Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-02-23 @ 8:09 PM
Study NCT ID:
NCT01691560
Status:
COMPLETED
Last Update Posted:
2014-05-29
First Post:
2012-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Exploratory Study to Evaluate an Occlusion Based Dentifrice in Relief of Dentinal Hypersensitivity
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003807', 'term': 'Dentin Sensitivity'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, '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': 'Adverse events were collected collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.', 'eventGroups': [{'id': 'EG000', 'title': '5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate', 'description': 'Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate', 'otherNumAtRisk': 34, 'otherNumAffected': 0, 'seriousNumAtRisk': 34, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate', 'description': 'Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate', 'otherNumAtRisk': 33, 'otherNumAffected': 0, 'seriousNumAtRisk': 33, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Sodium Monofluorophosphate', 'description': 'Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate', 'otherNumAtRisk': 34, 'otherNumAffected': 0, 'seriousNumAtRisk': 34, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Sodium Fluoride', 'description': 'Dentifrice containing 1100 ppm fluoride as sodium fluoride', 'otherNumAtRisk': 33, 'otherNumAffected': 0, 'seriousNumAtRisk': 33, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Evaporative Air Sensitivity Pain Response on Schiff Sensitivity Scale at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate', 'description': 'Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate'}, {'id': 'OG001', 'title': 'Sodium Monofluorophosphate', 'description': 'Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate'}, {'id': 'OG002', 'title': 'Sodium Fluoride', 'description': 'Dentifrice containing 1100 ppm fluoride as sodium fluoride'}, {'id': 'OG003', 'title': '0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate', 'description': 'Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.36', 'groupId': 'OG000', 'lowerLimit': '-0.53', 'upperLimit': '-0.20'}, {'value': '-0.43', 'groupId': 'OG001', 'lowerLimit': '-0.59', 'upperLimit': '-0.27'}, {'value': '-0.40', 'groupId': 'OG002', 'lowerLimit': '-0.57', 'upperLimit': '-0.23'}, {'value': '-0.45', 'groupId': 'OG003', 'lowerLimit': '-0.62', 'upperLimit': '-0.28'}]}]}], 'analyses': [{'pValue': '0.4553', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.09', 'ciLowerLimit': '-0.14', 'ciUpperLimit': '0.32', 'estimateComment': 'Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.', 'groupDescription': 'Null hypothesis considered change from baseline to be same for treatments in comparison.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'From ANCOVA model with treatment and baseline included as covariate.', 'testedNonInferiority': False}, {'pValue': '0.5689', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.07', 'ciLowerLimit': '-0.16', 'ciUpperLimit': '0.30', 'estimateComment': 'Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.', 'groupDescription': 'Null hypothesis considered change from baseline to be same for treatments in comparison.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'From ANCOVA model with treatment and baseline included as covariate.', 'testedNonInferiority': False}, {'pValue': '0.7517', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.04', 'ciLowerLimit': '-0.20', 'ciUpperLimit': '0.27', 'estimateComment': 'Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.', 'groupDescription': 'Null hypothesis considered change from baseline to be same for treatments in comparison.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'From ANCOVA model with treatment and baseline included as covariate.', 'testedNonInferiority': False}, {'pValue': '0.8549', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.02', 'ciLowerLimit': '-0.21', 'ciUpperLimit': '0.25', 'estimateComment': 'Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.', 'groupDescription': 'Null hypothesis considered change from baseline to be same for treatments in comparison.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'From ANCOVA model with treatment and baseline included as covariate.', 'testedNonInferiority': False}, {'pValue': '0.6685', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.05', 'ciLowerLimit': '-0.18', 'ciUpperLimit': '0.29', 'estimateComment': 'Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.', 'groupDescription': 'Null hypothesis considered change from baseline to be same for treatments in comparison.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'From ANCOVA model with treatment and baseline included as covariate.', 'testedNonInferiority': False}, {'pValue': '0.8031', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.03', 'ciLowerLimit': '-0.26', 'ciUpperLimit': '0.20', 'estimateComment': 'Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.', 'groupDescription': 'Null hypothesis considered change from baseline to be same for treatments in comparison.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to 4 weeks post administration of study treatment', 'description': 'Response to a constant jet of air applied to hypersensitive teeth was evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 - participant does not respond to air stimulation, 1 - participant responds to air stimulus but does not request discontinuation of stimulus, 2 - participant responds to air stimulus and request discontinuation of stimulus, 3 - participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT) population: All randomized participants administered with at least one study treatment during the study and provided at least one post baseline assessment of efficacy.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Tactile Sensitivity Pain Response (g) at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate', 'description': 'Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate'}, {'id': 'OG001', 'title': 'Sodium Monofluorophosphate', 'description': 'Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate'}, {'id': 'OG002', 'title': 'Sodium Fluoride', 'description': 'Dentifrice containing 1100 ppm fluoride as sodium fluoride'}, {'id': 'OG003', 'title': '0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate', 'description': 'Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate'}], 'classes': [{'categories': [{'measurements': [{'value': '7.31', 'spread': '11.227', 'groupId': 'OG000'}, {'value': '6.32', 'spread': '13.045', 'groupId': 'OG001'}, {'value': '4.09', 'spread': '4.752', 'groupId': 'OG002'}, {'value': '3.64', 'spread': '6.030', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0467', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '0', 'ciUpperLimit': '5', 'estimateComment': 'Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.', 'groupDescription': 'Null hypothesis considered change from baseline to be same for treatments in comparison.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Hodges-Lehmann Wilcoxon non-parametric test', 'testedNonInferiority': False}, {'pValue': '0.1133', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '0', 'ciUpperLimit': '5', 'estimateComment': 'Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.', 'groupDescription': 'Null hypothesis considered change from baseline to be same for treatments in comparison.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Hodges-Lehmann Wilcoxon non-parametric test.', 'testedNonInferiority': False}, {'pValue': '0.2579', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Median Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '0', 'ciUpperLimit': '5', 'estimateComment': 'Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.', 'groupDescription': 'Null hypothesis considered change from baseline to be same for treatments in comparison.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Hodges-Lehmann Wilcoxon non-parametric test', 'testedNonInferiority': False}, {'pValue': '0.6149', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '0', 'ciUpperLimit': '0', 'estimateComment': 'Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.', 'groupDescription': 'Null hypothesis considered change from baseline to be same for treatments in comparison.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Hodges-Lehmann Wilcoxon non-parametric test.', 'testedNonInferiority': False}, {'pValue': '0.3259', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '0', 'ciUpperLimit': '5', 'estimateComment': 'Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.', 'groupDescription': 'Null hypothesis considered change from baseline to be same for treatments in comparison.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Hodges-Lehmann Wilcoxon non-parametric test', 'testedNonInferiority': False}, {'pValue': '0.5721', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '0', 'ciUpperLimit': '0', 'estimateComment': 'Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.', 'groupDescription': 'Null hypothesis considered change from baseline to be same for treatments in comparison.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Hodges-Lehmann Wilcoxon non-parametric test', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 4 weeks post administration of study treatment', 'description': 'Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale. In tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response was recorded or the maximum force was reached.', 'unitOfMeasure': 'grams', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population: All randomized participants administered with at least one study treatment during the study and provided at least one post baseline assessment of efficacy.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Evaporative Air Sensitivity Pain Response on Schiff Sensitivity Scale at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate', 'description': 'Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate'}, {'id': 'OG001', 'title': 'Sodium Monofluorophosphate', 'description': 'Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate'}, {'id': 'OG002', 'title': 'Sodium Fluoride', 'description': 'Dentifrice containing 1100 ppm fluoride as sodium fluoride'}, {'id': 'OG003', 'title': '0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate', 'description': 'Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.55', 'groupId': 'OG000', 'lowerLimit': '-0.78', 'upperLimit': '-0.33'}, {'value': '-0.43', 'groupId': 'OG001', 'lowerLimit': '-0.66', 'upperLimit': '-0.20'}, {'value': '-0.43', 'groupId': 'OG002', 'lowerLimit': '-0.66', 'upperLimit': '-0.20'}, {'value': '-0.92', 'groupId': 'OG003', 'lowerLimit': '-1.15', 'upperLimit': '-0.68'}]}]}], 'analyses': [{'pValue': '0.0292', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.36', 'ciLowerLimit': '0.04', 'ciUpperLimit': '0.69', 'estimateComment': 'Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.', 'groupDescription': 'Null hypothesis considered change from baseline to be same for treatments in comparison.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'From ANCOVA model with treatment and baseline included as covariate.', 'testedNonInferiority': False}, {'pValue': '0.4484', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.12', 'ciLowerLimit': '-0.44', 'ciUpperLimit': '0.20', 'estimateComment': 'Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.', 'groupDescription': 'Null hypothesis considered change from baseline to be same for treatments in comparison.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'From ANCOVA model with treatment and baseline included as covariate.', 'testedNonInferiority': False}, {'pValue': '0.4537', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.12', 'ciLowerLimit': '-0.45', 'ciUpperLimit': '0.20', 'estimateComment': 'Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.', 'groupDescription': 'Null hypothesis considered change from baseline to be same for treatments in comparison.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'From ANCOVA model with treatment and baseline included as covariate.', 'testedNonInferiority': False}, {'pValue': '0.0037', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.49', 'ciLowerLimit': '0.16', 'ciUpperLimit': '0.81', 'estimateComment': 'Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.', 'groupDescription': 'Null hypothesis considered change from baseline to be same for treatments in comparison.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'From ANCOVA model with treatment and baseline included as covariate.', 'testedNonInferiority': False}, {'pValue': '0.0040', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.48', 'ciLowerLimit': '0.16', 'ciUpperLimit': '0.81', 'estimateComment': 'Treatment as fixed factor, baseline Schiff score as covariate. Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.', 'groupDescription': 'Null hypothesis considered change from baseline to be same for treatments in comparison.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'From ANCOVA model with treatment and baseline included as covariate.', 'testedNonInferiority': False}, {'pValue': '0.9974', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.00', 'ciLowerLimit': '-0.32', 'ciUpperLimit': '0.32', 'estimateComment': 'Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.', 'groupDescription': 'Null hypothesis considered change from baseline to be same for treatments in comparison.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'From ANCOVA model with treatment and baseline included as covariate.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to 8 weeks post administration of study treatment', 'description': 'Response to a constant jet of air applied to hypersensitive teeth was evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 - participant does not respond to air stimulation, 1 - participant responds to air stimulus but does not request discontinuation of stimulus, 2 - participant responds to air stimulus and request discontinuation of stimulus, 3 - participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population: All randomized participants administered with at least one study treatment during the study and provided at least one post baseline assessment of efficacy.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Tactile Sensitivity Pain Response (g) at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate', 'description': 'Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate'}, {'id': 'OG001', 'title': 'Sodium Monofluorophosphate', 'description': 'Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate'}, {'id': 'OG002', 'title': 'Sodium Fluoride', 'description': 'Dentifrice containing 1100 ppm fluoride as sodium fluoride'}, {'id': 'OG003', 'title': '0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate', 'description': 'Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate'}], 'classes': [{'categories': [{'measurements': [{'value': '10.15', 'spread': '15.100', 'groupId': 'OG000'}, {'value': '5.88', 'spread': '11.512', 'groupId': 'OG001'}, {'value': '4.39', 'spread': '5.556', 'groupId': 'OG002'}, {'value': '11.97', 'spread': '16.486', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.8861', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '-5', 'ciUpperLimit': '5', 'estimateComment': 'Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.', 'groupDescription': 'Null hypothesis considered change from baseline to be same for treatments in comparison.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Hodges-Lehmann Wilcoxon non-parametric test', 'testedNonInferiority': False}, {'pValue': '0.0641', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '0', 'ciUpperLimit': '5', 'estimateComment': 'Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.', 'groupDescription': 'Null hypothesis considered change from baseline to be same for treatments in comparison.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Hodges-Lehmann Wilcoxon non-parametric test', 'testedNonInferiority': False}, {'pValue': '0.1831', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Median Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '0', 'ciUpperLimit': '5', 'estimateComment': 'Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.', 'groupDescription': 'Null hypothesis considered change from baseline to be same for treatments in comparison.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Hodges-Lehmann Wilcoxon non-parametric test', 'testedNonInferiority': False}, {'pValue': '0.0871', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '-10', 'ciUpperLimit': '0', 'estimateComment': 'Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.', 'groupDescription': 'Null hypothesis considered change from baseline to be same for treatments in comparison.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Hodges-Lehmann Wilcoxon non-parametric test', 'testedNonInferiority': False}, {'pValue': '0.1690', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '-10', 'ciUpperLimit': '0', 'estimateComment': 'Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.', 'groupDescription': 'Null hypothesis considered change from baseline to be same for treatments in comparison.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Hodges-Lehmann Wilcoxon non-parametric test', 'testedNonInferiority': False}, {'pValue': '0.3829', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '-5', 'ciUpperLimit': '0', 'estimateComment': 'Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.', 'groupDescription': 'Null hypothesis considered change from baseline to be same for treatments in comparison.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Hodges-Lehmann Wilcoxon non-parametric test', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 8 weeks post administration of study treatment', 'description': 'Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale. In tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response was recorded or the maximum force was reached.', 'unitOfMeasure': 'grams', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population: All randomized participants administered with at least one study treatment during the study and provided at least one post baseline assessment of efficacy.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Evaporative Air Sensitivity Response on a Visual Rating Scale (VRS) at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate', 'description': 'Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium 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Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.03', 'ciLowerLimit': '-0.74', 'ciUpperLimit': '0.80', 'estimateComment': 'Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.', 'groupDescription': 'Null hypothesis considered change from baseline to be same for treatments in comparison.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.', 'testedNonInferiority': False}, {'pValue': '0.6918', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.15', 'ciLowerLimit': '-0.90', 'ciUpperLimit': '0.60', 'estimateComment': 'Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.', 'groupDescription': 'Null hypothesis considered change from baseline to be same for treatments in comparison.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.', 'testedNonInferiority': False}, {'pValue': '0.7421', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.13', 'ciLowerLimit': '-0.63', 'ciUpperLimit': '0.88', 'estimateComment': 'Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.', 'groupDescription': 'Null hypothesis considered change from baseline to be same for treatments in comparison.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.', 'testedNonInferiority': False}, {'pValue': '0.6433', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.18', 'ciLowerLimit': '-0.58', 'ciUpperLimit': '0.94', 'estimateComment': 'Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.', 'groupDescription': 'Null hypothesis considered change from baseline to be same for treatments in comparison.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.', 'testedNonInferiority': False}, {'pValue': '0.8010', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.10', 'ciLowerLimit': '-0.86', 'ciUpperLimit': '0.67', 'estimateComment': 'Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.', 'groupDescription': 'Null hypothesis considered change from baseline to be same for treatments in comparison.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.', 'testedNonInferiority': False}, {'pValue': '0.4692', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.28', 'ciLowerLimit': '-0.48', 'ciUpperLimit': '1.03', 'estimateComment': 'Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.', 'groupDescription': 'Null hypothesis considered change from baseline to be same for treatments in comparison.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to 4 weeks post administration of study treatment', 'description': 'Participants rated the intensity of their response to the stimulus using a 10 point Visual rating scale of 1 (no Pain) to 10 (intense pain).', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population: All randomized participants administered with at least one study treatment during the study and 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0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.76', 'groupId': 'OG000', 'lowerLimit': '-2.35', 'upperLimit': '-1.17'}, {'value': '-1.22', 'groupId': 'OG001', 'lowerLimit': '-1.81', 'upperLimit': '-0.63'}, {'value': '-1.31', 'groupId': 'OG002', 'lowerLimit': '-1.90', 'upperLimit': '-0.71'}, {'value': '-2.06', 'groupId': 'OG003', 'lowerLimit': '-2.67', 'upperLimit': '-1.46'}]}]}], 'analyses': [{'pValue': '0.4797', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.31', 'ciLowerLimit': '-0.55', 'ciUpperLimit': '1.16', 'estimateComment': 'Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.', 'groupDescription': 'Null hypothesis considered change from baseline to be same for treatments in comparison.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.', 'testedNonInferiority': False}, {'pValue': '0.2023', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.54', 'ciLowerLimit': '-1.37', 'ciUpperLimit': '0.29', 'estimateComment': 'Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.', 'groupDescription': 'Null hypothesis considered change from baseline to be same for treatments in comparison.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.', 'testedNonInferiority': False}, {'pValue': '0.2917', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.45', 'ciLowerLimit': '-1.29', 'ciUpperLimit': '0.39', 'estimateComment': 'Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.', 'groupDescription': 'Null hypothesis considered change from baseline to be same for treatments in comparison.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.', 'testedNonInferiority': False}, {'pValue': '0.0503', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.85', 'ciLowerLimit': '0.00', 'ciUpperLimit': '1.69', 'estimateComment': 'Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.', 'groupDescription': 'Null hypothesis considered change from baseline to be same for treatments in comparison.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.', 'testedNonInferiority': False}, {'pValue': '0.0811', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.76', 'ciLowerLimit': '-0.09', 'ciUpperLimit': '1.61', 'estimateComment': 'Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.', 'groupDescription': 'Null hypothesis considered change from baseline to be same for treatments in comparison.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.', 'testedNonInferiority': False}, {'pValue': '0.8322', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.09', 'ciLowerLimit': '-0.75', 'ciUpperLimit': '0.93', 'estimateComment': 'Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.', 'groupDescription': 'Null hypothesis considered change from baseline to be same for treatments in comparison.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to 8 weeks post administration of study treatment', 'description': 'Participants rated the intensity of their response to the stimulus using a 10 point VRS of 1 (no Pain) to 10 (intense pain).', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population: All randomized participants administered with at least one study treatment during the study and provided at least one post baseline assessment of efficacy.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate', 'description': 'Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500 parts per million (ppm) fluoride as sodium monofluorophosphate'}, {'id': 'FG001', 'title': '0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate', 'description': 'Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate'}, {'id': 'FG002', 'title': 'Sodium Monofluorophosphate', 'description': 'Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate'}, {'id': 'FG003', 'title': 'Sodium Fluoride', 'description': 'Dentifrice containing 1100 ppm fluoride as sodium fluoride'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '33'}, {'groupId': 'FG002', 'numSubjects': '34'}, {'groupId': 'FG003', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '33'}, {'groupId': 'FG002', 'numSubjects': '34'}, {'groupId': 'FG003', 'numSubjects': '33'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited at the clinical site.', 'preAssignmentDetails': 'Out of 152 screened participants, 16 did not meet the study criterion while 2 withdrew consent. Hence, a total of 134 participants were randomized into the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}, {'value': '134', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': '5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate', 'description': 'Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate'}, {'id': 'BG001', 'title': '0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate', 'description': 'Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate'}, {'id': 'BG002', 'title': 'Sodium Monofluorophosphate', 'description': 'Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate'}, {'id': 'BG003', 'title': 'Sodium Fluoride', 'description': 'Dentifrice containing 1100 ppm fluoride as sodium fluoride'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '35.4', 'spread': '10.45', 'groupId': 'BG000'}, {'value': '33.2', 'spread': '10.13', 'groupId': 'BG001'}, {'value': '38.2', 'spread': '8.88', 'groupId': 'BG002'}, {'value': '36.2', 'spread': '9.62', 'groupId': 'BG003'}, {'value': '35.8', 'spread': '9.85', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '98', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '36', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-01', 'studyFirstSubmitDate': '2012-09-20', 'resultsFirstSubmitDate': '2014-05-01', 'studyFirstSubmitQcDate': '2012-09-20', 'lastUpdatePostDateStruct': {'date': '2014-05-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-05-01', 'studyFirstPostDateStruct': {'date': '2012-09-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-05-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Evaporative Air Sensitivity Pain Response on Schiff Sensitivity Scale at Week 4', 'timeFrame': 'Baseline to 4 weeks post administration of study treatment', 'description': 'Response to a constant jet of air applied to hypersensitive teeth was evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 - participant does not respond to air stimulation, 1 - participant responds to air stimulus but does not request discontinuation of stimulus, 2 - participant responds to air stimulus and request discontinuation of stimulus, 3 - participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus.'}, {'measure': 'Change From Baseline in Tactile Sensitivity Pain Response (g) at Week 4', 'timeFrame': 'Baseline to 4 weeks post administration of study treatment', 'description': 'Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale. In tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response was recorded or the maximum force was reached.'}, {'measure': 'Change From Baseline in Evaporative Air Sensitivity Pain Response on Schiff Sensitivity Scale at Week 8', 'timeFrame': 'Baseline to 8 weeks post administration of study treatment', 'description': 'Response to a constant jet of air applied to hypersensitive teeth was evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 - participant does not respond to air stimulation, 1 - participant responds to air stimulus but does not request discontinuation of stimulus, 2 - participant responds to air stimulus and request discontinuation of stimulus, 3 - participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus.'}, {'measure': 'Change From Baseline in Tactile Sensitivity Pain Response (g) at Week 8', 'timeFrame': 'Baseline to 8 weeks post administration of study treatment', 'description': 'Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale. In tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response was recorded or the maximum force was reached.'}, {'measure': 'Change From Baseline in Evaporative Air Sensitivity Response on a Visual Rating Scale (VRS) at Week 4', 'timeFrame': 'Baseline to 4 weeks post administration of study treatment', 'description': 'Participants rated the intensity of their response to the stimulus using a 10 point Visual rating scale of 1 (no Pain) to 10 (intense pain).'}, {'measure': 'Change From Baseline in Evaporative Air Sensitivity Response on VRS at Week 8', 'timeFrame': 'Baseline to 8 weeks post administration of study treatment', 'description': 'Participants rated the intensity of their response to the stimulus using a 10 point VRS of 1 (no Pain) to 10 (intense pain).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Dentine Hypersensitivity']}, 'descriptionModule': {'briefSummary': 'The purpose of this exploratory study is to compare the treatment effect on dentinal hypersensitivity of a tubule occluding dentifrice as measured by Schiff and Tactile sensitivity. This proof of concept study will compare the test dentifrice with three other treatment groups.', 'detailedDescription': 'This will be a single center, eight week, randomized, controlled, examiner blind, four treatment arm, parallel design, stratified (by maximum baseline Schiff Sensitivity Score of the two selected test teeth), exploratory study in participants with at least two sensitive teeth that meet all the criteria at the Screening and Baseline visit. Participants will be assessed at Baseline, four and eight weeks to monitor clinical efficacy and safety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Participants between 18 and 55 years of age, in good general health, with pre-existing self-reported and clinically diagnosed tooth sensitivity are required for entry into the study\n2. Participants will be required to have at least four teeth with facial/cervical erosion, abrasion and/or gingival recession which respond to qualifying evaporative (air) assessment at the Screening visit and have at least two teeth (incisors, canines or pre-molars) demonstrating signs of sensitivity, measured by qualifying tactile threshold (Yeaple ≤ 20 gram (g)) and evaporative (air) (Schiff Sensitivity Score ≥ 2) assessments at the Baseline visit\n\nExclusion Criteria:\n\n1. Pregnancy: Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.\n2. Breast-feeding: Women who are breast-feeding.\n3. Medical History: a) Chronic debilitating disease is present b) Chronic disease or other condition is present that is associated with intermittent episodes or constant daily pain, such as arthritis, low back pain, dysmenorrhea, etc.\n4. Medications: Daily doses of medication, which in the opinion of the investigator, might interfere with the perception of pain, are being taken. Examples of such medications include analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquilizers, mood-altering and anti-inflammatory drugs.\n5. Dentition Exclusions: a) Sensitive teeth not expected to respond to treatment with an over-the- counter dentifrice in the opinion of the investigator. b) Teeth with exposed dentine but with deep, defective or facial restorations, teeth used as abutments for fixed or removable partial dentures, teeth with full crowns, orthodontic bands, extensive caries or cracked enamel. Sensitive teeth with contributing etiologies other than erosion, abrasion or recession of exposed dentine. c) Dental professional hygiene (includes dental prophylaxis, irrigation, and intensive anti-microbial/anti-biotic therapy) within 14 days of the screening visit. d) Presence of dental implants. e) Lip or tongue piercings. f) Periodontal surgical history within the past 6 months or have been scaled /root planed within the past 3 months.\n6. Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.\n7. Clinical Study/Experimental Medication: a) Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit b) Previous participation in this study.\n8. Other: Any subject who in the opinion of the investigator, should not participate in the study.'}, 'identificationModule': {'nctId': 'NCT01691560', 'briefTitle': 'Exploratory Study to Evaluate an Occlusion Based Dentifrice in Relief of Dentinal Hypersensitivity', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Proof of Concept Study to Evaluate the Efficacy of an Occlusion Based Dentifrice in the Relief of Dentinal Hypersensitivity', 'orgStudyIdInfo': {'id': 'RH01426'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '5% calcium sodium phosphosilicate/sodium monofluorophosphate', 'description': 'Dentifrice containing 5.0% w/w calcium sodium phosphosilicate with sodium monofluorophosphate containing 1500 parts per million fluoride (ppmF).', 'interventionNames': ['Drug: 5% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice']}, {'type': 'ACTIVE_COMPARATOR', 'label': '0% calcium sodium phosphosilicate/sodium monofluorophosphate', 'description': 'Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppmF as sodium monofluorophosphate', 'interventionNames': ['Drug: 0% calcium sodium phosphosilicate/sodium monofluorophosphate dentifrice']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sodium monofluorophosphate', 'description': 'Dentifrice containing 1000 ppmF as sodium monofluorophosphate', 'interventionNames': ['Drug: Sodium monofluorophosphate dentifrice']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sodium fluoride', 'description': 'Dentifrice containing 1100 ppmF as sodium fluoride', 'interventionNames': ['Drug: Sodium fluoride dentifrice']}], 'interventions': [{'name': '5% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice', 'type': 'DRUG', 'description': 'Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppmF as sodium monofluorophosphate', 'armGroupLabels': ['5% calcium sodium phosphosilicate/sodium monofluorophosphate']}, {'name': '0% calcium sodium phosphosilicate/sodium monofluorophosphate dentifrice', 'type': 'DRUG', 'description': 'Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppmF as sodium monofluorophosphate', 'armGroupLabels': ['0% calcium sodium phosphosilicate/sodium monofluorophosphate']}, {'name': 'Sodium monofluorophosphate dentifrice', 'type': 'DRUG', 'description': 'Dentifrice containing 1000 ppmF as sodium monofluorophosphate', 'armGroupLabels': ['Sodium monofluorophosphate']}, {'name': 'Sodium fluoride dentifrice', 'type': 'DRUG', 'description': 'Dentifrice containing 1100 ppmF as sodium fluoride', 'armGroupLabels': ['Sodium fluoride']}]}, 'contactsLocationsModule': {'locations': [{'zip': '89121-5466', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'BioSci Research America', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'BioSci Research', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}