Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-26 @ 2:44 AM
Study NCT ID:
NCT07154602
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-04
First Post:
2025-08-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Esthetic Outcome of 3D Printed Hybrid Ceramics as Final Restorations for Single Screw Retained Implant.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-26', 'studyFirstSubmitDate': '2025-08-25', 'studyFirstSubmitQcDate': '2025-08-26', 'lastUpdatePostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Aesthetic appearance', 'timeFrame': '6 months', 'description': 'using visual analogue scale, patient rating from 0 to 10 where 10 is satisfied the most while 0 is least satisfied'}], 'secondaryOutcomes': [{'measure': 'Prosthetic complications', 'timeFrame': '6 months', 'description': 'Abutment fracture or crown fracture'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['3D Printing']}, 'descriptionModule': {'briefSummary': "clinical trial\n\nThe goal of this clinical trial is to record the esthetic outcome of the 3d printed hybrid resin crowns. It will also test which method of fabrication is advantageous than the other one. The main questions it aims to answer are:\n\nDoes any of the fabrication methods differ in its esthetic outcome?\n\nResearcher will compare 3d printing fabrication to conventional fabrication method which is the milling technique to see if 3d printing of hybrid resin serves patients a better crown's esthetic outcome.\n\nParticipants will:\n\nReceive a crown after implants are osseointegrated Visit the clinic once every 3 months for checkups and tests Keep records of level of patient's satisfaction."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age: between 18 and 70 years old at the time of screening.\n* Patients with implants placed and in need for crown restoration\n* Medically free with no systemic diseases.\n* Good oral hygiene with no active periodontal disease.\n* Patient's having adequate interocclusal and mesiodistal restorative space for the fabrication of a single implant-supported crown.\n* Patients willing and able to provide written informed consent for participation in the study, understanding its risks, benefits, and alternative treatments.\n\nExclusion Criteria:\n\n* Uncontrolled systemic diseases (e.g., uncontrolled diabetes, severe cardiovascular disease, active autoimmune disorders, uncontrolled thyroid dysfunction).\n* Patients with composite restoration on the labial/buccal surface implant's neighbouring.\n* Immunocompromised patients or those undergoing immunosuppressive therapy.\n* Patients undergoing radiation therapy to the head and neck region, or chemotherapy.\n* Patients currently on or with a history of medications known to significantly affect bone metabolism (e.g., long-term bisphosphonates, corticosteroids).\n* Pregnancy or lactation.\n* Known allergies to titanium, resin components, or any other materials used in the study (e.g., composite, zirconia)."}, 'identificationModule': {'nctId': 'NCT07154602', 'briefTitle': 'Esthetic Outcome of 3D Printed Hybrid Ceramics as Final Restorations for Single Screw Retained Implant.', 'organization': {'class': 'NETWORK', 'fullName': 'International Dental Contiuing Education'}, 'officialTitle': 'Esthetic Outcome of 3D Printed Hybrid Ceramics as Final Restorations for Single Screw Retained Implant. A Clinical Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'IDCE-12208025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '3d printed hybrid ceramic crown', 'description': '3d printed hybrid ceramic crown for implant prosthesis in anterior and premolars maxillary teeth', 'interventionNames': ['Other: 3D printed hybrid resin ceramic crowns']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'milled hybrid resin ceramic crown', 'description': 'milled hybrid resin ceramic crown for implant prosthesis in anterior and premolar maxillary teeth', 'interventionNames': ['Other: milled hybrid resin ceramic crown']}], 'interventions': [{'name': '3D printed hybrid resin ceramic crowns', 'type': 'OTHER', 'description': '3D printed hybrid resin ceramic crowns in anterior and premolar maxillary teeth', 'armGroupLabels': ['3d printed hybrid ceramic crown']}, {'name': 'milled hybrid resin ceramic crown', 'type': 'OTHER', 'description': 'milled hybrid resin ceramic crown on implants in anterior and premolar maxillary teeth', 'armGroupLabels': ['milled hybrid resin ceramic crown']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Nourhan Gamal Dr.Nourhan Gamal AbdEl-Aziz, Master holder', 'role': 'CONTACT', 'email': 'nourhannegamal259@gmail.com', 'phone': '01064249441'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'International Dental Contiuing Education', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.Ingy Kastour', 'investigatorFullName': 'Ingy Ghobrial Kastour', 'investigatorAffiliation': 'International Dental Contiuing Education'}}}}