Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2025-12-28 @ 5:04 PM
Study NCT ID:
NCT06770868
Status:
COMPLETED
Last Update Posted:
2025-01-13
First Post:
2024-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Novel Alloplastic Patient Specific Temporalis Tendon Enthesis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'mandibular resection with coronoidectomy managed with patient specific reconstruction plate with custom made temporalis tendon enthesis'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-05-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-07', 'studyFirstSubmitDate': '2024-12-21', 'studyFirstSubmitQcDate': '2025-01-07', 'lastUpdatePostDateStruct': {'date': '2025-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mandibular Kinematics assessment', 'timeFrame': '6 months', 'description': 'range of mandibular excursions were recorded preoperatively (T0) and at 1-postopertive week (T1), 1-postoperative month (T2), 4-postoperative month (T3), 6- postoperative month (T4).'}], 'secondaryOutcomes': [{'measure': 'Postoperative temporalis muscle activity', 'timeFrame': '6 months', 'description': 'surface-Electromyogram (sEMG) was used by the patients during their maximum voluntary clenching by placement of two channels on the bilateral temporalis muscles'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mandibular resection', 'coronoid', 'computer assisted', 'computer-aided design,', 'computer-aided manufacturing'], 'conditions': ['Mandibular Resection']}, 'descriptionModule': {'briefSummary': 'Mandibular reconstruction of segmental defects is an arduous surgical procedure that requires an utmost degree of surgical fidelity. Whether primary bone reconstruction is feasible or not, alloplastic bridging between the remaining bone stumps is mandatory to achieve functional, aesthetic, and symmetrical demands of the lower third of the face. Mandibular reconstructive surgery should be directed toward the maintains of the normal orthognathic centric condylar position, mandibular kinematics, and muscles of mastication function. Mandibular resection with coronoid removal cause imbalance in the attachment of one of the large muscles of mastication, the temporalis muscle. The use of computer-aided surgery allowed the creation of custom made fixation plates with a plethora of advantages over the conventional plates.\n\nthe study aims to introduce a novel plate design, which creates an enthsis for the reattachment of the temporalis muscle tendon.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with mandibular lesion that require segmental resection.\n* Patients required coronoid processes resection within the safety margin of the lesion.\n* Brown Class I cases with preservation of the condyle process and no need for alloplastic TMJ replacement.\n* Complaisant patient that is able to complete at least 1 year follow up.\n\nExclusion Criteria:\n\n* Composite mandibular defect.\n* Malignant lesions that required postoperative adjunctive therapies (CT or RT).'}, 'identificationModule': {'nctId': 'NCT06770868', 'briefTitle': 'A Novel Alloplastic Patient Specific Temporalis Tendon Enthesis', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'A Novel Alloplastic Patient Specific Temporalis Tendon Enthesis for Mandibular Resection with Coronoidectomy', 'orgStudyIdInfo': {'id': '0118-21/24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patient specific reconstruction plate for patients suffering from mandibular segmental defects', 'description': 'Patients with mandibular segmental defect including coronoidectomy managed with patient specific reconstruction plate with custom made temporalis tendon enthesis', 'interventionNames': ['Device: Patient specific reconstruction plate for patients suffering from mandibular segmental defects']}], 'interventions': [{'name': 'Patient specific reconstruction plate for patients suffering from mandibular segmental defects', 'type': 'DEVICE', 'description': 'Patients with mandibular segmental defect including coronoidectomy managed with patient specific reconstruction plate with custom made temporalis tendon enthesis', 'armGroupLabels': ['Patient specific reconstruction plate for patients suffering from mandibular segmental defects']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alexandria', 'state': 'Alexandria Governorate', 'country': 'Egypt', 'facility': 'Faculty of Dentistry, Alexandria University', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}]}, 'ipdSharingStatementModule': {'infoTypes': ['SAP'], 'ipdSharing': 'YES', 'description': 'all data will be de-identified to protect the participant data. patients signed an informed consent for the use of their medical records and data for study', 'accessCriteria': 'to any one who required them after deidentification'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}