment and did not have any protocol violations deemed to affect efficacy. Missing enamel specimen values were imputed, by averaging over the available enamel specimens. | Posted | Mean | Standard Error | %SMHR | Baseline to 4 hours |
|
|
|
|
| Secondary | Percent Net Acid Resistance (%NAR) of Enamel Specimens | Changes in mineral content of enamel specimens exposed to dietary erosive challenge were determined by measuring the length of the indentations. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine NAR which compared the indentations values of sound enamel specimens at baseline (B), first demineralization challenge (D1) and second demineralization challenge (D2). Percent NAR was calculated by formula: [(D1-D2)/ (D1-B)]*100. | Per Protocol (PP) Population: All randomized participants who received at least one study product, had one efficacy assessment and did not have any protocol violations deemed to affect efficacy. Missing enamel specimen values were imputed, by averaging over the available enamel specimens. | Posted | Mean | Standard Error | %NAR | Baseline to 4 hours |
|
|
|
|
| Secondary | Enamel Fluoride Uptake | Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on amount of F divided by volume of the enamel cores and expressed as micrograms (μg)* F/centimeters(cm)^2. Difference between treatments was calculated with respect to F uptake by enamel. | Per Protocol (PP) Population: All randomized participants who received at least one study product, had one efficacy assessment and did not have any protocol violations deemed to affect efficacy. Missing enamel specimen values were imputed, by averaging over the available enamel specimens | Posted | Mean | Standard Error | μg*F/cm^2 | Baseline to 4 hours |
|
|
|
|
| 0 |
| 55 |
| 4 |
| 55 |
| EG001 | NaF Toothpaste (1000 Ppm F) | Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (1000 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided | 0 | 55 | 6 | 55 |
| EG002 | NaF Toothpaste (500 Ppm F) | Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (500 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided | 0 | 55 | 7 | 55 |
| EG003 | Placebo Toothpaste (0 Ppm F) | Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (0ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided | 0 | 55 | 6 | 55 |
| Lip injury | Skin and subcutaneous tissue disorders | MedDRA |
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| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | MedDRA |
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| Sinusitis | Ear and labyrinth disorders | MedDRA |
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| Pharyngitis streptococcal | Respiratory, thoracic and mediastinal disorders | MedDRA |
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| Oral herpes | Gastrointestinal disorders | MedDRA |
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| Ear infection | Ear and labyrinth disorders | MedDRA |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA |
|
| Chapped lips | Skin and subcutaneous tissue disorders | MedDRA |
|
| Gingival erythema | Musculoskeletal and connective tissue disorders | MedDRA |
|
| Blood urine present | Renal and urinary disorders | MedDRA |
|
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.
| Hydrofluoric Acid |
| D017611 | Fluorine Compounds |
| Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels. | ANOVA | The fixed factors for ANOVA were study period and treatment and the subject was random effect | 0.0168 | No adjustment was required for multiple comparisons as the primary comparison was pre-specified | Adjusted Mean Difference | 2.44 | 2-Sided | 95 | 0.44 | 4.43 | 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 was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels | ANOVA | The fixed factors for ANOVA were study period and treatment and the subject was random effect | 0.2352 | No adjustment was required for multiple comparisons as the primary comparison was pre-specified | Adjusted Mean Difference | 1.20 | 2-Sided | 95 | -0.79 | 3.19 | 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 was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels | ANOVA | The fixed factors for ANOVA were study period and treatment and the subject was random effect | <0.0001 | No adjustment was required for multiple comparisons as the primary comparison was pre-specified | Adjusted Mean difference | 34.86 | 2-Sided | 95 | 30.28 | 39.44 | 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 was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels | ANOVA | The fixed factors for ANOVA were study period and treatment and the subject was random effect | < 0.0001 | No adjustment was required for multiple comparisons as the primary comparison was pre-specified | Adjusted Mean Difference | 28.55 | 2-Sided | 95 | 23.97 | 33.13 | 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 was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels | ANOVA | The fixed factors for ANOVA were study period and treatment and the subject was random effect | 0.9292 | No adjustment was required for multiple comparisons as the primary comparison was pre-specified | Adjusted Mean Difference | -0.21 | 2-Sided | 95 | -4.79 | 4.38 | 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 was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels | ANOVA | The fixed factors for ANOVA were study period and treatment and the subject was random effect | 0.0094 | No adjustment was required for multiple comparisons as the primary comparison was pre-specified | Adjusted Mean Difference | 6.10 | 2-Sided | 95 | 1.52 | 10.69 | 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 was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels | ANOVA | The fixed factors for ANOVA were study period and treatment and the subject was random effect | 0.0073 | No adjustment was required for multiple comparisons as the primary comparison was pre-specified | Adjusted Mean Difference | 6.31 | 2-Sided | 95 | 1.72 | 10.89 | 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 was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels | ANOVA | The fixed factors for ANOVA were study period and treatment and the subject was random effect | <0.0001 | No adjustment was required for multiple comparisons as the primary comparison was pre-specified | Adjusted Mean Difference | 0.79 | 2-Sided | 95 | 0.58 | 0.99 | 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 was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels | ANOVA | The fixed factors for ANOVA were study period and treatment and the subject was random effect | < 0.0001 | No adjustment was required for multiple comparisons as the primary comparison was pre-specified | Adjusted Mean Difference | 0.49 | 2-Sided | 95 | 0.29 | 0.69 | 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 was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels | ANOVA | The fixed factors for ANOVA were study period and treatment and the subject was random effect | 0.9631 | No adjustment was required for multiple comparisons as the primary comparison was pre-specified | Adjusted Mean Difference | -0.005 | 2-Sided | 95 | -0.21 | 0.20 | 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 was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels | ANOVA | The fixed factors for ANOVA were study period and treatment and the subject was random effect | 0.0047 | No adjustment was required for multiple comparisons as the primary comparison was pre-specified | Adjusted Mean Difference | 0.29 | 2-Sided | 95 | 0.09 | 0.49 | 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 was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels | ANOVA | The fixed factors for ANOVA were study period and treatment and the subject was random effect | 0.0040 | No adjustment was required for multiple comparisons as the primary comparison was pre-specified | Adjusted Mean Difference | 0.30 | 2-Sided | 95 | 0.10 | 0.50 | Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment | No | Superiority or Other |