Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2025-12-28 @ 8:09 AM
Study NCT ID:
NCT04601103
Status:
TERMINATED
Last Update Posted:
2024-10-01
First Post:
2020-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
3M Oral Rinse Incidence and Patient Acceptance of Sloughing When Used With Sodium Lauryl Sulfate (SLS) Toothpastes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-10-18', 'type': 'ACTUAL'}}}}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bccoalwell1@mmm.com', 'phone': '16517362456', 'title': 'Brenda Coalwell, Clinical Affairs Manager', 'organization': '3M Health Care Business Group'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'The major limitation with this study is that the sample size goal was not reached given the early termination during the washout period of a two-period crossover design.'}}, 'adverseEventsModule': {'timeFrame': 'Within 3 weeks of starting treatment', 'eventGroups': [{'id': 'EG000', 'title': 'Comparator: No SLS Toothpaste', 'description': '3M Oral Rinse in combination with no SLS toothpaste (A)\n\nNo SLS toothpaste: Toothpaste no Sodium Lauryl Phosphate\n\nAnti-plaque: Rinse prevents bacterial adherence to teeth', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 15, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Comparator: Medium SLS Toothpaste', 'description': '3M Oral Rinse in combination with medium SLS toothpaste (B)\n\nMedium SLS toothpaste: Less than or equal to X ppm Sodium Lauryl Phosphate\n\nAnti-plaque: Rinse prevents bacterial adherence to teeth', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 15, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Comparator: High SLS Toothpaste', 'description': '3M Oral Rinse in combination with high SLS toothpaste (C)\n\nHigh SLS toothpaste: More than or equal to X ppm Sodium Lauryl Phosphate\n\nAnti-plaque: Rinse prevents bacterial adherence to teeth', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 16, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Aphthous ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Breath odor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Buccal mucosal roughening', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Glossitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hyperaesthesia teeth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypoaesthesia oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Mouth injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oral discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oral mucosal exfoliation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Salivary hypersecretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sensitivity of teeth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tongue biting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tongue exfoliation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Device failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Oral Mucosal Exfoliation (Oral Sloughing)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Comparator: No SLS Toothpaste', 'description': '3M Oral Rinse in combination with no SLS toothpaste (A)\n\nNo SLS toothpaste: Toothpaste no Sodium Lauryl Phosphate\n\nAnti-plaque: Rinse prevents bacterial adherence to teeth'}, {'id': 'OG001', 'title': 'Comparator: Medium SLS Toothpaste', 'description': '3M Oral Rinse in combination with medium SLS toothpaste (B)\n\nMedium SLS toothpaste: Less than or equal to X ppm Sodium Lauryl Phosphate\n\nAnti-plaque: Rinse prevents bacterial adherence to teeth'}, {'id': 'OG002', 'title': 'Comparator: High SLS Toothpaste', 'description': '3M Oral Rinse in combination with high SLS toothpaste (C)\n\nHigh SLS toothpaste: More than or equal to X ppm Sodium Lauryl Phosphate\n\nAnti-plaque: Rinse prevents bacterial adherence to teeth'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '.916', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': "Generalized Fisher's Exact Test was used to detect an association between the 3 treatment groups and the incidence of sloughing"}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'End of treatment (3 weeks)', 'description': 'Percentage of participants who experienced oral sloughing as reported either by the subject or determined by the dental evaluator.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Number of Participants With a Given Range of Average Oral Mucosal Sloughing Index Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Comparator: No SLS Toothpaste', 'description': '3M Oral Rinse in combination with no SLS toothpaste (A)\n\nNo SLS toothpaste: Toothpaste no Sodium Lauryl Phosphate\n\nAnti-plaque: Rinse prevents bacterial adherence to teeth'}, {'id': 'OG001', 'title': 'Comparator: Medium SLS Toothpaste', 'description': '3M Oral Rinse in combination with medium SLS toothpaste (B)\n\nMedium SLS toothpaste: Less than or equal to X ppm Sodium Lauryl Phosphate\n\nAnti-plaque: Rinse prevents bacterial adherence to teeth'}, {'id': 'OG002', 'title': 'Comparator: High SLS Toothpaste', 'description': '3M Oral Rinse in combination with high SLS toothpaste (C)\n\nHigh SLS toothpaste: More than or equal to X ppm Sodium Lauryl Phosphate\n\nAnti-plaque: Rinse prevents bacterial adherence to teeth'}], 'classes': [{'categories': [{'title': '0 no sloughing', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}, {'title': '(0.0, 0.5]', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}, {'title': '(0.5, 1.0]', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}, {'title': '(1.0, 1.5]', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}, {'title': '(1.5, 2.0]', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Mid-Treatment (10 days)', 'description': 'Average score based on the mean of sloughing scores over 12 intra-oral areas. The sloughing score uses a 6 point scale as follows: 0= no sloughing, 1=flecks of desquamation, 2=sheets of desquamation, 3=redness, not due to plaque, 4=erosion of mucosa, 5=ulcerated areas.\n\nThe twelve intra-oral areas of the mouth are as follows: dorsal and ventral surfaces of the tongue, floor and roof of the mouth, right and left buccal mucosa, gingival tissue.\n\n(upper right, upper anterior, upper left, lower left, lower anterior, lower right)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Number of Participants With a Given Range of Average Oral Mucosal Sloughing Index Scores.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Comparator: No SLS Toothpaste', 'description': '3M Oral Rinse in combination with no SLS toothpaste (A)\n\nNo SLS toothpaste: Toothpaste no Sodium Lauryl Phosphate\n\nAnti-plaque: Rinse prevents bacterial adherence to teeth'}, {'id': 'OG001', 'title': 'Comparator: Medium SLS Toothpaste', 'description': '3M Oral Rinse in combination with medium SLS toothpaste (B)\n\nMedium SLS toothpaste: Less than or equal to X ppm Sodium Lauryl Phosphate\n\nAnti-plaque: Rinse prevents bacterial adherence to teeth'}, {'id': 'OG002', 'title': 'Comparator: High SLS Toothpaste', 'description': '3M Oral Rinse in combination with high SLS toothpaste (C)\n\nHigh SLS toothpaste: More than or equal to X ppm Sodium Lauryl Phosphate\n\nAnti-plaque: Rinse prevents bacterial adherence to teeth'}], 'classes': [{'categories': [{'title': '0 No sloughing', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}, {'title': '(0.0, 0.5]', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}, {'title': '(0.5, 1.0]', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}, {'title': '(1.0, 1.5]', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'End of Treatment (3 weeks)', 'description': 'Average score based on the mean of sloughing scores over 12 intra-oral areas. The sloughing score uses a 6 point scale as follows: 0= no sloughing, 1=flecks of desquamation, 2=sheets of desquamation, 3=redness, not due to plaque, 4=erosion of mucosa, 5=ulcerated areas.\n\nThe twelve intra-oral areas of the mouth are as follows: dorsal and ventral surfaces of the tongue, floor and roof of the mouth, right and left buccal mucosa, gingival tissue.\n\n(upper right, upper anterior, upper left, lower left, lower anterior, lower right)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'The Number of Participants Reporting Their Acceptance Levels of Side Effects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Comparator: No SLS Toothpaste', 'description': '3M Oral Rinse in combination with no SLS toothpaste (A)\n\nNo SLS toothpaste: Toothpaste no Sodium Lauryl Phosphate\n\nAnti-plaque: Rinse prevents bacterial adherence to teeth'}, {'id': 'OG001', 'title': 'Comparator: Medium SLS Toothpaste', 'description': '3M Oral Rinse in combination with medium SLS toothpaste (B)\n\nMedium SLS toothpaste: Less than or equal to X ppm Sodium Lauryl Phosphate\n\nAnti-plaque: Rinse prevents bacterial adherence to teeth'}, {'id': 'OG002', 'title': 'Comparator: High SLS Toothpaste', 'description': '3M Oral Rinse in combination with high SLS toothpaste (C)\n\nHigh SLS toothpaste: More than or equal to X ppm Sodium Lauryl Phosphate\n\nAnti-plaque: Rinse prevents bacterial adherence to teeth'}], 'classes': [{'categories': [{'title': 'Completely unacceptable', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}, {'title': 'Somewhat unacceptable', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}, {'title': 'Somewhat acceptable', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}, {'title': 'Completely acceptable', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}, {'title': 'Did not experience side effects', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'End of Treatment (3 weeks)', 'description': 'Subjects were questioned regarding how acceptable were your side effects. Using the following responses of: Completely unacceptable, somewhat unacceptable, somewhat acceptable, completely acceptable, did not experience side effects', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Comparator: No SLS Toothpaste', 'description': '3M Oral Rinse in combination with no SLS toothpaste (A)\n\nNo SLS toothpaste: Toothpaste no Sodium Lauryl Phosphate\n\nAnti-plaque: Rinse prevents bacterial adherence to teeth'}, {'id': 'FG001', 'title': 'Comparator: Medium SLS Toothpaste', 'description': '3M Oral Rinse in combination with medium SLS toothpaste (B)\n\nMedium SLS toothpaste: Less than or equal to X ppm Sodium Lauryl Phosphate\n\nAnti-plaque: Rinse prevents bacterial adherence to teeth'}, {'id': 'FG002', 'title': 'Comparator: High SLS Toothpaste', 'description': '3M Oral Rinse in combination with high SLS toothpaste (C)\n\nHigh SLS toothpaste: More than or equal to X ppm Sodium Lauryl Phosphate\n\nAnti-plaque: Rinse prevents bacterial adherence to teeth'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '17'}]}], 'dropWithdraws': [{'type': 'Needed crown & cleaning', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'study was terminated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '16'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Comparator: No SLS Toothpaste', 'description': '3M Oral Rinse in combination with no SLS toothpaste (A)\n\nNo SLS toothpaste: Toothpaste no Sodium Lauryl Phosphate\n\nAnti-plaque: Rinse prevents bacterial adherence to teeth'}, {'id': 'BG001', 'title': 'Comparator: Medium SLS Toothpaste', 'description': '3M Oral Rinse in combination with medium SLS toothpaste (B)\n\nMedium SLS toothpaste: Less than or equal to X ppm Sodium Lauryl Phosphate\n\nAnti-plaque: Rinse prevents bacterial adherence to teeth'}, {'id': 'BG002', 'title': 'Comparator: High SLS Toothpaste', 'description': '3M Oral Rinse in combination with high SLS toothpaste (C)\n\nHigh SLS toothpaste: More than or equal to X ppm Sodium Lauryl Phosphate\n\nAnti-plaque: Rinse prevents bacterial adherence to teeth'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.2', 'spread': '10.3', 'groupId': 'BG000'}, {'value': '39.7', 'spread': '12.09', 'groupId': 'BG001'}, {'value': '38.5', 'spread': '11.82', 'groupId': 'BG002'}, {'value': '40.5', 'spread': '11.38', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Participants with Oral Tissue Sloughing at Baseline', 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-01-07', 'size': 2063387, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-09-16T10:26', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Assessors did not know what toothpaste subjects used.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study was designed as an imbalanced 2 Period Crossover Study. However, the study was terminated during the washout period and the results reported here reflect only the period 1 results.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'whyStopped': 'Device Deficiency', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-01-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2020-03-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-27', 'studyFirstSubmitDate': '2020-10-13', 'resultsFirstSubmitDate': '2021-09-16', 'studyFirstSubmitQcDate': '2020-10-22', 'lastUpdatePostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-10-25', 'studyFirstPostDateStruct': {'date': '2020-10-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The Number of Participants Reporting Their Acceptance Levels of Side Effects', 'timeFrame': 'End of Treatment (3 weeks)', 'description': 'Subjects were questioned regarding how acceptable were your side effects. Using the following responses of: Completely unacceptable, somewhat unacceptable, somewhat acceptable, completely acceptable, did not experience side effects'}], 'primaryOutcomes': [{'measure': 'Number of Participants With Oral Mucosal Exfoliation (Oral Sloughing)', 'timeFrame': 'End of treatment (3 weeks)', 'description': 'Percentage of participants who experienced oral sloughing as reported either by the subject or determined by the dental evaluator.'}], 'secondaryOutcomes': [{'measure': 'The Number of Participants With a Given Range of Average Oral Mucosal Sloughing Index Scores', 'timeFrame': 'Mid-Treatment (10 days)', 'description': 'Average score based on the mean of sloughing scores over 12 intra-oral areas. The sloughing score uses a 6 point scale as follows: 0= no sloughing, 1=flecks of desquamation, 2=sheets of desquamation, 3=redness, not due to plaque, 4=erosion of mucosa, 5=ulcerated areas.\n\nThe twelve intra-oral areas of the mouth are as follows: dorsal and ventral surfaces of the tongue, floor and roof of the mouth, right and left buccal mucosa, gingival tissue.\n\n(upper right, upper anterior, upper left, lower left, lower anterior, lower right)'}, {'measure': 'The Number of Participants With a Given Range of Average Oral Mucosal Sloughing Index Scores.', 'timeFrame': 'End of Treatment (3 weeks)', 'description': 'Average score based on the mean of sloughing scores over 12 intra-oral areas. The sloughing score uses a 6 point scale as follows: 0= no sloughing, 1=flecks of desquamation, 2=sheets of desquamation, 3=redness, not due to plaque, 4=erosion of mucosa, 5=ulcerated areas.\n\nThe twelve intra-oral areas of the mouth are as follows: dorsal and ventral surfaces of the tongue, floor and roof of the mouth, right and left buccal mucosa, gingival tissue.\n\n(upper right, upper anterior, upper left, lower left, lower anterior, lower right)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Oral Mucosal Disorder']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate the incidence of oral tissue sloughing through self-report by study subjects and by professional dental examinations.', 'detailedDescription': "The primary objective of this study is to evaluate the incidence of oral tissue sloughing through self-report by study subjects and by professional dental examinations. Adverse events will be tracked through study dental examinations and subject diaries with twice daily use of the 3M Oral Rinse used in combination with toothpaste containing one of three levels (no, medium, high) of Sodium Lauryl Sulfate (SLS).\n\nDetermine the subjects' acceptance of sloughing and/or other side effects"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria\n\n1. Able to understand and willing to sign the informed consent;\n2. Willing to agree to maintain confidentiality of the study and study materials;\n3. 3M employee aged 18 years and older;\n4. Willing to return to the study facility for scheduled study visits and recalls;\n5. Agree not to use other oral hygiene products (non-study toothpaste, non-study toothbrush, mouth rinse, chewing gum);\n6. Agree to the study instruction and schedule\n\n Exclusion Criteria:\n7. A member of the Medical Clinical Affairs (MCA) staff or Panda product team for the device under investigation;\n8. Have a dental appointment scheduled during study duration for professional cleaning;\n9. Is pregnant, nursing, or planning to become pregnant within the study duration;\n10. History of antibiotic therapy within the previous 30 days or have a condition that is likely to need antibiotic treatment over the course of the study (e.g., cardiac conditions requiring antibiotic prophylaxis such as heart murmurs, pacemakers, or prosthetic heart valves and prosthetic implants);\n11. History of using a prescription antimicrobial mouth rinse during the past 3 months;\n12. Currently taking medications which may alter gingival appearance/bleeding;\n13. Currently using anticonvulsants, calcium channel blockers, or other medications with side effects known to impact oral health;\n14. Participation in any other clinical study within the last 30 days;\n15. Resides in the same household with a subject already enrolled in the study;\n16. Known history of sensitivity to oral hygiene products;\n17. Currently using tobacco products (cigarettes, chewing tobacco) or vaping products (ecigarettes);\n18. History of diabetes;\n19. Have removable partial/full dentures;\n20. Have orthodontic appliances;\n21. Have medical or oral conditions that may compromise the subject's safety or interfere with the conduct and outcome of the study;\n22. Have known sloughing within the last 3 weeks;\n23. Have dry mouth;\n24. Have widespread caries or chronic neglect;\n25. Have gross pathological changes of oral soft tissues;\n26. Have advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive alveolar bone loss);\n27. Unsuitable for enrollment in this study based on the professional opinion of the dental examiner based on the oral exam or other reasons not specified in the protocol"}, 'identificationModule': {'nctId': 'NCT04601103', 'briefTitle': '3M Oral Rinse Incidence and Patient Acceptance of Sloughing When Used With Sodium Lauryl Sulfate (SLS) Toothpastes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Solventum US LLC'}, 'officialTitle': '3M Oral Rinse Evaluation of Incidence and Patient Acceptance of Sloughing When Used With Sodium Lauryl Sulfate (SLS) Toothpastes', 'orgStudyIdInfo': {'id': 'EM-11-050043'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Comparator: No SLS Toothpaste', 'description': '3M Oral Rinse in combination with no SLS toothpaste (A)', 'interventionNames': ['Drug: No SLS toothpaste', 'Device: Anti-plaque']}, {'type': 'EXPERIMENTAL', 'label': 'Comparator: Medium SLS Toothpaste', 'description': '3M Oral Rinse in combination with medium SLS toothpaste (B)', 'interventionNames': ['Drug: Medium SLS toothpaste', 'Device: Anti-plaque']}, {'type': 'EXPERIMENTAL', 'label': 'Comparator: High SLS Toothpaste', 'description': '3M Oral Rinse in combination with high SLS toothpaste (C)', 'interventionNames': ['Drug: High SLS toothpaste', 'Device: Anti-plaque']}], 'interventions': [{'name': 'No SLS toothpaste', 'type': 'DRUG', 'otherNames': ['Sensodyne ProNamel Fresh Breath Toothpaste'], 'description': 'Toothpaste no Sodium Lauryl Sulfate', 'armGroupLabels': ['Comparator: No SLS Toothpaste']}, {'name': 'Medium SLS toothpaste', 'type': 'DRUG', 'otherNames': ['Clinpro Tooth Creme'], 'description': 'Less than or equal to X ppm Sodium Lauryl Sulfate', 'armGroupLabels': ['Comparator: Medium SLS Toothpaste']}, {'name': 'High SLS toothpaste', 'type': 'DRUG', 'otherNames': ['Colgate Cavity Protection Toothpaste'], 'description': 'More than or equal to X ppm Sodium Lauryl Sulfate', 'armGroupLabels': ['Comparator: High SLS Toothpaste']}, {'name': 'Anti-plaque', 'type': 'DEVICE', 'otherNames': ['3M Oral Rinse'], 'description': 'Rinse prevents bacterial adherence to teeth', 'armGroupLabels': ['Comparator: High SLS Toothpaste', 'Comparator: Medium SLS Toothpaste', 'Comparator: No SLS Toothpaste']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55144', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': '3M Health Care', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}], 'overallOfficials': [{'name': 'Brenda C Coalwell, BA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '3M Health Care Business Group'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Solventum US LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': '3M', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}