Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2026-02-21 @ 11:17 PM
Study NCT ID:
NCT02548156
Status:
COMPLETED
Last Update Posted:
2017-01-18
First Post:
2015-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Intra Oral Kinetics of Fluoride Containing Dentifrices
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014077', 'term': 'Tooth Erosion'}], 'ancestors': [{'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D057085', 'term': 'Tooth Wear'}]}}, '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': {'eventGroups': [{'id': 'EG000', 'title': 'Test Dentifrice', 'description': '1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse', 'otherNumAtRisk': 28, 'otherNumAffected': 8, 'seriousNumAtRisk': 28, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Reference Dentifrice', 'description': '1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL water rinse', 'otherNumAtRisk': 29, 'otherNumAffected': 3, 'seriousNumAtRisk': 29, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Comparator Dentifrice', 'description': '1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse', 'otherNumAtRisk': 28, 'otherNumAffected': 5, 'seriousNumAtRisk': 28, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Chapped Lips', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Device failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Medical device complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Vaccination site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Infections and infestations'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Mouth injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Thermal burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Oropharyngeal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Concentrations of Fluoride Ions in Saliva 60 Minutes Post Brushing Prior to Administration of the Orange Juice or De-ionised Water Rinse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Dentifrice', 'description': '1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse'}, {'id': 'OG001', 'title': 'Reference Dentifrice', 'description': '1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL water rinse'}, {'id': 'OG002', 'title': 'Comparator Dentifrice', 'description': '1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse'}], 'classes': [{'categories': [{'measurements': [{'value': '0.23', 'spread': '0.0469', 'groupId': 'OG000'}, {'value': '0.23', 'spread': '0.0430', 'groupId': 'OG001'}, {'value': '0.15', 'spread': '0.0485', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'Ratio of LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.52', 'pValueComment': 'From ANCOVA of log transformed data: subject (random), treatment (fixed) and period (fixed) as factors, participant-level baseline and period-level baseline minus participant-level baseline as covariates.', 'estimateComment': 'Treatment difference from ANCOVA of log transformed data. This therefore represents the ratio of the first named treatment to the second named treatment. A ratio \\>1 favors the first named treatment.', 'groupDescription': 'Test and Reference dentifrice combined vs. Comparator dentifrice', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '60 minutes', 'description': 'Concentration of fluoride ions in saliva at 60 minutes after a single brushing with a fluoride dentifrice prior to rinsing with either de-ionised (DI) water or orange juice (OJ). Descriptive data is presented as least square (LS) mean and standard error (SE). SE for Fluoride is the SE of the raw mean.', 'unitOfMeasure': 'parts per million(ppm)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Per Protocol (PP) population was a subset of the ITT population (All randomized participants who had received study treatment and have at least one post-baseline efficacy measurement). n= number of participants analyzed for this outcome.'}, {'type': 'SECONDARY', 'title': 'Concentrations of Fluoride and Calcium Ions in Saliva Post Brushing Prior to Administration of Orange Juice or De-ionised Water Rinse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Dentifrice', 'description': '1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse'}, {'id': 'OG001', 'title': 'Reference Dentifrice', 'description': '1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL water rinse'}, {'id': 'OG002', 'title': 'Comparator Dentifrice', 'description': '1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse'}], 'classes': [{'title': 'Fluoride: At baseline (n=26, 28, 26)', 'categories': [{'measurements': [{'value': '0.045', 'spread': '0.0125', 'groupId': 'OG000'}, {'value': '0.032', 'spread': '0.0084', 'groupId': 'OG001'}, {'value': '0.031', 'spread': '0.0072', 'groupId': 'OG002'}]}]}, {'title': 'Fluoride: At 1 minute (n=27, 28, 26)', 'categories': [{'measurements': [{'value': '8.775', 'spread': '0.8301', 'groupId': 'OG000'}, {'value': '8.794', 'spread': '1.0562', 'groupId': 'OG001'}, {'value': '7.630', 'spread': '0.7497', 'groupId': 'OG002'}]}]}, {'title': 'Fluoride: At 5 minute (n=27, 27, 27)', 'categories': [{'measurements': [{'value': '3.881', 'spread': '0.4115', 'groupId': 'OG000'}, {'value': '4.132', 'spread': '0.4759', 'groupId': 'OG001'}, {'value': '3.492', 'spread': '0.4664', 'groupId': 'OG002'}]}]}, {'title': 'Fluoride: At 10 minute (n=26, 26, 26)', 'categories': [{'measurements': [{'value': '1.831', 'spread': '0.1980', 'groupId': 'OG000'}, {'value': '1.951', 'spread': '0.2654', 'groupId': 'OG001'}, {'value': '1.476', 'spread': '0.1524', 'groupId': 'OG002'}]}]}, {'title': 'Fluoride: At 15 minute (n=27, 27, 26)', 'categories': [{'measurements': [{'value': '1.346', 'spread': '0.1827', 'groupId': 'OG000'}, {'value': '1.188', 'spread': '0.1550', 'groupId': 'OG001'}, {'value': '0.942', 'spread': '0.1432', 'groupId': 'OG002'}]}]}, {'title': 'Fluoride: At 30 minute (n=26, 27, 27)', 'categories': [{'measurements': [{'value': '0.656', 'spread': '0.1065', 'groupId': 'OG000'}, {'value': '0.600', 'spread': '0.0810', 'groupId': 'OG001'}, {'value': '0.479', 'spread': '0.0723', 'groupId': 'OG002'}]}]}, {'title': 'Calcium: At Baseline (n=26, 25, 22)', 'categories': [{'measurements': [{'value': '29.749', 'spread': '0.9428', 'groupId': 'OG000'}, {'value': '28.357', 'spread': '1.0162', 'groupId': 'OG001'}, {'value': '28.661', 'spread': '1.0657', 'groupId': 'OG002'}]}]}, {'title': 'Calcium: At 1 minute (n=23, 28, 25)', 'categories': [{'measurements': [{'value': '28.300', 'spread': '1.5171', 'groupId': 'OG000'}, {'value': '27.217', 'spread': '1.0689', 'groupId': 'OG001'}, {'value': '14.931', 'spread': '1.0999', 'groupId': 'OG002'}]}]}, {'title': 'Calcium: At 5 minute (n=16, 17, 22)', 'categories': [{'measurements': [{'value': '27.818', 'spread': '1.3743', 'groupId': 'OG000'}, {'value': '26.070', 'spread': '1.4638', 'groupId': 'OG001'}, {'value': '17.227', 'spread': '0.9170', 'groupId': 'OG002'}]}]}, {'title': 'Calcium: At 10 minute (n=16, 16, 21)', 'categories': [{'measurements': [{'value': '27.472', 'spread': '1.0061', 'groupId': 'OG000'}, {'value': '25.672', 'spread': '1.1944', 'groupId': 'OG001'}, {'value': '20.133', 'spread': '1.0395', 'groupId': 'OG002'}]}]}, {'title': 'Calcium: At 15 minute (n=18, 20, 20)', 'categories': [{'measurements': [{'value': '28.319', 'spread': '1.0783', 'groupId': 'OG000'}, {'value': '27.227', 'spread': '0.8656', 'groupId': 'OG001'}, {'value': '23.761', 'spread': '1.2803', 'groupId': 'OG002'}]}]}, {'title': 'Calcium: At 30 minute (n=17, 18, 20)', 'categories': [{'measurements': [{'value': '28.650', 'spread': '1.0725', 'groupId': 'OG000'}, {'value': '27.323', 'spread': '1.0325', 'groupId': 'OG001'}, {'value': '24.196', 'spread': '1.3196', 'groupId': 'OG002'}]}]}, {'title': 'Calcium: At 60 minute (n=23, 20, 22)', 'categories': [{'measurements': [{'value': '28.198', 'spread': '1.0073', 'groupId': 'OG000'}, {'value': '27.094', 'spread': '1.0560', 'groupId': 'OG001'}, {'value': '27.104', 'spread': '1.3777', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 60 minutes', 'description': 'Concentration of fluoride and calcium ions in saliva at baseline, 1, 5, 10, 15, 30 and 60 minutes (for calcium only) after a single brushing with a fluoride dentifrice', 'unitOfMeasure': 'ppm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Per Protocol (PP) population was a subset of the ITT population (All randomized participants who had received study treatment and have at least one post-baseline efficacy measurement). n= number of participants analyzed for this outcome.'}, {'type': 'SECONDARY', 'title': 'Concentrations of Fluoride and Calcium Ions in Saliva Following Administration of the Orange Juice or De-ionised Water Rinse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Dentifrice', 'description': '1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse'}, {'id': 'OG001', 'title': 'Reference Dentifrice', 'description': '1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL water rinse'}, {'id': 'OG002', 'title': 'Comparator Dentifrice', 'description': '1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse'}], 'classes': [{'title': 'Fluoride Ion concentration(n=27, 28, 27)', 'categories': [{'measurements': [{'value': '0.349', 'spread': '0.0349', 'groupId': 'OG000'}, {'value': '0.169', 'spread': '0.1104', 'groupId': 'OG001'}, {'value': '0.277', 'spread': '0.1601', 'groupId': 'OG002'}]}]}, {'title': 'Calcium Ion concentration (n=26, 22, 25)', 'categories': [{'measurements': [{'value': '15.015', 'spread': '4.3355', 'groupId': 'OG000'}, {'value': '27.263', 'spread': '4.7113', 'groupId': 'OG001'}, {'value': '14.805', 'spread': '4.0473', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '60 minutes', 'description': 'Concentration of fluoride and calcium ions in saliva following a rinse with either de ionised water or OJ 60 minutes after a single brushing with a fluoride dentifrice', 'unitOfMeasure': 'ppm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Per Protocol (PP) population was a subset of the ITT population (All randomized participants who had received study treatment and have at least one post-baseline efficacy measurement). n= number of participants analyzed for this outcome.'}, {'type': 'SECONDARY', 'title': 'Concentrations of Fluoride and Calcium Ions in the Initial Expectorate, De-ionised Water Rinse Post Brushing Expectorate, and 60 Minutes Post Brushing Following Administration of Orange Juice or De-ionised Water Rinse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Dentifrice', 'description': '1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse'}, {'id': 'OG001', 'title': 'Reference Dentifrice', 'description': '1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL water rinse'}, {'id': 'OG002', 'title': 'Comparator Dentifrice', 'description': '1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse'}], 'classes': [{'title': 'Fluoride: In initial expectorate', 'categories': [{'measurements': [{'value': '178.522', 'spread': '61.1593', 'groupId': 'OG000'}, {'value': '168.728', 'spread': '54.3780', 'groupId': 'OG001'}, {'value': '164.708', 'spread': '54.2632', 'groupId': 'OG002'}]}]}, {'title': 'Fluoride: Post-Brushing De-Ionised Water Rinse Ex', 'categories': [{'measurements': [{'value': '8.377', 'spread': '4.2346', 'groupId': 'OG000'}, {'value': '7.721', 'spread': '4.1721', 'groupId': 'OG001'}, {'value': '7.443', 'spread': '3.4546', 'groupId': 'OG002'}]}]}, {'title': 'Fluoride: 60 Minutes Post Brushing', 'categories': [{'measurements': [{'value': '0.166', 'spread': '0.0609', 'groupId': 'OG000'}, {'value': '0.046', 'spread': '0.0370', 'groupId': 'OG001'}, {'value': '0.135', 'spread': '0.0563', 'groupId': 'OG002'}]}]}, {'title': 'Calcium: In initial expectorate', 'categories': [{'measurements': [{'value': '17.096', 'spread': '4.7864', 'groupId': 'OG000'}, {'value': '17.467', 'spread': '4.1241', 'groupId': 'OG001'}, {'value': '2.500', 'spread': '0.0000', 'groupId': 'OG002'}]}]}, {'title': 'Calcium: Post-Brushing De-Ionised Water Rinse Ex', 'categories': [{'measurements': [{'value': '4.959', 'spread': '2.2712', 'groupId': 'OG000'}, {'value': '4.438', 'spread': '2.2141', 'groupId': 'OG001'}, {'value': '2.500', 'spread': '0.0000', 'groupId': 'OG002'}]}]}, {'title': 'Calcium: 60 Minutes Post Brushing', 'categories': [{'measurements': [{'value': '96.165', 'spread': '9.2357', 'groupId': 'OG000'}, {'value': '4.600', 'spread': '2.0507', 'groupId': 'OG001'}, {'value': '99.189', 'spread': '17.2771', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 60 minutes', 'description': 'Concentration of fluoride and calcium ions in the initial expectorate, de-ionized water rinse post brushing expectorate, and 60 minutes post brushing following administration of orange juice or de-ionised water rinse', 'unitOfMeasure': 'ppm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Per Protocol (PP) population was a subset of the ITT population (All randomized participants who had received study treatment and have at least one post-baseline efficacy measurement). n= number of participants analyzed for this outcome.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sequence 1: Test/Comparator/Reference: Dentifrice', 'description': 'Firstly 1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; secondly 1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; thirdly 1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL DI water rinse were given to participants in Period 1, Period 2 and Period 3 respectively. Each period was separated by washout period of 7+/-1 day.'}, {'id': 'FG001', 'title': 'Sequence 2: Test/Reference/Comparator: Dentifrice', 'description': 'Firstly 1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; secondly 1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL DI water rinse; thirdly 1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse were given to participants in Period 1, Period 2 and Period 3 respectively. Each period was separated by washout period of 7+/-1 day.'}, {'id': 'FG002', 'title': 'Sequence 3: Comparator/Test/Reference: Dentifrice', 'description': 'Firstly 1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; secondly 1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; thirdly 1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL DI water rinse were given to participants in Period 1, Period 2 and Period 3 respectively. Each period was separated by washout period of 7+/-1 day.'}, {'id': 'FG003', 'title': 'Sequence 4: Comparator/Reference/Test: Dentifrice', 'description': 'Firstly 1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; secondly 1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL DI water rinse; thirdly 1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse were given to participants in Period 1, Period 2 and Period 3 respectively. Each period was separated by washout period of 7+/-1 day.'}, {'id': 'FG004', 'title': 'Sequence 5: Reference/Test/Comparator: Dentifrice', 'description': 'Firstly 1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL DI water rinse; secondly 1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; thirdly 1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse were given to participants in Period 1, Period 2 and Period 3 respectively. Each period was separated by washout period of 7+/-1 day.'}, {'id': 'FG005', 'title': 'Sequence 6: Reference/Comparator/Test: Dentifrice', 'description': 'Firstly 1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL DI water rinse; secondly 1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; thirdly 1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse were given to participants in Period 1, Period 2 and Period 3 respectively. Each period was separated by washout period of 7+/-1 day.'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Washout Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Washout Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Period 3', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited at one Centre United Kingdom.', 'preAssignmentDetails': 'A total of 59 participants were screened, out of which 29 were randomized. Of the 29 randomized participants, 28 completed the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall Study', 'description': 'All the participants randomized in this study.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34.8', 'spread': '9.12', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-16', 'studyFirstSubmitDate': '2015-09-10', 'resultsFirstSubmitDate': '2016-06-16', 'studyFirstSubmitQcDate': '2015-09-10', 'lastUpdatePostDateStruct': {'date': '2017-01-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-06-16', 'studyFirstPostDateStruct': {'date': '2015-09-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-07-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Concentrations of Fluoride Ions in Saliva 60 Minutes Post Brushing Prior to Administration of the Orange Juice or De-ionised Water Rinse', 'timeFrame': '60 minutes', 'description': 'Concentration of fluoride ions in saliva at 60 minutes after a single brushing with a fluoride dentifrice prior to rinsing with either de-ionised (DI) water or orange juice (OJ). Descriptive data is presented as least square (LS) mean and standard error (SE). SE for Fluoride is the SE of the raw mean.'}], 'secondaryOutcomes': [{'measure': 'Concentrations of Fluoride and Calcium Ions in Saliva Post Brushing Prior to Administration of Orange Juice or De-ionised Water Rinse', 'timeFrame': 'up to 60 minutes', 'description': 'Concentration of fluoride and calcium ions in saliva at baseline, 1, 5, 10, 15, 30 and 60 minutes (for calcium only) after a single brushing with a fluoride dentifrice'}, {'measure': 'Concentrations of Fluoride and Calcium Ions in Saliva Following Administration of the Orange Juice or De-ionised Water Rinse', 'timeFrame': '60 minutes', 'description': 'Concentration of fluoride and calcium ions in saliva following a rinse with either de ionised water or OJ 60 minutes after a single brushing with a fluoride dentifrice'}, {'measure': 'Concentrations of Fluoride and Calcium Ions in the Initial Expectorate, De-ionised Water Rinse Post Brushing Expectorate, and 60 Minutes Post Brushing Following Administration of Orange Juice or De-ionised Water Rinse', 'timeFrame': 'up to 60 minutes', 'description': 'Concentration of fluoride and calcium ions in the initial expectorate, de-ionized water rinse post brushing expectorate, and 60 minutes post brushing following administration of orange juice or de-ionised water rinse'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Tooth Erosion']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess the impact of formulation differences on fluoride retention clearance with US levels of fluoride (1150 ppm of fluoride) by evaluating and comparing between treatments the concentrations of fluoride and calcium ions in saliva over 60 minutes after a single brushing with US marketed fluoridated dentifrices and following a dietary acid challenge post 60 minutes of brushing with study treatment.'}, '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\n* Understands and is willing, able and likely to comply with all study procedures and restrictions\n* Good general and mental health with, in the opinion of the investigator or medically qualified designee:\n\n 1. No clinically significant and relevant abnormalities of medical history or oral examination\n 2. Absence of any condition that would impact on the participant's safety or well being or affect the individual's ability to understand and follow study procedures and requirements\n* A minimum of 20 permanent natural teeth\n* A gum-base stimulated whole saliva flow rate ≥ 0.8 mL/min and an unstimulated whole saliva flow rate ≥ 0.5 mL/min.\n\nExclusion Criteria:\n\n* Pregnant or breast feeding women\n* Presence of chronic debilitating disease.\n* Any condition that causes xerostomia as determined by the Investigator.\n* Evidence of untreated caries.\n* Gross periodontal disease.\n* Tongue or lip piercing or presence of dental implants. Professional tooth cleaning or dental treatment during study. Oral surgery or extraction within 6 weeks of the screening visit.\n* Self reported oral symptoms including lesions, sores or inflammation\n* Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients\n* Currently taking antibiotics or have taken antibiotics within 2 weeks of the screening visit\n* Any medication that could affect salivary flow or cause xerostomia as determined by the Investigator\n* Use of multivitamins, calcium supplements and or fluoride supplements within 7 days of treatment phase\n* Participant unwilling to abstain from smoking for at least 4 hours on the day of each test visit\n* Recent history (within the last year) of alcohol or other substance abuse."}, 'identificationModule': {'nctId': 'NCT02548156', 'briefTitle': 'Intra Oral Kinetics of Fluoride Containing Dentifrices', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'Intra-oral Kinetics of Fluoride Containing Dentifrices in a Modified Saliva Clearance Study', 'orgStudyIdInfo': {'id': '204777'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Test dentifrice', 'description': '1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse', 'interventionNames': ['Other: Test Dentifrice', 'Other: Orange Juice', 'Other: De-ionised water']}, {'type': 'OTHER', 'label': 'Reference dentifrice', 'description': '1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL water rinse', 'interventionNames': ['Other: Reference Dentifrice', 'Other: De-ionised water']}, {'type': 'OTHER', 'label': 'Comparator dentifrice', 'description': '1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse', 'interventionNames': ['Other: Comparator Dentifrice', 'Other: Orange Juice', 'Other: De-ionised water']}], 'interventions': [{'name': 'Test Dentifrice', 'type': 'OTHER', 'description': 'Marketed dentifrice containing 1150ppm fluoride and 5% w/w KNO3', 'armGroupLabels': ['Test dentifrice']}, {'name': 'Reference Dentifrice', 'type': 'OTHER', 'description': 'Marketed dentifrice containing 1150ppm fluoride and 5% w/w KNO3', 'armGroupLabels': ['Reference dentifrice']}, {'name': 'Comparator Dentifrice', 'type': 'OTHER', 'description': 'Marketed dentifrice containing 1150ppm fluoride and 5% w/w KNO3', 'armGroupLabels': ['Comparator dentifrice']}, {'name': 'Orange Juice', 'type': 'OTHER', 'description': 'Teeth will be rinsed with orange juice followed by rinsing with de-ionised water in test dentifrice and comparator dentifrice arms.', 'armGroupLabels': ['Comparator dentifrice', 'Test dentifrice']}, {'name': 'De-ionised water', 'type': 'OTHER', 'description': 'Teeth will be rinsed with de-ionised water followed by reference dentifrice and followed by rinsing with orange juice in test dentifrice and comparator dentifrice arms.', 'armGroupLabels': ['Comparator dentifrice', 'Reference dentifrice', 'Test dentifrice']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CH65 4BW', 'city': 'Ellesmere Port', 'state': 'Cheshire', 'country': 'United Kingdom', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 53.27875, 'lon': -2.90134}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}