Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-26 @ 1:45 AM
Study NCT ID:
NCT06934460
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-18
First Post:
2025-04-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Direct Versus Indirect Endocrowns on Endodontically Treated Molars
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019553', 'term': 'Tooth, Nonvital'}], 'ancestors': [{'id': 'D003788', 'term': 'Dental Pulp Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Statistician'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized clinical trial comparing direct composite resin and lithium disilicate endocrowns on endodontically treated molar teeth.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-10-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2028-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-11', 'studyFirstSubmitDate': '2025-04-11', 'studyFirstSubmitQcDate': '2025-04-11', 'lastUpdatePostDateStruct': {'date': '2025-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Abutment tooth success', 'timeFrame': '5 years', 'description': 'failure was defined as tooth extraction, the presence of endodontic pathology, or the necessity for (non-)surgical endodontic retreatment'}, {'measure': 'Patient satisfaction', 'timeFrame': '1 and 5 years', 'description': 'Patient satisfaction measured on VAS-scale (0-100)'}], 'primaryOutcomes': [{'measure': 'Restoration survival', 'timeFrame': '5 years', 'description': 'Failure is defined as restoration replacement or tooth extraction due to secondary decay or vertical root fracture (FDI scre 5). A FDI score of 4 or less indicates survival.'}], 'secondaryOutcomes': [{'measure': 'Abutment tooth survival', 'timeFrame': '5 years', 'description': 'Failure defined as tooth extraction, regardless of cause.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['endocrown', 'endocrown restoration', 'composite resin', 'direct composite', 'endodontically-treated teeth'], 'conditions': ['Endodontically-Treated Teeth', 'Endocrown Restoration', 'Restoration of Posterior Teeth', 'Composite Resins']}, 'descriptionModule': {'briefSummary': "In this clinical trial the performance of monolithic restorations made of indirect lithium disilicate ceramic and direct resin composite materials on severe structurally compromised endodontically treated molar teeth is evaluated.\n\nRationale: It is presumed that indirect restoration of extensively restored endodontically treated molar teeth contributes to durability. However, there is a lack of evidence concerning the performance of both indirect ceramic and direct composite monolithic restorations. Such restorations are commonly named 'endocrowns'.\n\nObjective: The objective of the study is to investigate which treatment modality, indirect ceramic or direct composite endocrowns, provide the best restoration of severe structurally compromised endodontically treated molar teeth in terms of clinical performance.\n\nStudy design: Randomised 5-year clinical trial with endodontically treated molar teeth restored with either indirect glass ceramic (experimental) or direct resin composite endocrowns (control).\n\nStudy population: A total of 102 severe structurally compromised endodontically treated molar teeth that need to be restored, with a maximum of two restorations per patiënt. Patients are healthy volunteers over 18 years.\n\nIntervention: Each patiënt with a restorative indication for endodontically treated first and second molar teeth will be randomly assigned to one of two treatment groups: indirect glass ceramic endocrown or direct composite endocrown.", 'detailedDescription': "In this clinical trial the performance of monolithic restorations made of indirect lithium disilicate ceramic and direct resin composite materials on severe structurally compromised endodontically treated molar teeth is evaluated.\n\nRationale: It is presumed that indirect restoration of extensively restored endodontically treated molar teeth contributes to durability. However, there is a lack of evidence concerning the performance of both indirect ceramic and direct composite monolithic restorations. Such restorations are commonly named 'endocrowns'.\n\nObjective: The objective of the study is to investigate which treatment modality, indirect ceramic or direct composite endocrowns, provide the best restoration of severe structurally compromised endodontically treated molar teeth in terms of clinical performance.\n\nStudy design: Randomised 5-year clinical trial with endodontically treated molar teeth restored with either indirect glass ceramic (experimental) or direct resin composite endocrowns (control).\n\nStudy population: A total of 102 severe structurally compromised endodontically treated molar teeth that need to be restored, with a maximum of two restorations per patiënt. Patients are healthy volunteers over 18 years.\n\nIntervention: Each patiënt with a restorative indication for endodontically treated first and second molar teeth will be randomly assigned to one of two treatment groups: indirect glass ceramic endocrown or direct composite endocrown."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nASA i or II \\[de Jong, 1994\\], This ASA score is already known before participation, due to regular check-ups.\n\n* Asymptomatic endodontically treated and heavily restored upper and lower molar teeth with an indication for a (new) restoration.\n* Pulp chamber height of at least 2 millimeters.\n* Need of cuspal coverage;\n* Pockets around the molar 3-5 mm.\n* Moderate to low caries risk.\n\nExclusion Criteria:\n\n* ASA III or higher.\n\n * Pockets around the molar \\>5mm.\n * Presence of an accessible furcation.\n * No biological width present (3mm).\n * Rubber dam placement not possible.\n * No antagonistic tooth.\n * History of severe parafunction.\n * High caries risk.'}, 'identificationModule': {'nctId': 'NCT06934460', 'acronym': 'Endocrowns', 'briefTitle': 'Direct Versus Indirect Endocrowns on Endodontically Treated Molars', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Center Groningen'}, 'officialTitle': 'A Randomised Clinical Study on Indirect Lithium Disilicate Versus Direct Composite Restorations in Severely Compromised Endodontically Treated Molar Teeth', 'orgStudyIdInfo': {'id': '201500425'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Direct composite resin endocrown', 'description': 'Direct restoration with a microhybrid composite resin', 'interventionNames': ['Device: Composite resin']}, {'type': 'EXPERIMENTAL', 'label': 'Lithium disilicate endocrown', 'description': 'Indirect restoration with a lithium disilicate endocrown in conjunction with Immediate Dentin Sealing', 'interventionNames': ['Device: lithium disilicate endocrown']}], 'interventions': [{'name': 'Composite resin', 'type': 'DEVICE', 'description': 'Direct composite resin restoration after application of an adhesive system', 'armGroupLabels': ['Direct composite resin endocrown']}, {'name': 'lithium disilicate endocrown', 'type': 'DEVICE', 'description': 'Lithium disilicate endocrown in conjunction with Immediate Dentin Sealing', 'armGroupLabels': ['Lithium disilicate endocrown']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Marco S. Cune, Prof.dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Restorative Dentistry and Biomaterials - Center for Dentistry and Oral Hygiene - University Medical Center Groningen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Start before 2019 with the inclusion and was not mentioned in informed consent forms specifically'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Center Groningen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}