Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2026-02-25 @ 8:59 PM
Study NCT ID:
NCT02773758
Status:
COMPLETED
Last Update Posted:
2017-09-29
First Post:
2016-05-12
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Investigate the Efficacy of an Occluding Dentifrice in Providing Relief From Dentine Hypersensitivity
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003807', 'term': 'Dentin Sensitivity'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From start of screening to 5 days following last administration of the study product (up to 39 days)', 'description': 'Safety population included 72 participants in treatment arm "stannous fluoride dentifrice" \\& 69 participants in treatment arm "sodium monofluorophosphate dentifrice".', 'eventGroups': [{'id': 'EG000', 'title': 'Stannous Fluoride Dentifrice', 'description': 'Participants were instructed to topically dose a dry toothbrush with a full strip of toothpaste, then brush each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute twice daily (morning and evening). Participants were permitted to rinse with tap water.', 'otherNumAtRisk': 72, 'deathsNumAtRisk': 72, 'otherNumAffected': 3, 'seriousNumAtRisk': 72, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sodium Monofluorophosphate Dentifrice', 'description': 'Participants were instructed to topically apply a full brush head of toothpaste to a dry toothbrush, then brush the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water.', 'otherNumAtRisk': 69, 'deathsNumAtRisk': 69, 'otherNumAffected': 0, 'seriousNumAtRisk': 69, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Schiff Sensitivity Score at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stannous Fluoride Dentifrice', 'description': 'Participants were instructed to dose a dry toothbrush with a full strip of toothpaste, then brush each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute twice daily (morning and evening). Participants were permitted to rinse with tap water.'}, {'id': 'OG001', 'title': 'Sodium Monofluorophosphate Dentifrice', 'description': 'Participants were instructed to apply a full brush head of toothpaste to a dry toothbrush, and then brush the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water.'}], 'classes': [{'title': 'At Baseline', 'categories': [{'measurements': [{'value': '2.70', 'spread': '0.427', 'groupId': 'OG000'}, {'value': '2.74', 'spread': '0.423', 'groupId': 'OG001'}]}]}, {'title': 'Change From Baseline at Day 14', 'categories': [{'measurements': [{'value': '-1.38', 'spread': '0.843', 'groupId': 'OG000'}, {'value': '-0.10', 'spread': '0.405', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square (LS) mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.29', 'ciLowerLimit': '-1.509', 'ciUpperLimit': '-1.071', 'estimateComment': 'Difference is first named dentifrice minus second named dentifrice such that a negative difference favours first named dentifrice.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'From ANCOVA model with change from baseline in Schiff Sensitivity Score as response and treatment and baseline Schiff sensitivity score as covariates.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 14', 'description': "Schiff Sensitivity Score is an examiner based index, was scored immediately following administration of the evaporative air stimulus by directing a maximum one second application of air from a dental air syringe to the exposed dentine surface from a distance of approximately 1 cm. The examiner indicated the participant's response to the evaporative air stimulus, after the stimulation of each individual tooth, using the Schiff sensitivity scale as follows: 0= participant does not respond to air stimulation; 1= participant responds to air stimulus but does not request discontinuation of stimulus; 2= participant responds to air stimulus and requests discontinuation or moves from stimulus; 3= participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis for this outcome was conducted on Intent-to-treat (ITT) population which included all participants who were randomized, received at least one dose of the study treatment and provided at least one post-baseline assessment of efficacy.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Schiff Sensitivity Score at Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stannous Fluoride Dentifrice', 'description': 'Participants were instructed to dose a dry toothbrush with a full strip of toothpaste, then brush each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute twice daily (morning and evening). Participants were permitted to rinse with tap water.'}, {'id': 'OG001', 'title': 'Sodium Monofluorophosphate Dentifrice', 'description': 'Participants were instructed to apply a full brush head of toothpaste to a dry toothbrush, and then brush the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water.'}], 'classes': [{'title': 'At Baseline', 'categories': [{'measurements': [{'value': '2.70', 'spread': '0.427', 'groupId': 'OG000'}, {'value': '2.74', 'spread': '0.423', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline at Week 7', 'categories': [{'measurements': [{'value': '-0.74', 'spread': '0.446', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '0.374', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 7', 'description': "Schiff Sensitivity Score is an examiner based index, was scored immediately following administration of the evaporative air stimulus by directing a maximum one second application of air from a dental air syringe to the exposed dentine surface from a distance of approximately 1 cm. The examiner indicated the participant's response to the evaporative air stimulus, after the stimulation of each individual tooth, using the Schiff sensitivity scale as follows: 0= participant does not respond to air stimulation; 1= participant responds to air stimulus but does not request discontinuation of stimulus; 2= participant responds to air stimulus and requests discontinuation or moves from stimulus; 3= participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received at least one dose of the study treatment and provided at least one post-baseline assessment of efficacy.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Tactile Threshold at Day 7 and Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stannous Fluoride Dentifrice', 'description': 'Participants were instructed to dose a dry toothbrush with a full strip of toothpaste, then brush each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute twice daily (morning and evening). Participants were permitted to rinse with tap water.'}, {'id': 'OG001', 'title': 'Sodium Monofluorophosphate Dentifrice', 'description': 'Participants were instructed to apply a full brush head of toothpaste to a dry toothbrush, and then brush the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water.'}], 'classes': [{'title': 'At Baseline', 'categories': [{'measurements': [{'value': '11.83', 'spread': '3.189', 'groupId': 'OG000'}, {'value': '11.50', 'spread': '2.992', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Day 7', 'categories': [{'measurements': [{'value': '5.92', 'spread': '6.113', 'groupId': 'OG000'}, {'value': '0.86', 'spread': '3.898', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Day 14', 'categories': [{'measurements': [{'value': '15.21', 'spread': '11.663', 'groupId': 'OG000'}, {'value': '0.86', 'spread': '3.708', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 7 and Day 14', 'description': "A tactile stimulus was administered using a constant pressure probe (Yeaple Probe). Response to this stimulus was evaluated as tactile threshold. The constant pressure probe allowed the examiner to vary the force applied to the dentine surface from 10 g to an upper threshold of 80 g in increments of 10 g. The tactile threshold is the maximum pressure applied without the participant's reporting pain or discomfort. The greater the tactile threshold, the less sensitive the tooth.", 'unitOfMeasure': 'gram (g)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received at least one dose of the study treatment and provided at least one post-baseline assessment of efficacy.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Stannous Fluoride Dentifrice', 'description': 'Participants were instructed to dose a dry toothbrush with a full strip of toothpaste containing 0.454% weight by weight (w/w) stannous fluoride (1100 parts per million \\[ppm\\] fluoride), then brush each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute twice daily (morning and evening). Participants were permitted to rinse with tap water.'}, {'id': 'FG001', 'title': 'Sodium Monofluorophosphate Dentifrice', 'description': 'Participants were instructed to apply a full brush head of toothpaste to a dry toothbrush containing 0.76% sodium monofluorophosphate (1000ppm fluoride), and then brush the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '70'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '70'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited at a single center in Canada.', 'preAssignmentDetails': 'A total of 143 participants were enrolled in the study. Out of which 141 participants were randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '141', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Stannous Fluoride Dentifrice', 'description': 'Participants were instructed to dose a dry toothbrush with a full strip of toothpaste containing 0.454% weight by weight (w/w) stannous fluoride (1100 parts per million \\[ppm\\] fluoride), then brush each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute twice daily (morning and evening). Participants were permitted to rinse with tap water.'}, {'id': 'BG001', 'title': 'Sodium Monofluorophosphate Dentifrice', 'description': 'Participants were instructed to apply a full brush head of toothpaste to a dry toothbrush containing 0.76% sodium monofluorophosphate (1000ppm fluoride), and then brush the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.7', 'spread': '10.27', 'groupId': 'BG000'}, {'value': '48.0', 'spread': '10.58', 'groupId': 'BG001'}, {'value': '47.9', 'spread': '10.39', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'One participant was randomized to sodium monofluorophosphate dentifrice but received stannous fluoride dentifrice, therefore, treatment arm "stannous fluoride dentifrice" included 72 participants \\& treatment arm "sodium monofluorophosphate dentifrice" included 69 participants.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 143}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2016-03-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-31', 'studyFirstSubmitDate': '2016-05-12', 'resultsFirstSubmitDate': '2016-10-17', 'studyFirstSubmitQcDate': '2016-05-12', 'lastUpdatePostDateStruct': {'date': '2017-09-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-10-17', 'studyFirstPostDateStruct': {'date': '2016-05-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-12-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Schiff Sensitivity Score at Day 14', 'timeFrame': 'Baseline, Day 14', 'description': "Schiff Sensitivity Score is an examiner based index, was scored immediately following administration of the evaporative air stimulus by directing a maximum one second application of air from a dental air syringe to the exposed dentine surface from a distance of approximately 1 cm. The examiner indicated the participant's response to the evaporative air stimulus, after the stimulation of each individual tooth, using the Schiff sensitivity scale as follows: 0= participant does not respond to air stimulation; 1= participant responds to air stimulus but does not request discontinuation of stimulus; 2= participant responds to air stimulus and requests discontinuation or moves from stimulus; 3= participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus."}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Schiff Sensitivity Score at Day 7', 'timeFrame': 'Baseline, Day 7', 'description': "Schiff Sensitivity Score is an examiner based index, was scored immediately following administration of the evaporative air stimulus by directing a maximum one second application of air from a dental air syringe to the exposed dentine surface from a distance of approximately 1 cm. The examiner indicated the participant's response to the evaporative air stimulus, after the stimulation of each individual tooth, using the Schiff sensitivity scale as follows: 0= participant does not respond to air stimulation; 1= participant responds to air stimulus but does not request discontinuation of stimulus; 2= participant responds to air stimulus and requests discontinuation or moves from stimulus; 3= participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus."}, {'measure': 'Change From Baseline in Tactile Threshold at Day 7 and Day 14', 'timeFrame': 'Baseline, Day 7 and Day 14', 'description': "A tactile stimulus was administered using a constant pressure probe (Yeaple Probe). Response to this stimulus was evaluated as tactile threshold. The constant pressure probe allowed the examiner to vary the force applied to the dentine surface from 10 g to an upper threshold of 80 g in increments of 10 g. The tactile threshold is the maximum pressure applied without the participant's reporting pain or discomfort. The greater the tactile threshold, the less sensitive the tooth."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Dentin Sensitivity']}, 'descriptionModule': {'briefSummary': 'This will be a single centre, two week, randomised, examiner blind, two treatment arm, parallel design, stratified (by maximum baseline Schiff sensitivity score of the two selected test teeth), controlled study, in participant with at least two sensitive teeth that meet the study criteria at the Screening and Baseline visits. The study will be conducted in participants in good general health, with pre-existing self-reported and clinically diagnosed tooth sensitivity at screening.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.\n* Aged 18-65 years inclusive.\n* Good general and mental health with:\n\nNo clinically significant and relevant abnormalities of medical history or oral examination.\n\nAbsence of any condition that would impact on the participant's safety or wellbeing or affect the individual's ability to understand and follow study procedures and requirements.\n\n* Self-reported history of dentinal hypersensitivity (DH) lasting more than six months but not more than 10 years.\n* Minimum of 20 natural teeth.\n* Minimum of 2 accessible non-adjacent teeth (incisors, canines, pre-molars), preferably in different quadrants, that meet all of the following criteria at screening: Signs of facial/cervical gingival recession and/or signs of erosion or abrasion (EAR).\n\nTooth with MGI score =0 adjacent to the test area (exposed dentine) only and a clinical mobility of ≤1.\n\nTooth with signs of sensitivity measured by qualifying evaporative air assessment (yes\\[Y\\]/No\\[N\\] response).\n\n* Minimum of two, non-adjacent accessible teeth (incisors, canines, pre-molars), that meet all of the following criteria at screening:\n\nTooth with signs of sensitivity, measured by response to a qualifying tactile stimulus (Yeaple ≤ 20g) and evaporative air assessment (Schiff sensitivity score ≥ 2).\n\nExclusion Criteria:\n\n* Women who are breast-feeding, known to be pregnant or who are intending to become pregnant over the duration of the study.\n* Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.\n* Previous participation in this study or participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit.\n* Recent history (within the last year) of alcohol or other substance abuse.\n* Presence of chronic debilitating disease which, in the opinion of the investigator, could affect study outcomes or causing xerostomia.\n* Dental prophylaxis within 4 weeks of Screening.\n* Tongue or lip piercing or presence of dental implants.\n* Gross periodontal disease, treatment of periodontal disease (including surgery) within 12 months of Screening, scaling or root planning within 3 months of Screening.\n* Teeth bleaching within 8 weeks of Screening.\n* Tooth with evidence of current or recent caries, or reported treatment of decay within 12 months of Screening.\n* Tooth with exposed dentine but with deep, defective or facial restorations, teeth used as abutments for fixed or removable partial dentures, teeth with full crowns or veneers, orthodontic bands or cracked enamel. Sensitive teeth with contributing aetiologies other than erosion, abrasion or recession of exposed dentine.\n* Sensitive tooth not expected to respond to treatment with an over-the-counter dentifrice.\n* Use of an oral care product indicated for the relief of dentine hypersensitivity within 8 weeks of screening.\n* Daily doses of medication/treatments which, in the opinion of the investigator, could interfere with the perception of pain.\n\nExamples of such medications include analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquilisers, anti-depressants, mood-altering and anti-inflammatory drugs.\n\n* Currently taking antibiotics or has taken antibiotics within 2 weeks of Baseline.\n* Daily dose of a medication which, in the opinion of the Investigator, is causing xerostomia."}, 'identificationModule': {'nctId': 'NCT02773758', 'briefTitle': 'Study to Investigate the Efficacy of an Occluding Dentifrice in Providing Relief From Dentine Hypersensitivity', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'Short Term Clinical Study Investigating the Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity', 'orgStudyIdInfo': {'id': '205201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stannous Fluoride Dentifrice', 'description': 'Participants will be instructed to topically dose a dry toothbrush with a full strip of toothpaste, then brush each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute twice daily (morning and evening). Participants will be permitted to rinse with tap water.', 'interventionNames': ['Other: Stannous Fluoride Dentifrice']}, {'type': 'OTHER', 'label': 'Sodium monofluorophosphate Dentifrice', 'description': 'Participants will be instructed to topically apply a full brush head of toothpaste to a dry toothbrush, then brush the whole mouth thoroughly for at least 1 minute. Participants will be permitted to rinse with tap water.', 'interventionNames': ['Other: Sodium monofluorophosphate Dentifrice']}], 'interventions': [{'name': 'Stannous Fluoride Dentifrice', 'type': 'OTHER', 'description': 'Experimental dentifrice containing 0.454%w/w stannous fluoride (1100ppm fluoride)', 'armGroupLabels': ['Stannous Fluoride Dentifrice']}, {'name': 'Sodium monofluorophosphate Dentifrice', 'type': 'OTHER', 'description': 'Dentifrice containing 0.76% w/w sodium monofluorophosphate (1000ppm fluoride)', 'armGroupLabels': ['Sodium monofluorophosphate Dentifrice']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L4W 0C2', 'city': 'Mississauga', 'state': 'Ontario', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 43.5789, 'lon': -79.6583}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}