Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-26 @ 1:21 AM
Study NCT ID:
NCT07263633
Status:
COMPLETED
Last Update Posted:
2025-12-04
First Post:
2025-11-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Additive Versus Subtractive Manufacturing Techniques of Custom-Made Plates for the Fixation of Interforaminal Mandibular Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050723', 'term': 'Fractures, Bone'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-12-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-10-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-23', 'studyFirstSubmitDate': '2025-11-16', 'studyFirstSubmitQcDate': '2025-11-23', 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tensile Strength', 'timeFrame': 'After fabrication of the plates (baseline biomechanical assessment)', 'description': 'Tensile strength will be measured using a universal testing machine (Instron) to evaluate the resistance of each plate to tensile forces according to standardized biomechanical testing protocols.\n\nUnit of Measure:\n\nNewton (N)\n\nMeasurement Tool:\n\nInstron Universal Testing Machine.'}, {'measure': 'Shear Strength', 'timeFrame': 'Immediately after fixation (within 24 hours)', 'description': 'Shear strength will be tested using the Instron universal testing machine to determine the resistance of the plate to shear loading.\n\nTime Frame:\n\nAfter fabrication of the plates (baseline biomechanical assessment)\n\nUnit of Measure:\n\nNewton (N)\n\nMeasurement Tool:\n\nInstron Universal Testing Machine.'}, {'measure': 'Outcome Measure', 'timeFrame': 'Immediately after fixation (within 24 hours)', 'description': 'Title: Overall Mechanical Stability Description: Overall biomechanical stability will be evaluated based on combined tensile, shear results.\n\nTime Frame: Within 24 hours after surgical fixation Unit of Measure: Stability index (unitless)'}], 'secondaryOutcomes': [{'measure': 'Mouth Opening Measurement', 'timeFrame': '1 week, 2 weeks, 1 month, 3 months, and 6 months after surgery', 'description': 'Maximum inter-incisal distance will be measured using a digital caliper to assess functional recovery and detect any restrictions.\n\nUnit of Measure:\n\nMillimeters (mm)\n\nMeasurement Tool:\n\nDigital caliper'}, {'measure': 'Wound Healing Score', 'timeFrame': '1 week, 2 weeks, 1 month, 3 months, and 6 months after surgery', 'description': 'Wound healing will be assessed using the Landry, Turnbull, and Howley Wound Healing Index, which evaluates tissue color, bleeding on palpation, granulation tissue, and overall appearance.\n\nUnit of Measure:\n\nScore (0-5 scale)\n\nMeasurement Tool:\n\nLandry, Turnbull \\& Howley Index (clinical scale)'}, {'measure': 'Postoperative Edema Measurement', 'timeFrame': '1 week, 2 weeks, 1 month, 3 months, and 6 months after surgery', 'description': 'Edema will be measured using standardized linear facial measurements (tragus-pogonion and gonion-pogonion distances) to quantify postoperative swelling.\n\nUnit of Measure:\n\nMillimeters (mm)\n\nMeasurement Tool:\n\nFacial linear measurement with ruler/caliper.'}, {'measure': 'Postoperative Infection Assessment', 'timeFrame': '1 week, 2 weeks, 1 month, 3 months, and 6 months after surgery', 'description': 'Infection will be evaluated using the CDC Surgical Site Infection (SSI) criteria, including redness, swelling, warmth, purulent discharge, fever \\>38°C, and localized tenderness at the surgical site.Unit of Measure:\n\nPresence or absence (Yes/No)\n\nMeasurement Tool:\n\nCDC SSI Diagnostic Criteria (clinical assessment)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Additive', 'Subtractive', 'Custom-Made Plates', 'Interforaminal', 'Mandibular', 'Fractures'], 'conditions': ['Anterior Mandibular Fracture']}, 'descriptionModule': {'briefSummary': 'This study aims to compare the mechanical properties, including tensile strength, shear strength, and flexural strength, as well as the clinical outcomes of additive and subtractive manufacturing techniques used to fabricate custom-made plates for the fixation of interforaminal mandibular fractures. A total of 16 patients were included and allocated into two groups: one treated using plates fabricated with the additive manufacturing technique and the other with the subtractive manufacturing technique. Mechanical performance was evaluated using standardized biomechanical testing, while clinical outcomes were assessed during scheduled postoperative follow-up visits. The objective of the study is to determine which fixation approach provides superior biomechanical performance and favorable clinical healing outcomes.', 'detailedDescription': 'This randomized clinical study included 18 patients who were assessed for eligibility. Two patients were excluded-one did not meet the inclusion criteria and another declined participation-leaving a final sample of 16 patients who were randomly allocated into two equal groups (n=8 per group). All included patients were followed throughout the entire study period, and none were lost to follow-up.\n\nBoth study groups demonstrated comparable baseline characteristics with no statistically significant differences regarding age, sex distribution, trauma side, cause of injury, type of fracture, and operative time. All surgical procedures were performed using standardized operative protocols, and postoperative evaluations were conducted at fixed intervals.\n\nClinical outcomes included wound healing status, postoperative edema, infection, and wound dehiscence. Functional performance was evaluated through maximum mouth opening measurements and patient-reported outcomes involving occlusion and self-chewing ability. Radiographic and mechanical assessments were also performed, including tensile strength, shear strength, and flexural bending tests for the fixation systems used in each group.\n\nAcross the follow-up period, both groups showed satisfactory wound healing, absence of infection or dehiscence, progressive improvement in mouth opening, and gradual restoration of occlusal stability and chewing function, with no significant intergroup differences in clinical parameters. Mechanical testing demonstrated significant differences between the two fixation systems.\n\nAll collected data were statistically analyzed, and outcomes were reported in accordance with CONSORT guidelines.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Isolated or non-isolated mandibular fractures located between the mental foramina (interforaminal fractures).\n\nExclusion Criteria:\n\n* Patients with relevant systemic diseases that affect bone healing.\n* Comminuted fractures in which it is difficult to fix.'}, 'identificationModule': {'nctId': 'NCT07263633', 'briefTitle': 'Additive Versus Subtractive Manufacturing Techniques of Custom-Made Plates for the Fixation of Interforaminal Mandibular Fractures', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Additive Versus Subtractive Manufacturing Techniques of Custom-Made Plates for the Fixation of Interforaminal Mandibular Fractures:A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'TANTAOMSF-IFMF-149'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'additive plating group', 'description': 'Additive manufacturing typically describes any process where material is gradually added, layer by layer, to form a final product. The term is often used interchangeably with 3D printing and rapid prototyping, although rapid prototyping can also involve other techniques beyond additive methods', 'interventionNames': ['Device: additive plating group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'subtractive plating group', 'description': 'In subtractive manufacturing, objects are created by progressively removing material from a solid block or sheet through processes such as cutting, drilling, boring, or grinding. While these processes can be performed manually, they are more commonly executed using computer numeric control (CNC). CNC machining is the most widely used subtractive manufacturing process today', 'interventionNames': ['Device: subtractive plating group']}], 'interventions': [{'name': 'additive plating group', 'type': 'DEVICE', 'description': 'Additive manufacturing is the process of creating parts by joining materials based on 3D model data, typically layer by layer, in contrast to subtractive and formative manufacturing methods. While most of the global activity in additive manufacturing currently involves polymer-based systems, there has been increasing interest and activity in fabricating metallic parts', 'armGroupLabels': ['additive plating group']}, {'name': 'subtractive plating group', 'type': 'DEVICE', 'description': 'In CNC machining, cutting tool removes material to achieve the desired geometry. The process involves using CAD to create the model to be machined and CAM to provide instructions to the CNC machine on how to remove the material. There are three major machining processes for material removal based on 3D models: turning, drilling, and milling. Additional subtractive manufacturing techniques, such as laser cutting, waterjet cutting, electrical discharge machining, and plasma cutting, are typically used for 2D machining', 'armGroupLabels': ['subtractive plating group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31527', 'city': 'Tanta', 'state': 'Gharbia Governorate', 'country': 'Egypt', 'facility': 'Faculty of Dentistry, Tanta University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'overallOfficials': [{'name': 'FARIS I ALANAZI', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Dentistry, Tanta University'}, {'name': 'Rafic R Bedir', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Dentistry, Tanta University'}, {'name': 'Ahmed G Abushahba', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Dentistry, Tanta University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Principal Investigator, Master's Student, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Tanta University", 'investigatorFullName': 'FARIS INAD S ALANAZI', 'investigatorAffiliation': 'Tanta University'}}}}