Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2025-12-25 @ 2:16 PM
Study NCT ID:
NCT02533466
Status:
COMPLETED
Last Update Posted:
2017-08-02
First Post:
2015-08-24
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
In Vivo Investigation of Initial Stages of Enamel Erosion
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014077', 'term': 'Tooth Erosion'}], 'ancestors': [{'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D057085', 'term': 'Tooth Wear'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012969', 'term': 'Sodium Fluoride'}, {'id': 'C023844', 'term': 'potassium nitrate'}], 'ancestors': [{'id': 'D005459', 'term': 'Fluorides'}, {'id': 'D006858', 'term': 'Hydrofluoric Acid'}, {'id': 'D017611', 'term': 'Fluorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D002327', 'term': 'Cariostatic Agents'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, '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': 'Baseline upto Day 2', 'eventGroups': [{'id': 'EG000', 'title': 'Test Product', 'description': 'Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.', 'otherNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Reference Product', 'description': 'Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.', 'otherNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Immediately Following an Acid Challenge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Product', 'description': 'Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.'}, {'id': 'OG001', 'title': 'Reference Product', 'description': 'Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.75', 'spread': '1.917', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '4'}, {'value': '3.17', 'spread': '1.882', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '4'}]}]}], 'analyses': [{'pValue': '0.2673', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.08', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '0.0', 'pValueComment': 'P-value was calculated from Wilcoxon Rank Sum test.', 'estimateComment': 'Median difference and 95% CI intervals were calculated from the Hodges Lehnmann estimate.\n\nDifference was calculated as reference product minus test product.', 'statisticalMethod': 'Wilcoxon Rank Sum test', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Equivalent analyses was executed using scale transformation or non-parametric methods.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 30 minutes post dietary acid challenge', 'description': 'The impressions of the tooth surface were analysed using scanning electron microscopy (SEM) to investigate changes in the enamel surface topography to determine degree of early stage enamel erosion. Interrogation of the tooth surface via impressions using SEM followed by visual image analysis was used to investigate the enamel surface topography.\n\nThe Images were graded as follows:\n\n1. \\- No signs of surface erosive wear (no evidence of the "lock and key" structure)\n2. \\- Early signs of erosive surface changes\n3. \\- Mild signs of erosive surface changes (early signs of the "lock and key" structure).\n4. \\- Moderate signs of erosive surface changes\n5. \\- Severe signs of erosive surface changes ("lock and key" structure and enamel "pits") X - Not evaluable', 'unitOfMeasure': 'Scores on grading scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Per Protocol (PP) population was defined as those subjects in the ITT (intent to treat) population who have at least one assessment of efficacy considered unaffected by protocol violation. Assessments of efficacy considered affected by protocol violation were excluded from PP analyses. The primary population was the PP population.'}, {'type': 'SECONDARY', 'title': 'Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Following 2 Hours Post Acid Challenge.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Product', 'description': 'Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.'}, {'id': 'OG001', 'title': 'Reference Product', 'description': 'Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.83', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '4.0'}, {'value': '2.33', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '3.8'}]}]}], 'analyses': [{'pValue': '0.0690', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.92', 'ciLowerLimit': '-1.8', 'ciUpperLimit': '0.0', 'pValueComment': 'P-value was calculated from Wilcoxon Rank Sum test.', 'estimateComment': 'Median difference and 95% CI intervals were calculated from the Hodges Lehnmann estimate.\n\nDifference was calculated as reference product minus test product.', 'statisticalMethod': 'Wilcoxon Rank Sum Test', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Equivalent analyses was executed using scale transformation or non-parametric methods'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 2 hours post acid challenge', 'description': 'The impressions of the tooth surface were analysed using scanning electron microscopy (SEM) to investigate changes in the enamel surface topography to determine degree of early stage enamel erosion. Interrogation of the tooth surface via impressions using SEM followed by visual image analysis was used to investigate the enamel surface topography.\n\nThe Images were graded as follows:\n\n1. \\- No signs of surface erosive wear (no evidence of the "lock and key" structure)\n2. \\- Early signs of erosive surface changes\n3. \\- Mild signs of erosive surface changes (early signs of the "lock and key" structure).\n4. \\- Moderate signs of erosive surface changes\n5. \\- Severe signs of erosive surface changes ("lock and key" structure and enamel "pits") X - Not evaluable', 'unitOfMeasure': 'Scores on grading scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The PP population was defined as those subjects in the ITT population who have at least one assessment of efficacy considered unaffected by protocol violation. Assessments of efficacy considered affected by protocol violation were excluded from PP analyses. The primary population was the PP population.'}, {'type': 'SECONDARY', 'title': 'Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Following 4 Hours Post Acid Challenge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Product', 'description': 'Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.'}, {'id': 'OG001', 'title': 'Reference Product', 'description': 'Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.17', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '4.0'}, {'value': '1.08', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.7'}]}]}], 'analyses': [{'pValue': '0.0680', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.50', 'ciLowerLimit': '-2.7', 'ciUpperLimit': '0.0', 'pValueComment': 'P-value was calculated from Wilcoxon Rank Sum test.', 'estimateComment': 'Median difference and 95% CI intervals were calculated from the Hodges Lehnmann estimate.\n\nDifference was calculated as reference product minus test product.', 'statisticalMethod': 'Wilcoxon Rank Sum test', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Equivalent analyses was executed using scale transformation or non-parametric methods'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 4 hours post acid challenge', 'description': 'The impressions of the tooth surface were analysed using scanning electron microscopy (SEM) to investigate changes in the enamel surface topography to determine degree of early stage enamel erosion. Interrogation of the tooth surface via impressions using SEM followed by visual image analysis was used to investigate the enamel surface topography.\n\nThe Images were graded as follows:\n\n1. \\- No signs of surface erosive wear (no evidence of the "lock and key" structure)\n2. \\- Early signs of erosive surface changes\n3. \\- Mild signs of erosive surface changes (early signs of the "lock and key" structure).\n4. \\- Moderate signs of erosive surface changes\n5. \\- Severe signs of erosive surface changes ("lock and key" structure and enamel "pits") X - Not evaluable', 'unitOfMeasure': 'Scores on grading scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The PP population was defined as those subjects in the ITT population who have at least one assessment of efficacy considered unaffected by protocol violation. Assessments of efficacy considered affected by protocol violation were excluded from PP analyses. The primary population was the PP population.'}, {'type': 'SECONDARY', 'title': 'Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Following 7 Hours Post Acid Challenge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Product', 'description': 'Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.'}, {'id': 'OG001', 'title': 'Reference Product', 'description': 'Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.58', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '4.0'}, {'value': '0.75', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.0'}]}]}], 'analyses': [{'pValue': '0.0654', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.83', 'ciLowerLimit': '-3.0', 'ciUpperLimit': '0.0', 'pValueComment': 'P-value is calculated from Wilcoxon Rank Sum test.', 'estimateComment': 'Median difference and 95% CI intervals were calculated from the Hodges Lehnmann estimate.\n\nDifference was calculated as reference product minus test product', 'statisticalMethod': 'Wilcoxon Rank Sum test.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Equivalent analyses was executed using scale transformation or non-parametric methods'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 7 hours post acid challenge', 'description': 'The impressions of the tooth surface were analysed using scanning electron microscopy (SEM) to investigate changes in the enamel surface topography to determine degree of early stage enamel erosion. Interrogation of the tooth surface via impressions using SEM followed by visual image analysis was used to investigate the enamel surface topography.\n\nThe Images were graded as follows:\n\n1. \\- No signs of surface erosive wear (no evidence of the "lock and key" structure)\n2. \\- Early signs of erosive surface changes\n3. \\- Mild signs of erosive surface changes (early signs of the "lock and key" structure).\n4. \\- Moderate signs of erosive surface changes\n5. \\- Severe signs of erosive surface changes ("lock and key" structure and enamel "pits") X - Not evaluable', 'unitOfMeasure': 'Scores on grading scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The PP population was defined as those subjects in the ITT population who have at least one assessment of efficacy considered unaffected by protocol violation. Assessments of efficacy considered affected by protocol violation were excluded from PP analyses. The primary population was the PP population.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of Salivary Calcium Concentration at 30 Mins Post Dietary Acid Challenge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Product', 'description': 'Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.'}, {'id': 'OG001', 'title': 'Reference Product', 'description': 'Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.'}], 'classes': [{'categories': [{'measurements': [{'value': '-12.81', 'spread': '9.101', 'groupId': 'OG000'}, {'value': '-16.29', 'spread': '12.041', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6061', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.4', 'ciLowerLimit': '-6.8', 'ciUpperLimit': '4.1', 'pValueComment': 'P value obtained from the ANCOVA analysis', 'estimateComment': 'Difference and 95 % CI obtained from the ANCOVA analysis. Difference was calculated as reference product minus test product.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Equivalent analyses was executed using scale transformation or non-parametric methods.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 30 mins post dietary acid challenge', 'description': 'Saliva stored at 0 - 20°C was used for determining calcium concentration', 'unitOfMeasure': 'ppm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PP population was defined as those subjects in the ITT population who have at least one assessment of efficacy considered unaffected by protocol violation. Assessments of efficacy considered affected by protocol violation was excluded from PP analyses. The primary population was the PP population.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of Salivary Calcium Concentration 7 Hours Post Dietary Acid Challenge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Product', 'description': 'Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.'}, {'id': 'OG001', 'title': 'Reference Product', 'description': 'Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.38', 'spread': '10.308', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '11.094', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4080', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.3', 'ciLowerLimit': '-7.9', 'ciUpperLimit': '3.3', 'pValueComment': 'P value obtained from the ANCOVA analysis.', 'estimateComment': 'Difference and 95 % CI obtained from the ANCOVA analysis. Difference was calculated as reference product minus test product', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Equivalent analyses was executed using scale transformation or non-parametric methods.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 7 hours post dietary acid challenge', 'description': 'Saliva stored at 0 - 20°C was used for determining calcium concentration', 'unitOfMeasure': 'ppm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PP population was defined as those subjects in the ITT population who have at least one assessment of efficacy considered unaffected by protocol violation. Assessments of efficacy considered affected by protocol violation was excluded from PP analyses. The primary population was the PP population.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of pH Measurement at 30 Mins Post Dietary Acid Challenge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Product', 'description': 'Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.'}, {'id': 'OG001', 'title': 'Reference Product', 'description': 'Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.71', 'spread': '0.854', 'groupId': 'OG000'}, {'value': '-0.51', 'spread': '0.620', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4611', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.21', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '0.8', 'pValueComment': 'P value obtained from the ANCOVA analysis.', 'estimateComment': 'Difference and 95 % CI obtained from the ANCOVA analysis. Difference was calculated as reference product minus test product.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Equivalent analyses was executed using scale transformation or non-parametric methods.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 30 mins post dietary acid challenge', 'description': 'Saliva stored at 0 - 20°C was used for determining pH', 'unitOfMeasure': 'pH units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PP population was defined as those subjects in the ITT population who have at least one assessment of efficacy considered unaffected by protocol violation. Assessments of efficacy considered affected by protocol violation was excluded from PP analyses. The primary population was the PP population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of pH Measurement 7 Hours Post Dietary Acid Challenge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Product', 'description': 'Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.'}, {'id': 'OG001', 'title': 'Reference Product', 'description': 'Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.00', 'spread': '0.219', 'groupId': 'OG000'}, {'value': '0.16', 'spread': '0.569', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3939', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.09', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '0.3', 'pValueComment': 'P value obtained from the ANCOVA analysis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Equivalent analyses was executed using scale transformation or non-parametric methods.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 7 hours post dietary acid challenge', 'description': 'Saliva stored at 0 - 20°C was used for determining pH', 'unitOfMeasure': 'pH units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PP population was defined as those subjects in the ITT population who have at least one assessment of efficacy considered unaffected by protocol violation. Assessments of efficacy considered affected by protocol violation was excluded from PP analyses. The primary population was the PP population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Buffering Capacity at 30 Mins Post Dietary Acid Challenge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Product', 'description': 'Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water'}, {'id': 'OG001', 'title': 'Reference Product', 'description': 'Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.81', 'spread': '3.885', 'groupId': 'OG000'}, {'value': '-1.50', 'spread': '3.322', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7829', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.34', 'ciLowerLimit': '-2.2', 'ciUpperLimit': '2.8', 'pValueComment': 'P value obtained from the ANCOVA analysis.', 'estimateComment': 'Difference and 95 % CI obtained from the ANCOVA analysis. Difference was calculated as reference product minus test product.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Equivalent analyses was executed using scale transformation or non-parametric methods.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 30 mins post dietary acid challenge', 'description': 'Saliva was collected and stored at 0 - 20°C. A Saliva-check Buffer Kit was used to determine the buffer capacity. The colourimetric assay yielded a coloured pattern on a paper diagnostic using a 0-12 scale where 0-5 was deemed to be very low, 6-9 was deemed low and 10-12 was deemed normal-high.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PP population was defined as those subjects in the ITT population who have at least one assessment of efficacy considered unaffected by protocol violation. Assessments of efficacy considered affected by protocol violation was excluded from PP analyses. The primary population was the PP population.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Buffering Capacity 7 Hours Post Dietary Acid Challenge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Product', 'description': 'Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water'}, {'id': 'OG001', 'title': 'Reference Product', 'description': 'Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.25', 'spread': '2.463', 'groupId': 'OG000'}, {'value': '-0.36', 'spread': '2.706', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9121', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.08', 'ciLowerLimit': '-1.6', 'ciUpperLimit': '1.4', 'pValueComment': 'P value obtained from the ANCOVA analysis.', 'estimateComment': 'Difference and 95 % CI obtained from the ANCOVA analysis. Difference was calculated as reference product minus test product.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Equivalent analyses was executed using scale transformation or non-parametric methods'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 7 hours post dietary acid challenge', 'description': 'Saliva was collected and stored at 0 - 20°C. A Saliva-check Buffer Kit was used to determine the buffer capacity. The colourimetric assay yielded a coloured pattern on a paper diagnostic using a 0-12 scale where 0-5 was deemed to be very low, 6-9 was deemed low and 10-12 was deemed normal-high.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PP population was defined as those subjects in the ITT population who have at least one assessment of efficacy considered unaffected by protocol violation. Assessments of efficacy considered affected by protocol violation was excluded from PP analyses. The primary population was the PP population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Test Product', 'description': 'Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.'}, {'id': 'FG001', 'title': 'Reference Product', 'description': 'Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited at 1 center in United Kingdom.', 'preAssignmentDetails': 'A total of 30 participants were screened and all of them were randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Test Product', 'description': 'Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush and swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.'}, {'id': 'BG001', 'title': 'Reference Product', 'description': 'Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36.1', 'spread': '11.17', 'groupId': 'BG000'}, {'value': '38.1', 'spread': '12.21', 'groupId': 'BG001'}, {'value': '37.1', 'spread': '11.51', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Per Protocol (PP) population was the primary population.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2015-11-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-28', 'studyFirstSubmitDate': '2015-08-24', 'resultsFirstSubmitDate': '2016-07-06', 'studyFirstSubmitQcDate': '2015-08-24', 'lastUpdatePostDateStruct': {'date': '2017-08-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-03-30', 'studyFirstPostDateStruct': {'date': '2015-08-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-11-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Immediately Following an Acid Challenge', 'timeFrame': 'Baseline, 30 minutes post dietary acid challenge', 'description': 'The impressions of the tooth surface were analysed using scanning electron microscopy (SEM) to investigate changes in the enamel surface topography to determine degree of early stage enamel erosion. Interrogation of the tooth surface via impressions using SEM followed by visual image analysis was used to investigate the enamel surface topography.\n\nThe Images were graded as follows:\n\n1. \\- No signs of surface erosive wear (no evidence of the "lock and key" structure)\n2. \\- Early signs of erosive surface changes\n3. \\- Mild signs of erosive surface changes (early signs of the "lock and key" structure).\n4. \\- Moderate signs of erosive surface changes\n5. \\- Severe signs of erosive surface changes ("lock and key" structure and enamel "pits") X - Not evaluable'}], 'secondaryOutcomes': [{'measure': 'Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Following 2 Hours Post Acid Challenge.', 'timeFrame': 'Baseline, 2 hours post acid challenge', 'description': 'The impressions of the tooth surface were analysed using scanning electron microscopy (SEM) to investigate changes in the enamel surface topography to determine degree of early stage enamel erosion. Interrogation of the tooth surface via impressions using SEM followed by visual image analysis was used to investigate the enamel surface topography.\n\nThe Images were graded as follows:\n\n1. \\- No signs of surface erosive wear (no evidence of the "lock and key" structure)\n2. \\- Early signs of erosive surface changes\n3. \\- Mild signs of erosive surface changes (early signs of the "lock and key" structure).\n4. \\- Moderate signs of erosive surface changes\n5. \\- Severe signs of erosive surface changes ("lock and key" structure and enamel "pits") X - Not evaluable'}, {'measure': 'Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Following 4 Hours Post Acid Challenge', 'timeFrame': 'Baseline, 4 hours post acid challenge', 'description': 'The impressions of the tooth surface were analysed using scanning electron microscopy (SEM) to investigate changes in the enamel surface topography to determine degree of early stage enamel erosion. Interrogation of the tooth surface via impressions using SEM followed by visual image analysis was used to investigate the enamel surface topography.\n\nThe Images were graded as follows:\n\n1. \\- No signs of surface erosive wear (no evidence of the "lock and key" structure)\n2. \\- Early signs of erosive surface changes\n3. \\- Mild signs of erosive surface changes (early signs of the "lock and key" structure).\n4. \\- Moderate signs of erosive surface changes\n5. \\- Severe signs of erosive surface changes ("lock and key" structure and enamel "pits") X - Not evaluable'}, {'measure': 'Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Following 7 Hours Post Acid Challenge', 'timeFrame': 'Baseline, 7 hours post acid challenge', 'description': 'The impressions of the tooth surface were analysed using scanning electron microscopy (SEM) to investigate changes in the enamel surface topography to determine degree of early stage enamel erosion. Interrogation of the tooth surface via impressions using SEM followed by visual image analysis was used to investigate the enamel surface topography.\n\nThe Images were graded as follows:\n\n1. \\- No signs of surface erosive wear (no evidence of the "lock and key" structure)\n2. \\- Early signs of erosive surface changes\n3. \\- Mild signs of erosive surface changes (early signs of the "lock and key" structure).\n4. \\- Moderate signs of erosive surface changes\n5. \\- Severe signs of erosive surface changes ("lock and key" structure and enamel "pits") X - Not evaluable'}, {'measure': 'Change From Baseline of Salivary Calcium Concentration at 30 Mins Post Dietary Acid Challenge', 'timeFrame': 'Baseline, 30 mins post dietary acid challenge', 'description': 'Saliva stored at 0 - 20°C was used for determining calcium concentration'}, {'measure': 'Change From Baseline of Salivary Calcium Concentration 7 Hours Post Dietary Acid Challenge', 'timeFrame': 'Baseline, 7 hours post dietary acid challenge', 'description': 'Saliva stored at 0 - 20°C was used for determining calcium concentration'}, {'measure': 'Change From Baseline of pH Measurement at 30 Mins Post Dietary Acid Challenge', 'timeFrame': 'Baseline, 30 mins post dietary acid challenge', 'description': 'Saliva stored at 0 - 20°C was used for determining pH'}, {'measure': 'Change From Baseline of pH Measurement 7 Hours Post Dietary Acid Challenge', 'timeFrame': 'Baseline, 7 hours post dietary acid challenge', 'description': 'Saliva stored at 0 - 20°C was used for determining pH'}, {'measure': 'Change From Baseline in Buffering Capacity at 30 Mins Post Dietary Acid Challenge', 'timeFrame': 'Baseline, 30 mins post dietary acid challenge', 'description': 'Saliva was collected and stored at 0 - 20°C. A Saliva-check Buffer Kit was used to determine the buffer capacity. The colourimetric assay yielded a coloured pattern on a paper diagnostic using a 0-12 scale where 0-5 was deemed to be very low, 6-9 was deemed low and 10-12 was deemed normal-high.'}, {'measure': 'Change From Baseline in Buffering Capacity 7 Hours Post Dietary Acid Challenge', 'timeFrame': 'Baseline, 7 hours post dietary acid challenge', 'description': 'Saliva was collected and stored at 0 - 20°C. A Saliva-check Buffer Kit was used to determine the buffer capacity. The colourimetric assay yielded a coloured pattern on a paper diagnostic using a 0-12 scale where 0-5 was deemed to be very low, 6-9 was deemed low and 10-12 was deemed normal-high.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Tooth Erosion']}, 'descriptionModule': {'briefSummary': 'This exploratory study is designed to help develop a clinical model to measure the earlier stages of dietary acid medicated enamel loss. The study will use fluoride as positive control to explore the validity of this design.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Demonstrates understanding of the study procedures, restrictions 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* Aged at least 18 years\n* Good general and mental health with, in the opinion of the investigator or medically qualified designee no clinically significant and relevant abnormalities in medical history or upon oral examination.\n* Absence of any condition that would impact the participant's safety or well-being, or affect the participant's ability to understand and follow study procedures and requirements.\n* Two anterior maxillary teeth, without signs of toothwear or exposed dentine, facial restorations, abutments for fixed or removable partial dentures, full crowns or veneers, orthodontic bands or cracked enamel that would interfere with the study evaluations.\n\nExclusion Criteria:\n\n* Pregnant or breast feeding women\n* Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients\n* Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit\n* Recent history (within the last year) of alcohol or other substance abuse\n* Presence of a disease or medication which in the opinion of the investigator, will impact on assessments\n* Gross periodontal disease, treatment of periodontal disease (including surgery) within 12 months of screening, scaling or root planning within 3 months of screening\n* Surface irregularities, discoloration due to trauma, restorations and hypo or hyperplasic areas which, in the opinion of the investigator or dental assessor, would prevent accurate impressions and grading\n* Daily doses of a medication which, in the opinion of the investigator, could impact the assessment, for example acidic medications\n* Any condition that would impact on the subject's safety or wellbeing or affect the individual's ability to understand and follow study procedures and requirements"}, 'identificationModule': {'nctId': 'NCT02533466', 'briefTitle': 'In Vivo Investigation of Initial Stages of Enamel Erosion', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'Study to Investigate the Initial Stages of Enamel Erosion in Vivo', 'orgStudyIdInfo': {'id': '204739'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test Product', 'description': 'Subjects will apply a full ribbon of dentifrice and brush their teeth for 1 timed minute using a wetted toothbrush, swish the resulting slurry around the mouth for 30 seconds making sure it contacts the selected teeth, spit out slurry and rinse mouth for 10 seconds with water.', 'interventionNames': ['Other: Sodium fluoride + potassium nitrate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Reference Product', 'description': 'Subjects will apply a full ribbon of dentifrice and brush their teeth for 1 timed minute using a wetted toothbrush, swish the resulting slurry around the mouth for 30 seconds making sure it contacts the selected teeth, spit out slurry and rinse mouth for 10 seconds with water.', 'interventionNames': ['Other: Potassium nitrate']}], 'interventions': [{'name': 'Sodium fluoride + potassium nitrate', 'type': 'OTHER', 'description': 'Marketed toothpaste containing 1450ppm fluoride as sodium fluoride and 5% potassium nitrate', 'armGroupLabels': ['Test Product']}, {'name': 'Potassium nitrate', 'type': 'OTHER', 'description': 'Experimental toothpaste containing 5% potassium nitrate', 'armGroupLabels': ['Reference Product']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'BS1 2LY', 'city': 'Bristol', 'country': 'United Kingdom', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}