Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2026-02-20 @ 6:40 PM
Study NCT ID:
NCT05248204
Status:
COMPLETED
Last Update Posted:
2025-12-17
First Post:
2022-02-10
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Scotchbond Universal Plus Compared to Scotchbond Universal for Posterior Class I & II Restorations With Filtek Universal
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-11-07', 'type': 'ESTIMATED'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003731', 'term': 'Dental Caries'}], 'ancestors': [{'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'pemyhre1@solventum.com', 'phone': '6513948069', 'title': 'Paula Myhre', 'organization': 'Solventum US LLC'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Planned randomization of treating pairs of 2 molars or 2 premolars was not always followed. There were 16 subjects who had pairs of 1 molar and 1 premolar treated. These changes were not expected to impact the results of the study and no adjustments to the analysis plan were made.'}}, 'adverseEventsModule': {'timeFrame': 'All device-related and serious adverse events were collected from the time of restoration through the 24-month follow-up visit. Non-serious, non-device related adverse events were collected from the time of restoration through the 6-month follow-up visit.', 'eventGroups': [{'id': 'EG000', 'title': 'Scotchbond Universal Plus Treatment', 'description': 'Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using Scotchbond Universal Plus (SBU+) Adhesive (Treatment).\n\nScotchbond™ Universal Plus Adhesive: Eligible tooth with Class I or Class II carious lesion randomized to the SBU+ treatment group will undergo restoration with Scotchbond™ Universal Plus Adhesive using self-etch mode and Filtek Universal Restorative', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 8, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Scotchbond Universal Comparator', 'description': 'Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using the predicate device, Scotchbond Universal (SBU) Adhesive (Control).\n\nScotchbond™ Universal Adhesive: Eligible tooth with Class I or Class II carious lesion randomized to the SBU control group will undergo restoration with Scotchbond™ Universal Adhesive using self-etch mode and Filtek Universal Restorative', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 8, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dental Restoration Failure', 'notes': 'Complications associated with device not elsewhere classified (NEC). Non-device related adverse event involving a dental restoration or temporary crown on a non-study tooth. NOTE: This event is listed in both groups for a total of 2 events.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Hyperaesthesia teeth', 'notes': 'Dental pain and sensation disorders. Non-device related sensitivity of teeth. NOTE: Subjects have two teeth treated with 1 tooth per treatment group. This event is listed in both groups for a total of 2 non-device related events.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Dental caries', 'notes': 'Dental and gingival conditions. Dental cavity non-device related. NOTE: Subjects have two teeth treated with 1 tooth per treatment group. This event is listed in both groups but there was 1 non-device related event total.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Gingival Pain', 'notes': 'Dental and gingival conditions. Gum pain non-device related. NOTE: Subjects have two teeth treated with 1 tooth per treatment group. This event is listed in both groups but there was 1 non-device related event total.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Periodontal Inflammation', 'notes': 'Dental and gingival conditions. Periodontal inflammation non-device related. NOTE: Subjects have two teeth treated with 1 tooth per treatment group. This event is listed in both groups but there was 1 non-device related event total.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Tooth Fracture', 'notes': 'Dental disorder not elsewhere categorized (NEC) non-device related. NOTE: Subjects have two teeth treated with 1 tooth per treatment group. This event is listed in both groups but there was 1 non-device related event total.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Tooth Infection', 'notes': 'Dental and Oral soft tissue infections. Non-device related. NOTE: Subjects have two teeth treated with 1 tooth per treatment group. This event is listed in both groups but there was 1 non-device related event total.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Ligament Sprain', 'notes': 'Muscle, tendon and ligament injuries. Ankle sprain non-device related. NOTE: Subjects have two teeth treated with 1 tooth per treatment group. This event is listed in both groups but there was 1 non-device related event total.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Retention of Restorative Material', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}, {'units': 'Restorations', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Scotchbond Universal Plus Treatment', 'description': 'Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using Scotchbond Universal Plus (SBU+) Adhesive (Treatment).\n\nScotchbond™ Universal Plus Adhesive: Eligible tooth with Class I or Class II carious lesion randomized to the SBU+ treatment group will undergo restoration with Scotchbond™ Universal Plus Adhesive using self-etch mode and Filtek Universal Restorative'}, {'id': 'OG001', 'title': 'Scotchbond Universal Comparator', 'description': 'Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using the predicate device, Scotchbond Universal (SBU) Adhesive (Control).\n\nScotchbond™ Universal Adhesive: Eligible tooth with Class I or Class II carious lesion randomized to the SBU control group will undergo restoration with Scotchbond™ Universal Adhesive using self-etch mode and Filtek Universal Restorative'}], 'classes': [{'title': 'No loss of restorative material', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Partial or complete loss of restorative material', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 months post-restoration', 'description': 'The percentage of restorations with partial or complete loss of the restoration materials', 'unitOfMeasure': 'percentage of restorations', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Restorations', 'denomUnitsSelected': 'Restorations', 'populationDescription': '38 subjects completed the study; 1 subject in the treatment group had 1 tooth withdrawn prior to 24 months'}, {'type': 'PRIMARY', 'title': 'Fracture of Restorative Material', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}, {'units': 'Restorations', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Scotchbond Universal Plus Treatment', 'description': 'Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using Scotchbond Universal Plus (SBU+) Adhesive (Treatment).\n\nScotchbond™ Universal Plus Adhesive: Eligible tooth with Class I or Class II carious lesion randomized to the SBU+ treatment group will undergo restoration with Scotchbond™ Universal Plus Adhesive using self-etch mode and Filtek Universal Restorative'}, {'id': 'OG001', 'title': 'Scotchbond Universal Comparator', 'description': 'Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using the predicate device, Scotchbond Universal (SBU) Adhesive (Control).\n\nScotchbond™ Universal Adhesive: Eligible tooth with Class I or Class II carious lesion randomized to the SBU control group will undergo restoration with Scotchbond™ Universal Adhesive using self-etch mode and Filtek Universal Restorative'}], 'classes': [{'title': '1. Excellent/Very Good', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': '2. Good', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '3. Sufficient/Satisfactory', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '4. Unsatisfactory', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 months post-restoration', 'description': 'Fractures on study teeth graded on a 0-4 grading scale with a score of 1 being Excellent/very good and a score of 4 being Unsatisfactory. Grading scale is based on modified FDI (Fédération Dentaire Internationale) World Dental Federation criteria.', 'unitOfMeasure': 'percentage of restorations', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Restorations', 'denomUnitsSelected': 'Restorations', 'populationDescription': '38 subjects completed the study; 1 subject had 1 tooth withdrawn prior to 24 months\n\nScoring categories for the fracture of restorative material are defined as follows:\n\n1. Excellent/very good: No fractures/cracks\n2. Good: Small hairline cracks\n3. Sufficient/Satisfactory: Two or more or larger hairline cracks and/or material chip fracture not affecting the marginal integrity or approximal contact\n4. Unsatisfactory: Material chip fractures which damage marginal quality or approximal contacts'}, {'type': 'PRIMARY', 'title': 'Marginal Adaptation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}, {'units': 'Restorations', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Scotchbond Universal Plus Treatment', 'description': 'Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using Scotchbond Universal Plus (SBU+) Adhesive (Treatment).\n\nScotchbond™ Universal Plus Adhesive: Eligible tooth with Class I or Class II carious lesion randomized to the SBU+ treatment group will undergo restoration with Scotchbond™ Universal Plus Adhesive using self-etch mode and Filtek Universal Restorative'}, {'id': 'OG001', 'title': 'Scotchbond Universal Comparator', 'description': 'Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using the predicate device, Scotchbond Universal (SBU) Adhesive (Control).\n\nScotchbond™ Universal Adhesive: Eligible tooth with Class I or Class II carious lesion randomized to the SBU control group will undergo restoration with Scotchbond™ Universal Adhesive using self-etch mode and Filtek Universal Restorative'}], 'classes': [{'title': '1. Excellent/Very Good', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': '2. Good', 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}]}, {'title': '3. Sufficient/Satisfactory', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '4. Unsatisfactory', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '5. Poor', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 months post-restoration', 'description': 'Marginal adaptation of restorations graded on a scale of 1-5 with a score of 1 being Excellent/very good and a score of 5 being Poor. Grading scale is based on modified FDI World Dental Federation criteria.', 'unitOfMeasure': 'percentage of restorations', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Restorations', 'denomUnitsSelected': 'Restorations', 'populationDescription': 'Scoring categories for marginal adaptation are defined as follows:\n\n1. Excellent/very good: No clinically detectable gap.\n2. Good: Marginal integrity deviates from the ideal but could be upgraded to ideal by polishing.\n3. Sufficient/satisfactory: Leakage/discoloration is present but limited to the marginal area.\n4. Unsatisfactory: Localized major gap that may result in exposure of dentine or base.\n5. Poor: Generalized major gap or irregularities; or the restoration is loose but in situ.'}, {'type': 'SECONDARY', 'title': 'Retention of Restorative Material', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}, {'units': 'Restorations', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Scotchbond Universal Plus Treatment', 'description': 'Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using Scotchbond Universal Plus (SBU+) Adhesive (Treatment).\n\nScotchbond™ Universal Plus Adhesive: Eligible tooth with Class I or Class II carious lesion randomized to the SBU+ treatment group will undergo restoration with Scotchbond™ Universal Plus Adhesive using self-etch mode and Filtek Universal Restorative'}, {'id': 'OG001', 'title': 'Scotchbond Universal Comparator', 'description': 'Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using the predicate device, Scotchbond Universal (SBU) Adhesive (Control).\n\nScotchbond™ Universal Adhesive: Eligible tooth with Class I or Class II carious lesion randomized to the SBU control group will undergo restoration with Scotchbond™ Universal Adhesive using self-etch mode and Filtek Universal Restorative'}], 'classes': [{'title': 'No loss of restorative material', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Partial or complete loss of restorative material', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months post-restoration', 'description': 'The percentage of restorations with partial or complete loss of the restoration materials', 'unitOfMeasure': 'percentage of restorations', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Restorations', 'denomUnitsSelected': 'Restorations', 'populationDescription': 'Ten (10) of 51 subjects missed the 6-month follow-up visit.'}, {'type': 'SECONDARY', 'title': 'Retention of Restorative Material', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}, {'units': 'Restorations', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Scotchbond Universal Plus Treatment', 'description': 'Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using Scotchbond Universal Plus (SBU+) Adhesive (Treatment).\n\nScotchbond™ Universal Plus Adhesive: Eligible tooth with Class I or Class II carious lesion randomized to the SBU+ treatment group will undergo restoration with Scotchbond™ Universal Plus Adhesive using self-etch mode and Filtek Universal Restorative'}, {'id': 'OG001', 'title': 'Scotchbond Universal Comparator', 'description': 'Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using the predicate device, Scotchbond Universal (SBU) Adhesive (Control).\n\nScotchbond™ Universal Adhesive: Eligible tooth with Class I or Class II carious lesion randomized to the SBU control group will undergo restoration with Scotchbond™ Universal Adhesive using self-etch mode and Filtek Universal Restorative'}], 'classes': [{'title': 'No loss of restorative material', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Partial or complete loss of restorative material', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months post-restoration', 'description': 'The percentage of restorations with partial or complete loss of the restoration materials', 'unitOfMeasure': 'percentage of restorations', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Restorations', 'denomUnitsSelected': 'Restorations', 'populationDescription': 'Six (6) of 51 subjects missed the 1-year follow-up visit. One (1) subject completed the 1-year follow-up visit, but outside the allowed time window and was excluded from this analysis.'}, {'type': 'SECONDARY', 'title': 'Fracture of Restorative Material', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}, {'units': 'Restorations', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Scotchbond Universal Plus Treatment', 'description': 'Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using Scotchbond Universal Plus (SBU+) Adhesive (Treatment).\n\nScotchbond™ Universal Plus Adhesive: Eligible tooth with Class I or Class II carious lesion randomized to the SBU+ treatment group will undergo restoration with Scotchbond™ Universal Plus Adhesive using self-etch mode and Filtek Universal Restorative'}, {'id': 'OG001', 'title': 'Scotchbond Universal Comparator', 'description': 'Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using the predicate device, Scotchbond Universal (SBU) Adhesive (Control).\n\nScotchbond™ Universal Adhesive: Eligible tooth with Class I or Class II carious lesion randomized to the SBU control group will undergo restoration with Scotchbond™ Universal Adhesive using self-etch mode and Filtek Universal Restorative'}], 'classes': [{'title': '1. Excellent/Very Good', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}]}, {'title': '2. Good', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '3. Sufficient/Satisfactory', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '4. Unsatisfactory', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months post-restoration', 'description': 'Fractures on study teeth graded on a 0-4 grading scale with a score of 1 being Excellent/very good and a score of 4 being Unsatisfactory. Grading scale is based on modified FDI World Dental Federation criteria.', 'unitOfMeasure': 'percentage of restorations', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Restorations', 'denomUnitsSelected': 'Restorations', 'populationDescription': 'Ten (10) of 51 subjects missed the 6-month follow-up visit.\n\nScoring categories for the fracture of restorative material are defined as follows:\n\n1. Excellent/very good: No fractures/cracks\n2. Good: Small hairline cracks\n3. Sufficient/Satisfactory: Two or more or larger hairline cracks and/or material chip fracture not affecting the marginal integrity or approximal contact\n4. Unsatisfactory: Material chip fractures which damage marginal quality or approximal contacts'}, {'type': 'SECONDARY', 'title': 'Fracture of Restorative Material', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}, {'units': 'Restorations', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Scotchbond Universal Plus Treatment', 'description': 'Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using Scotchbond Universal Plus (SBU+) Adhesive (Treatment).\n\nScotchbond™ Universal Plus Adhesive: Eligible tooth with Class I or Class II carious lesion randomized to the SBU+ treatment group will undergo restoration with Scotchbond™ Universal Plus Adhesive using self-etch mode and Filtek Universal Restorative'}, {'id': 'OG001', 'title': 'Scotchbond Universal Comparator', 'description': 'Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using the predicate device, Scotchbond Universal (SBU) Adhesive (Control).\n\nScotchbond™ Universal Adhesive: Eligible tooth with Class I or Class II carious lesion randomized to the SBU control group will undergo restoration with Scotchbond™ Universal Adhesive using self-etch mode and Filtek Universal Restorative'}], 'classes': [{'title': '1. Excellent/Very Good', 'categories': [{'measurements': [{'value': '95.4', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': '2. Good', 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '3. Sufficient/Satisfactory', 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '4. Unsatisfactory', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months post-restoration', 'description': 'Fractures on study teeth graded on a 0-4 grading scale with a score of 1 being Excellent/very good and a score of 4 being Unsatisfactory. Grading scale is based on modified FDI World Dental Federation criteria.', 'unitOfMeasure': 'percentage of restorations', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Restorations', 'denomUnitsSelected': 'Restorations', 'populationDescription': 'Six of 51 subjects missed 1-year visit; 1 completed this visit but outside allowed window and was excluded from analysis.\n\nScoring categories for this endpoint are:\n\n1. Excellent/very good: No fractures/cracks\n2. Good: Small hairline cracks\n3. Sufficient/Satisfactory: Two or more or larger hairline cracks and/or material chip fracture not affecting the marginal integrity or approximal contact\n4. Unsatisfactory: Material chip fractures which damage marginal quality or approximal contacts'}, {'type': 'SECONDARY', 'title': 'Marginal Adaptation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}, {'units': 'Restorations', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Scotchbond Universal Plus Treatment', 'description': 'Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using Scotchbond Universal Plus (SBU+) Adhesive (Treatment).\n\nScotchbond™ Universal Plus Adhesive: Eligible tooth with Class I or Class II carious lesion randomized to the SBU+ treatment group will undergo restoration with Scotchbond™ Universal Plus Adhesive using self-etch mode and Filtek Universal Restorative'}, {'id': 'OG001', 'title': 'Scotchbond Universal Comparator', 'description': 'Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using the predicate device, Scotchbond Universal (SBU) Adhesive (Control).\n\nScotchbond™ Universal Adhesive: Eligible tooth with Class I or Class II carious lesion randomized to the SBU control group will undergo restoration with Scotchbond™ Universal Adhesive using self-etch mode and Filtek Universal Restorative'}], 'classes': [{'title': '1. Excellent/Very Good', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}, {'title': '2. Good', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}]}, {'title': '3. Sufficient/Satisfactory', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '4. Unsatisfactory', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '5. Poor', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'baseline day of restoration', 'description': 'Marginal adaptation of restorations graded on a scale of 1-5 with a score of 1 being Excellent/very good and a score of 5 being Poor. Grading scale is based on modified FDI World Dental Federation criteria.', 'unitOfMeasure': 'percentage of restorations', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Restorations', 'denomUnitsSelected': 'Restorations', 'populationDescription': 'Scoring categories for marginal adaptation are defined as follows:\n\n1. Excellent/very good: No clinically detectable gap.\n2. Good: Marginal integrity deviates from the ideal but could be upgraded to ideal by polishing.\n3. Sufficient/satisfactory: Leakage/discoloration is present but limited to the marginal area.\n4. Unsatisfactory: Localized major gap that may result in exposure of dentine or base.\n5. Poor: Generalized major gap or irregularities; or the restoration is loose but in situ.'}, {'type': 'SECONDARY', 'title': 'Marginal Adaptation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}, {'units': 'Restorations', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Scotchbond Universal Plus Treatment', 'description': 'Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using Scotchbond Universal Plus (SBU+) Adhesive (Treatment).\n\nScotchbond™ Universal Plus Adhesive: Eligible tooth with Class I or Class II carious lesion randomized to the SBU+ treatment group will undergo restoration with Scotchbond™ Universal Plus Adhesive using self-etch mode and Filtek Universal Restorative'}, {'id': 'OG001', 'title': 'Scotchbond Universal Comparator', 'description': 'Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using the predicate device, Scotchbond Universal (SBU) Adhesive (Control).\n\nScotchbond™ Universal Adhesive: Eligible tooth with Class I or Class II carious lesion randomized to the SBU control group will undergo restoration with Scotchbond™ Universal Adhesive using self-etch mode and Filtek Universal Restorative'}], 'classes': [{'title': '1. Excellent/Very Good', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '17.1', 'groupId': 'OG001'}]}]}, {'title': '2. Good', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '80.5', 'groupId': 'OG001'}]}]}, {'title': '3. Sufficient/Satisfactory', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2.4', 'groupId': 'OG001'}]}]}, {'title': '4. Unsatisfactory', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '5. Poor', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months post-restoration', 'description': 'Marginal adaptation of restorations graded on a scale of 1-5 with a score of 1 being Excellent/very good and a score of 5 being Poor. Grading scale is based on modified FDI World Dental Federation criteria.', 'unitOfMeasure': 'percentage of restorations', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Restorations', 'denomUnitsSelected': 'Restorations', 'populationDescription': '10 of 51 subjects missed 6-month visit.\n\nScoring categories for this result are:\n\n1. Excellent/very good: No clinically detectable gap\n2. Good: Marginal integrity deviates from the ideal but could be upgraded to ideal by polishing\n3. Sufficient/satisfactory: Leakage/discoloration is present but limited to the marginal area\n4. Unsatisfactory: Localized major gap that may result in exposure of dentine or base\n5. Poor: Generalized major gap or irregularities; or restoration is loose but in situ'}, {'type': 'SECONDARY', 'title': 'Marginal Adaptation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}, {'units': 'Restorations', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Scotchbond Universal Plus Treatment', 'description': 'Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using Scotchbond Universal Plus (SBU+) Adhesive (Treatment).\n\nScotchbond™ Universal Plus Adhesive: Eligible tooth with Class I or Class II carious lesion randomized to the SBU+ treatment group will undergo restoration with Scotchbond™ Universal Plus Adhesive using self-etch mode and Filtek Universal Restorative'}, {'id': 'OG001', 'title': 'Scotchbond Universal Comparator', 'description': 'Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using the predicate device, Scotchbond Universal (SBU) Adhesive (Control).\n\nScotchbond™ Universal Adhesive: Eligible tooth with Class I or Class II carious lesion randomized to the SBU control group will undergo restoration with Scotchbond™ Universal Adhesive using self-etch mode and Filtek Universal Restorative'}], 'classes': [{'title': '1. Excellent/Very Good', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '29.55', 'groupId': 'OG001'}]}]}, {'title': '2. Good', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '65.9', 'groupId': 'OG001'}]}]}, {'title': '3. Sufficient/Satisfactory', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4.55', 'groupId': 'OG001'}]}]}, {'title': '4. Unsatisfactory', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '5. Poor', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months post-restoration', 'description': 'Marginal adaptation of restorations graded on a scale of 1-5 with a score of 1 being Excellent/very good and a score of 5 being Poor. Grading scale is based on modified FDI World Dental Federation criteria.', 'unitOfMeasure': 'percentage of restorations', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Restorations', 'denomUnitsSelected': 'Restorations', 'populationDescription': '44/51 subjects returned for this visit.\n\nScoring categories for this result are:\n\n1. Excellent/very good: No clinically detectable gap\n2. Good: Marginal integrity deviates from the ideal but could be upgraded to ideal by polishing\n3. Sufficient/satisfactory: Leakage/discoloration is present but limited to the marginal area\n4. Unsatisfactory: Localized major gap that may result in exposure of dentine or base\n5. Poor: Generalized major gap or irregularities; or restoration is loose but in situ'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Scotchbond Universal Plus Treatment', 'description': 'Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using Scotchbond Universal Plus (SBU+) Adhesive (Treatment).\n\nScotchbond™ Universal Plus Adhesive: Eligible tooth with Class I or Class II carious lesion randomized to the SBU+ treatment group will undergo restoration with Scotchbond™ Universal Plus Adhesive using self-etch mode and Filtek Universal Restorative'}, {'id': 'FG001', 'title': 'Scotchbond Universal Comparator', 'description': 'Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using the predicate device, Scotchbond Universal (SBU) Adhesive (Control).\n\nScotchbond™ Universal Adhesive: Eligible tooth with Class I or Class II carious lesion randomized to the SBU control group will undergo restoration with Scotchbond™ Universal Adhesive using self-etch mode and Filtek Universal Restorative'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'A total of 51 subjects were included in the study, each with 2 Class I or Class II restorations performed. Teeth were randomized in a 1:1 ratio such that 51 teeth were restored using SBU+ Adhesive (Treatment), and 51 teeth underwent restoration using SBU Adhesive (Control) for a total of 102 restorations in the study.', 'achievements': [{'groupId': 'FG000', 'numUnits': '51', 'numSubjects': '51'}, {'groupId': 'FG001', 'numUnits': '51', 'numSubjects': '51'}]}, {'type': 'COMPLETED', 'comment': 'A total of 38 subjects completed the study. One subject had one tooth withdrawn due to non-compliance with study restrictions, for a total of 37 restorations with SBU+ and 38 restorations with SBU completing the study.', 'achievements': [{'groupId': 'FG000', 'numUnits': '37', 'numSubjects': '37'}, {'groupId': 'FG001', 'numUnits': '38', 'numSubjects': '38'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '14', 'numSubjects': '14'}, {'groupId': 'FG001', 'numUnits': '13', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'Restorations', 'recruitmentDetails': 'The patient population was selected from current patients under clinical treatment at the University of Minnesota Dental School. Patients were between the ages of 18 and 70 years old at time of consent, of either sex, and of any ethnic background. Eligible patients needed to have at least two direct composite restorations for posterior (premolars or molars) Class I or Class II carious lesions in vital teeth that were asymptomatic and with minimal mobility.', 'preAssignmentDetails': 'Subjects were required to meet all inclusion and none of the exclusion criteria to be eligible for study participation. Any subject with pulp exposure of either study tooth during the restoration procedure was excluded from the study. Two Class I or Class II restorations were placed per patient. Selected study teeth were randomized in a 1:1 ratio with one tooth restored using SBU+ Adhesive (Treatment), and the other tooth restored using SBU Adhesive (Control).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}, {'units': 'Restorations', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Scotchbond Universal Plus Treatment', 'description': 'Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using Scotchbond Universal Plus (SBU+) Adhesive (Treatment).\n\nScotchbond™ Universal Plus Adhesive: Eligible tooth with Class I or Class II carious lesion randomized to the SBU+ treatment group will undergo restoration with Scotchbond™ Universal Plus Adhesive using self-etch mode and Filtek Universal Restorative'}, {'id': 'BG001', 'title': 'Scotchbond Universal Comparator', 'description': 'Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using the predicate device, Scotchbond Universal (SBU) Adhesive (Control).\n\nScotchbond™ Universal Adhesive: Eligible tooth with Class I or Class II carious lesion randomized to the SBU control group will undergo restoration with Scotchbond™ Universal Adhesive using self-etch mode and Filtek Universal Restorative'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33', 'spread': '12.4', 'groupId': 'BG000'}, {'value': '33', 'spread': '12.4', 'groupId': 'BG001'}, {'value': '33', 'spread': '12.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Participants'}, {'title': 'Age, Customized', 'classes': [{'title': '<=18 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': '19 years to 64 years', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}, {'title': '>= 65 years', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race: American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Race: Asian', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Race: Black or African American', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Race: Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Race: White', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}, {'title': 'Race: Other', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Race: Multiple Race', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Ethnicity: Hispanic or Latino', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Ethnicity: Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}, {'title': 'Ethnicity: Unknown or Not Reported', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Tooth Characteristic: Restoration Class', 'classes': [{'title': 'Class I Restorations', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}, {'title': 'Class II Restorations', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'unitOfMeasure': 'Restorations', 'denomUnitsSelected': 'Restorations', 'populationDescription': '51 subjects each had 2 teeth treated in a 1:1 randomization with 1 tooth in each treatment group for a total of 102 restorations (55 Class I restorations and 47 Class II restorations).'}], 'typeUnitsAnalyzed': 'Restorations', 'populationDescription': '51 subjects each had 2 teeth treated in a 1:1 randomization with 1 tooth in each treatment group for a total of 102 restorations.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-01-27', 'size': 775149, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-10-22T09:51', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'All assessments will be performed by two dental examiners that are independent of the dentist that placed the restorations and are blinded to the treatment arms.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a prospective, randomized, controlled, open-label, assessor-blinded, split-mouth, single-center post-market clinical follow-up study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-03-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-01', 'studyFirstSubmitDate': '2022-02-10', 'resultsFirstSubmitDate': '2025-10-22', 'studyFirstSubmitQcDate': '2022-02-10', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-12-01', 'studyFirstPostDateStruct': {'date': '2022-02-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-03-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retention of Restorative Material', 'timeFrame': '24 months post-restoration', 'description': 'The percentage of restorations with partial or complete loss of the restoration materials'}, {'measure': 'Fracture of Restorative Material', 'timeFrame': '24 months post-restoration', 'description': 'Fractures on study teeth graded on a 0-4 grading scale with a score of 1 being Excellent/very good and a score of 4 being Unsatisfactory. Grading scale is based on modified FDI (Fédération Dentaire Internationale) World Dental Federation criteria.'}, {'measure': 'Marginal Adaptation', 'timeFrame': '24 months post-restoration', 'description': 'Marginal adaptation of restorations graded on a scale of 1-5 with a score of 1 being Excellent/very good and a score of 5 being Poor. Grading scale is based on modified FDI World Dental Federation criteria.'}], 'secondaryOutcomes': [{'measure': 'Retention of Restorative Material', 'timeFrame': '6 months post-restoration', 'description': 'The percentage of restorations with partial or complete loss of the restoration materials'}, {'measure': 'Retention of Restorative Material', 'timeFrame': '12 months post-restoration', 'description': 'The percentage of restorations with partial or complete loss of the restoration materials'}, {'measure': 'Fracture of Restorative Material', 'timeFrame': '6 months post-restoration', 'description': 'Fractures on study teeth graded on a 0-4 grading scale with a score of 1 being Excellent/very good and a score of 4 being Unsatisfactory. Grading scale is based on modified FDI World Dental Federation criteria.'}, {'measure': 'Fracture of Restorative Material', 'timeFrame': '12 months post-restoration', 'description': 'Fractures on study teeth graded on a 0-4 grading scale with a score of 1 being Excellent/very good and a score of 4 being Unsatisfactory. Grading scale is based on modified FDI World Dental Federation criteria.'}, {'measure': 'Marginal Adaptation', 'timeFrame': 'baseline day of restoration', 'description': 'Marginal adaptation of restorations graded on a scale of 1-5 with a score of 1 being Excellent/very good and a score of 5 being Poor. Grading scale is based on modified FDI World Dental Federation criteria.'}, {'measure': 'Marginal Adaptation', 'timeFrame': '6 months post-restoration', 'description': 'Marginal adaptation of restorations graded on a scale of 1-5 with a score of 1 being Excellent/very good and a score of 5 being Poor. Grading scale is based on modified FDI World Dental Federation criteria.'}, {'measure': 'Marginal Adaptation', 'timeFrame': '12 months post-restoration', 'description': 'Marginal adaptation of restorations graded on a scale of 1-5 with a score of 1 being Excellent/very good and a score of 5 being Poor. Grading scale is based on modified FDI World Dental Federation criteria.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['dental materials', 'dental adhesives', 'dental fillings', 'dental cavities', 'Scotchbond Universal Plus', 'Scotchbond Universal', 'Filtek Universal Restorative'], 'conditions': ['Cavities of Teeth', 'Dental Decay']}, 'referencesModule': {'references': [{'pmid': '20628774', 'type': 'BACKGROUND', 'citation': 'Hickel R, Peschke A, Tyas M, Mjor I, Bayne S, Peters M, Hiller KA, Randall R, Vanherle G, Heintze SD. FDI World Dental Federation: clinical criteria for the evaluation of direct and indirect restorations-update and clinical examples. Clin Oral Investig. 2010 Aug;14(4):349-66. doi: 10.1007/s00784-010-0432-8. Epub 2010 Jul 14.'}, {'pmid': '19492717', 'type': 'BACKGROUND', 'citation': 'Perdigao J, Dutra-Correa M, Anauate-Netto C, Castilhos N, Carmo AR, Lewgoy HR, Amore R, Cordeiro HJ. Two-year clinical evaluation of self-etching adhesives in posterior restorations. J Adhes Dent. 2009 Apr;11(2):149-59.'}]}, 'descriptionModule': {'briefSummary': 'This research study is looking at a new bond-promoting substance (a dental adhesive called 3M™ Scotchbond™ Universal Plus Adhesive) used between the tooth and dental restoration (filling). This is a randomized, split-mouth study designed to evaluate whether Scotchbond™ Universal Plus Adhesive (SBU+) is as effective at bonding dental fillings as Scotchbond™ Universal Adhesive (SBU) for preparation of posterior Class I and Class II restorations in adult patients. Participants must have at least two (2) back teeth that need a filling either on the chewing surface alone (Class I) and/or on the chewing surface and between your teeth (Class II). One tooth will be restored using SBU+ and the other tooth will be restored using SBU adhesive, both filled using Filtek™ Universal Restorative as the filling material.', 'detailedDescription': 'This is a prospective, randomized, controlled, open-label, assessor-blinded, split-mouth, single-center post-market clinical follow-up study. The study is designed to compare the clinical efficacy of Scotchbond™ Universal Plus Adhesive with Scotchbond™ Universal Adhesive when used in self-etch mode for preparation of posterior Class I and Class II restorations using Filtek™ Universal Restorative material in adult patients.\n\nSelected endpoints are based partly on the FDI World Dental Federation criteria. Subjects who meet all inclusion and none of the exclusion criteria and who have provided informed consent will be eligible for enrollment and must be treated within 21 days of screening. Either two pre-molars or two molars from each Subject will be randomized in a 1:1 ratio such that one of the teeth will be randomized to undergo restoration using SBU+ Adhesive (Treatment), and the other tooth will undergo restoration using SBU Adhesive (Control). Both study teeth will be restored using Filtek™ Universal Restorative material as the filling material. Individual subject participation is expected to last 2 years (± 45 days) with scheduled study visits at screening, day of restoration/baseline, and follow-up visits at 6 months (± 14 days), 1 year (± 30 days), and 2 years (± 45 days) after restoration. The entire duration of the study is expected to last approximately 3 years, with individual Subject participation expected to last up to 2 years (± 45 days).\n\nTo help minimize or avoid bias in the study, randomization of study teeth will occur after teeth preparation but before the initial application of any adhesive. All assessments will be performed by two dental examiners that are independent of the dentist that placed the restorations and are blinded to the treatment arms. All examiners will be trained and calibrated for the scoring criteria before any Subject assessment occurs, and examiners will be retrained and recalibrated if any new evaluator is added to the list of assessors. After the second examiner has completed their assessments, then the examiners will compare their evaluations and a consensus will be reached for each of the scoring criteria at each visit. A consensus will be reached before the Subject leaves the visit, and the consensus assessments will be entered into the Case Report Form (CRF).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The Subject is between the ages of 18 and 70 years old at time of consent.\n2. The Subject requires at least two direct composite restorations for posterior Class I or Class II carious lesions in vital teeth that are asymptomatic and with minimal mobility (\\< 1 mm in the buccolingual direction).\n3. Study teeth have a minimum buccolingual diameter of the occlusal surface that is at least 1/3 of the distance between the buccal and lingual cusps\n4. Teeth selected for Class II restorations need to have an adjacent tooth in a position that will allow for a contact relationship to be established.\n5. The Subject is able and willing to sign Informed Consent Form in English without assistance.\n6. The Subject is able and willing to be available for all scheduled study visits.\n7. The Subject is in good general health (ie, meets American Society of Anesthesiologists (ASA) Level I or ASA Level II classification criteria).\n8. The selected teeth need to have occlusal contact with an antagonistic natural tooth.\n9. The Subject has existing radiographic images of the study teeth of current and acceptable diagnostic quality obtained within the previous 12 months.\n\nExclusion Criteria:\n\n1. The Subject has a history of adverse reaction to any materials used in this study.\n2. The Subject is pregnant or breast feeding at the time of screening.\n3. The Subject has fewer than 20 teeth.\n4. The Subject is taking part in or planned to be enrolled in an evaluation of other restorative materials at any time during the study.\n5. The Subject has advanced periodontal disease (ie, Grace \\& Smales Mobility Index grade ≥ 2) that involve the study teeth.\n6. The Subject had orthodontic appliance treatment within the previous 3 months.\n7. The Subject has pronounced enamel wear facets, indicating severe, on-going bruxism.\n8. The Subject has severe xerostomia.\n9. The study tooth has a history of or existing, prolonged tooth hypersensitivity.\n10. The study tooth is an abutment for fixed or removable prostheses.\n11. The study tooth has a fracture or is visibly cracked such that it may impact the longevity of the tooth.\n12. The carious lesion is stage RC5 or RC6 of the ICDAS radiographic scoring system.\n13. The Subject is unable to understand study procedures or provide consent in English.\n14. The Subject is an employee or student of the study investigator(s).\n\nIntraoperative Exclusion Criteria:\n\n1\\) The Subject has pulp exposure of either study tooth during the restoration procedure.'}, 'identificationModule': {'nctId': 'NCT05248204', 'briefTitle': 'Scotchbond Universal Plus Compared to Scotchbond Universal for Posterior Class I & II Restorations With Filtek Universal', 'organization': {'class': 'INDUSTRY', 'fullName': 'Solventum US LLC'}, 'officialTitle': 'Prospective, Randomized, Split-mouth Study Evaluating Clinical Performance of 3M™ Scotchbond™ Universal Plus Adhesive Compared to 3M Scotchbond Universal Adhesive for Posterior Class I & II Restorations With 3M Filtek™ Universal Restorative', 'orgStudyIdInfo': {'id': 'EM-11-050069'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Scotchbond Universal Plus Treatment', 'description': 'Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using Scotchbond Universal Plus (SBU+) Adhesive (Treatment).', 'interventionNames': ['Device: Scotchbond™ Universal Plus Adhesive']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Scotchbond Universal Comparator', 'description': 'Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using the predicate device, Scotchbond Universal (SBU) Adhesive (Control).', 'interventionNames': ['Device: Scotchbond™ Universal Adhesive']}], 'interventions': [{'name': 'Scotchbond™ Universal Plus Adhesive', 'type': 'DEVICE', 'description': 'Eligible tooth with Class I or Class II carious lesion randomized to the SBU+ treatment group will undergo restoration with Scotchbond™ Universal Plus Adhesive using self-etch mode and Filtek Universal Restorative', 'armGroupLabels': ['Scotchbond Universal Plus Treatment']}, {'name': 'Scotchbond™ Universal Adhesive', 'type': 'DEVICE', 'description': 'Eligible tooth with Class I or Class II carious lesion randomized to the SBU control group will undergo restoration with Scotchbond™ Universal Adhesive using self-etch mode and Filtek Universal Restorative', 'armGroupLabels': ['Scotchbond Universal Comparator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota School of Dentristry', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Jorge Perdigao, DMD, MS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Solventum US LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}