Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2025-12-25 @ 9:42 PM
Study NCT ID:
NCT01592851
Status:
COMPLETED
Last Update Posted:
2014-06-03
First Post:
2012-05-03
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Clinical Efficacy of a Toothpaste in Providing Relief From the Pain 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014002', 'term': 'Tin Fluorides'}, {'id': 'C012980', 'term': 'fluorophosphate'}], 'ancestors': [{'id': 'D005459', 'term': 'Fluorides'}, {'id': 'D006858', 'term': 'Hydrofluoric Acid'}, {'id': 'D017611', 'term': 'Fluorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017971', 'term': 'Tin 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, or for up to 5 days after the last administration of investigational product were recorded.', 'eventGroups': [{'id': 'EG000', 'title': 'SnF Dentifrice', 'description': 'Participants brushed each of the 2 selected sensitive teeth for 30 seconds each, followed by the whole mouth with 1 inch strip of the test dentifrice (0.454% SnF) for at least 1 minute and rinsing with 5mL of water.', 'otherNumAtRisk': 56, 'otherNumAffected': 0, 'seriousNumAtRisk': 56, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'NaMFP Dentifrice', 'description': 'Participants brushed whole mouth with 1-inch strip of the control dentifrice (0.76% NaMFP) for one timed minute, followed by rinsing with 5 mL of water.', 'otherNumAtRisk': 57, 'otherNumAffected': 0, 'seriousNumAtRisk': 57, 'seriousNumAffected': 0}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SnF Dentifrice', 'description': 'Participants brushed each of the 2 selected sensitive teeth for 30 seconds each, followed by the whole mouth with 1 inch strip of the test dentifrice (0.454% SnF) for at least 1 minute and rinsing with 5mL of water.'}, {'id': 'OG001', 'title': 'NaMFP Dentifrice', 'description': 'Participants brushed whole mouth with 1-inch strip of the control dentifrice (0.76% NaMFP) for one timed minute, followed by rinsing with 5 mL of water.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.20', 'spread': '0.70', 'groupId': 'OG000'}, {'value': '-0.37', 'spread': '0.43', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.83', 'ciLowerLimit': '-1.03', 'ciUpperLimit': '-0.63', 'pValueComment': 'No adjustment made for multiple comparisons, as primary comparison was pre-specified.', 'estimateComment': 'Difference is 0.454% SnF minus 0.76% NaMFP such that a negative difference favours first named treatment.', 'groupDescription': 'Null hypothesis considered change from baseline to be same for both treatments.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA with treatment as fixed factor and baseline Schiff Score as covariate.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 14', 'description': 'Response to a constant jet of air applied to hypersensitive teeth is 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. Those teeth that met the tactile threshold inclusion criterion (tactile threshold ≤ 20g) were assessed at baseline and Day 14. The Investigator directed a second application of air from a standard dental syringe to the facial surface of the two sensitive teeth selected at baseline. The Schiff Sensitivity Score was calculated as the subject level mean change (on two teeth) from baseline.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent To Treat (ITT) population: All randomized participants, who were administered with at least one study treatment during the study and provided at least one post-baseline assessment of efficacy.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale Immediately Post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SnF Dentifrice', 'description': 'Participants brushed each of the 2 selected sensitive teeth for 30 seconds each, followed by the whole mouth with 1 inch strip of the test dentifrice (0.454% SnF) for at least 1 minute and rinsing with 5mL of water.'}, {'id': 'OG001', 'title': 'NaMFP Dentifrice', 'description': 'Participants brushed whole mouth with 1-inch strip of the control dentifrice (0.76% NaMFP) for one timed minute, followed by rinsing with 5 mL of water.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.40', 'spread': '0.46', 'groupId': 'OG000'}, {'value': '-0.14', 'spread': '0.35', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0006', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.26', 'ciLowerLimit': '-0.41', 'ciUpperLimit': '-0.12', 'pValueComment': 'No adjustment made for multiple comparisons, as primary comparison was pre-specified.', 'estimateComment': 'Difference is 0.454% SnF minus 0.76% NaMFP such that a negative difference favours first named treatment.', 'groupDescription': 'Null hypothesis considered change from baseline to be same for both treatments.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA with treatment as fixed factor and baseline Schiff Score as covariate.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to immediately post treatment administration', 'description': 'Response to a constant jet of air applied to hypersensitive teeth is 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. Those teeth that met the tactile threshold inclusion criterion (tactile threshold ≤ 20g) were assessed at baseline and immediately after treatment. The Investigator directed a second application of air from a standard dental syringe to the facial surface of the two sensitive teeth selected at baseline. The Schiff Sensitivity Score was calculated as the subject level mean change (on two teeth) from baseline.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population: All randomized participants, who were administered with at least one study treatment during the study and provided at least one post-baseline assessment of efficacy.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SnF Dentifrice', 'description': 'Participants brushed each of the 2 selected sensitive teeth for 30 seconds each, followed by the whole mouth with 1 inch strip of the test dentifrice (0.454% SnF) for at least 1 minute and rinsing with 5mL of water.'}, {'id': 'OG001', 'title': 'NaMFP Dentifrice', 'description': 'Participants brushed whole mouth with 1-inch strip of the control dentifrice (0.76% NaMFP) for one timed minute, followed by rinsing with 5 mL of water.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.70', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '-0.25', 'spread': '0.39', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.45', 'ciLowerLimit': '-0.63', 'ciUpperLimit': '-0.28', 'pValueComment': 'No adjustment made for multiple comparisons, as primary comparison was pre-specified.', 'estimateComment': 'Difference is 0.454% SnF minus 0.76% NaMFP such that a negative difference favours first named treatment.', 'groupDescription': 'Null hypothesis considered change from baseline to be same for both treatments.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA with treatment as fixed factor and baseline Schiff Score as covariate.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 3', 'description': 'Response to a constant jet of air applied to hypersensitive teeth is 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. Those teeth that met the tactile threshold inclusion criterion (tactile threshold ≤ 20g) were assessed at baseline and Day 3. The Investigator directed a second application of air from a standard dental syringe to the facial surface of the two sensitive teeth selected at baseline. The Schiff Sensitivity Score was calculated as the subject level mean change (on two teeth) from baseline.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population: All randomized participants, who were administered with at least one study treatment during the study and provided at least one post-baseline assessment of efficacy.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Tactile Pain Threshold Score at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SnF Dentifrice', 'description': 'Participants brushed each of the 2 selected sensitive teeth for 30 seconds each, followed by the whole mouth with 1 inch strip of the test dentifrice (0.454% SnF) for at least 1 minute and rinsing with 5mL of water.'}, {'id': 'OG001', 'title': 'NaMFP Dentifrice', 'description': 'Participants brushed whole mouth with 1-inch strip of the control dentifrice (0.76% NaMFP) for one timed minute, followed by rinsing with 5 mL of water.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.9', 'spread': '21.14', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '5.67', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19.42', 'ciLowerLimit': '13.70', 'ciUpperLimit': '25.15', 'pValueComment': 'No adjustment made for multiple comparisons, as primary comparison was pre-specified.', 'estimateComment': 'Difference is 0.454% SnF minus 0.76% NaMFP such that a positive difference favours first named treatment.', 'groupDescription': 'Null hypothesis considered change from baseline to be same for both treatments.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA with treatment as fixed factor and baseline Schiff Score as covariate.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 14', 'description': 'The Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale (10g to 80g). According to this tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response to pain is recorded or the maximum force has been reached. Tactile testing begins with a force of 10g and it is increased by 10g, with each successive challenge, until either a "yes" response is recorded or the maximum force (80g) is reached. An increase in tactile score from baseline represents an improvement in sensitivity', 'unitOfMeasure': 'Force (grams)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population: All randomized participants, who were administered with at least one study treatment during the study and provided at least one post-baseline assessment of efficacy.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Tactile Pain Threshold Score at Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SnF Dentifrice', 'description': 'Participants brushed each of the 2 selected sensitive teeth for 30 seconds each, followed by the whole mouth with 1 inch strip of the test dentifrice (0.454% SnF) for at least 1 minute and rinsing with 5mL of water.'}, {'id': 'OG001', 'title': 'NaMFP Dentifrice', 'description': 'Participants brushed whole mouth with 1-inch strip of the control dentifrice (0.76% NaMFP) for one timed minute, followed by rinsing with 5 mL of water.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.8', 'spread': '15.52', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '4.90', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0021', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.84', 'ciLowerLimit': '2.54', 'ciUpperLimit': '11.13', 'pValueComment': 'No adjustment made for multiple comparisons, as primary comparison was pre-specified.', 'estimateComment': 'Difference is 0.454% SnF minus 0.76% NaMFP such that a positive difference favours first named treatment.', 'groupDescription': 'Null hypothesis considered change from baseline to be same for both treatments.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA with treatment as fixed factor and baseline Schiff Score as covariate.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 3', 'description': 'The Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale (10g to 80g). According to this tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response to pain is recorded or the maximum force has been reached. Tactile testing begins with a force of 10g and it is increased by 10g, with each successive challenge, until either a "yes" response is recorded or the maximum force (80g) is reached. An increase in tactile score from baseline represents an improvement in sensitivity.', 'unitOfMeasure': 'Force (grams)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population: All randomized participants, who were administered with at least one study treatment during the study and provided at least one post-baseline assessment of efficacy.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Tactile Pain Threshold Score Immediately Post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SnF Dentifrice', 'description': 'Participants brushed each of the 2 selected sensitive teeth for 30 seconds each, followed by the whole mouth with 1 inch strip of the test dentifrice (0.454% SnF) for at least 1 minute and rinsing with 5mL of water.'}, {'id': 'OG001', 'title': 'NaMFP Dentifrice', 'description': 'Participants brushed whole mouth with 1-inch strip of the control dentifrice (0.76% NaMFP) for one timed minute, followed by rinsing with 5 mL of water.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.8', 'spread': '10.17', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '3.24', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0070', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Mean DIfference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.87', 'ciLowerLimit': '1.08', 'ciUpperLimit': '6.65', 'pValueComment': 'No adjustment made for multiple comparisons, as primary comparison was pre-specified.', 'estimateComment': 'Difference is 0.454% SnF minus 0.76% NaMFP such that a positive difference favours first named treatment.', 'groupDescription': 'Null hypothesis considered change from baseline to be same for both treatments.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA with treatment as fixed factor and baseline Schiff Score as covariate.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to immediately post treatment administration', 'description': 'The Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale (10g to 80g). According to this tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response to pain is recorded or the maximum force has been reached. Tactile testing begins with a force of 10g and it is increased by 10g, with each successive challenge, until either a "yes" response is recorded or the maximum force (80g) is reached. An increase in tactile score from baseline represents an improvement in sensitivity.', 'unitOfMeasure': 'Force (grams)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population: All randomized participants, who were 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': 'Stannous Fluoride (SnF) Dentifrice', 'description': 'Participants brushed each of the 2 selected sensitive teeth for 30 seconds each, followed by the whole mouth with 1 inch strip of the test dentifrice (0.454% SnF) for at least 1 minute and rinsing with 5mL of water.'}, {'id': 'FG001', 'title': 'Sodium Monofluorophosphate (NaMFP) Dentifrice', 'description': 'Participants brushed whole mouth with 1-inch strip of the control dentifrice (0.76% Sodium Monofluorophosphate \\[NaMFP\\]) for one timed minute, followed by rinsing with 5 mL of water.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '57'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '57'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited at the clinical site.', 'preAssignmentDetails': 'Of 126 participants screened, 9 participants did not meet the study criteria, 3 were lost to follow up and 1 withdrew consent before randomization. Remaining 113 participants were randomized to study treatments.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'SnF Dentifrice', 'description': 'Participants brushed each of the 2 selected sensitive teeth for 30 seconds each, followed by the whole mouth with 1 inch strip of the test dentifrice (0.454% SnF) for at least 1 minute and rinsing with 5mL of water.'}, {'id': 'BG001', 'title': 'NaMFP Dentifrice', 'description': 'Participants brushed whole mouth with 1-inch strip of the control dentifrice (0.76% NaMFP) for one timed minute, followed by rinsing with 5 mL of water.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.1', 'spread': '10.70', 'groupId': 'BG000'}, {'value': '34.8', 'spread': '9.86', 'groupId': 'BG001'}, {'value': '36.5', 'spread': '10.37', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 113}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-01', 'studyFirstSubmitDate': '2012-05-03', 'resultsFirstSubmitDate': '2013-04-05', 'studyFirstSubmitQcDate': '2012-05-03', 'lastUpdatePostDateStruct': {'date': '2014-06-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-05-01', 'studyFirstPostDateStruct': {'date': '2012-05-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Day 14', 'timeFrame': 'Baseline to Day 14', 'description': 'Response to a constant jet of air applied to hypersensitive teeth is 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. Those teeth that met the tactile threshold inclusion criterion (tactile threshold ≤ 20g) were assessed at baseline and Day 14. The Investigator directed a second application of air from a standard dental syringe to the facial surface of the two sensitive teeth selected at baseline. The Schiff Sensitivity Score was calculated as the subject level mean change (on two teeth) from baseline.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale Immediately Post-treatment', 'timeFrame': 'Baseline to immediately post treatment administration', 'description': 'Response to a constant jet of air applied to hypersensitive teeth is 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. Those teeth that met the tactile threshold inclusion criterion (tactile threshold ≤ 20g) were assessed at baseline and immediately after treatment. The Investigator directed a second application of air from a standard dental syringe to the facial surface of the two sensitive teeth selected at baseline. The Schiff Sensitivity Score was calculated as the subject level mean change (on two teeth) from baseline.'}, {'measure': 'Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Day 3', 'timeFrame': 'Baseline to Day 3', 'description': 'Response to a constant jet of air applied to hypersensitive teeth is 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. Those teeth that met the tactile threshold inclusion criterion (tactile threshold ≤ 20g) were assessed at baseline and Day 3. The Investigator directed a second application of air from a standard dental syringe to the facial surface of the two sensitive teeth selected at baseline. The Schiff Sensitivity Score was calculated as the subject level mean change (on two teeth) from baseline.'}, {'measure': 'Change From Baseline in Tactile Pain Threshold Score at Day 14', 'timeFrame': 'Baseline to Day 14', 'description': 'The Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale (10g to 80g). According to this tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response to pain is recorded or the maximum force has been reached. Tactile testing begins with a force of 10g and it is increased by 10g, with each successive challenge, until either a "yes" response is recorded or the maximum force (80g) is reached. An increase in tactile score from baseline represents an improvement in sensitivity'}, {'measure': 'Change From Baseline in Tactile Pain Threshold Score at Day 3', 'timeFrame': 'Baseline to Day 3', 'description': 'The Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale (10g to 80g). According to this tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response to pain is recorded or the maximum force has been reached. Tactile testing begins with a force of 10g and it is increased by 10g, with each successive challenge, until either a "yes" response is recorded or the maximum force (80g) is reached. An increase in tactile score from baseline represents an improvement in sensitivity.'}, {'measure': 'Change From Baseline in Tactile Pain Threshold Score Immediately Post-treatment', 'timeFrame': 'Baseline to immediately post treatment administration', 'description': 'The Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale (10g to 80g). According to this tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response to pain is recorded or the maximum force has been reached. Tactile testing begins with a force of 10g and it is increased by 10g, with each successive challenge, until either a "yes" response is recorded or the maximum force (80g) is reached. An increase in tactile score from baseline represents an improvement in sensitivity.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Dentine Hypersensitivity']}, 'referencesModule': {'references': [{'pmid': '27093773', 'type': 'DERIVED', 'citation': 'Parkinson CR, Hughes N, Hall C, Whelton H, Gallob J, Mason S. Three randomized clinical trials to assess the short-term efficacy of anhydrous 0.454% w/w stannous fluoride dentifrices for the relief of dentin hypersensitivity. Am J Dent. 2016 Feb;29(1):25-32.'}]}, 'descriptionModule': {'briefSummary': 'A study to compare the efficacy of a test dentifrice against a control dentifrice in reducing dentinal hypersensitivity over a two week treatment period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': '\\- Subjects who suffer from tooth sensitivity.'}, 'identificationModule': {'nctId': 'NCT01592851', 'briefTitle': 'Clinical Efficacy of a Toothpaste in Providing Relief From the Pain of Dentinal Hypersensitivity', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Clinical Study Investigating the Efficacy of a Dentifrice in Providing Short Term Relief From Dentinal Hypersensitivity', 'orgStudyIdInfo': {'id': 'RH01324'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': 'Dentifrice containing stannous fluoride', 'interventionNames': ['Drug: Stannous Fluoride']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 2', 'description': 'Marketed dentifrice containing Sodium Monofluorophosphate', 'interventionNames': ['Drug: Sodium Monofluorophosphate']}], 'interventions': [{'name': 'Stannous Fluoride', 'type': 'DRUG', 'description': 'dentifrice containing stannous fluoride', 'armGroupLabels': ['Arm 1']}, {'name': 'Sodium Monofluorophosphate', 'type': 'DRUG', 'description': 'dentifrice containing Sodium Monofluorophosphate', 'armGroupLabels': ['Arm 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '89121', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'BioSci Research America, Inc.', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}