Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-03-04 @ 11:11 PM
Study NCT ID:
NCT03221660
Status:
COMPLETED
Last Update Posted:
2025-04-13
First Post:
2017-07-13
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Investigation of the F-Composite 2 System in Direct Filling Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'lukas.enggist@ivoclarvivadent.com', 'phone': '+423 235 34 46', 'title': 'Dr. med. dent. Lukas Enggist, Dentist internal clinic (Principal Investigator)', 'organization': 'Ivoclar Vivadent AG'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '12 months', 'eventGroups': [{'id': 'EG000', 'title': 'F-Composite 2 System', 'description': 'Tooth (teeth) affected by dental caries or with an existing defective filling will be restored using the F-Composite 2 system.\n\nF-Composite 2 system: Procedures will be done using local anesthesia (if the patients wants that). The cavity is prepared according to the principles of the adhesive technique. First the adhesive will be applied and polymerized, afterwards the flowable resin-based restorative material will be applied and polymerized and then the sculptable resin-based restorative material will be applied and polymerized; all materials will be light-cured within short time with an experimental curing light.', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 4, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Long-term hypersensitivity', 'notes': 'Fillings needed to be replaced due to long-term hypersensitivity. It is generally related to this type of clinical procedure and might also be dependent on the applied light intensity, the used adhesive or the backstory of the tooth.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Unrelated: Fracture of disto-lingual cusp next to study tooth', 'notes': 'The fracture was partly at the border to the study restoration. But the restoration remained intact and was available for the 60-month recall. This adverse event is unrelated to the clinical procedure and to the investigational device itself.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Restored Teeth With Postoperative Sensitivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}, {'units': 'Teeth', 'counts': [{'value': '75', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'F-Composite 2 System', 'description': '75 teeth affected by dental caries or with an existing defective filling were restored using the F-Composite 2 system. 25 participants received two fillings and 25 received only one filling.\n\nF-Composite 2 system: Procedures was done using local anesthesia (if the patients wants that). The cavity was prepared according to the principles of the adhesive technique. First the adhesive was applied and polymerized, afterwards the flowable resin-based restorative material was applied and polymerized. Then the sculptable resin-based restorative material was applied and polymerized. All materials were light-cured within short time with an experimental curing light.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month', 'description': 'The postoperative sensitivity is assessed by tests with thermal stimuli and occlusal forces (during biting) determined by VAS (Visual Analog Scale, from 0 "no pain" to 10 "maximum pain") following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable".\n\nA maximum of 10% postoperative hypersensitivities are defined as acceptable after one month.', 'unitOfMeasure': 'percentage restored hypersensitive teeth', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Teeth', 'denomUnitsSelected': 'Teeth'}, {'type': 'SECONDARY', 'title': 'Number of Restored Teeth With Loss of Vitality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}, {'units': 'Teeth', 'counts': [{'value': '73', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'F-Composite 2 System', 'description': '75 teeth affected by dental caries or with an existing defective filling were restored using the F-Composite 2 system. 25 participants received two fillings and 25 received only one filling.\n\nF-Composite 2 system: Procedures was done using local anesthesia (if the patients wants that). The cavity was prepared according to the principles of the adhesive technique. First the adhesive was applied and polymerized, afterwards the flowable resin-based restorative material was applied and polymerized. Then the sculptable resin-based restorative material was applied and polymerized. All materials were light-cured within short time with an experimental curing light.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'The loss of vitality of restored teeth is assessed by a cold stimuli test (cotton pellet and refrigerating spray) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable".\n\nA maximum of 1 tooth with loss of vitality within 12 months is determined to be acceptable.', 'unitOfMeasure': 'teeth', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Teeth', 'denomUnitsSelected': 'Teeth', 'populationDescription': 'The participants analyzed and number of teeth (units) analyzed differs from the number of participants and units assigned to the arm as 1 participant with 2 fillings did not attend the 12-month recall.'}, {'type': 'SECONDARY', 'title': 'Replacement of Filling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}, {'units': 'Teeth', 'counts': [{'value': '73', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'F-Composite 2 System', 'description': '75 teeth affected by dental caries or with an existing defective filling were restored using the F-Composite 2 system. 25 participants received two fillings and 25 received only one filling.\n\nF-Composite 2 system: Procedures was done using local anesthesia (if the patients wants that). The cavity was prepared according to the principles of the adhesive technique. First the adhesive was applied and polymerized, afterwards the flowable resin-based restorative material was applied and polymerized. Then the sculptable resin-based restorative material was applied and polymerized. All materials were light-cured within short time with an experimental curing light.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'maximum of 3 fillings which have to be replaced due to a lack of quality after 2 years', 'unitOfMeasure': 'replaced fillings due to quality', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Teeth', 'denomUnitsSelected': 'Teeth'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'FDI 1 Surface Luster, FDI Score 1-5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}, {'units': 'teeth', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'F-Composite 2 System', 'description': '75 teeth affected by dental caries or with an existing defective filling were restored using the F-Composite 2 system. 25 participants received two fillings and 25 received only one filling.\n\nF-Composite 2 system: Procedures was done using local anesthesia (if the patients wants that). The cavity was prepared according to the principles of the adhesive technique. First the adhesive was applied and polymerized, afterwards the flowable resin-based restorative material was applied and polymerized. Then the sculptable resin-based restorative material was applied and polymerized. All materials were light-cured within short time with an experimental curing light.'}], 'classes': [{'title': 'FDI 1 Surface Luster, FDI Score 1', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'FDI 1 Surface Luster, FDI Score 2', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}]}]}, {'title': 'FDI 1 Surface Luster, FDI Score 3', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'FDI 1 Surface Luster, FDI Score 4-5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '60 months', 'description': 'assessed on patient teeth (comparing surface of filling with enamel) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"', 'unitOfMeasure': 'Teeth', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'teeth', 'denomUnitsSelected': 'teeth', 'populationDescription': '7 patients with 12 restorations were not able to attend final recall after 5 years. 3 restorations were replaced because patient suffered from hypersensitivoity on bitting/chewing. 60 from the initial 75 restoratons were analyzed'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'FDI 2 Surface Staining, FDI Score 1-5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}, {'units': 'Teeth', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'F-Composite 2 System', 'description': '75 teeth affected by dental caries or with an existing defective filling were restored using the F-Composite 2 system. 25 participants received two fillings and 25 received only one filling.\n\nF-Composite 2 system: Procedures was done using local anesthesia (if the patients wants that). The cavity was prepared according to the principles of the adhesive technique. First the adhesive was applied and polymerized, afterwards the flowable resin-based restorative material was applied and polymerized. Then the sculptable resin-based restorative material was applied and polymerized. All materials were light-cured within short time with an experimental curing light.'}], 'classes': [{'title': 'FDI 2 Surface Staining, FDI Score 1', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}]}]}, {'title': 'FDI 2 Surface Staining, FDI Score 2', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'FDI 2 Surface Staining, FDI Score 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'FDI 2 Surface Staining, FDI Score 4-5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '60 month', 'description': 'assessed on patient teeth by checking surface staining of restoration following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"', 'unitOfMeasure': 'teeth', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Teeth', 'denomUnitsSelected': 'Teeth', 'populationDescription': '7 patients with 12 restorations were not able to attend final recall after 5 years. 3 restorations were replaced because patient suffered from hypersensitivoity on bitting/chewing. 60 from the initial 75 restoratons were analyzed'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'FDI 3 Translucency, FDI Score 1-5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}, {'units': 'Teeth', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'F-Composite 2 System', 'description': '75 teeth affected by dental caries or with an existing defective filling were restored using the F-Composite 2 system. 25 participants received two fillings and 25 received only one filling.\n\nF-Composite 2 system: Procedures was done using local anesthesia (if the patients wants that). The cavity was prepared according to the principles of the adhesive technique. First the adhesive was applied and polymerized, afterwards the flowable resin-based restorative material was applied and polymerized. Then the sculptable resin-based restorative material was applied and polymerized. All materials were light-cured within short time with an experimental curing light.'}], 'classes': [{'title': 'FDI 3 Translucency, FDI Score 1', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}]}]}, {'title': 'FDI 3 Translucency, FDI Score 2', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'FDI 3 Translucency, FDI Score 3-5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '60 month', 'description': 'assessed on patient teeth by checking differences in shade and translucency following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"', 'unitOfMeasure': 'Teeth', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Teeth', 'denomUnitsSelected': 'Teeth', 'populationDescription': '7 patients with 12 restorations were not able to attend final recall after 5 years. 3 restorations were replaced because patient suffered from hypersensitivoity on bitting/chewing. 60 from the initial 75 restoratons were analyzed'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'FDI 5 Retention/Fracture of Restorations, FDI Score 1-5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}, {'units': 'Teeth', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'F-Composite 2 System', 'description': '75 teeth affected by dental caries or with an existing defective filling were restored using the F-Composite 2 system. 25 participants received two fillings and 25 received only one filling.\n\nF-Composite 2 system: Procedures was done using local anesthesia (if the patients wants that). The cavity was prepared according to the principles of the adhesive technique. First the adhesive was applied and polymerized, afterwards the flowable resin-based restorative material was applied and polymerized. Then the sculptable resin-based restorative material was applied and polymerized. All materials were light-cured within short time with an experimental curing light.'}], 'classes': [{'title': 'FDI 5 Fracture of material and retention, FDI Score 1', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}]}]}, {'title': 'FDI 5 Fracture of material and retention, FDI Score 2', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'FDI 5 Fracture of material and retention, FDI Score 3', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'FDI 5 Fracture of material and retention, FDI Score 4-5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '60 month', 'description': 'assessed on patient teeth (checking irestorations for fractures, cracks, small hairline cracks, chip fractures, material damage) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"', 'unitOfMeasure': 'Teeth', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Teeth', 'denomUnitsSelected': 'Teeth', 'populationDescription': '7 patients with 12 restorations were not able to attend final recall after 5 years. 3 restorations were replaced because patient suffered from hypersensitivoity on bitting/chewing. 60 from the initial 75 restoratons were analyzed'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'FDI 6 Marginal Adaption, FDI Score 1-5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}, {'units': 'Teeth', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'F-Composite 2 System', 'description': '75 teeth affected by dental caries or with an existing defective filling were restored using the F-Composite 2 system. 25 participants received two fillings and 25 received only one filling.\n\nF-Composite 2 system: Procedures was done using local anesthesia (if the patients wants that). The cavity was prepared according to the principles of the adhesive technique. First the adhesive was applied and polymerized, afterwards the flowable resin-based restorative material was applied and polymerized. Then the sculptable resin-based restorative material was applied and polymerized. All materials were light-cured within short time with an experimental curing light.'}], 'classes': [{'title': 'FDI 6 Marginal Gap, FDI Score 1', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}]}]}, {'title': 'FDI 6 Marginal Gap, FDI Score 2', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'FDI 6 Marginal Gap, FDI Score 3', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'FDI 6 Marginal Gap, FDI Score 4-5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '60 month', 'description': 'assessed on patient teeth (checking for hamonious outline, gaps and white/discolored lines)) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"', 'unitOfMeasure': 'Teeth', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Teeth', 'denomUnitsSelected': 'Teeth', 'populationDescription': '7 patients with 12 restorations were not able to attend final recall after 5 years. 3 restorations were replaced because patient suffered from hypersensitivoity on bitting/chewing. 60 from the initial 75 restoratons were analyzed'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': "FDI 10 Patient's View, FDI Scire 1-5", 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}, {'units': 'Teeth', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'F-Composite 2 System', 'description': '75 teeth affected by dental caries or with an existing defective filling were restored using the F-Composite 2 system. 25 participants received two fillings and 25 received only one filling.\n\nF-Composite 2 system: Procedures was done using local anesthesia (if the patients wants that). The cavity was prepared according to the principles of the adhesive technique. First the adhesive was applied and polymerized, afterwards the flowable resin-based restorative material was applied and polymerized. Then the sculptable resin-based restorative material was applied and polymerized. All materials were light-cured within short time with an experimental curing light.'}], 'classes': [{'title': "FDI 10 Patient's View, FDI Score 1", 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}]}]}, {'title': "FDI 10 Patient's View, FDI Score 2-5", 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '60 month', 'description': 'assessed by discussion with the patient (satisfied with esthetics and function) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"', 'unitOfMeasure': 'Teeth', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Teeth', 'denomUnitsSelected': 'Teeth', 'populationDescription': '7 patients with 12 restorations were not able to attend final recall after 5 years. 3 restorations were replaced because patient suffered from hypersensitivoity on bitting/chewing. 60 from the initial 75 restoratons were analyzed'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'FDI 11 Postoperative Hypersensitivity and Tooth Vitality, FDI Scores 1-5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}, {'units': 'Teeth', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'F-Composite 2 System', 'description': '75 teeth affected by dental caries or with an existing defective filling were restored using the F-Composite 2 system. 25 participants received two fillings and 25 received only one filling.\n\nF-Composite 2 system: Procedures was done using local anesthesia (if the patients wants that). The cavity was prepared according to the principles of the adhesive technique. First the adhesive was applied and polymerized, afterwards the flowable resin-based restorative material was applied and polymerized. Then the sculptable resin-based restorative material was applied and polymerized. All materials were light-cured within short time with an experimental curing light.'}], 'classes': [{'title': 'FDI 11 Postoperative hypersensitivity and tooth vitality, FDI Score 1', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}]}]}, {'title': 'FDI 11 Postoperative hypersensitivity and tooth vitality, FDI Score 2-5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '60 month', 'description': 'Hypersensitivity was assessed by tests with thermal stimuli and occlusal forces (during biting) determined by VAS (Visual Analog Scale) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable".\n\nTooth vtality assessed by a cold stimuli test on the patient teeth (cotton pellet and refrigerating spray) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"', 'unitOfMeasure': 'Teeth', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Teeth', 'denomUnitsSelected': 'Teeth', 'populationDescription': '7 patients with 12 restorations were not able to attend final recall after 5 years. 3 restorations were replaced because patient suffered from hypersensitivoity on bitting/chewing. 60 from the initial 75 restoratons were analyzed'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'FDI 12 Recurrence of Caries (CAR), Erosion, Abfraction, FDI Scores 1-5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}, {'units': 'Teeth', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'F-Composite 2 System', 'description': '75 teeth affected by dental caries or with an existing defective filling were restored using the F-Composite 2 system. 25 participants received two fillings and 25 received only one filling.\n\nF-Composite 2 system: Procedures was done using local anesthesia (if the patients wants that). The cavity was prepared according to the principles of the adhesive technique. First the adhesive was applied and polymerized, afterwards the flowable resin-based restorative material was applied and polymerized. Then the sculptable resin-based restorative material was applied and polymerized. All materials were light-cured within short time with an experimental curing light.'}], 'classes': [{'title': 'FDI 12 Recurrence of Caries (CAR), erosion, abfraction, FDI Score 1', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}]}]}, {'title': 'FDI 12 Recurrence of Caries (CAR), erosion, abfraction, FDI Score 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'FDI 12 Recurrence of Caries (CAR), erosion, abfraction, FDI Score 3-5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '60 month', 'description': 'assessed on patient teeth (primary caries, areas of demineralization erosion or abfraction)) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"', 'unitOfMeasure': 'Teeth', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Teeth', 'denomUnitsSelected': 'Teeth', 'populationDescription': '7 patients with 12 restorations were not able to attend final recall after 5 years. 3 restorations were replaced because patient suffered from hypersensitivoity on bitting/chewing. 60 from the initial 75 restoratons were analyzed'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'FDI 13 Tooth Integrity, FDI Scores 1-5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}, {'units': 'Teeth', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'F-Composite 2 System', 'description': '75 teeth affected by dental caries or with an existing defective filling were restored using the F-Composite 2 system. 25 participants received two fillings and 25 received only one filling.\n\nF-Composite 2 system: Procedures was done using local anesthesia (if the patients wants that). The cavity was prepared according to the principles of the adhesive technique. First the adhesive was applied and polymerized, afterwards the flowable resin-based restorative material was applied and polymerized. Then the sculptable resin-based restorative material was applied and polymerized. All materials were light-cured within short time with an experimental curing light.'}], 'classes': [{'title': 'FDI 13 Tooth integrity, FDI Score 1', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}]}]}, {'title': 'FDI 13 Tooth integrity, FDI Score 2-3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'FDI 13 Tooth integrity, FDI Score 4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'FDI 13 Tooth integrity, FDI Score 5', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '60 month', 'description': 'assessed on patient teeth by checking tooth integrity (looking for enamel cracks, tooth fractures) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"', 'unitOfMeasure': 'Teeth', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Teeth', 'denomUnitsSelected': 'Teeth', 'populationDescription': '7 patients with 12 restorations were not able to attend final recall after 5 years. 3 restorations were replaced because patient suffered from hypersensitivoity on bitting/chewing. 60 from the initial 75 restoratons were analyzed'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'F-Composite 2 System', 'description': '75 teeth affected by dental caries or with an existing defective filling were restored using the F-Composite 2 system. 25 participants received two fillings and 25 received only one filling.\n\nF-Composite 2 system: Procedures was done using local anesthesia (if the patients wants that). The cavity was prepared according to the principles of the adhesive technique. First the adhesive was applied and polymerized, afterwards the flowable resin-based restorative material was applied and polymerized. Then the sculptable resin-based restorative material was applied and polymerized. All materials were light-cured within short time with an experimental curing light.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '75', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '60', 'numSubjects': '42'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '15', 'numSubjects': '8'}]}]}], 'typeUnitsAnalyzed': 'teeth'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}, {'units': 'Teeth', 'counts': [{'value': '75', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'F-Composite 2 System', 'description': '75 teeth affected by dental caries or with an existing defective filling were restored using the F-Composite 2 system. 25 participants received two fillings and 25 received only one filling.\n\nF-Composite 2 system: Procedures was done using local anesthesia (if the patients wants that). The cavity was prepared according to the principles of the adhesive technique. First the adhesive was applied and polymerized, afterwards the flowable resin-based restorative material was applied and polymerized. Then the sculptable resin-based restorative material was applied and polymerized. All materials were light-cured within short time with an experimental curing light.'}], 'measures': [{'title': 'Age, Categorical', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}, {'units': 'Teeth', 'counts': [{'value': '75', 'groupId': 'BG000'}]}], 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '50', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Sex: Female, Male', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}, {'units': 'Teeth', 'counts': [{'value': '75', 'groupId': 'BG000'}]}], 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '32', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}, {'units': 'Teeth', 'counts': [{'value': '75', 'groupId': 'BG000'}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}, {'units': 'Teeth', 'counts': [{'value': '75', 'groupId': 'BG000'}]}], 'classes': [{'title': 'Liechtenstein', 'categories': [{'measurements': [{'value': '75', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Teeth', 'denomUnitsSelected': 'Teeth'}], 'typeUnitsAnalyzed': 'Teeth'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-10-09', 'size': 270114, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-10-09T09:50', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2023-07-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-26', 'studyFirstSubmitDate': '2017-07-13', 'resultsFirstSubmitDate': '2020-10-09', 'studyFirstSubmitQcDate': '2017-07-13', 'lastUpdatePostDateStruct': {'date': '2025-04-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-11-20', 'studyFirstPostDateStruct': {'date': '2017-07-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-12-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'FDI 1 Surface Luster, FDI Score 1-5', 'timeFrame': '60 months', 'description': 'assessed on patient teeth (comparing surface of filling with enamel) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"'}, {'measure': 'FDI 2 Surface Staining, FDI Score 1-5', 'timeFrame': '60 month', 'description': 'assessed on patient teeth by checking surface staining of restoration following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"'}, {'measure': 'FDI 3 Translucency, FDI Score 1-5', 'timeFrame': '60 month', 'description': 'assessed on patient teeth by checking differences in shade and translucency following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"'}, {'measure': 'FDI 5 Retention/Fracture of Restorations, FDI Score 1-5', 'timeFrame': '60 month', 'description': 'assessed on patient teeth (checking irestorations for fractures, cracks, small hairline cracks, chip fractures, material damage) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"'}, {'measure': 'FDI 6 Marginal Adaption, FDI Score 1-5', 'timeFrame': '60 month', 'description': 'assessed on patient teeth (checking for hamonious outline, gaps and white/discolored lines)) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"'}, {'measure': "FDI 10 Patient's View, FDI Scire 1-5", 'timeFrame': '60 month', 'description': 'assessed by discussion with the patient (satisfied with esthetics and function) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"'}, {'measure': 'FDI 11 Postoperative Hypersensitivity and Tooth Vitality, FDI Scores 1-5', 'timeFrame': '60 month', 'description': 'Hypersensitivity was assessed by tests with thermal stimuli and occlusal forces (during biting) determined by VAS (Visual Analog Scale) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable".\n\nTooth vtality assessed by a cold stimuli test on the patient teeth (cotton pellet and refrigerating spray) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"'}, {'measure': 'FDI 12 Recurrence of Caries (CAR), Erosion, Abfraction, FDI Scores 1-5', 'timeFrame': '60 month', 'description': 'assessed on patient teeth (primary caries, areas of demineralization erosion or abfraction)) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"'}, {'measure': 'FDI 13 Tooth Integrity, FDI Scores 1-5', 'timeFrame': '60 month', 'description': 'assessed on patient teeth by checking tooth integrity (looking for enamel cracks, tooth fractures) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"'}], 'primaryOutcomes': [{'measure': 'Percentage of Restored Teeth With Postoperative Sensitivity', 'timeFrame': '1 month', 'description': 'The postoperative sensitivity is assessed by tests with thermal stimuli and occlusal forces (during biting) determined by VAS (Visual Analog Scale, from 0 "no pain" to 10 "maximum pain") following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable".\n\nA maximum of 10% postoperative hypersensitivities are defined as acceptable after one month.'}], 'secondaryOutcomes': [{'measure': 'Number of Restored Teeth With Loss of Vitality', 'timeFrame': '12 months', 'description': 'The loss of vitality of restored teeth is assessed by a cold stimuli test (cotton pellet and refrigerating spray) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable".\n\nA maximum of 1 tooth with loss of vitality within 12 months is determined to be acceptable.'}, {'measure': 'Replacement of Filling', 'timeFrame': '2 years', 'description': 'maximum of 3 fillings which have to be replaced due to a lack of quality after 2 years'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['filling material, polymerization'], 'conditions': ['Dental Caries', 'Unsatisfactory or Defective Restoration of Tooth']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the clinical performance of F-Composite 2 system in Class I and Class II cavities in permanent teeth.\n\nThe materials of the system can be polymerized in short time with a curing light which is part of the system.\n\nThe study will be carried out as a prospective study, with evaluation of the restorations after 7-10 days (baseline), at 6 months, at 12 months, at 24 months and 60 months according to defined criteria.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Indication for direct filling of Class I or II with permanent premolars or permanent molars\n* replacement of insufficient fillings (e.g., due to edge caries, filling fracture, Lack of quality of the surface, lack of aesthetics, undesirable filling material, leaky edge, edge gap, etc.)\n* extensive primary caries\n* Vital tooth (cold test)\n* One-, two- or three-surface fillings in the lateral tooth area, with a maximum of 25% single-faced (Class I) with antagonists.\n* The occlusal area of the filling must be at least 1/3 of the total area of the filling tooth. This criterion is estimated.\n* Patient wishes to receive care within the framework of the study (written consent after detailed elucidation and study of patient information).\n* Maximum of 2 restorations per patient.\n* Preoperative complaints on the tooth to be restored (maximum 3 on visual Analog scale (0 = complaint-free, 10 = maximum possible pain) to temperature or bite sensitivity\n* Sufficient language skills\n\nExclusion Criteria:\n\n* Unfinished hygiene phase or poor oral hygiene\n* Sufficient draining of the operating field is not possible\n* Patients with proven allergy to one of the ingredients of the materials used\n* Patient has allergies to local anesthetic agents Ultracain DS (active substance: articaine; Vasoconstrictor), if anesthesia is desired\n* Patients with severe systemic diseases\n* Devital or pulpitic teeth\n* Periodontal insufficiency\n* Supplements with cusp attachments\n* open side bite\n* missing antagonist\n* Indication for direct capping\n* Pregnancy (women of childbearing age receive a free pregnancy test for self application, the negative result of which is shown with her confirmed consent).'}, 'identificationModule': {'nctId': 'NCT03221660', 'briefTitle': 'Clinical Investigation of the F-Composite 2 System in Direct Filling Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ivoclar Vivadent AG'}, 'officialTitle': 'Clinical Investigation of the F-Composite 2 System in Direct Filling Therapy', 'orgStudyIdInfo': {'id': '621211'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'F-Composite 2 system', 'description': 'Tooth (teeth) affected by dental caries or with an existing defective filling will be restored using the F-Composite 2 system.', 'interventionNames': ['Device: F-Composite 2 system']}], 'interventions': [{'name': 'F-Composite 2 system', 'type': 'DEVICE', 'description': 'Procedures will be done using local anesthesia (if the patients wants that). The cavity is prepared according to the principles of the adhesive technique. First the adhesive will be applied and polymerized, afterwards the flowable resin-based restorative material will be applied and polymerized and then the sculptable resin-based restorative material will be applied and polymerized; all materials will be light-cured within short time with an experimental curing light.', 'armGroupLabels': ['F-Composite 2 system']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9494', 'city': 'Schaan', 'country': 'Liechtenstein', 'facility': 'Ivoclar Vivadent', 'geoPoint': {'lat': 47.16498, 'lon': 9.50867}}], 'overallOfficials': [{'name': 'Lukas Enggist, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'dentist internal clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ivoclar Vivadent AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}