Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-29 @ 8:59 AM
Study NCT ID:
NCT01075256
Status:
COMPLETED
Last Update Posted:
2013-06-03
First Post:
2010-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dose Response of a Tubule Occlusion Agent
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003807', 'term': 'Dentin Sensitivity'}, {'id': 'D014098', 'term': 'Toothache'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D001733', 'term': 'Bites and Stings'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D005157', 'term': 'Facial Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D011041', 'term': 'Poisoning'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'An issue with study product packaging was discovered post-study completion. The nature indicated that subject response was likely to have been liable to a positive bias. Efficacy cannot be considered as valid and no reliable conclusions possible.'}}, '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': '7.5% Sodium Calcium Phosphosilicate Toothpaste', 'description': 'Participants brushed their teeth for two minutes, twice daily for 15 days with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.', 'otherNumAtRisk': 63, 'otherNumAffected': 3, 'seriousNumAtRisk': 63, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '5% Sodium Calcium Phosphosilicate Toothpaste', 'description': 'Participants brushed their teeth for two minutes, twice daily for 15 days with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.', 'otherNumAtRisk': 66, 'otherNumAffected': 3, 'seriousNumAtRisk': 66, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo Toothpaste', 'description': 'Participants brushed their teeth for two minutes, twice daily for 15 days with a sodium calcium phosphosilicate free placebo toothpaste. All study treatments were fluoride free.', 'otherNumAtRisk': 66, 'otherNumAffected': 3, 'seriousNumAtRisk': 66, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gingival Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mouth Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thermal Burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pharyngitis Streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tonsilitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinus Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sensitivity of teeth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Adjusted Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a Visual Analog Scale (VAS) at Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '7.5% Sodium Calcium Phosphosilicate Toothpaste', 'description': 'Participants brushed their teeth for two minutes, twice daily for 15 days with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.'}, {'id': 'OG001', 'title': '5% Sodium Calcium Phosphosilicate Toothpaste', 'description': 'Participants brushed their teeth for two minutes, twice daily for 15 days with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.'}, {'id': 'OG002', 'title': 'Placebo Toothpaste', 'description': 'Participants brushed their teeth for two minutes, twice daily for 15 days with a sodium calcium phosphosilicate free placebo toothpaste. All study treatments were fluoride free.'}], 'classes': [{'categories': [{'measurements': [{'value': '-26.1', 'groupId': 'OG000', 'lowerLimit': '-29.40', 'upperLimit': '-22.72'}, {'value': '-28.4', 'groupId': 'OG001', 'lowerLimit': '-31.60', 'upperLimit': '-25.12'}, {'value': '-26.2', 'groupId': 'OG002', 'lowerLimit': '-29.54', 'upperLimit': '-22.95'}]}]}], 'analyses': [{'pValue': '0.3628', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.1', 'ciLowerLimit': '-6.70', 'ciUpperLimit': '2.46', 'pValueComment': 'No adjustment was made for multiple comparisons.', 'estimateComment': 'Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.', 'groupDescription': 'The null hypothesis was no diference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity', 'testedNonInferiority': False}, {'pValue': '0.9361', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-4.45', 'ciUpperLimit': '4.83', 'pValueComment': 'No adjustment was made for multiple comparisons.', 'estimateComment': 'Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.', 'groupDescription': 'The null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity.', 'testedNonInferiority': False}, {'pValue': '0.3257', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.3', 'ciLowerLimit': '-2.31', 'ciUpperLimit': '6.92', 'pValueComment': 'No adustment was made for multiple comparisons.', 'estimateComment': 'Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.', 'groupDescription': 'The null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 15', 'description': 'Response to a constant jet of air applied to a hypersensitive tooth was evaluated using a 100 millimeter (mm) VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat (ITT) population: All randomized participants who received at least one dose of investigational product who have at least one post-baseline efficacy measure. Missing data was not imputed. Due to drop outs, there was difference in number of participants analyzed.'}, {'type': 'SECONDARY', 'title': 'Adjusted Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a VAS at Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '7.5% Sodium Calcium Phosphosilicate Toothpaste', 'description': 'Participants brushed their teeth for two minutes, twice daily with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.'}, {'id': 'OG001', 'title': '5% Sodium Calcium Phosphosilicate Toothpaste', 'description': 'Participants brushed their teeth for two minutes, twice daily with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.'}, {'id': 'OG002', 'title': 'Placebo Toothpaste', 'description': 'Participants brushed their teeth for two minutes, twice daily with a sodium calcium phosphosilicate free placebo toothpaste. All study treatments were fluoride free.'}], 'classes': [{'categories': [{'measurements': [{'value': '-16.4', 'groupId': 'OG000', 'lowerLimit': '-19.80', 'upperLimit': '-12.93'}, {'value': '-17.4', 'groupId': 'OG001', 'lowerLimit': '-20.75', 'upperLimit': '-14.10'}, {'value': '-16.4', 'groupId': 'OG002', 'lowerLimit': '-19.78', 'upperLimit': '-13.02'}]}]}], 'analyses': [{'pValue': '0.6674', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.0', 'ciLowerLimit': '-5.73', 'ciUpperLimit': '3.68', 'pValueComment': 'No adjustment was made for multiple comparisons.', 'estimateComment': 'Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.', 'groupDescription': 'The null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity', 'testedNonInferiority': False}, {'pValue': '0.9888', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-4.74', 'ciUpperLimit': '4.81', 'pValueComment': 'No adjustments for multiple comparisons.', 'estimateComment': 'Difference is the high concentration minus placebo such that a positive difference favors the first named treatment.', 'groupDescription': 'The null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity', 'testedNonInferiority': False}, {'pValue': '0.6599', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '-3.69', 'ciUpperLimit': '5.81', 'pValueComment': 'No adjustments for multiple comparisons.', 'estimateComment': 'Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.', 'groupDescription': 'The null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 7', 'description': 'Response to a constant jet of air applied to a hypersensitive tooth was evaluated using a 100 millimeter (mm) VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population: All randomized participants who received at least one dose of investigational product who have at least one post-baseline efficacy measure. Missing data was not imputed. Due to drop outs, there was difference in number of participants analyzed.'}, {'type': 'PRIMARY', 'title': 'Adjusted Mean Change From Baseline in Cold Water Sensitivity Pain Response on a VAS at Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '7.5% Sodium Calcium Phosphosilicate Toothpaste', 'description': 'Participants brushed their teeth for two minutes, twice daily for 15 days with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.'}, {'id': 'OG001', 'title': '5% Sodium Calcium Phosphosilicate Toothpaste', 'description': 'Participants brushed their teeth for two minutes, twice daily for 15 days with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.'}, {'id': 'OG002', 'title': 'Placebo Toothpaste', 'description': 'Participants brushed their teeth for two minutes, twice daily for 15 days with a sodium calcium phosphosilicate free placebo toothpaste. All study treatments were fluoride free.'}], 'classes': [{'categories': [{'measurements': [{'value': '-32.8', 'groupId': 'OG000', 'lowerLimit': '-37.55', 'upperLimit': '-28.00'}, {'value': '-32.2', 'groupId': 'OG001', 'lowerLimit': '-36.86', 'upperLimit': '-27.59'}, {'value': '-32.3', 'groupId': 'OG002', 'lowerLimit': '-37.04', 'upperLimit': '-27.60'}]}]}], 'analyses': [{'pValue': '0.9759', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-6.34', 'ciUpperLimit': '6.54', 'pValueComment': 'No adjustments for multiple comparisons', 'estimateComment': 'Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.', 'groupDescription': 'The null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity', 'testedNonInferiority': False}, {'pValue': '0.8903', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-6.97', 'ciUpperLimit': '6.06', 'pValueComment': 'No adjustments for multiple comparisons.', 'estimateComment': 'Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.', 'groupDescription': 'The null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity', 'testedNonInferiority': False}, {'pValue': '0.8662', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-7.04', 'ciUpperLimit': '5.93', 'pValueComment': 'No adjustments for multiple comparisons', 'estimateComment': 'Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.', 'groupDescription': 'Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 15', 'description': 'Response of exposed dentine surface to application of 1 ml freshly melted ice cold water was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population: All randomized participants who received at least one dose of investigational product who have at least one post-baseline efficacy measure. Missing data was not imputed. Due to drop outs, there was difference in number of participants analyzed.'}, {'type': 'SECONDARY', 'title': 'Adjusted Mean Change From Baseline in Cold Water Sensitivity Pain Response on a VAS at Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '7.5% Sodium Calcium Phosphosilicate Toothpaste', 'description': 'Participants brushed their teeth for two minutes, twice daily with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.'}, {'id': 'OG001', 'title': '5% Sodium Calcium Phosphosilicate Toothpaste', 'description': 'Participants brushed their teeth for two minutes, twice daily with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.'}, {'id': 'OG002', 'title': 'Placebo Toothpaste', 'description': 'Participants brushed their teeth for two minutes, twice daily with a sodium calcium phosphosilicate free placebo toothpaste. All study treatments were fluoride free.'}], 'classes': [{'categories': [{'measurements': [{'value': '-21.5', 'groupId': 'OG000', 'lowerLimit': '-26.14', 'upperLimit': '-16.81'}, {'value': '-22.5', 'groupId': 'OG001', 'lowerLimit': '-26.99', 'upperLimit': '-17.93'}, {'value': '-21.8', 'groupId': 'OG002', 'lowerLimit': '-26.44', 'upperLimit': '-17.21'}]}]}], 'analyses': [{'pValue': '0.8419', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-6.93', 'ciUpperLimit': '5.66', 'pValueComment': 'No adjustments for multiple comparisons.', 'estimateComment': 'Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.', 'groupDescription': 'Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity', 'testedNonInferiority': False}, {'pValue': '0.9147', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-6.03', 'ciUpperLimit': '6.72', 'pValueComment': 'No adjustments for multiple comparisons.', 'estimateComment': 'Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.', 'groupDescription': 'Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity', 'testedNonInferiority': False}, {'pValue': '0.7600', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.0', 'ciLowerLimit': '-5.36', 'ciUpperLimit': '7.33', 'pValueComment': 'No adjustments for multiple comparisons.', 'estimateComment': 'Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.', 'groupDescription': 'Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 7', 'description': 'Response of exposed dentine surface to application of 1 ml freshly melted ice cold water was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population: All randomized participants who received at least one dose of investigational product who have at least one post-baseline efficacy measure. Missing data was not imputed. Due to drop outs, there was difference in number of participants analyzed.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Adjusted Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a VAS at Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '7.5% Sodium Calcium Phosphosilicate Toothpaste', 'description': 'Participants brushed their teeth for two minutes, twice daily with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.'}, {'id': 'OG001', 'title': '5% Sodium Calcium Phosphosilicate Toothpaste', 'description': 'Participants brushed their teeth for two minutes, twice daily with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.'}, {'id': 'OG002', 'title': 'Placebo Toothpaste', 'description': 'Participants brushed their teeth for two minutes, twice daily with a sodium calcium phosphosilicate (NovaMin) free placebo toothpaste. All study treatments were fluoride free.'}], 'classes': [{'categories': [{'measurements': [{'value': '-28.7', 'groupId': 'OG000', 'lowerLimit': '-34.90', 'upperLimit': '-22.43'}, {'value': '-22.7', 'groupId': 'OG001', 'lowerLimit': '-33.70', 'upperLimit': '-21.67'}, {'value': '-28.2', 'groupId': 'OG002', 'lowerLimit': '-34.46', 'upperLimit': '-21.88'}]}]}], 'analyses': [{'pValue': '0.9124', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '-8.28', 'ciUpperLimit': '9.24', 'pValueComment': 'No adjustment was made for multiple comparisons.', 'estimateComment': 'Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.', 'groupDescription': 'Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity', 'testedNonInferiority': False}, {'pValue': '0.9083', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-9.13', 'ciUpperLimit': '8.14', 'pValueComment': 'No adjustment was made for multiple comparisons.', 'estimateComment': 'Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.', 'groupDescription': 'Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity', 'testedNonInferiority': False}, {'pValue': '0.8231', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.0', 'ciLowerLimit': '-9.73', 'ciUpperLimit': '7.77', 'pValueComment': 'No adjustment was made for multiple comparisons.', 'estimateComment': 'Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.', 'groupDescription': 'Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 10', 'description': 'Response to a constant jet of air applied to a hypersensitive tooth was evaluated using a 100mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population subset: A subset of randomized participants who received at least one dose of investigational product who have at least one post-baseline efficacy measure. Missing data was not imputed. Due to drop outs, there was difference in number of participants analyzed.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Adjusted Mean Change From Baseline in Cold Water Sensitivity Pain Response on a VAS at Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '7.5% Sodium Calcium Phosphosilicate Toothpaste', 'description': 'Participants brushed their teeth for two minutes, twice daily with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.'}, {'id': 'OG001', 'title': '5% Sodium Calcium Phosphosilicate Toothpaste', 'description': 'Participants brushed their teeth for two minutes, twice daily with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.'}, {'id': 'OG002', 'title': 'Placebo Toothpaste', 'description': 'Participants brushed their teeth for two minutes, twice daily with sodium calcium phosphosilicate free placebo toothpaste. All study treatments were fluoride free.'}], 'classes': [{'categories': [{'measurements': [{'value': '-34.7', 'groupId': 'OG000', 'lowerLimit': '-44.24', 'upperLimit': '-25.09'}, {'value': '-31.3', 'groupId': 'OG001', 'lowerLimit': '-40.03', 'upperLimit': '-22.62'}, {'value': '-34.7', 'groupId': 'OG002', 'lowerLimit': '-44.22', 'upperLimit': '-25.21'}]}]}], 'analyses': [{'pValue': '0.5946', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.4', 'ciLowerLimit': '-9.32', 'ciUpperLimit': '16.09', 'pValueComment': 'No adjustment was made for multiple comparisons.', 'estimateComment': 'Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.', 'groupDescription': 'Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity', 'testedNonInferiority': False}, {'pValue': '0.9944', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-12.51', 'ciUpperLimit': '12.60', 'pValueComment': 'No adjustment was made for multiple comparisons.', 'estimateComment': 'Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.', 'groupDescription': 'Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity', 'testedNonInferiority': False}, {'pValue': '0.5998', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.3', 'ciLowerLimit': '-16.06', 'ciUpperLimit': '9.38', 'pValueComment': 'No adjustment was made for multiple comparisons.', 'estimateComment': 'Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.', 'groupDescription': 'Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 10', 'description': 'Response of exposed dentine surface to application of 1 ml freshly melted ice cold water was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population subset: A subset of randomized participants who received at least one dose of investigational product who have at least one post-baseline efficacy measure. Missing data was not imputed. Due to drop outs, there was difference in number of participants analyzed.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Adjusted Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a VAS at Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '7.5% Sodium Calcium Phosphosilicate Toothpaste', 'description': 'Participants brushed their teeth for two minutes, twice daily with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.'}, {'id': 'OG001', 'title': '5% Sodium Calcium Phosphosilicate Toothpaste', 'description': 'Participants brushed their teeth for two minutes, twice daily with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.'}, {'id': 'OG002', 'title': 'Placebo Toothpaste', 'description': 'Participants brushed their teeth for two minutes, twice daily with sodium calcium phosphosilicate free placebo toothpaste. All study treatments were fluoride free.'}], 'classes': [{'categories': [{'measurements': [{'value': '-13.5', 'groupId': 'OG000', 'lowerLimit': '-20.08', 'upperLimit': '-6.87'}, {'value': '-12.3', 'groupId': 'OG001', 'lowerLimit': '-18.66', 'upperLimit': '-5.90'}, {'value': '-11.1', 'groupId': 'OG002', 'lowerLimit': '-17.74', 'upperLimit': '-4.40'}]}]}], 'analyses': [{'pValue': '0.7952', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.2', 'ciLowerLimit': '-10.51', 'ciUpperLimit': '8.09', 'pValueComment': 'No adjustment was made for multiple comparisons.', 'estimateComment': 'Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.', 'groupDescription': 'Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity', 'testedNonInferiority': False}, {'pValue': '0.6010', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.4', 'ciLowerLimit': '-11.56', 'ciUpperLimit': '6.76', 'pValueComment': 'No adjustment was made for multiple comparisons.', 'estimateComment': 'Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.', 'groupDescription': 'The null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity', 'testedNonInferiority': False}, {'pValue': '0.7976', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.2', 'ciLowerLimit': '-10.48', 'ciUpperLimit': '8.10', 'pValueComment': 'No adjustment was made for multiple comparisons.', 'estimateComment': 'Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.', 'groupDescription': 'Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 3', 'description': 'Response to a constant jet of air applied to a hypersensitive tooth was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population subset: A subset of randomized participants who received at least one dose of investigational product who have at least one post-baseline efficacy measure. Missing data was not imputed. Due to drop outs, there was difference in number of participants analyzed.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Adjusted Mean Change From Baseline in Cold Water Sensitivity Pain Response on a VAS at Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '7.5% Sodium Calcium Phosphosilicate Toothpaste', 'description': 'Participants brushed their teeth for two minutes, twice daily with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.'}, {'id': 'OG001', 'title': '5% Sodium Calcium Phosphosilicate Toothpaste', 'description': 'Participants brushed their teeth for two minutes, twice daily with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.'}, {'id': 'OG002', 'title': 'Placebo Toothpaste', 'description': 'Participants brushed their teeth for two minutes, twice daily with a sodium calcium phosphosilicate free placebo toothpaste. All study treatments were fluoride free.'}], 'classes': [{'categories': [{'measurements': [{'value': '-19.3', 'groupId': 'OG000', 'lowerLimit': '-27.56', 'upperLimit': '-11.02'}, {'value': '-16.9', 'groupId': 'OG001', 'lowerLimit': '-24.44', 'upperLimit': '-9.44'}, {'value': '-17.6', 'groupId': 'OG002', 'lowerLimit': '-25.79', 'upperLimit': '-9.40'}]}]}], 'analyses': [{'pValue': '0.9060', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7', 'ciLowerLimit': '-10.38', 'ciUpperLimit': '11.68', 'pValueComment': 'No adjustment was made for multiple comparisons.', 'estimateComment': 'Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.', 'groupDescription': 'Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity', 'testedNonInferiority': False}, {'pValue': '0.7575', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.7', 'ciLowerLimit': '-12.63', 'ciUpperLimit': '9.25', 'pValueComment': 'No adjustment was made for multiple comparisons.', 'estimateComment': 'Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.', 'groupDescription': 'Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity', 'testedNonInferiority': False}, {'pValue': '0.6727', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.3', 'ciLowerLimit': '-13.42', 'ciUpperLimit': '8.73', 'pValueComment': 'No adjustment was made for multiple comparisons.', 'estimateComment': 'Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.', 'groupDescription': 'Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 3', 'description': 'Response of exposed dentine surface to application of 1 ml freshly melted ice cold water was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population subset: A subset of randomized participants who received at least one dose of investigational product who have at least one post-baseline efficacy measure. Missing data was not imputed. Due to drop outs, there was difference in number of participants analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '7.5% Sodium Calcium Phosphosilicate Toothpaste', 'description': 'Participants brushed their teeth for two minutes, twice daily for 15 days with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.'}, {'id': 'FG001', 'title': '5% Sodium Calcium Phosphosilicate Toothpaste', 'description': 'Participants brushed their teeth for two minutes, twice daily for 15 days with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.'}, {'id': 'FG002', 'title': 'Placebo Toothpaste', 'description': 'Participants brushed their teeth for two minutes, twice daily for 15 days with a sodium calcium phosphosilicate free placebo toothpaste. All study treatments were fluoride free.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}, {'groupId': 'FG001', 'numSubjects': '66'}, {'groupId': 'FG002', 'numSubjects': '65'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '66'}, {'groupId': 'FG002', 'numSubjects': '65'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited at the clinical site.', 'preAssignmentDetails': 'During the first 4 weeks of the study all participants brushed with an acclimatization toothpaste (sodium fluoride \\[NaF\\] toothpaste containing 1100 parts per million \\[ppm\\] fluoride \\[F\\]) for maintaining wash-out period and standardizing the oral conditions.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '195', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': '5% Sodium Calcium Phosphosilicate Toothpaste', 'description': 'Participants brushed their teeth for two minutes, twice daily for 15 days with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.'}, {'id': 'BG001', 'title': '7.5% Sodium Calcium Phosphosilicate Toothpaste', 'description': 'Participants brushed their teeth for two minutes, twice daily for 15 days with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.'}, {'id': 'BG002', 'title': 'Placebo Toothpaste', 'description': 'Participants brushed their teeth for two minutes, twice daily for 15 days with a sodium calcium phosphosilicate free placebo toothpaste. All study treatments were fluoride free.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.30', 'spread': '8.925', 'groupId': 'BG000'}, {'value': '37.63', 'spread': '8.920', 'groupId': 'BG001'}, {'value': '36.61', 'spread': '9.885', 'groupId': 'BG002'}, {'value': '37.51', 'spread': '9.239', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '154', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Safety population reported as treated- one randomized participant in the High concentration group received placebo and is included in the placebo count.', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 195}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-25', 'studyFirstSubmitDate': '2010-02-23', 'resultsFirstSubmitDate': '2011-09-23', 'studyFirstSubmitQcDate': '2010-02-23', 'lastUpdatePostDateStruct': {'date': '2013-06-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-04-25', 'studyFirstPostDateStruct': {'date': '2010-02-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adjusted Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a VAS at Day 10', 'timeFrame': 'Baseline to Day 10', 'description': 'Response to a constant jet of air applied to a hypersensitive tooth was evaluated using a 100mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.'}, {'measure': 'Adjusted Mean Change From Baseline in Cold Water Sensitivity Pain Response on a VAS at Day 10', 'timeFrame': 'Baseline to Day 10', 'description': 'Response of exposed dentine surface to application of 1 ml freshly melted ice cold water was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.'}, {'measure': 'Adjusted Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a VAS at Day 3', 'timeFrame': 'Baseline to Day 3', 'description': 'Response to a constant jet of air applied to a hypersensitive tooth was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.'}, {'measure': 'Adjusted Mean Change From Baseline in Cold Water Sensitivity Pain Response on a VAS at Day 3', 'timeFrame': 'Baseline to Day 3', 'description': 'Response of exposed dentine surface to application of 1 ml freshly melted ice cold water was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.'}], 'primaryOutcomes': [{'measure': 'Adjusted Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a Visual Analog Scale (VAS) at Day 15', 'timeFrame': 'Baseline to Day 15', 'description': 'Response to a constant jet of air applied to a hypersensitive tooth was evaluated using a 100 millimeter (mm) VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.'}, {'measure': 'Adjusted Mean Change From Baseline in Cold Water Sensitivity Pain Response on a VAS at Day 15', 'timeFrame': 'Baseline to Day 15', 'description': 'Response of exposed dentine surface to application of 1 ml freshly melted ice cold water was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.'}], 'secondaryOutcomes': [{'measure': 'Adjusted Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a VAS at Day 7', 'timeFrame': 'Baseline to Day 7', 'description': 'Response to a constant jet of air applied to a hypersensitive tooth was evaluated using a 100 millimeter (mm) VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.'}, {'measure': 'Adjusted Mean Change From Baseline in Cold Water Sensitivity Pain Response on a VAS at Day 7', 'timeFrame': 'Baseline to Day 7', 'description': 'Response of exposed dentine surface to application of 1 ml freshly melted ice cold water was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['sensitivity', 'occlusion'], 'conditions': ['Dentine Hypersensitivity', 'Dental Pain']}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy of two different concentrations of a tubule occlusion agent - calcium sodium phosphosilicate in treatment of dentine hypersensitivity', 'detailedDescription': 'Dentine hypersensitivity is characterized by short, sharp pain arising from exposed dentine typically in response to chemical, thermal, tactile or osmotic stimuli. Dentine hypersensitivity may be treated by either making the nerve in the tooth less sensitive or by occluding the tubules to limit exposure of the nerve to external stimuli. Bioactive and biocompatible glasses react with oral fluid to deposit a mineral that is chemically analogous to that found in both enamel and dentine thus preventing exposure of the nerve to external stimuli.\n\nA number of controlled clinical trials have been reported indicating that a calcium sodium phosphosilicate bioactive glass, when incorporated into a toothpaste formulation, significantly reduce pain from dentine hypersensitivity. The aim of this study is to evaluate the effectiveness of two currently marketed toothpastes, containing 5% calcium sodium phosphosilicate and the other containing 7.5% calcium sodium phosphosilicate in the treatment of dentine hypersensitivity compared to a matched placebo control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Consent: Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.\n2. Age: Aged between 20 - 50 years.\n3. General Health: Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history.\n4. Contraception: Females of childbearing potential who are, in the opinion of the investigator, practising a reliable method of contraception.\n5. Erosion/Abrasion/Recession:Study teeth must show signs of facial/cervical erosion, abrasion and/or gingival recession.\n6. Gingival Health / Tooth Mobility Grade:Study teeth must have Löe and Silness Gingival Index (GI) score less than or equal to 2 and clinical mobility less than or equal to grade I.\n7. Current Product Use: Participants must have been using the same brand of toothpaste for at least 2 months and should not have used desensitizing toothpaste during the 4 weeks preceding screening. Participants will be required to bring in their current toothpaste(s) in order to verify the ingredients.\n8. VAS Training: Successfully completes the VAS training exercise at Screening.\n9. Sensitivity: Self-reported history of dentinal hypersensitivity and a primary complaint of sensitive teeth lasting a maximum of 10 years. At Screening: A minimum of 5 evaporative (air) sensitive lateral incisors, canines or pre-molars must display a response greater than 25 mm on a 100 mm VAS. At Baseline: A minimum of 3 of the 5 evaporative (air) sensitive teeth identified at screening must display a response greater than 25 mm on a 100 mm VAS. All teeth meeting the sensitivity Inclusion Criteria will be followed and assessed using both efficacy parameters.\n10. Compliance: Understands and is willing, able and likely to comply with all study procedures and restrictions.\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 (OTC) 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 aetiologies 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. Xerostomia: Any condition or medication that causes xerostomia.\n9. Personnel: An employee of the sponsor or the study site or members of their immediate family.\n10. Other: Any subject who in the opinion of the investigator, should not participate in the study.'}, 'identificationModule': {'nctId': 'NCT01075256', 'briefTitle': 'Dose Response of a Tubule Occlusion Agent', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'An Exploratory Clinical Study to Evaluate the Efficacy of Two Currently Marketed Toothpastes Containing Different Concentrations of a Tubule Occlusion Agent', 'orgStudyIdInfo': {'id': 'Z3690607'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '5% calcium sodium phosphosilicate toothpaste', 'description': 'Participants to brush their teeth for two minutes, twice daily for 15 days with 5% sodium calcium phosphosilicate toothpaste.', 'interventionNames': ['Device: 5% calcium sodium phosphosilicate toothpaste']}, {'type': 'ACTIVE_COMPARATOR', 'label': '7.5% calcium sodium phosphosilicate toothpaste', 'description': 'Participants to brush their teeth for two minutes, twice daily for 15 days with 7.5% sodium calcium phosphosilicate toothpaste.', 'interventionNames': ['Device: 7.5% calcium sodium phosphosilicate toothpaste']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo toothpaste', 'description': 'Participants to brush their teeth for two minutes, twice daily for 15 days with placebo toothpaste.', 'interventionNames': ['Device: Placebo toothpaste']}], 'interventions': [{'name': '5% calcium sodium phosphosilicate toothpaste', 'type': 'DEVICE', 'description': 'Low concentration calcium sodium phosphosilicate tubule occlusion agent', 'armGroupLabels': ['5% calcium sodium phosphosilicate toothpaste']}, {'name': '7.5% calcium sodium phosphosilicate toothpaste', 'type': 'DEVICE', 'description': 'High concentration calcium sodium phosphosilicate tubule occlusion agent', 'armGroupLabels': ['7.5% calcium sodium phosphosilicate toothpaste']}, {'name': 'Placebo toothpaste', 'type': 'DEVICE', 'description': 'Placebo toothpaste', 'armGroupLabels': ['Placebo toothpaste']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46825', 'city': 'Fort Wayne', 'state': 'Indiana', 'country': 'United States', 'facility': 'University Park Research Center (UPRC)', 'geoPoint': {'lat': 41.1306, 'lon': -85.12886}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}