[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mandibular-reconstruction\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mandibular-reconstruction":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,48,78,105],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":28,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100617615","patient-specific-reconstruction-plate-for-segmental-mandibular-defects-100617615",false,"NCT07320924","Patient-specific Reconstruction Plate for Segmental Mandibular Defects","Patient-specific Reconstruction Plate for Alloplastic Bridging of Segmental Mandibular Defects. A Clinical and Radiographic Study.","Inclusion Criteria:\n\n1. Patients with a segmental mandibular continuity defect, not involving the condyle.\n2. Patients suffering from benign, locally invasive or malignant lesions that involving the lower border of the mandible.\n3. Patients with recurrent lesions after resection.\n4. Patients dealing with osteomyelitis or jaw osteonecrosis that is indicated for sequestrectomy.\n\n   • Stage-III jaw osteonecrosis.\n5. Patients with traumatic defects.\n6. Patients with post-gunshot mandibular defects.\n\nExclusion Criteria:\n\n1. Medically compromised patients contradict the operation.\n2. Patients with segmental mandibular defects that require condylar process resection\n3. Patients with lateral segmental mandibular defects involving the condyle that require reconstruction using an alloplastic total joint.\n4. Patients with an active infection at the site of resection.","ALL",{"count":18,"type":19},14,"ESTIMATED","INTERVENTIONAL",[22],"NA","The mandible's horseshoe-shaped anatomy makes the reconstruction of segmental defects a challenging procedure. Conventional reconstruction typically relies on alloplastic plates to bridge bony stumps; however, these require extensive intraoperative bending, often resulting in imperfect adaptation, press-to-contact fixation, and residual stresses that increase the risk of hardware fatigue and fracture. Recent advances in computer-aided design and manufacturing (CAD\u002FCAM) and virtual surgical planning (VSP) have improved precision in maxillofacial reconstruction. Patient-Specific Reconstruction Plates (PSRP), developed from virtual planning and patient-specific anatomical data, offer a bespoke contour adaptation, predictable screw positioning, and elimination of press-fit deformation. This customization improves alignment, mechanical stability, and long-term outcomes.",[25,26,27],"Mandibular Resection","Mandibular Reconstruction* \u002F Methods","Mandibular Reconstruction",[29,30,31,32,33,34],"mandibular resection","surgery","computer-assisted","computer-aided design","computer-aided manufacturing","software","RECRUITING","2025-12-20",{"date":38,"type":39},"2026-01-06","ACTUAL",{"date":41,"type":39},"2025-01-01",{"date":43,"type":19},"2026-08-30",{"name":45,"class":46},"Alexandria University","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":58,"studyType":59,"phases":4,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"100370038","registry-to-collect-data-on-patients-undergoing-segmental-mandibular-defect-reconstruction-following-oral-squamous-cell-carcinoma-resection-and-drugs-induced-osteonecrosis-100370038","NCT04098146","Registry to Collect Data on Patients Undergoing Segmental Mandibular Defect Reconstruction Following Oral Squamous Cell Carcinoma Resection and Drugs-induced Osteonecrosis","A Prospective, International, Multicenter Registry of Patients Undergoing Segmental Mandibular Defects Reconstruction (SMDR) After Mandibular Resection for Tumors and Drugs-induced Osteonecrosis","Inclusion Criteria:\n\n* The study includes patients with an initial pathological\u002Fhistologic diagnosis of mandibular involvement by oral tumors (such as OSCC, osteosarcoma, and ameloblastoma), bisphosphonate- or immunomodulatory drug-induced osteonecrosis, and mandibular lesions from metastatic conditions originating from other sites including lung, breast, prostate, or kidney.\n* Age 18 years and older\n* Bisphosphonate related osteonecrosis of the mandible\n* Immunomodulatory drugs induced mandibular osteonecrosis\n* Patients presented with ameloblastoma affecting the mandible\n* Patients presented with osteosarcomas of the mandible\n* Patients presented with oral metastases related mandibular lesions that are indicated for segmental resection, common primary tumor sites include lung, breast, prostate and kidney\n* Undergoing primary curative treatment with segmental resection of the mandible ≥2 cm\n* Intention to undergo mandibular reconstruction with autologous bone using a primary (one-stage) or secondary (two-stage) approach\n* Informed consent obtained, ie:\n\n  * Ability to understand the content of the patient information\u002FICF\n  * Willingness and ability to participate in the clinical investigation according to the registry plan (RP) o Signed and dated IRB\u002FEC approved ICF OR\n  * Written consent provided according to the IRB\u002FEC defined and approved procedures for patients who are not able to provide to provide independent written informed consent\n\nExclusion Criteria:\n\n* Tumors affecting the condyle\n* Patients under palliative care\n* Previous extensive mandibular surgeries (including reconstructions, e.g., TMJ replacement) that may potentially confound the outcome measures\n\nIntraoperative exclusion criteria:\n\n* Nonsegmental mandibular defect (eg. box resection\u002Fpartial resection)\n* Segmental mandibular defect of less than 2 cm\n* Mandibular defects extending beyond the sigmoid notch into the condyles\n\nAdditional exclusion criterion:\n\n• No osseous reconstruction with autologous bone performed within 18 months from resection","18 Years",{"count":57,"type":19},300,"2 Years","OBSERVATIONAL","Prospective will be collected in a minimum of 300 patients presenting with an acquired segmental mandibular defect ≥ 2 cm secondary to OSSC removal and drugs-induced osteonecrosis, and who require mandibular reconstruction.",[27,62],"Segmental Mandibular Defects",[64,65,66,67],"Mandibular osteotomy","Free bone flap","Reconstructive surgical procedure","Adjuvant Irradiation \u002F Chemotherapy","2025-08-28",{"date":70,"type":39},"2025-09-04",{"date":72,"type":39},"2022-09-12",{"date":74,"type":19},"2030-12-31",{"name":76,"class":46},"AO Innovation Translation Center",19,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":20,"phases":87,"briefSummary":88,"conditions":89,"keywords":90,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":47},"100534380","evaluation-of-an-universal-surgical-device-for-mandibular-reconstruction-100534380","NCT06238076","Evaluation of an Universal Surgical Device for Mandibular Reconstruction.","Universal Surgical Device for Mandibular Reconstruction Using Fibula Free Flap : Feasibility Study.","FIBUMAND","Inclusion Criteria:\n\n* Admitted in the maxillofacial surgery department for mandibular fibula free flap reconstruction including a symphysial bone fragment\n* Patients insured under the French social security system\n* Free and informed consent\n\nExclusion Criteria:\n\n* Lateral mandibular reconstruction without symphysis reconstruction\n* Legally incompetent\n* Inclusion in another protocol of research , involving mandibular reconstruction\n* Pregnant or breastfeeding women",{"count":77,"type":19},[22],"Fibula free flap is the gold standard for mandibular reconstruction. The shape of the fibula requires osteotomy that can be performed with a custom surgical guide. The use of surgical guide shorten surgical time, enhances the precision of the surgeon and reduces morbidity.\n\nSince 2008 custom surgical guide have been used in the hospital department and the clinical team have noticed a number of elements, which leads investigator to think that it would be possible to perform this kind of procedure using an universal guide.\n\nThe aim of this study is to assess the possibility to perform mandibular fibula free flap reconstruction with an universal guide.",[27],[91,27,92,93,94,95],"Mandible","Computer-Aided Design","Fibular free flap","Computer Assisted three dimensional imaging","Surgical equipment","2025-03-12",{"date":98,"type":39},"2025-03-17",{"date":100,"type":39},"2024-03-28",{"date":102,"type":19},"2026-05",{"name":104,"class":46},"University Hospital, Toulouse",{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":114,"conditions":115,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":129},"100363097","validation-of-the-o-bridge-protocol-a-prospective-multicenter-trial-100363097","NCT04007783","Validation of the O-bridge Protocol: a Prospective, Multicenter Trial","Validation of the O-bridge Protocol, Ensuring Immediate or Delayed Prosthetic Rehabilitation in Oncology Patients Undergoing Jaw Reconstruction: a Prospective, Multicenter Trial","Inclusion Criteria:\n\n* Patients with a histologically or clinically confirmed diagnosis of ORN, MRONJ, as classified by respectively Lyons et al. (Lyons, et al., 2014) and Ruggiero et al. (Ruggiero, et al., 2009) (Ruggiero, et al., 2014) or a benign or malignant tumour located in the oral cavity and jaw bone (NCCN, 2015) (Sobin, et al., 2009), requiring marginal, segmental or total jaw resection\n* Patients eligible for jaw and oral cavity reconstruction combined with immediate\u002Fdelayed implant loading for fixed prosthetic rehabilitation\n* Patients not eligible for conventional removable prosthetic rehabilitation\n\nExclusion Criteria:\n\n* Patients not eligible to the abovementioned criteria\n* Patients with a clinically confirmed diagnosis of osteonecrosis not related to an oncological diagnosis or treatment\n* Patients with medical contraindications for jaw reconstruction combined with immediate implant loading for fixed prosthetic rehabilitation\n* Patients whose maternal language is non-Dutch or non-English will be excluded from the acoustic speech evaluation. A perceptual evaluation of speech intelligibility can still be performed.",{"count":113,"type":19},80,"Surgical reconstruction to restore oral function and aesthetics after major ablative surgery in the oral cavity forms a challenge to maxillofacial surgeons, and greatly impacts patient' quality of life (QOL). The \"Oncological-bridge (O-bridge®)\" protocol, which offers (immediate\u002Fdelayed) fixed prosthetic rehabilitation in a minimum of sessions and a strongly reduced two-week treatment time.",[116,117,27,118,119],"Benign or Malignant Tumour of the Oral Cavity","Stage III-IV Osteonecrosis","Fixed Dental Restoration","Quality of Life","2022-02-23",{"date":122,"type":39},"2022-02-24",{"date":124,"type":39},"2017-03-04",{"date":126,"type":19},"2027-12",{"name":128,"class":46},"AZ Sint-Jan AV",5]