Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2025-12-30 @ 8:47 AM
Study NCT ID:
NCT00763269
Status:
COMPLETED
Last Update Posted:
2012-03-07
First Post:
2008-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Efficacy of a Toothpaste to Reduce Sensitivity
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': 'D014260', 'term': 'Triclosan'}, {'id': 'D012822', 'term': 'Silicon Dioxide'}, {'id': 'D005459', 'term': 'Fluorides'}], 'ancestors': [{'id': 'D010647', 'term': 'Phenyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D008903', 'term': 'Minerals'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}, {'id': 'D017655', 'term': 'Silicon Compounds'}, {'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}, {'id': 'D006858', 'term': 'Hydrofluoric Acid'}, {'id': 'D017611', 'term': 'Fluorine Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'William_Devizio@colpal.com', 'phone': '732-878-7901', 'title': 'William De Vizio', 'organization': 'Colgate Palmolive Co.'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '8 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'A-Experimental Toothpatse', 'description': 'fluoride/triclosan/silica dioxide toothpaste (Sensitive teeth formula)', 'otherNumAtRisk': 314, 'otherNumAffected': 3, 'seriousNumAtRisk': 314, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'B -Control Toothpaste', 'description': 'Fluoride/Triclosan control toothpaste', 'otherNumAtRisk': 312, 'otherNumAffected': 4, 'seriousNumAtRisk': 312, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Burning sensation of mucosa', 'notes': 'subject reported burning sensation on tongue, cheeks and lips. subject discontinued during the 4 weeks visit.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Redness in Perioral area (possible allergic reaction)', 'notes': 'subject observed redness in perioral area. visited dermatologist who diagnosed a possible allergic reaction and recommended to discontinue study toothpaste.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Physical Accidents w/ injuries', 'notes': 'Several subjects reported accident. 1 had a workplace accident and was put on bedrest. 1 fell and broke wrist while walking.1 fell in backyard and broke a bone in left foot. adn 1 subject reported 2 events(a foot sprain and a broken left foot bone.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Hypersensitivity Tactile(Yeaple Probe)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'OG000'}, {'value': '312', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A-Experimental Toothpatse', 'description': 'fluoride/triclosan/silica dioxide toothpaste (Sensitive teeth formula)'}, {'id': 'OG001', 'title': 'B -Control Toothpaste', 'description': 'Fluoride/Triclosan control toothpaste'}], 'classes': [{'categories': [{'measurements': [{'value': '19.81', 'spread': '9.56', 'groupId': 'OG000'}, {'value': '13.94', 'spread': '6.42', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'The null hypothesis states that there is no difference between groups.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 50 grams of force are applied to hypersensitive tooth until pain elicited. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. For Tactile Hypersensitivity: The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitivity. Hypersensitivity scores on a per study subject basis are recorded as mean scores of two hypersensitive teeth', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Hypersensitivity Tactile (Yeaple Probe)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'OG000'}, {'value': '312', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A-Experimental Toothpatse', 'description': 'fluoride/triclosan/silica dioxide toothpaste (Sensitive teeth formula)'}, {'id': 'OG001', 'title': 'B -Control Toothpaste', 'description': 'Fluoride/Triclosan control toothpaste'}], 'classes': [{'categories': [{'measurements': [{'value': '31.90', 'spread': '12.26', 'groupId': 'OG000'}, {'value': '17.28', 'spread': '8.86', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'The null hypothesis states that there is no difference between groups.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 50 grams of force are applied to hypersensitive tooth until pain elicited. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. For Tactile Hypersensitivity: The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitivity. Hypersensitivity scores on a per study subject basis are recorded as mean scores of two hypersensitive teeth', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Air Blast Hypersensitivity (4 Week)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'OG000'}, {'value': '312', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A-Experimental Toothpatse', 'description': 'fluoride/triclosan/silica dioxide toothpaste (Sensitive teeth formula)'}, {'id': 'OG001', 'title': 'B -Control Toothpaste', 'description': 'Fluoride/Triclosan control toothpaste'}], 'classes': [{'categories': [{'measurements': [{'value': '1.61', 'spread': '0.62', 'groupId': 'OG000'}, {'value': '2.18', 'spread': '0.60', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'The null hypothesis states that there is no difference between groups.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Examiner rates the response to stimulation of hypersensitive teeth using a jet of air (constant stimulus on the basis of duration, pressure, temperature, distance from target). Response is rated based on the Schiff Cold Air Sensitivity Scale.This analog scale scores for the tooth is 0,1,2 or 3:"0"No subject response to stimulus"1"responds but will continue"2"responds and moves or requests discontinuation"3"Painful response to stimulus, discontinuation requested. The lower the score, the lower the hypersensitivity.Scores per study subject are recorded as mean scores of two hypersensitive teeth.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Air Blast Hypersensitivity (8 Week)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'OG000'}, {'value': '312', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A-Experimental Toothpatse', 'description': 'fluoride/triclosan/silica dioxide toothpaste (Sensitive teeth formula)'}, {'id': 'OG001', 'title': 'B -Control Toothpaste', 'description': 'Fluoride/Triclosan control toothpaste'}], 'classes': [{'categories': [{'measurements': [{'value': '0.89', 'spread': '0.69', 'groupId': 'OG000'}, {'value': '1.80', 'spread': '0.72', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'The null hypothesis states that there is no difference between groups.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'Examiner rates the response to stimulation of hypersensitive teeth using a jet of air (constant stimulus on the basis of duration, pressure, temperature, distance from target). Response is rated based on the Schiff Cold Air Sensitivity Scale.This analog scale scores for the tooth is 0,1,2 or 3:"0"No subject response to stimulus"1"responds but will continue"2"responds and moves or requests discontinuation"3"Painful response to stimulus, discontinuation requested. The lower the score, the lower the hypersensitivity.Scores per study subject are recorded as mean scores of two hypersensitive teeth.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'A-Experimental Toothpatse', 'description': 'fluoride/triclosan/silica dioxide toothpaste (Sensitive teeth formula)'}, {'id': 'FG001', 'title': 'B -Control Toothpaste', 'description': 'Fluoride/Triclosan control toothpaste'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '314'}, {'groupId': 'FG001', 'numSubjects': '312'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '302'}, {'groupId': 'FG001', 'numSubjects': '299'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '13'}]}]}], 'recruitmentDetails': 'subjects were recruited by the PI at the clinical site', 'preAssignmentDetails': 'subjects were screened for medical and oral health criteria and then entered a 1 week washout before study treatment period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '626', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'A-Experimental Toothpatse', 'description': 'fluoride/triclosan/silica dioxide toothpaste (Sensitive teeth formula)'}, {'id': 'BG001', 'title': 'B -Control Toothpaste', 'description': 'Fluoride/Triclosan control toothpaste'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '301', 'groupId': 'BG000'}, {'value': '306', 'groupId': 'BG001'}, {'value': '607', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.6', 'spread': '13.4', 'groupId': 'BG000'}, {'value': '41.4', 'spread': '12.1', 'groupId': 'BG001'}, {'value': '41', 'spread': '12.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '226', 'groupId': 'BG000'}, {'value': '233', 'groupId': 'BG001'}, {'value': '459', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '167', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '314', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '626', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 626}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-05', 'studyFirstSubmitDate': '2008-09-26', 'resultsFirstSubmitDate': '2010-08-24', 'studyFirstSubmitQcDate': '2008-09-26', 'lastUpdatePostDateStruct': {'date': '2012-03-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-08-24', 'studyFirstPostDateStruct': {'date': '2008-09-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-09-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hypersensitivity Tactile(Yeaple Probe)', 'timeFrame': '4 weeks', 'description': 'Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 50 grams of force are applied to hypersensitive tooth until pain elicited. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. For Tactile Hypersensitivity: The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitivity. Hypersensitivity scores on a per study subject basis are recorded as mean scores of two hypersensitive teeth'}, {'measure': 'Hypersensitivity Tactile (Yeaple Probe)', 'timeFrame': '8 weeks', 'description': 'Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 50 grams of force are applied to hypersensitive tooth until pain elicited. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. For Tactile Hypersensitivity: The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitivity. Hypersensitivity scores on a per study subject basis are recorded as mean scores of two hypersensitive teeth'}], 'secondaryOutcomes': [{'measure': 'Air Blast Hypersensitivity (4 Week)', 'timeFrame': '4 weeks', 'description': 'Examiner rates the response to stimulation of hypersensitive teeth using a jet of air (constant stimulus on the basis of duration, pressure, temperature, distance from target). Response is rated based on the Schiff Cold Air Sensitivity Scale.This analog scale scores for the tooth is 0,1,2 or 3:"0"No subject response to stimulus"1"responds but will continue"2"responds and moves or requests discontinuation"3"Painful response to stimulus, discontinuation requested. The lower the score, the lower the hypersensitivity.Scores per study subject are recorded as mean scores of two hypersensitive teeth.'}, {'measure': 'Air Blast Hypersensitivity (8 Week)', 'timeFrame': '8 weeks', 'description': 'Examiner rates the response to stimulation of hypersensitive teeth using a jet of air (constant stimulus on the basis of duration, pressure, temperature, distance from target). Response is rated based on the Schiff Cold Air Sensitivity Scale.This analog scale scores for the tooth is 0,1,2 or 3:"0"No subject response to stimulus"1"responds but will continue"2"responds and moves or requests discontinuation"3"Painful response to stimulus, discontinuation requested. The lower the score, the lower the hypersensitivity.Scores per study subject are recorded as mean scores of two hypersensitive teeth.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Dentin Hypersensitivity']}, 'descriptionModule': {'briefSummary': 'Hypersensitivity'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female subjects, ages: 12 years or older.\n* Availability for the eight-week duration of the study.\n* Two sensitive teeth, which must be anterior to the molars, and demonstrate cervical erosion/abrasion or gingival recession.\n* Qualifying response to Tactile stimuli (Yeaple Probe) as defined by a score between 10-50 grams of force.\n* Qualifying response to the Air Blast stimuli as defined by a score of 2 or 3 on the Schiff Cold Air Sensitivity Scale.\n* Subjects need to satisfy the qualifying response to stimuli for both parameters assessed (Tactile or Air Blast) on at least two teeth to be entered into the study.\n* Good general health with no known allergies to products being tested.\n* Use of a non-desensitizing dentifrice for one month prior to entry into the study.\n* Signed Informed Consent Form.\n\nExclusion Criteria:\n\n* Gross oral pathology, chronic disease, or history of allergy to test products.\n* Advanced periodontal disease or treatment for periodontal disease (including surgery) within the past twelve months.\n* Sensitive teeth with a mobility greater than one.\n* Teeth with extensive/defective restorations (including prosthetic crowns), suspected pulpitis, caries, cracked enamel, or used as abutments for removable partial dentures.\n* Regular use of anticonvulsants, antihistamines, sedatives, tranquilizers, anti-inflammatory drugs, or analgesics.\n* Participation in a desensitizing dentifrice study or regular use of a desensitizing dentifrice within the past one month.\n* Current participation in any other clinical study.\n* Allergies to triclosan, or oral care products, personal care consumer products, or their ingredients.\n* Medical condition which prohibits not eating/drinking for 4 hours.'}, 'identificationModule': {'nctId': 'NCT00763269', 'briefTitle': 'The Efficacy of a Toothpaste to Reduce Sensitivity', 'organization': {'class': 'INDUSTRY', 'fullName': 'Colgate Palmolive'}, 'officialTitle': 'The Efficacy of a Toothpaste to Reduce Sensitivity', 'orgStudyIdInfo': {'id': 'CRO-0208-TOT-SEN-PR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'sensitive toothpaste', 'interventionNames': ['Drug: Triclosan, Silicon dioxide, fluoride']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'description': 'Triclosan control toothpaste', 'interventionNames': ['Drug: Triclosan, fluoride']}], 'interventions': [{'name': 'Triclosan, Silicon dioxide, fluoride', 'type': 'DRUG', 'description': 'Brush twice daily', 'armGroupLabels': ['A']}, {'name': 'Triclosan, fluoride', 'type': 'DRUG', 'description': 'Brush twice daily', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08225', 'city': 'Cedar Knolls', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Concordia Clinical Research', 'geoPoint': {'lat': 40.82204, 'lon': -74.44876}}], 'overallOfficials': [{'name': 'Augusto Elias, DDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Univ of Puerto Rico'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Colgate Palmolive', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}