Ignite Creation Date:
2025-12-24 @ 1:19 PM
Ignite Modification Date:
2026-01-04 @ 12:15 AM
Study NCT ID:
NCT02360995
Status:
COMPLETED
Last Update Posted:
2016-03-30
First Post:
2015-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Clinical Investigation of Toothpaste as Compared to Toothpaste and Mouthwash in Reducing Plaque and Gingivitis: A Six-week Clinical Study in the US
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003773', 'term': 'Dental Plaque'}, {'id': 'D005891', 'term': 'Gingivitis'}], 'ancestors': [{'id': 'D003741', 'term': 'Dental Deposits'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D005882', 'term': 'Gingival Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014260', 'term': 'Triclosan'}, {'id': 'C546060', 'term': 'hydrated silica gel-based toothpaste'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'yli@llu.edu', 'phone': '909-558-8069', 'title': 'Yiming Li, DDS', 'organization': 'Loma Linda University School of Dentistry'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline, 4 and 6 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Total Toothpaste', 'description': 'Triclosan/fluoride toothpaste\n\nTriclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (study duration).', 'otherNumAtRisk': 43, 'otherNumAffected': 0, 'seriousNumAtRisk': 43, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Toothpaste + Mouthwash', 'description': 'Stannous fluoride toothpaste \\& cetylpyridinium chloride Mouthwash\n\nstannous fluoride toothpaste \\& cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest Pro-Health Mouthrinse for 30 seconds each time.', 'otherNumAtRisk': 43, 'otherNumAffected': 0, 'seriousNumAtRisk': 43, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Control Group', 'description': 'fluoride toothpaste +fluoride mouthwash\n\nfluoride toothpaste + fluoride mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest fluoride Mouthrinse for 30 seconds each time.', 'otherNumAtRisk': 43, 'otherNumAffected': 0, 'seriousNumAtRisk': 43, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Dental Plaque Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Toothpaste', 'description': 'Triclosan/fluoride toothpaste\n\nTriclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (study duration).'}, {'id': 'OG001', 'title': 'Toothpaste + Mouthwash', 'description': 'Stannous fluoride toothpaste \\& cetylpyridinium chloride Mouthwash\n\nstannous fluoride toothpaste \\& cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest Pro-Health Mouthrinse for 30 seconds each time.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'fluoride toothpaste +fluoride mouthwash\n\nfluoride toothpaste + fluoride mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest fluoride Mouthrinse for 30 seconds each time.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.91', 'spread': '0.31', 'groupId': 'OG000'}, {'value': '3.86', 'spread': '0.45', 'groupId': 'OG001'}, {'value': '3.84', 'spread': '0.23', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.652', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'The null hypothesis states that there is no difference between groups.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Dental Plaque Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Toothpaste', 'description': 'Triclosan/fluoride toothpaste\n\nTriclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (study duration).'}, {'id': 'OG001', 'title': 'Toothpaste + Mouthwash', 'description': 'Stannous fluoride toothpaste \\& cetylpyridinium chloride Mouthwash\n\nstannous fluoride toothpaste \\& cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest Pro-Health Mouthrinse for 30 seconds each time.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'fluoride toothpaste +fluoride mouthwash\n\nfluoride toothpaste + fluoride mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest fluoride Mouthrinse for 30 seconds each time.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.42', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '3.69', 'spread': '0.06', 'groupId': 'OG001'}, {'value': '3.73', 'spread': '0.06', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', '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': 'Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Dental Plaque Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Toothpaste', 'description': 'Triclosan/fluoride toothpaste\n\nTriclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (study duration).'}, {'id': 'OG001', 'title': 'Toothpaste + Mouthwash', 'description': 'Stannous fluoride toothpaste \\& cetylpyridinium chloride Mouthwash\n\nstannous fluoride toothpaste \\& cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest Pro-Health Mouthrinse for 30 seconds each time.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'fluoride toothpaste +fluoride mouthwash\n\nfluoride toothpaste + fluoride mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest fluoride Mouthrinse for 30 seconds each time.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.05', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '1.15', 'spread': '0.04', 'groupId': 'OG001'}, {'value': '1.24', 'spread': '0.04', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'The null hypothesis states that there is no difference between groups.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': 'Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Gingivitis Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Toothpaste', 'description': 'Triclosan/fluoride toothpaste\n\nTriclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (study duration).'}, {'id': 'OG001', 'title': 'Toothpaste + Mouthwash', 'description': 'Stannous fluoride toothpaste \\& cetylpyridinium chloride Mouthwash\n\nstannous fluoride toothpaste \\& cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest Pro-Health Mouthrinse for 30 seconds each time.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'fluoride toothpaste +fluoride mouthwash\n\nfluoride toothpaste + fluoride mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest fluoride Mouthrinse for 30 seconds each time.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.38', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '1.35', 'spread': '0.24', 'groupId': 'OG001'}, {'value': '1.41', 'spread': '0.24', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.533', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'The null hypothesis states that there is no difference between groups.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Gingivitis scale (Loe \\& Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Gingivitis Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Toothpaste', 'description': 'Triclosan/fluoride toothpaste\n\nTriclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (study duration).'}, {'id': 'OG001', 'title': 'Toothpaste + Mouthwash', 'description': 'Stannous fluoride toothpaste \\& cetylpyridinium chloride Mouthwash\n\nstannous fluoride toothpaste \\& cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest Pro-Health Mouthrinse for 30 seconds each time.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'fluoride toothpaste +fluoride mouthwash\n\nfluoride toothpaste + fluoride mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest fluoride Mouthrinse for 30 seconds each time.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.15', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '1.20', 'spread': '0.04', 'groupId': 'OG001'}, {'value': '1.30', 'spread': '0.04', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', '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': 'Gingivitis scale (Loe \\& Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Gingivitis Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Toothpaste', 'description': 'Triclosan/fluoride toothpaste\n\nTriclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (study duration).'}, {'id': 'OG001', 'title': 'Toothpaste + Mouthwash', 'description': 'Stannous fluoride toothpaste \\& cetylpyridinium chloride Mouthwash\n\nstannous fluoride toothpaste \\& cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest Pro-Health Mouthrinse for 30 seconds each time.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'fluoride toothpaste +fluoride mouthwash\n\nfluoride toothpaste + fluoride mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest fluoride Mouthrinse for 30 seconds each time.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.05', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '1.15', 'spread': '0.04', 'groupId': 'OG001'}, {'value': '1.24', 'spread': '0.04', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'The null hypothesis states that there is no difference between groups.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': 'Gingivitis scale (Loe \\& Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Total Toothpaste', 'description': 'Triclosan/fluoride toothpaste\n\nTriclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (study duration).'}, {'id': 'FG001', 'title': 'Toothpaste + Mouthwash', 'description': 'Stannous fluoride toothpaste \\& cetylpyridinium chloride Mouthwash\n\nstannous fluoride toothpaste \\& cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest Pro-Health Mouthrinse for 30 seconds each time.'}, {'id': 'FG002', 'title': 'Control Group', 'description': 'fluoride toothpaste +fluoride mouthwash\n\nfluoride toothpaste + fluoride mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest fluoride Mouthrinse for 30 seconds each time.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '43'}, {'groupId': 'FG002', 'numSubjects': '43'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '42'}, {'groupId': 'FG002', 'numSubjects': '41'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subject recruitment is completed locally by the clinical site', 'preAssignmentDetails': 'There is no wash out or pre-assignment of any study product.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '129', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Total Toothpaste', 'description': 'Triclosan/fluoride toothpaste\n\nTriclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (study duration).'}, {'id': 'BG001', 'title': 'Toothpaste + Mouthwash', 'description': 'Stannous fluoride toothpaste \\& cetylpyridinium chloride Mouthwash\n\nstannous fluoride toothpaste \\& cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest Pro-Health Mouthrinse for 30 seconds each time.'}, {'id': 'BG002', 'title': 'Control Group', 'description': 'fluoride toothpaste +fluoride mouthwash\n\nfluoride toothpaste + fluoride mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest fluoride Mouthrinse for 30 seconds each time.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.68', 'spread': '16.85', 'groupId': 'BG000'}, {'value': '44.90', 'spread': '15.51', 'groupId': 'BG001'}, {'value': '44.39', 'spread': '13.68', 'groupId': 'BG002'}, {'value': '44.47', 'spread': '15.26', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '57', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '129', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 129}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-29', 'studyFirstSubmitDate': '2015-02-06', 'resultsFirstSubmitDate': '2016-02-01', 'studyFirstSubmitQcDate': '2015-02-06', 'lastUpdatePostDateStruct': {'date': '2016-03-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-02-29', 'studyFirstPostDateStruct': {'date': '2015-02-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-03-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dental Plaque Scores', 'timeFrame': 'Baseline', 'description': 'Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)'}, {'measure': 'Dental Plaque Scores', 'timeFrame': '4 weeks', 'description': 'Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)'}, {'measure': 'Dental Plaque Scores', 'timeFrame': '6 weeks', 'description': 'Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)'}, {'measure': 'Gingivitis Scores', 'timeFrame': 'Baseline', 'description': 'Gingivitis scale (Loe \\& Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)'}, {'measure': 'Gingivitis Scores', 'timeFrame': '4 weeks', 'description': 'Gingivitis scale (Loe \\& Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)'}, {'measure': 'Gingivitis Scores', 'timeFrame': '6 weeks', 'description': 'Gingivitis scale (Loe \\& Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Dental Plaque', 'Gingivitis']}, 'descriptionModule': {'briefSummary': 'The objective of this clinical research study is to evaluate clinical efficacy of Colgate Total Toothpaste as compared to Crest Pro-Health Toothpaste and Crest Pro-Health Mouthwash, and Crest Cavity Protection Toothpaste and Crest Fluoride Mouthwash in reducing gingivitis and dental plaque in adults in a six-week clinical study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects, ages 18-70, inclusive.\n2. Availability for the six-week duration of the clinical research study.\n3. Good general health.\n4. Minimum of 20 uncrowned permanent natural teeth (excluding third molars).\n5. Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index.\n6. Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification).\n7. Signed Informed Consent Form\n\nExclusion Criteria:\n\n1. Presence of orthodontic bands.\n2. Presence of partial removable dentures.\n3. Tumor(s) of the soft or hard tissues of the oral cavity.\n4. Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone).\n5. Five or more carious lesions requiring immediate restorative treatment.\n6. Antibiotic use any time during the one month prior to entry into the study.\n7. Participation in any other clinical study or test panel within the one month prior to entry into the study.\n8. Dental prophylaxis during the past two weeks prior to baseline examinations.\n9. History of allergies to oral care/personal care consumer products or their ingredients.\n10. On any prescription medicines that might interfere with the study outcome.\n11. An existing medical condition which prohibits eating or drinking for periods up to 4 hours.\n12. History of alcohol or drug abuse.\n13. Pregnant or lactating subjects.'}, 'identificationModule': {'nctId': 'NCT02360995', 'briefTitle': 'The Clinical Investigation of Toothpaste as Compared to Toothpaste and Mouthwash in Reducing Plaque and Gingivitis: A Six-week Clinical Study in the US', 'organization': {'class': 'INDUSTRY', 'fullName': 'Colgate Palmolive'}, 'officialTitle': 'The Clinical Investigation of Colgate Total Toothpaste as Compared to Crest Pro-Health Toothpaste and Crest Pro-Health Mouthwash, and Crest Cavity Protection Toothpaste and Crest Fluoride Mouthwash in Reducing Plaque and Gingivitis: A Six-week Clinical Study in the US', 'orgStudyIdInfo': {'id': 'CRO-2014-06-PLAGIN-CT-YPZ'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Total Toothpaste', 'description': 'Triclosan/fluoride toothpaste', 'interventionNames': ['Drug: Triclosan/fluoride toothpaste']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Toothpaste + Mouthwash', 'description': 'Stannous fluoride toothpaste \\& cetylpyridinium chloride Mouthwash', 'interventionNames': ['Drug: stannous fluoride toothpaste', 'Drug: cetylpyridinium chloride Mouthwash']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'fluoride toothpaste +fluoride mouthwash', 'interventionNames': ['Drug: fluoride toothpaste', 'Drug: Fluoride Mouthwash']}], 'interventions': [{'name': 'Triclosan/fluoride toothpaste', 'type': 'DRUG', 'otherNames': ['Total toothpaste'], 'description': 'Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (study duration).', 'armGroupLabels': ['Total Toothpaste']}, {'name': 'stannous fluoride toothpaste', 'type': 'DRUG', 'otherNames': ['Crest Pro-Health toothpaste'], 'description': 'Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 weeks (study duration).', 'armGroupLabels': ['Toothpaste + Mouthwash']}, {'name': 'fluoride toothpaste', 'type': 'DRUG', 'otherNames': ['Crest Cavity Protection toothpaste'], 'description': 'Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 weeks (study duration).', 'armGroupLabels': ['Control group']}, {'name': 'Fluoride Mouthwash', 'type': 'DRUG', 'otherNames': ['Crest Pro-Health For Me Breezy Mint mouthwash'], 'description': 'Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest fluoride Mouthrinse for 30 seconds each time.', 'armGroupLabels': ['Control group']}, {'name': 'cetylpyridinium chloride Mouthwash', 'type': 'DRUG', 'otherNames': ['Crest Pro-Health Multi-Protection mouthwash'], 'description': 'Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest Pro-Health Mouthrinse for 30 seconds each time.', 'armGroupLabels': ['Toothpaste + Mouthwash']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92350', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Loma Linda University', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}], 'overallOfficials': [{'name': 'Yimimg Li, DDS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Loma Linda University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Colgate Palmolive', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}