Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2025-12-29 @ 6:43 PM
Study NCT ID:
NCT01005966
Status:
COMPLETED
Last Update Posted:
2013-07-29
First Post:
2009-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
In Situ Caries Model of Fluoride Toothpastes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'interventionBrowseModule': {'meshes': [{'id': 'C012980', 'term': 'fluorophosphate'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': '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.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '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.', 'eventGroups': [{'id': 'EG000', 'title': 'NaF Toothpaste (1426ppmF)', 'description': 'Study toothpaste containing NaF/ silica (1426ppmF)', 'otherNumAtRisk': 57, 'otherNumAffected': 1, 'seriousNumAtRisk': 57, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'AmF Toothpaste (1400ppmF)', 'description': 'Reference toothpaste containing AmF (1400ppmF)', 'otherNumAtRisk': 57, 'otherNumAffected': 5, 'seriousNumAtRisk': 57, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'NaMFP/ NaF Toothpaste (1450ppmF)', 'description': 'Reference toothpaste containing NaMFP/ NaF (1450ppmF - 1000ppmF as NaMFP and 450ppmF as NaF)', 'otherNumAtRisk': 59, 'otherNumAffected': 0, 'seriousNumAtRisk': 59, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'NaF Toothpaste (675ppmF)', 'description': 'Toothpaste containing NaF/ silica (675ppmF)', 'otherNumAtRisk': 59, 'otherNumAffected': 3, 'seriousNumAtRisk': 59, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Placebo Toothpaste (0ppmF)', 'description': 'Placebo: fluoride free toothpaste', 'otherNumAtRisk': 59, 'otherNumAffected': 2, 'seriousNumAtRisk': 59, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Overall', 'otherNumAtRisk': 65, 'otherNumAffected': 10, 'seriousNumAtRisk': 65, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 59, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 65, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Infections and infestations'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Surface Microhardness (SMH) Recovery of Enamel Specimens Exposed to NaF Toothpaste (1426ppmF) and AmF Toothpaste (1400ppmF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NaF Toothpaste (1426ppmF)', 'description': 'Study toothpaste containing NaF/ silica (1426ppmF)'}, {'id': 'OG001', 'title': 'AmF Toothpaste (1400ppmF)', 'description': 'Reference toothpaste containing AmF (1400ppmF)'}], 'classes': [{'categories': [{'measurements': [{'value': '38.05', 'spread': '2.52', 'groupId': 'OG000'}, {'value': '41.06', 'spread': '2.53', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2117', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.01', 'ciLowerLimit': '-7.75', 'ciUpperLimit': '1.73', 'pValueComment': 'No adjustment made for multiple comparisons as the primary comparison was pre-specified.', 'estimateComment': 'Statistical tests were 2-sided with a significance level of 0.05.', 'groupDescription': 'Null hypothesis considered population means for NaF toothpaste and AmF toothpaste to be equal with respect to enamel remineralization potential.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Analysis of variance (ANOVA) based on a mixed model with the factors subject, treatment and period was used.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 14 days', 'description': 'SMH recovery test was used to assess the changes in 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. Difference in percent SMH recovery was calculated by comparing study NaF toothpaste (1426ppmF) with reference AmF toothpaste (1400ppmF).', 'unitOfMeasure': 'Percentage SMHR', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol (PP) population: All randomized participants who received at least one dose of the study treatments and provided at least one measurement SMH. Participants without any major protocol violations in given study treatment period were included in the PP population.'}, {'type': 'SECONDARY', 'title': 'Percent SMH Recovery of Enamel Specimens Exposed to NaF Toothpaste (1426ppmF), NaF Toothpaste (675ppmF), NaMFP/NaF Toothpaste (1400ppm F) and Placebo (0ppmF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}, {'value': '59', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'NaF Toothpaste (1426ppmF)', 'description': 'Study toothpaste containing NaF/ silica (1426ppmF)'}, {'id': 'OG001', 'title': 'AmF Toothpaste (1400ppmF)', 'description': 'Reference toothpaste containing AmF(1400ppmF)'}, {'id': 'OG002', 'title': 'NaMFP/NaF Toothpaste (1450ppmF)', 'description': 'Reference toothpaste containing NaMFP/NaF (1450ppmF- 1000ppmF as NaMFP and 450ppmF as NaF)'}, {'id': 'OG003', 'title': 'NaF Toothpaste (675ppmF)', 'description': 'Toothpaste containing NaF/silica (675ppmF)'}, {'id': 'OG004', 'title': 'Placebo Toothpaste (0ppmF)', 'description': 'Placebo - fluoride free toothpaste'}], 'classes': [{'categories': [{'measurements': [{'value': '38.05', 'spread': '2.52', 'groupId': 'OG000'}, {'value': '41.06', 'spread': '2.53', 'groupId': 'OG001'}, {'value': '33.48', 'spread': '2.49', 'groupId': 'OG002'}, {'value': '29.08', 'spread': '2.50', 'groupId': 'OG003'}, {'value': '14.49', 'spread': '2.48', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.0002', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.96', 'ciLowerLimit': '4.27', 'ciUpperLimit': '13.66', 'pValueComment': 'No adjustment made for multiple comparisons as the primary comparison was pre-specified.', 'estimateComment': 'Statistical tests were 2-sided with a significance level of 0.05.', 'groupDescription': 'Null hypothesis considered population means for the NaF toothpaste (1426ppmF) and NaF toothpaste (675ppmF) to be equal with respect to enamel remineralization potential.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANOVA based on a mixed model with factors subject, treatment and period was used.', 'testedNonInferiority': False}, {'pValue': '0.0557', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Mean Difference', 'ciPctValue': '95', 'paramValue': '4.57', 'ciLowerLimit': '-0.11', 'ciUpperLimit': '9.24', 'pValueComment': 'No adjustment made for multiple comparisons as the primary comparison was pre-specified.', 'estimateComment': 'Statistical tests were 2-sided with a significance level of 0.05.', 'groupDescription': 'Null hypothesis considered population means for the NaF toothpaste (1426ppmF) and Na MFP/NaF toothpaste (1450ppmF) to be equal with respect to enamel remineralization potential.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANOVA based on a mixed model with factors subject, treatment and period was used.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '23.55', 'ciLowerLimit': '18.86', 'ciUpperLimit': '28.24', 'pValueComment': 'No adjustment made for multiple comparisons as the primary comparison was pre-specified.', 'estimateComment': 'Statistical tests were 2-sided with a significance level of 0.05.', 'groupDescription': 'Null hypothesis considered population means for the NaF toothpaste (1426ppmF) and Placebo toothpaste (0ppmF) to be equal with respect to enamel remineralization potential.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANOVA based on a mixed model with factors subject, treatment and period was used.', 'testedNonInferiority': False}, {'pValue': '0.0625', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.40', 'ciLowerLimit': '-0.23', 'ciUpperLimit': '9.03', 'pValueComment': 'No adjustment made for multiple comparisons as the primary comparison was pre-specified.', 'estimateComment': 'Statistical tests were 2-sided with a significance level of 0.05.', 'groupDescription': 'Null hypothesis considered population means for the Na MFP/NaF toothpaste (1450ppmF) and NaF toothpaste (675ppmF) to be equal with respect to enamel remineralization potential.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANOVA based on a mixed model with factors subject, treatment and period was used.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18.99', 'ciLowerLimit': '14.36', 'ciUpperLimit': '23.61', 'pValueComment': 'No adjustment made for multiple comparisons as the primary comparison was pre-specified.', 'estimateComment': 'Statistical tests were 2-sided with a significance level of 0.05.', 'groupDescription': 'Null hypothesis considered population means for the Na MFP/NaF toothpaste (1450ppmF) and Placebo toothpaste (0ppmF) to be equal with respect to enamel remineralization potential.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANOVA based on a mixed model with factors subject, treatment and period was used.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.59', 'ciLowerLimit': '9.95', 'ciUpperLimit': '19.23', 'pValueComment': 'No adjustment made for multiple comparisons as the primary comparison was pre-specified.', 'estimateComment': 'Statistical tests were 2-sided with a significance level of 0.05.', 'groupDescription': 'Null hypothesis considered population means for the NaF toothpaste (675ppmF) and Placebo toothpaste (0ppmF) to be equal with respect to enamel remineralization potential.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANOVA based on a mixed model with factors subject, treatment and period was used.', 'testedNonInferiority': False}, {'pValue': '0.0017', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.58', 'ciLowerLimit': '2.88', 'ciUpperLimit': '12.27', 'pValueComment': 'No adjustment made for multiple comparisons as the primary comparison was pre-specified.', 'estimateComment': 'Statistical tests were 2-sided with a significance level of 0.05.', 'groupDescription': 'Null hypothesis considered population means for the AmF toothpaste (1400ppmF) and Na MFP/NaF toothpaste (1450ppmF) to be equal with respect to enamel remineralization potential.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANOVA based on a mixed model with factors subject, treatment and period was used.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.97', 'ciLowerLimit': '7.31', 'ciUpperLimit': '16.64', 'pValueComment': 'No adjustment made for multiple comparisons as the primary comparison was pre-specified.', 'estimateComment': 'Statistical tests were 2-sided with a significance level of 0.05.', 'groupDescription': 'Null hypothesis considered population means for AmF toothpaste (1400ppmF) and NaF toothpaste (675ppmF) to be equal with respect to enamel remineralization potential.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANOVA based on a mixed model with factors subject, treatment and period was used.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '26.56', 'ciLowerLimit': '21.88', 'ciUpperLimit': '31.24', 'pValueComment': 'No adjustment made for multiple comparisons as the primary comparison was pre-specified.', 'estimateComment': 'Statistical tests were 2-sided with a significance level of 0.05.', 'groupDescription': 'Null hypothesis considered population means for AmF toothpaste (1400ppmF) and placebo toothpaste (0ppmF) to be equal with respect to enamel remineralization potential.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANOVA based on a mixed model with factors subject, treatment and period was used.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 14 days', 'description': 'SMH test was used to assess the changes in 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. Differences in percent SMH recovery due to study and reference toothpastes were calculated.', 'unitOfMeasure': 'Percentage SMHR', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'PP population: All randomized participants who received at least one dose of the study treatments or provided at least one measurement SMH. Participants without any major protocol violations in given study treatment period were included in the PP population.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Enamel Fluoride Uptake Potential', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}, {'value': '59', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'NaF Toothpaste (1426ppmF)', 'description': 'Study toothpaste containing NaF/ silica (1426ppmF)'}, {'id': 'OG001', 'title': 'AmF Toothpaste (1400ppmF)', 'description': 'Reference toothpaste containing AmF (1400ppmF)'}, {'id': 'OG002', 'title': 'Na MFP/NaF Toothpaste (1450ppmF)', 'description': 'Reference toothpaste containing NaMFP/NaF (1450ppmF - 1000ppmF as NaMFP and 450ppmF as NaF)'}, {'id': 'OG003', 'title': 'NaF Toothpaste (675ppmF)', 'description': 'Toothpaste containing NaF/ silica (675ppmF)'}, {'id': 'OG004', 'title': 'Placebo Toothpaste (0ppmF)', 'description': 'Placebo: Fluoride free toothpaste'}], 'classes': [{'categories': [{'measurements': [{'value': '2342.35', 'spread': '123.65', 'groupId': 'OG000'}, {'value': '2305.11', 'spread': '123.83', 'groupId': 'OG001'}, {'value': '1809.74', 'spread': '121.83', 'groupId': 'OG002'}, {'value': '1649.44', 'spread': '121.93', 'groupId': 'OG003'}, {'value': '462.95', 'spread': '120.92', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.7912', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '37.24', 'ciLowerLimit': '-239.62', 'ciUpperLimit': '314.09', 'pValueComment': 'No adjustment made for multiple comparisons as the primary comparison was pre-specified.', 'estimateComment': 'Statistical tests were 2-sided with a significance level of 0.05.', 'groupDescription': 'Null hypothesis considered population means for the NaF toothpaste (1426ppmF) and AmF toothpaste (1400ppmF) to be equal with respect to enamel fluoride uptake potential.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANOVA based on a mixed model with factors subject, treatment and period was used.', 'testedNonInferiority': False}, {'pValue': '0.0002', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '532.61', 'ciLowerLimit': '259.06', 'ciUpperLimit': '806.16', 'pValueComment': 'No adjustment made for multiple comparisons as the primary comparison was pre-specified.', 'estimateComment': 'Statistical tests were 2-sided with a significance level of 0.05.', 'groupDescription': 'Null hypothesis considered population means for the NaF toothpaste (1426ppmF) and Na MFP/NaF toothpaste (1450ppmF) to be equal with respect to enamel fluoride uptake potential.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANOVA based on a mixed model with factors subject, treatment and period was used.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '692.91', 'ciLowerLimit': '418.73', 'ciUpperLimit': '967.09', 'pValueComment': 'No adjustment made for multiple comparisons as the primary comparison was pre-specified.', 'estimateComment': 'Statistical tests were 2-sided with a significance level of 0.05', 'groupDescription': 'Null hypothesis considered population means for the NaF toothpaste (1426ppmF) and NaF toothpaste (675ppmF) to be equal with respect to enamel fluoride uptake potential.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANOVA based on a mixed model with factors subject, treatment and period was used.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1879.40', 'ciLowerLimit': '1605.75', 'ciUpperLimit': '2153.04', 'pValueComment': 'No adjustment made for multiple comparisons as the primary comparison was pre-specified.', 'estimateComment': 'Statistical tests were 2-sided with a significance level of 0.05.', 'groupDescription': 'Null hypothesis considered population means for the NaF toothpaste (1426ppmF) and Placebo toothpaste (0ppmF) to be equal with respect to enamel fluoride uptake potential.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANOVA based on a mixed model with factors subject, treatment and period was used.', 'testedNonInferiority': False}, {'pValue': '0.0005', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '495.38', 'ciLowerLimit': '221.09', 'ciUpperLimit': '769.66', 'pValueComment': 'No adjustment made for multiple comparisons as the primary comparison was pre-specified.', 'estimateComment': 'Statistical tests were 2-sided with a significance level of 0.05.', 'groupDescription': 'Null hypothesis considered population means for AmF toothpaste (1400ppmF) and Na MFP/ NaF toothpaste (1450ppmF) and to be equal with respect to enamel fluoride uptake potential.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANOVA based on a mixed model with factors subject, treatment and period was used.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '655.67', 'ciLowerLimit': '382.41', 'ciUpperLimit': '928.93', 'pValueComment': 'No adjustment made for multiple comparisons as the primary comparison was pre-specified.', 'estimateComment': 'Statistical tests were 2-sided with a significance level of 0.05.', 'groupDescription': 'Null hypothesis considered population means for AmF toothpaste (1400ppmF) and NaF toothpaste (675ppmF) to be equal with respect to enamel fluoride uptake potential.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANOVA based on a mixed model with factors subject, treatment and period was used.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1842.16', 'ciLowerLimit': '1568.73', 'ciUpperLimit': '2115.60', 'pValueComment': 'No adjustment made for multiple comparisons as the primary comparison was pre-specified.', 'estimateComment': 'Statistical tests were 2-sided with a significance level of 0.05.', 'groupDescription': 'Null hypothesis considered population means for AmF toothpaste (1400ppmF) and placebo toothpaste (0ppmF) to be equal with respect to enamel fluoride uptake potential.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANOVA based on a mixed model with factors subject, treatment and period was used.', 'testedNonInferiority': False}, {'pValue': '0.2448', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '160.30', 'ciLowerLimit': '-110.58', 'ciUpperLimit': '431.18', 'pValueComment': 'No adjustment made for multiple comparisons as the primary comparison was pre-specified.', 'estimateComment': 'Statistical tests were 2-sided with a significance level of 0.05.', 'groupDescription': 'Null hypothesis considered population means for the Na MFP/NaF toothpaste (1450ppmF) and NaF toothpaste (675ppmF) to be equal with respect to enamel fluoride uptake potential.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANOVA based on a mixed model with factors subject, treatment and period was used.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1346.79', 'ciLowerLimit': '1076.46', 'ciUpperLimit': '1617.11', 'pValueComment': 'No adjustment made for multiple comparisons as the primary comparison was pre-specified.', 'estimateComment': 'Statistical tests were 2-sided with a significance level of 0.05.', 'groupDescription': 'Null hypothesis considered population means for the Na MFP/NaF toothpaste (1450ppmF) and Placebo toothpaste (0ppmF) to be equal with respect to enamel fluoride uptake potential.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANOVA based on a mixed model with factors subject, treatment and period was used.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1186.49', 'ciLowerLimit': '915.38', 'ciUpperLimit': '1457.60', 'pValueComment': 'No adjustment made for multiple comparisons as the primary comparison was pre-specified.', 'estimateComment': 'Statistical tests were 2-sided with a significance level of 0.05.', 'groupDescription': 'Null hypothesis considered population means for the NaF toothpaste (675ppmF) and Placebo toothpaste (0ppmF) to be equal with respect to enamel fluoride uptake potential.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANOVA based on a mixed model with factors subject, treatment and period was used.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 14 days', 'description': 'Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on the amount of fluoride (F) divided by the area of the enamel cores. The difference between treatments was calculated with respect to fluoride uptake by enamel.', 'unitOfMeasure': 'micrograms (μg)* F/centimeters(cm)^2', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'PP population: All randomized participants who received at least one dose of the study treatments or provided at least one significant measurement of fluoride uptake. Participants without any major protocol violations in given study treatment period were included in the PP population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sodium Fluoride(NaF) Toothpaste[1426parts Per Million(Ppm)F]', 'description': 'Study toothpaste containing sodium fluoride/ silica (1426ppm fluoride as NaF)'}, {'id': 'FG001', 'title': 'Amine Fluoride(AmF) Toothpaste (1400ppmF)', 'description': 'Reference toothpaste containing amine fluoride (1400ppm fluoride as AmF)'}, {'id': 'FG002', 'title': 'Sodium Monofluorophosphate (NaMFP)/NaF Toothpaste (1450ppmF)', 'description': 'Reference toothpaste containing sodium monofluorophosphate and sodium fluoride (1450ppmF - 1000ppmF as NaMFP and 450ppmF as NaF)'}, {'id': 'FG003', 'title': 'NaF Toothpaste (675ppmF)', 'description': 'Study toothpaste containing sodium fluoride and silica (675ppmF as NaF)'}, {'id': 'FG004', 'title': 'Placebo Toothpaste (0ppmF)', 'description': 'Placebo fluoride free toothpaste'}], 'periods': [{'title': 'Treatment Period 1 (14 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '13'}, {'groupId': 'FG004', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '13'}, {'groupId': 'FG004', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Washout Period 1 (4 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '13'}, {'groupId': 'FG004', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period 2 (14 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Due to crossover design, a different set of subjects received this treatment compared to Period 1', 'groupId': 'FG000', 'numSubjects': '13'}, {'comment': 'Due to crossover design, a different set of subjects received this treatment compared to Period 1', 'groupId': 'FG001', 'numSubjects': '13'}, {'comment': 'Due to crossover design, a different set of subjects received this treatment compared to Period 1', 'groupId': 'FG002', 'numSubjects': '12'}, {'comment': 'Due to crossover design, a different set of subjects received this treatment compared to Period 1', 'groupId': 'FG003', 'numSubjects': '12'}, {'comment': 'Due to crossover design, a different set of subjects received this treatment compared to Period 1', 'groupId': 'FG004', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '11'}, {'groupId': 'FG004', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Washout Period 2 (4 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '11'}, {'groupId': 'FG004', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '11'}, {'groupId': 'FG004', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period 3 (14 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Due to crossover design, a different set of subjects received this treatment compared to Period 2', 'groupId': 'FG000', 'numSubjects': '12'}, {'comment': 'Due to crossover design, a different set of subjects received this treatment compared to Period 2', 'groupId': 'FG001', 'numSubjects': '8'}, {'comment': 'Due to crossover design, a different set of subjects received this treatment compared to Period 2', 'groupId': 'FG002', 'numSubjects': '12'}, {'comment': 'Due to crossover design, a different set of subjects received this treatment compared to Period 2', 'groupId': 'FG003', 'numSubjects': '13'}, {'comment': 'Due to crossover design, a different set of subjects received this treatment compared to Period 2', 'groupId': 'FG004', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '13'}, {'groupId': 'FG004', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}]}, {'title': 'Washout Period 3 ( 4 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '13'}, {'groupId': 'FG004', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '13'}, {'groupId': 'FG004', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period 4 (14 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Due to crossover design, a different set of subjects received this treatment compared to Period 3', 'groupId': 'FG000', 'numSubjects': '10'}, {'comment': 'Due to crossover design, a different set of subjects received this treatment compared to Period 3', 'groupId': 'FG001', 'numSubjects': '11'}, {'comment': 'Due to crossover design, a different set of subjects received this treatment compared to Period 3', 'groupId': 'FG002', 'numSubjects': '11'}, {'comment': 'Due to crossover design, a different set of subjects received this treatment compared to Period 3', 'groupId': 'FG003', 'numSubjects': '10'}, {'comment': 'Due to crossover design, a different set of subjects received this treatment compared to Period 3', 'groupId': 'FG004', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Other Reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}]}, {'title': 'Washout Period 4 (4 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period 5 (14 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Due to crossover design, a different set of subjects received this treatment compared to Period 4', 'groupId': 'FG000', 'numSubjects': '9'}, {'comment': 'Due to crossover design, a different set of subjects received this treatment compared to Period 4', 'groupId': 'FG001', 'numSubjects': '12'}, {'comment': 'Due to crossover design, a different set of subjects received this treatment compared to Period 4', 'groupId': 'FG002', 'numSubjects': '11'}, {'comment': 'Due to crossover design, a different set of subjects received this treatment compared to Period 4', 'groupId': 'FG003', 'numSubjects': '11'}, {'comment': 'Due to crossover design, a different set of subjects received this treatment compared to Period 4', 'groupId': 'FG004', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '11'}, {'groupId': 'FG004', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited at the clinical site.', 'preAssignmentDetails': '83 participants were screened and 18 participants did not meet the study criteria thus 65 participants were enrolled into the study. The subjects were randomized to receive all 5 study treatments in a pre-determined computerized randomised order as per a typical cross-over design.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Randomized Participants', 'description': 'All randomized participants who received at least one dose of the study treatments or who have been evaluated for AEs were included.'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.0', 'spread': '9.97', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '41', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '65', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'dispFirstSubmitDate': '2012-11-28', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-20', 'studyFirstSubmitDate': '2009-10-15', 'dispFirstSubmitQcDate': '2013-06-20', 'resultsFirstSubmitDate': '2012-11-28', 'studyFirstSubmitQcDate': '2009-10-29', 'dispFirstPostDateStruct': {'date': '2013-07-29', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2013-07-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-06-20', 'studyFirstPostDateStruct': {'date': '2009-11-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Surface Microhardness (SMH) Recovery of Enamel Specimens Exposed to NaF Toothpaste (1426ppmF) and AmF Toothpaste (1400ppmF)', 'timeFrame': 'Baseline to 14 days', 'description': 'SMH recovery test was used to assess the changes in 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. Difference in percent SMH recovery was calculated by comparing study NaF toothpaste (1426ppmF) with reference AmF toothpaste (1400ppmF).'}], 'secondaryOutcomes': [{'measure': 'Percent SMH Recovery of Enamel Specimens Exposed to NaF Toothpaste (1426ppmF), NaF Toothpaste (675ppmF), NaMFP/NaF Toothpaste (1400ppm F) and Placebo (0ppmF)', 'timeFrame': 'Baseline to 14 days', 'description': 'SMH test was used to assess the changes in 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. Differences in percent SMH recovery due to study and reference toothpastes were calculated.'}, {'measure': 'Change From Baseline in Enamel Fluoride Uptake Potential', 'timeFrame': 'Baseline to 14 days', 'description': 'Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on the amount of fluoride (F) divided by the area of the enamel cores. The difference between treatments was calculated with respect to fluoride uptake by enamel.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['remineralization', 'enamel', 'in situ', 'fluoride', 'caries'], 'conditions': ['Caries']}, 'descriptionModule': {'briefSummary': 'This study is to evaluate the effect of fluoride dentrifrices on enamel with artificial caries lesions in an in situ model'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Consent:Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form\n* Age:Aged 18 to 80 years inclusive\n* Compliance: Understands and is willing, able and likely to comply with all study procedures and restrictions\n* General Health:Good general health with (in the opinion of the investigator) no clinically significant and/or relevant abnormalities of medical history or oral examination that could interfere with subject safety during the study period\n* Residency: Currently living in the Indianapolis, Indiana area\n* Dentures: a) Currently wearing a removable mandibular partial denture with sufficient room in the posterior buccal flange area to accommodate two enamel specimens (required dimensions 12 x 7 millimeters (mm). b) Willing and capable of wearing their removable partial dentures 24 hours per day during each two week treatment period. c) All restorations in a good state of repair\n* Salivary Flow: Have a salivary flow rate in the range of normal values (unstimulated whole saliva flow rate ≥ 0.2 mL/minute; gum base stimulated whole saliva flow rate ≥ 0.8 mL/minute).\n\nExclusion Criteria:\n\n* Pregnancy:Women who are known to be pregnant or who are intending to become pregnant over the duration of the study\n* Breast-feeding: Women who are breast-feeding\n* Allergy/Intolerance:Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients\n* Clinical Study/Experimental Medication: a. Participation in another clinical study or receipt of an investigational drug within 30 days of the first treatment visit, with the exception of study GSK dental studies where the wash in period prior to treatment is sufficient. b. Previous participation in this study\n* Antibiotics: Currently taking antibiotics or have taken antibiotics in the two weeks prior to the screening visit\n* Fluoride: Prescribed or professionally recommended use of fluoride supplements or fluoride mouthrinse\n* Substance abuse: Recent history (within last year) of alcohol or other substance abuse\n* Dental Health: Current active caries or periodontal disease that may compromise the study or health of the subjects\n* Personnel: a. A member of the site study staff who is directly working on the project or living in that staff's household. b. An employee of the sponsor c. Any employee of any toothpaste manufacturer or their spouse or family member"}, 'identificationModule': {'nctId': 'NCT01005966', 'briefTitle': 'In Situ Caries Model of Fluoride Toothpastes', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'Clinical Efficacy of Fluoride Toothpastes Using an in Situ Caries Model', 'orgStudyIdInfo': {'id': 'T3508605'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Run in', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Sodium Fluoride Toothpaste', 'description': 'Sodium fluoride toothpaste', 'interventionNames': ['Drug: Sodium Fluoride Toothpaste']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Amine Fluoride Toothpaste', 'description': 'Amine Fluoride', 'interventionNames': ['Drug: Amine Fluoride Toothpaste']}, {'type': 'OTHER', 'label': '675ppmf toothpaste', 'description': 'Dose response', 'interventionNames': ['Drug: 675 ppmf toothpaste']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sodium monofluorophosphate/sodium fluoride Toothpaste', 'description': 'Sodium monofluorophosphate/sodium fluoride Toothpaste', 'interventionNames': ['Drug: Sodium monofluorophosphate/Sodium Fluoride Toothpaste']}, {'type': 'PLACEBO_COMPARATOR', 'label': '0 ppmf toothpaste', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Sodium Fluoride Toothpaste', 'type': 'DRUG', 'description': 'Test product', 'armGroupLabels': ['Sodium Fluoride Toothpaste']}, {'name': 'Amine Fluoride Toothpaste', 'type': 'DRUG', 'description': 'Test product', 'armGroupLabels': ['Amine Fluoride Toothpaste']}, {'name': 'Sodium monofluorophosphate/Sodium Fluoride Toothpaste', 'type': 'DRUG', 'description': 'test product', 'armGroupLabels': ['Sodium monofluorophosphate/sodium fluoride Toothpaste']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'placebo and washout treatment', 'armGroupLabels': ['0 ppmf toothpaste', 'Run in']}, {'name': '675 ppmf toothpaste', 'type': 'DRUG', 'description': 'dose response', 'armGroupLabels': ['675ppmf toothpaste']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}