Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2026-02-21 @ 6:01 AM
Study NCT ID:
NCT02481557
Status:
COMPLETED
Last Update Posted:
2019-06-11
First Post:
2015-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of an Oxalate Containing Product on Dentinal Hypersensitivity With Dental Prophylaxis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003807', 'term': 'Dentin Sensitivity'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'peters.j.2@pg.com', 'phone': '513-622-2489', 'title': 'Clinical Trial Manager', 'organization': 'The Procter & Gamble Company'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Oxalate Salt Solution', 'description': 'Professionally applied\n\nOxalate Salt Solution: Applied by dentist', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 0, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'No Treatment', 'description': 'No Treatment', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline Air Challenge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxalate Salt Solution', 'description': 'Professionally applied\n\nOxalate Salt Solution: Applied by dentist'}, {'id': 'OG001', 'title': 'No Treatment', 'description': 'No Treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.412', 'spread': '0.537', 'groupId': 'OG000'}, {'value': '-0.132', 'spread': '0.403', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 Minutes', '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': 'Thirty-Six (36) subjects received products. Thirty-Six (36) subjects completed the study.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline for Yeaple Probe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxalate Salt Solution', 'description': 'Professionally applied\n\nOxalate Salt Solution: Applied by dentist'}, {'id': 'OG001', 'title': 'No Treatment', 'description': 'No Treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '10.000', 'spread': '8.101', 'groupId': 'OG000'}, {'value': '1.316', 'spread': '6.634', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 Minutes', 'description': 'Tactile Threshold was measured using a Yeaple probe. Testing was performed beginning at 10 g. The examiner recorded tactile scores for responding teeth. After treatment, testing began at 10 g and increase by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increased until a "yes" response was repeated. If a second "yes" was not obtained, the force setting was increased to the next step and continued until a force was found which elicited two consecutive "yes" responses and was recorded as the threshold on the Tactile Sensitivity Score form. The mean change from Baseline was calculated for this measure.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Thirty-six (36) subjects received study products. Thirty-six (36) subjects completed the study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Oxalate Salt Solution', 'description': 'Professionally applied\n\nOxalate Salt Solution: Applied by dentist'}, {'id': 'FG001', 'title': 'No Treatment', 'description': 'No study treatment'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Oxalate Salt Solution', 'description': 'Professionally applied\n\nOxalate Salt Solution: Applied by dentist'}, {'id': 'BG001', 'title': 'No Treatment', 'description': 'No Treatment'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34.5', 'spread': '14.14', 'groupId': 'BG000'}, {'value': '34.5', 'spread': '10.11', 'groupId': 'BG001'}, {'value': '34.5', 'spread': '12.00', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Ethnicity', 'categories': [{'title': 'Hispanic', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Asian Oriental', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Black', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Caucasian', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Multi-Racial', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-28', 'studyFirstSubmitDate': '2015-06-23', 'resultsFirstSubmitDate': '2019-04-26', 'studyFirstSubmitQcDate': '2015-06-24', 'lastUpdatePostDateStruct': {'date': '2019-06-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-05-28', 'studyFirstPostDateStruct': {'date': '2015-06-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-05-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline Air Challenge', 'timeFrame': '10 Minutes', '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.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline for Yeaple Probe', 'timeFrame': '10 Minutes', 'description': 'Tactile Threshold was measured using a Yeaple probe. Testing was performed beginning at 10 g. The examiner recorded tactile scores for responding teeth. After treatment, testing began at 10 g and increase by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increased until a "yes" response was repeated. If a second "yes" was not obtained, the force setting was increased to the next step and continued until a force was found which elicited two consecutive "yes" responses and was recorded as the threshold on the Tactile Sensitivity Score form. The mean change from Baseline was calculated for this measure.'}]}, 'conditionsModule': {'conditions': ['Dentin Sensitivity']}, 'descriptionModule': {'briefSummary': 'This study will assess sensitivity during a dental prophylaxis with or without the use of a potassium oxalate salt solution.'}, '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* sign an informed consent form and be given a copy\n* be in good general health as determined by the Investigator/designee\n* agree to delay any elective dentistry, and to report any dentistry received during the course of the study\n* agree to not participate in any other oral care study for the duration of this study\n* agree to return for scheduled visits and follow all study procedures\n* have at least one tooth with a Schiff sensitivity score of at least 1 in response to air challenge and a Yeaple Probe score of 10-40 in response to tactile challenge.\n\nExclusion Criteria:\n\n* severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession\n* active treatment for periodontitis\n* any diseases or conditions that might interfere with the subject safely completing the study\n* inability to undergo study procedures\n* fixed orthodontic appliances'}, 'identificationModule': {'nctId': 'NCT02481557', 'briefTitle': 'Effects of an Oxalate Containing Product on Dentinal Hypersensitivity With Dental Prophylaxis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Procter and Gamble'}, 'orgStudyIdInfo': {'id': '2015069'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oxalate Salt Solution', 'description': 'Professionally applied', 'interventionNames': ['Device: Oxalate Salt Solution']}, {'type': 'NO_INTERVENTION', 'label': 'No Treatment', 'description': 'No Treatment'}], 'interventions': [{'name': 'Oxalate Salt Solution', 'type': 'DEVICE', 'description': 'Applied by dentist', 'armGroupLabels': ['Oxalate Salt Solution']}]}, 'contactsLocationsModule': {'locations': [{'zip': '89146', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Silverstone Research Group', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Procter and Gamble', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}