Ignite Creation Date:
2025-12-24 @ 2:45 PM
Ignite Modification Date:
2026-01-07 @ 3:54 AM
Study NCT ID:
NCT03405259
Status:
COMPLETED
Last Update Posted:
2019-06-17
First Post:
2018-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Clinical Study to Compare Professional Treatments for Dentinal Hypersensitivity
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'peters.j.2@pg.com', 'phone': '513-622-2489', 'title': 'Clinical Trial Manager', 'organization': 'The Procter & Gamble Company'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Super Seal® Desensitizer', 'description': 'Professionally Applied\n\nSuper Seal® Desensitizer: Single dose professional application.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Acclean® Fluoride Varnish', 'description': 'Professionally Applied\n\nAcclean® Fluoride Varnish: Single dose professional application.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline Air Challenge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Super Seal® Desensitizer', 'description': 'Professionally Applied\n\nSuper Seal® Desensitizer: Single dose professional application.'}, {'id': 'OG001', 'title': 'Acclean® Fluoride Varnish', 'description': 'Professionally Applied\n\nAcclean® Fluoride Varnish: Single dose professional application.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.55', 'spread': '0.69', 'groupId': 'OG000'}, {'value': '-0.95', 'spread': '0.93', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Within 5 minutes after treatment was applied', 'description': 'The Schiff Sensitivity Scale was assessed for each test tooth via an evaporative air challenge. The examiner recorded the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A negative change from Baseline score represents a decrease in sensitivity from baseline.The mean change from Baseline was calculated for this measure.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Twenty-two (22) subjects received study product and completed the study.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline Visual Analog Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Super Seal® Desensitizer', 'description': 'Professionally Applied\n\nSuper Seal® Desensitizer: Single dose professional application.'}, {'id': 'OG001', 'title': 'Acclean® Fluoride Varnish', 'description': 'Professionally Applied\n\nAcclean® Fluoride Varnish: Single dose professional application.'}], 'classes': [{'categories': [{'measurements': [{'value': '-17.60', 'spread': '21.32', 'groupId': 'OG000'}, {'value': '-19.55', 'spread': '25.15', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Within 5 minutes after treatment was applied', 'description': 'Visual Analog Scale (VAS) - subjects are asked to look at a VAS and designate the level of hypersensitivity they experienced as a result of the thermal and water challenges using a continuum scale of 0 = No tooth pain up to 100 = Worst tooth pain ever experienced. A negative change from Baseline score represents a decrease in sensitivity from baseline.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Twenty-two (22) subjects received product and completed the study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Super Seal® Desensitizer', 'description': 'Professionally Applied\n\nSuper Seal® Desensitizer: Single dose professional application.'}, {'id': 'FG001', 'title': 'Acclean® Fluoride Varnish', 'description': 'Professionally Applied\n\nAcclean® Fluoride Varnish: Single dose professional application.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Super Seal® Desensitizer', 'description': 'Professionally Applied\n\nSuper Seal® Desensitizer: Single dose professional application.'}, {'id': 'BG001', 'title': 'Acclean® Fluoride Varnish', 'description': 'Professionally Applied\n\nAcclean® Fluoride Varnish: Single dose professional application.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.6', 'spread': '9.84', 'groupId': 'BG000'}, {'value': '48.1', 'spread': '19.71', 'groupId': 'BG001'}, {'value': '46.4', 'spread': '15.30', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian Oriental', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Caucasian', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2013-09-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-14', 'studyFirstSubmitDate': '2018-01-12', 'resultsFirstSubmitDate': '2019-04-26', 'studyFirstSubmitQcDate': '2018-01-18', 'lastUpdatePostDateStruct': {'date': '2019-06-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-06-14', 'studyFirstPostDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-06-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-09-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline Air Challenge', 'timeFrame': 'Within 5 minutes after treatment was applied', 'description': 'The Schiff Sensitivity Scale was assessed for each test tooth via an evaporative air challenge. The examiner recorded the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A negative change from Baseline score represents a decrease in sensitivity from baseline.The mean change from Baseline was calculated for this measure.'}, {'measure': 'Change From Baseline Visual Analog Scale', 'timeFrame': 'Within 5 minutes after treatment was applied', 'description': 'Visual Analog Scale (VAS) - subjects are asked to look at a VAS and designate the level of hypersensitivity they experienced as a result of the thermal and water challenges using a continuum scale of 0 = No tooth pain up to 100 = Worst tooth pain ever experienced. A negative change from Baseline score represents a decrease in sensitivity from baseline.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Dentinal Hypersensitivity']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to compare professional treatments for dentinal hypersensitivity immediately following a single, professionally-applied treatment and again approximately 2 months following treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* be at least 18 years of age;\n* provide written informed consent prior to participation and be given a signed copy of the informed consent form;\n* be in good general health as determined by the Investigator/designee; and\n* have at least one tooth with a VAS score of greater than or equal to 30 in response to the air challenge.\n\nExclusion Criteria:\n\n* allergy to rosin or to pine nuts;\n* self-reported pregnancy or nursing;\n* severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession;\n* active treatment for periodontitis;\n* fixed facial orthodontic appliances;\n* any diseases or conditions that might interfere with the safe completion of the study; or\n* an inability to undergo any study procedures.'}, 'identificationModule': {'nctId': 'NCT03405259', 'briefTitle': 'A Clinical Study to Compare Professional Treatments for Dentinal Hypersensitivity', 'organization': {'class': 'INDUSTRY', 'fullName': 'Procter and Gamble'}, 'officialTitle': 'A Pilot Clinical Study to Compare Professional Treatments for Dentinal Hypersensitivity', 'orgStudyIdInfo': {'id': '2013077'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Super Seal® Desensitizer', 'description': 'Professionally Applied', 'interventionNames': ['Device: Super Seal® Desensitizer']}, {'type': 'SHAM_COMPARATOR', 'label': 'Acclean® Fluoride Varnish', 'description': 'Professionally Applied', 'interventionNames': ['Device: Acclean® Fluoride Varnish']}], 'interventions': [{'name': 'Super Seal® Desensitizer', 'type': 'DEVICE', 'description': 'Single dose professional application.', 'armGroupLabels': ['Super Seal® Desensitizer']}, {'name': 'Acclean® Fluoride Varnish', 'type': 'DEVICE', 'description': 'Single dose professional application.', 'armGroupLabels': ['Acclean® Fluoride Varnish']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Procter and Gamble', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}