Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2025-12-27 @ 1:14 PM
Study NCT ID:
NCT01657903
Status:
COMPLETED
Last Update Posted:
2015-01-26
First Post:
2012-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Efficacy of Experimental Gel to Foam Dentifrices in Dental 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': 'All adverse events 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/KNO3 Toothpaste 1', 'description': 'Participants brushed with 1.5 g of low RDA gel to foam toothpaste containing 1450 parts per million of fluoride as NaF and 5% w/w KNO3.', 'otherNumAtRisk': 55, 'otherNumAffected': 2, 'seriousNumAtRisk': 55, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'NaF/KNO3 Toothpaste 2', 'description': 'Participants brushed with 1.5 g of medium RDA gel to foam toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.', 'otherNumAtRisk': 55, 'otherNumAffected': 0, 'seriousNumAtRisk': 55, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'NaF/KNO3 Toothpaste 3', 'description': 'Participants brushed with 1.5 g of NaF/KNO3 toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.', 'otherNumAtRisk': 54, 'otherNumAffected': 1, 'seriousNumAtRisk': 54, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'No Fluoride/KNO3 Toothpaste', 'description': 'Participants brushed with a fluoride free toothpaste (0 ppmF) containing only 5% w/w KNO3.', 'otherNumAtRisk': 56, 'otherNumAffected': 2, 'seriousNumAtRisk': 56, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Gingival Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Relative Erosion Resistance (RER) of Enamel Specimens Post 4 Hours of Treatment Exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'NaF/KNO3 Toothpaste 1', 'description': 'Participants brushed with 1.5 g of low RDA gel to foam toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.'}, {'id': 'OG001', 'title': 'NaF/KNO3 Toothpaste 2', 'description': 'Participants brushed with 1.5 g of medium RDA gel to foam toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.'}, {'id': 'OG002', 'title': 'NaF/KNO3 Toothpaste 3', 'description': 'Participants brushed with 1.5 g of NaF/KNO3 toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.'}, {'id': 'OG003', 'title': 'No Fluoride/KNO3 Toothpaste', 'description': 'Participants brushed with a fluoride free toothpaste (0 ppmF) containing only 5% w/w KNO3.'}], 'classes': [{'categories': [{'measurements': [{'value': '-36.66', 'spread': '2.824', 'groupId': 'OG000'}, {'value': '-36.53', 'spread': '2.848', 'groupId': 'OG001'}, {'value': '-36.98', 'spread': '2.847', 'groupId': 'OG002'}, {'value': '-77.82', 'spread': '2.799', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '41.15', 'ciLowerLimit': '34.42', 'ciUpperLimit': '47.89', 'pValueComment': 'No adjustments made for multiple comparisons as the primary comparison was pre-specified.', 'estimateComment': 'Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.', 'groupDescription': 'Null hypothesis considered population means for the treatments in comparison to be equal with respect to %RER. Statistical tests were 2-sided with a significance level of 0.05.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANOVA with factors for treatment, study period, and subject (random effect).', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '41.28', 'ciLowerLimit': '34.51', 'ciUpperLimit': '48.06', 'pValueComment': 'No adjustments made for multiple comparisons as the primary comparison was pre-specified.', 'estimateComment': 'Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.', 'groupDescription': 'Null hypothesis considered population means for the treatments in comparison to be equal with respect to %RER. Statistical tests were 2-sided with a significance level of 0.05.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANOVA with factors for treatment, study period, and subject (random effect).', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '40.83', 'ciLowerLimit': '34.06', 'ciUpperLimit': '47.61', 'pValueComment': 'No adjustments made for multiple comparisons as the primary comparison was pre-specified.', 'estimateComment': 'Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.', 'groupDescription': 'Null hypothesis considered population means for the treatments in comparison to be equal with respect to %RER. Statistical tests were 2-sided with a significance level of 0.05.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANOVA with factors for treatment, study period, and subject (random effect).', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 4 hours post treatment in each treatment period', 'description': 'Enamel specimens were exposed to dietary erosive challenge and set of five indentations within each specimen was measured. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine RER which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent RER was calculated by formula: \\[(E1-E2)/ (E1-B)\\]\\*100. Smaller the negative RER, better is treatment regimen in imparting resistance to enamel.', 'unitOfMeasure': 'Percentage RER', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol (PP) population: All randomized subjects who had at least one assessment of efficacy and considered unaffected by major protocol deviations, were included in analysis. Due to drop outs, there was difference in number of participants analyzed.'}, {'type': 'PRIMARY', 'title': 'Surface Microhardness (SMH) Recovery of Enamel Specimens Post 4 Hours of Treatment Exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'NaF/KNO3 Toothpaste 1', 'description': 'Participants brushed with 1.5 g of low RDA gel to foam toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.'}, {'id': 'OG001', 'title': 'NaF/KNO3 Toothpaste 2', 'description': 'Participants brushed with 1.5 g of medium RDA gel to foam toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.'}, {'id': 'OG002', 'title': 'NaF/KNO3 Toothpaste 3', 'description': 'Participants brushed with 1.5 g of NaF/KNO3 toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.'}, {'id': 'OG003', 'title': 'No Fluoride/KNO3 Toothpaste', 'description': 'Participants brushed with a fluoride free toothpaste (0 ppm F) containing only 5% w/w KNO3.'}], 'classes': [{'categories': [{'measurements': [{'value': '32.24', 'spread': '1.469', 'groupId': 'OG000'}, {'value': '32.32', 'spread': '1.480', 'groupId': 'OG001'}, {'value': '34.53', 'spread': '1.480', 'groupId': 'OG002'}, {'value': '22.87', 'spread': '1.457', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.36', 'ciLowerLimit': '6.01', 'ciUpperLimit': '12.72', 'pValueComment': 'No adjustments made for multiple comparisons as the primary comparison was pre-specified.', 'estimateComment': 'Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.', 'groupDescription': 'Null hypothesis considered population means for the treatments in comparison to be equal with respect to %SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANOVA with factors for treatment, study period, and subject (random effect).', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.45', 'ciLowerLimit': '6.07', 'ciUpperLimit': '12.82', 'pValueComment': 'No adjustments made for multiple comparisons as the primary comparison was pre-specified.', 'estimateComment': 'Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.', 'groupDescription': 'Null hypothesis considered population means for the treatments in comparison to be equal with respect to %SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANOVA with factors for treatment, study period, and subject (random effect).', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.66', 'ciLowerLimit': '8.28', 'ciUpperLimit': '15.03', 'pValueComment': 'No adjustments made for multiple comparisons as the primary comparison was pre-specified.', 'estimateComment': 'Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.', 'groupDescription': 'Null hypothesis considered population means for the treatments in comparison to be equal with respect to %SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANOVA with factors for treatment, study period, and subject (random effect).', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 4 hours post treatment in each treatment period', 'description': 'SMH test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMH recovery was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: \\[(E1- R)/ (E1-B)\\]\\*100. A higher percentage values indicate a better outcome.', 'unitOfMeasure': 'Percentage SMH', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'PP population: All randomized subjects who had at least one assessment of efficacy and considered unaffected by major protocol deviations, were included in analysis. Due to drop outs, there was difference in number of participants analyzed.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'RER of Enamel Specimens Post 2 Hours of Treatment Exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'NaF/KNO3 Toothpaste 1', 'description': 'Participants brushed with 1.5 g of low RDA gel to foam toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.'}, {'id': 'OG001', 'title': 'NaF/KNO3 Toothpaste 2', 'description': 'Participants brushed with 1.5 g of medium RDA gel to foam toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.'}, {'id': 'OG002', 'title': 'NaF/KNO3 Toothpaste 3', 'description': 'Participants brushed with 1.5 g of NaF/KNO3 toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.'}, {'id': 'OG003', 'title': 'No Fluoride/KNO3 Toothpaste', 'description': 'Participants brushed with a fluoride free toothpaste (0 ppmF) containing only 5% w/w KNO3.'}], 'classes': [{'categories': [{'measurements': [{'value': '-43.76', 'spread': '3.182', 'groupId': 'OG000'}, {'value': '-43.33', 'spread': '3.211', 'groupId': 'OG001'}, {'value': '-41.88', 'spread': '3.210', 'groupId': 'OG002'}, {'value': '-85.88', 'spread': '3.154', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 2 hours post treatment in each treatment period', 'description': 'Enamel specimens were exposed to dietary erosive challenge and set of five indentations within each specimen was measured. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine RER which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent RER was calculated by formula: \\[(E1-E2)/ (E1-B)\\]\\*100. Smaller the negative RER, better is treatment regimen in imparting resistance to enamel.', 'unitOfMeasure': '% RER', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'PP population: All randomized subjects who had at least one assessment of efficacy and considered unaffected by major protocol deviations, were included in analysis. Due to drop outs, there was difference in number of participants analyzed.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'SMH Recovery of Enamel Specimens Post 2 Hours of Treatment Exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'NaF/KNO3 Toothpaste 1', 'description': 'Participants brushed with 1.5 g of low RDA gel to foam toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.'}, {'id': 'OG001', 'title': 'NaF/KNO3 Toothpaste 2', 'description': 'Participants brushed with 1.5 g of medium RDA gel to foam toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.'}, {'id': 'OG002', 'title': 'NaF/KNO3 Toothpaste 3', 'description': 'Participants brushed with 1.5 g of NaF/KNO3 toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.'}, {'id': 'OG003', 'title': 'No Fluoride/KNO3 Toothpaste', 'description': 'Participants brushed with a fluoride free toothpaste (0 ppm F) containing only 5% w/w KNO3.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.96', 'spread': '1.600', 'groupId': 'OG000'}, {'value': '28.92', 'spread': '1.615', 'groupId': 'OG001'}, {'value': '28.30', 'spread': '1.615', 'groupId': 'OG002'}, {'value': '17.90', 'spread': '1.585', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 2 hours post treatment in each treatment period', 'description': 'SMH test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMH recovery was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: \\[(E1- R)/ (E1-B)\\]\\*100. A higher percentage values indicate a better outcome.', 'unitOfMeasure': 'Percentage SMH', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'PP population: All randomized subjects who had at least one assessment of efficacy and considered unaffected by major protocol deviations, were included in analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Overall', 'description': 'This was a 4-way crossover study. Participants brushed with 1.5 g of low relative dentine abrasivity (RDA) gel to foam toothpaste (Toothpaste 1) containing 1450 parts per million (ppm) of fluoride (F) as sodium fluoride (NaF) and 5% weight by weight (w/w) potassium nitrate (KNO3); 1.5 g of medium RDA gel to foam toothpaste (Toothpaste 2) containing 1450 ppm F as NaF and 5% w/w KNO3; 1.5 g of Marketed toothpaste (Toothpaste 3) containing 1450 ppm F as NaF and 5% w/w KNO3; and 1.5 g of placebo toothpaste containing no fluoride but 5% w/w KNO3. There was a washout period of 2 days following each treatment session. In this washout period, participants used a non-fluoridated toothpaste to ensure no carry over effect.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}]}, {'type': 'Received Placebo (No NaF/KNO3)Toothpaste', 'achievements': [{'comment': 'One participant was lost to follow up in study period 1', 'groupId': 'FG000', 'numSubjects': '56'}]}, {'type': 'Received NaF/KNO3 Toothpaste 1', 'achievements': [{'comment': 'One participant withdrew consent in study period 3', 'groupId': 'FG000', 'numSubjects': '55'}]}, {'type': 'Received NaF/KNO3 Toothpaste 3', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}]}, {'type': 'Received NaF/KNO3 Toothpaste 2', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were recruited at the clinical site.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Randomized Participants', 'description': 'All randomized participants were evaluated for baseline parameters.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.7', 'spread': '13.77', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-22', 'studyFirstSubmitDate': '2012-08-02', 'resultsFirstSubmitDate': '2014-01-16', 'studyFirstSubmitQcDate': '2012-08-02', 'lastUpdatePostDateStruct': {'date': '2015-01-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-01-22', 'studyFirstPostDateStruct': {'date': '2012-08-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'RER of Enamel Specimens Post 2 Hours of Treatment Exposure', 'timeFrame': 'Baseline, 2 hours post treatment in each treatment period', 'description': 'Enamel specimens were exposed to dietary erosive challenge and set of five indentations within each specimen was measured. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine RER which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent RER was calculated by formula: \\[(E1-E2)/ (E1-B)\\]\\*100. Smaller the negative RER, better is treatment regimen in imparting resistance to enamel.'}, {'measure': 'SMH Recovery of Enamel Specimens Post 2 Hours of Treatment Exposure', 'timeFrame': 'Baseline, 2 hours post treatment in each treatment period', 'description': 'SMH test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMH recovery was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: \\[(E1- R)/ (E1-B)\\]\\*100. A higher percentage values indicate a better outcome.'}], 'primaryOutcomes': [{'measure': 'Relative Erosion Resistance (RER) of Enamel Specimens Post 4 Hours of Treatment Exposure', 'timeFrame': 'Baseline, 4 hours post treatment in each treatment period', 'description': 'Enamel specimens were exposed to dietary erosive challenge and set of five indentations within each specimen was measured. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine RER which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent RER was calculated by formula: \\[(E1-E2)/ (E1-B)\\]\\*100. Smaller the negative RER, better is treatment regimen in imparting resistance to enamel.'}, {'measure': 'Surface Microhardness (SMH) Recovery of Enamel Specimens Post 4 Hours of Treatment Exposure', 'timeFrame': 'Baseline, 4 hours post treatment in each treatment period', 'description': 'SMH test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMH recovery was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: \\[(E1- R)/ (E1-B)\\]\\*100. A higher percentage values indicate a better outcome.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Dental Erosion', 'Acid Wear']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare and evaluate the ability of two European Union (EU) regulated gel to foam toothpaste formulations versus a non-fluoride toothpaste using a modified in-situ model of dental erosion and remineralization. A positive control i.e fluoride containing toothpaste marketed in EU will also be compared to non-fluoride toothpaste.', 'detailedDescription': 'The aim of this study is to assess the remineralization effects of two EU gel to foam toothpaste formulations with 1450 parts per million (ppm) of fluoride as sodium fluoride (NaF) and 5% potassium nitrate (KNO3) versus a non-fluoride (0 ppm F)/KNO3 toothpaste as a negative control. The two experimental gel to foam toothpaste formulations differ in their relative dentine abrasivity (RDA) values which is an in-vitro measure of a toothpaste abrasivity to the dentinal tissues. A marketed toothpaste containing NaF and KNO3 will serve as a positive control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* General and Oral Health: Good general health with (in the opinion of the investigator) no clinically OST and OHT examinations.\n* Oral Requirements:\n\n * An intact maxillary dental arch suitable for the retention of the palatal appliance and an intact mandibular dental arch. Subjects may have fixed bridges replacing missing teeth.\n * A gum base stimulated whole saliva flow rate ≥ 0.8 g/min and an unstimulated whole saliva flow rate ≥ 0.2 g/min.\n* Contraception: Women of childbearing potential who are, in the opinion of the investigator, practicing a reliable method of contraception.\n\nExclusion Criteria:\n\n* Oral Health:\n\n * Current active caries or periodontal disease that may compromise the study or the health of the subjects.\n * Lesions of the oral cavity that could interfere with the study evaluations, including severe gingivitis, grossly carious lesions, periodontitis and other severe periodontal disease.\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:\n\n * Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit\n * Previous participation in this study\n* Substance abuse: Recent history (within the last year) of alcohol or other substance abuse.\n* Pregnancy: Women who are pregnant or who are intending to become pregnant over the duration of the study\n* Breast-feeding: Women who are breast-feeding'}, 'identificationModule': {'nctId': 'NCT01657903', 'briefTitle': 'Evaluation of Efficacy of Experimental Gel to Foam Dentifrices in Dental Erosion', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Placebo Controlled Study to Evaluate the Effectiveness of Experimental Foaming Gel Toothpastes Using an In-situ Erosion Remineralization Model', 'orgStudyIdInfo': {'id': 'Z6961385'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NaF/KNO3 toothpaste, Low RDA', 'description': 'Participants to brush with 1.5 g of low RDA gel to foam toothpaste containing 1450 ppm F - EU level as NaF. All study treatments contain 5% weight by weight (w/w) KNO3.', 'interventionNames': ['Drug: Sodium Fluoride', 'Drug: Potassium nitrate']}, {'type': 'EXPERIMENTAL', 'label': 'NaF/KNO3 toothpaste, Medium RDA', 'description': 'Participants to brush with 1.5 g of medium RDA gel to foam toothpaste containing 1450 ppm F - EU level as NaF. All study treatments contain 5% w/w KNO3.', 'interventionNames': ['Drug: Sodium Fluoride', 'Drug: Potassium nitrate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NaF/KNO3 toothpaste', 'description': 'Participants to brush with 1.5 g of NaF/KNO3 toothpaste containing 1450 ppm F - EU level as NaF. All study treatments contain 5% w/w KNO3.', 'interventionNames': ['Drug: Sodium Fluoride', 'Drug: Potassium nitrate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'No fluoride/KNO3 toothpaste', 'description': 'Participants to brush with a fluoride free toothpaste (0 ppmF). All study treatments contain 5% w/w KNO3.', 'interventionNames': ['Drug: Potassium nitrate']}], 'interventions': [{'name': 'Sodium Fluoride', 'type': 'DRUG', 'description': 'Toothpaste containing 1450 ppm F - EU level as NaF.', 'armGroupLabels': ['NaF/KNO3 toothpaste', 'NaF/KNO3 toothpaste, Low RDA', 'NaF/KNO3 toothpaste, Medium RDA']}, {'name': 'Potassium nitrate', 'type': 'DRUG', 'description': 'All study treatments contain 5% w/w KNO3.', 'armGroupLabels': ['NaF/KNO3 toothpaste', 'NaF/KNO3 toothpaste, Low RDA', 'NaF/KNO3 toothpaste, Medium RDA', 'No fluoride/KNO3 toothpaste']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University School of Dentistry', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}