[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mandible-fracture\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mandible-fracture":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,49,83,115,138,164,183,201],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":4},"100644552","effect-of-adipose-tissue-derived-autologous-mesenchymal-stem-cell-concentrate-on-bone-quality-in-mandibular-fracture-healing-100644552",false,"NCT07671183","Effect of Adipose Tissue Derived Autologous Mesenchymal Stem Cell Concentrate on Bone Quality in Mandibular Fracture Healing.","Bone Quality Assessment Following Application of Adipose Tissue Derived Autologous Mesenchymal Stem Cell Concentrate in the Management of Mandibular Fractures. A Randomized Clinical Trial","Inclusion Criteria:\n\n* Patients with mandibular fracture.\n* Patients who are willing to participate in the study\n\nExclusion Criteria:\n\n* Patients with systemic diseases influence bone healing\n* Patients with pathological fractures.\n* Infection located at the zone to be treated","ALL","18 Years","40 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24],"NA","* The goal of study is to evaluate the effectiveness of adipose tissue derived-MSCs concentrate application in mandibular fractures. The main question it aims to answer is: Does intervention enhance bone quality, reduce complications and reduce bone regeneration time.\n* Researchers will compare the effectiveness of adipose tissue derived-MSCs concentrate application with ORIF to ORIF alone to see if MSCs improve healing in mandibular fractures.\n* Participants will:\n\n  * Be managed either by adipose tissue derived-MSCs concentrate application with ORIF or ORIF alone.\n  * Undergo CBCT immediately (T1) and 3 months (T4) postoperatively for bone density radiographic evaluation\n  * Visit the clinic postoperatively at one week (T2), one month (T3), three months (T4) for clinical examination",[27],"Mandible Fracture",[29,30,31,32,33,34,35,36],"bone quality","bone healing","mandibular fractures","mesenchymal stem cells","randomized clinical trial","fracture repair","bone regeneration","regenerative medicine","NOT_YET_RECRUITING","2026-06-25",{"date":40,"type":41},"2026-06-29","ACTUAL",{"date":43,"type":21},"2026-07",{"date":45,"type":21},"2027-02",{"name":47,"class":48},"Cairo University","OTHER",{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":60,"conditions":61,"keywords":65,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":82},"100608995","phase-2-comparison-of-submucosal-dexamethasone-and-methylprednisolone-in-postoperative-sequelae-of-parasymphsis-fractures-100608995","NCT07208799","Comparison of Submucosal Dexamethasone and Methylprednisolone in Postoperative Sequelae of Parasymphsis Fractures","Comparison of Effectiveness of Submucosal Dexamethasone and Methylprednisolone in Management of Postoperative Sequelae in Mandibular Parasymphysis Fractures","Inclusion Criteria:\n\n1. Patients aged 18 to 40.\n2. Both Gender.\n3. Fracture less than a week old.\n4. Isolated mandibular parasymphysis fractures.\n\nExclusion Criteria:\n\n* 1\\. Immunocompromised patients (due to increased risk of infection and complications).\n\n  2\\. Patients experiencing acute pain from conditions such as pulpitis, abscesses, or other acute infections (to ensure that acute pain does not confound the study results).\n\n  3\\. Patients reporting hypersensitivity to steroids (to avoid adverse reactions).\n\n  4\\. Patients taking or requiring prophylactic antibiotics or anti-inflammatory drugs before surgery (to prevent confounding effects on study outcomes).\n\n  5\\. Patients with a history of systemic steroid administration for 15 days (as this could affect the study's outcomes).\n\n  6\\. Patients with chronic pain problems or mental disorders (to maintain consistency in response to treatment).\n\n  7\\. Patients with comminuted fractures (to maintain consistency in fracture type).\n\n  8\\. Pregnant or lactating women (to avoid potential risks to the fetus and nursing infant).\n\n  9\\. Smokers who smoke at least 10 cigarettes per day for 2 years (to minimize the impact of smoking on healing and recovery).\n\nria:",{"count":57,"type":21},72,[59],"PHASE2","The rationale of the current research is to address the limitation of existing knowledge as it is not clear which of the two drugs (Dexamethasone or Methylprednisolone) is more effective in reduction of postoperative sequelae in patient with mandibular parasymphysis fracture. This study fills the gap by providing sound evidence on the preferred steroid option to help clinicians have more data to make decisions and improve patients' health. The result of this research will then be added to the evidence-based protocols for the treatment of parasymphysis fractures.",[27,62,63,64],"Edema Face","Pain Management","Corticosteroid Injection",[66,67,68,69,70,71],"mandible fracture","edema","pain","submucosal","dexamethasone","methylprednisolone","RECRUITING","2026-04-02",{"date":75,"type":41},"2026-04-06",{"date":77,"type":41},"2026-01-03",{"date":79,"type":21},"2026-12-01",{"name":81,"class":48},"Nishtar Medical University",1,{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":22,"phases":93,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":114},"100513336","phase-3-the-mantra-trial-mandibular-trauma-and-antibiotic-use-100513336","NCT05964140","The MANTRA Trial (MANdibular TRauma and Antibiotic Use)","Should we Use Post-operative Antibiotics Following Surgery for Patients With Mandible Fractures? The MANTRA Trial (MANdibular TRauma and Antibiotic Use)","MANTRA","All adult patients aged 18 years or over with mandible fractures requiring surgery. Most of these patients will be identified from the A\\&E department via the on-call OMFS team or seen in dedicated OMFS trauma clinics. A small proportion of our study population will be seen in an OMFS clinic following referral from GP\u002FGDP.\n\nInclusion Criteria:\n\n* Ability to provide written informed consent\n* Age≥18 years\n* Hospital episode of mandible fracture(s)\n* Planned treatment is surgery - (ORIF with titanium miniplates)\n\nExclusion Criteria:\n\n* Isolated mandibular condylar fractures\n* Existing fracture site infection\n* Immunocompromised (transplant patients, haematological malignancies, HIV\u002FAIDS) - a clear definition will be provided in the protocol\n* Pathological fracture (e.g., malignancy, osteoradionecrosis, cysts, Medication-Related Osteonecrosis of the Jaws \\[MRONJ\\])\n* Fractures open to skin\n* Inability to provide written informed consent\n* Other injuries or infections mandating ongoing post-operative antibiotics (e.g., panfacial fractures with mandible fracture component)\n* Patients allergic to first and second-line antibiotic prophylaxis (as outlined above)",{"count":92,"type":21},2841,[94],"PHASE3","1. FULL TITLE OF THE PROJECT Should we use post-operative antibiotics following surgery for patients with mandible fractures? The MANTRA trial (MANdibular TRauma and Antibiotic use)\n2. SUMMARY OF RESEARCH (ABSTRACT) Research Question: Are post-operative antibiotics required following surgery for patients with mandible fractures? Background: Mandible fractures are the commonest facial fractures needing surgery and account for a significant percentage of the acute workload in Oral \\& Maxillofacial Surgery (OMFS) units. The UK records over 6000 new cases per year. Patients having surgery for mandible fractures have a theoretical risk of developing surgical site infection, due to the proximity of the fracture lines to the oral cavity microbes and the presence of foreign body (titanium fixation miniplates). For this reason, clinicians often prescribe antibiotics after surgery, to reduce the risk of infection. Previous systematic reviews and a multicentre cohort study performed by this team, revealed significant clinical variation in post-operative antibiotic prescription amongst UK OMFS clinicians and the presence of clinical equipoise. Antibiotic overuse can lead to antibiotic resistance and other antibiotic-related side effects; judicious antibiotic use and stewardship is of paramount importance.\n\nAim: To determine whether post-operative antibiotics are required at all, following surgery for mandible fractures, and, if so, what is the most clinically- and cost-effective regimen\n\nObjectives:\n\nPrimary Objective To conduct a Randomized Controlled Trial (MANTRA) in order to establish the non-inferiority (or not) of not giving post-operative antibiotics versus 2 other post-operative antibiotic regimens. An internal pilot phase will optimise recruitment and retention.\n\nSecondary Objectives\n\n* Measure the cost-effectiveness of the proposed antibiotic pathways\n* Assess patient and clinician acceptability to change clinical practice\n* Process evaluation to inform dissemination and implementation Methods: The investigators designed and propose the MANTRA RCT to compare 3 post-operative antibiotic approaches to prevent Surgical Site Infections (SSIs) following surgery for mandible fractures. The MANTRA trial is a large open label, multicentre study in NHS OMFS units. The 3 study arms represent the most common clinical pathways in the UK based on previous work; the control group is the approach prescribed by most UK OMFS clinicians. All patients will receive 1 dose of IV antibiotics (co-amoxiclav 1.2g, if no penicillin allergy, which is the most commonly used prophylactic antibiotic currently) on induction of anaesthesia, prior to their surgery.\n\nThe participants will be randomised to the following (1:1:1):\n\nGroup A: No further antibiotics Group B: 2 further postoperative IV doses of co-amoxiclav 1.2g Group C: 2 further postoperative IV doses (as above), followed by a 5-day course of oral co-amoxiclav 625mg every 8 hours if no penicillin allergy (Control).\n\nTrial processes will be optimised by an internal pilot phase ensuring we recruit, randomise, and retain participants with clear progression criteria. We will also conduct cost-effectiveness analyses and process evaluation for dissemination and implementation\n\nTimeline:\n\nStart of grant: 1st July 2023 Start of RCT \u002F pilot: 1st January 2024 End of pilot: 30th June 2024 End of recruitment: 31st December 2026 End of follow-up: 30th June 2027 Completion: 31st December 2027\n\nImpact and dissemination:\n\n* Practice changing outputs that standardise the use of antibiotics in mandible fractures in the NHS and provide a framework for other surgical prophylaxis research\n* A bespoke clinical dissemination plan via an engagement and training legacy\n* Cost-effectiveness data to inform policy making\n* A research legacy and change of culture in the specialty of OMFS",[27,97],"Post-operative Antibiotics",[99,100,101,102,103,104],"Mandible fractures","Antibiotics","Open Reduction and Internal Fixation","Co-amoxiclav","Antibiotic Resistance","Surgical Site Infection","2026-01-21",{"date":107,"type":41},"2026-01-22",{"date":109,"type":41},"2024-12-06",{"date":111,"type":21},"2027-12-31",{"name":113,"class":48},"East Lancashire Hospitals NHS Trust",2,{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":16,"minAge":122,"maxAge":123,"enrollmentInfo":124,"targetDuration":4,"studyType":22,"phases":126,"briefSummary":127,"conditions":128,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":82},"100600907","sagittal-split-plate-versus-two-miniplates-in-the-treatment-of-mandibular-angle-fractures-100600907","NCT07103590","Sagittal Split Plate Versus Two Miniplates in the Treatment of Mandibular Angle Fractures","New Design Sagittal Split Plate Versus Two Miniplates in the Treatment of Mandibular Angle Fractures (Randomized Controlled Clinical Trial)","Inclusion Criteria:\n\n* Patients suffering from recent, uninfected angle mandibular fracture.\n* Fracture that demands open reduction and internal fixation.\n\nExclusion Criteria:\n\n* Medically compromised patients contradicting the operation.\n* Existence of infection at the fracture line.\n* Pathological fracture.\n* An old fracture.","20 Years","50 Years",{"count":125,"type":21},16,[24],"Mandibular fractures are the second most common maxillofacial fracture after nasal bone fracture. As a result, a lot of research work has gone into improving treatment methods for these fractures including, reduction of immobilization period and enhancement of rigid fixation. One of these modalities is the use of Sagittal Split plate at the angle of the mandible.",[27],"2025-07-29",{"date":131,"type":41},"2025-08-05",{"date":133,"type":41},"2025-07-16",{"date":135,"type":21},"2025-12-01",{"name":137,"class":48},"Alexandria University",{"id":139,"slug":140,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":4,"eligibilityCriteria":144,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":145,"targetDuration":4,"studyType":22,"phases":147,"briefSummary":148,"conditions":149,"keywords":152,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":4},"100588339","clinical-and-radiographical-assessment-of-patients-with-sub-condylar-fracture-using-polyetheretherketone-peek-trapezoidal-plates-versus-titanium-trapezoidal-plates-100588339","NCT06940115","Clinical and Radiographical Assessment of Patients With Sub-condylar Fracture Using Polyetheretherketone (PEEK) Trapezoidal Plates Versus Titanium Trapezoidal Plates","Clinical and Radiographical Assessment of Patients With Sub-condylar Fracture Using CAD\u002FCAM Polyetheretherketone (PEEK) Trapezoidal Plates Versus CAD\u002FCAM Titanium Trapezoidal Plates: Randomized Controlled Clinical Study","Inclusion Criteria:\n\n* Patients aged 18 years or older, irrespective of gender\n* Recent mandibular subcondylar fractures indicated for open reduction and internal fixation\n\nExclusion Criteria:\n\n* Medically compromised patients contradicting operation (ASA III, IV \\& V).\n* Patients receiving radiotherapy or chemotherapy.\n* Infection at the fracture line.\n* Pathological fractures and old fractures\n* comminuted fractures",{"count":146,"type":21},24,[24],"Some of titanium's drawbacks that is commonly used in maxillofacial surgery included scatter artefacts on regular imaging, implant exposure and inflammation, high thermal conductivity, and high elastic modulus. Very few clinical studies have been published on using a PEEK plate in the mandibular fractures and to the best of the author's knowledge, this is the first study that will be done comparing trapezoidal condylar 3D printed PEEK plates and titanium trapezoidal condylar plate in subcondylar fractures in terms of clinical and radiographical outcomes.",[150,151,27],"Condylar Neck Fractures","Polyetheretherketone",[153,154,155],"PEEK PLATES","TRAPEZOIDAL PLATES","CAD\u002FCAM","2025-04-22",{"date":158,"type":41},"2025-04-23",{"date":160,"type":21},"2025-05-01",{"date":162,"type":21},"2026-06-01",{"name":47,"class":48},{"id":165,"slug":166,"hasResults":11,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":4,"eligibilityCriteria":170,"healthyVolunteers":11,"sex":16,"minAge":171,"maxAge":4,"enrollmentInfo":172,"targetDuration":4,"studyType":22,"phases":173,"briefSummary":174,"conditions":175,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":180,"leadSponsor":181,"locationsCount":4},"100585157","z-mini-plate-with-lingual-extension-versus-conventional-2-mini-plates-100585157","NCT06898710","z Mini-plate With Lingual Extension Versus Conventional 2 Mini Plates","Evaluating the Efficacy of Patient Specific Z-shape Mini-plate With Lingual Extension Versus Usual Two Mini-plates in Mandibular Class III Fracture Management","Inclusion Criteria:\n\n* \\- Class III mandibular fracture\n* medically stable patient\n* aged above 21 years\n* no medical condition affect the bone healing\n\nExclusion Criteria:\n\n* • absence of other facial trauma, mandibular condylar fracture\n\n  * patient refuse the follow up","21 Years",{"count":20,"type":21},[24],"The collected patients according to the eligibility criteria will be randomly distributed into one of these groups:\n\nGroup I : 10 patients suffering class III mandibular fracture will be managed by patient specific Z shape mini-plate with lingual extension (study group).\n\nGroup II : 10 patients suffering class III mandibular fracture will be managed by 2 mini plates at superior and inferior borders (control group).\n\nThe allocation sequence will be generated using computerized random numbers and kept in sealed envelopes, which will be opened prior to surgery. All patients will provide the informed consent after declaration the procedures, benefits, and harms",[27],"2025-03-21",{"date":178,"type":41},"2025-03-27",{"date":160,"type":21},{"date":135,"type":21},{"name":182,"class":48},"Fayoum University",{"id":184,"slug":185,"hasResults":11,"nctId":186,"briefTitle":187,"officialTitle":188,"acronym":4,"eligibilityCriteria":189,"healthyVolunteers":11,"sex":16,"minAge":171,"maxAge":4,"enrollmentInfo":190,"targetDuration":4,"studyType":22,"phases":191,"briefSummary":192,"conditions":193,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":4},"100585223","finite-element-and-z-shap-mini-plate-with-lingual-extension-100585223","NCT06899568","Finite Element and z Shap Mini Plate With Lingual Extension","Finite Element Evaluation of Patient Specific Z-shaped Plate With Lingual Extension Versus Conventional Two Mini Plates for Mandibular Parasymphyseal Fracture Fixation","Inclusion Criteria:\n\n\\- parasymhyseal fracture\n\nExclusion Criteria:\n\n• absence of other facial trauma, mandibular condylar fracture",{"count":82,"type":21},[24],"* A cone beam CT (CBCT) scan of the patient, will be used to create a 3D scanned image of parasympheseal mandibular fracture\n* 3D images will be introduced to finite element (FA)software to evaluate Stresses (MPa) and Life time (cycle) For each model and determine which plate is the best",[27],{"date":195,"type":41},"2025-03-28",{"date":197,"type":21},"2025-04-27",{"date":199,"type":21},"2025-06-27",{"name":182,"class":48},{"id":202,"slug":203,"hasResults":11,"nctId":204,"briefTitle":205,"officialTitle":205,"acronym":4,"eligibilityCriteria":206,"healthyVolunteers":11,"sex":16,"minAge":207,"maxAge":208,"enrollmentInfo":209,"targetDuration":4,"studyType":22,"phases":210,"briefSummary":211,"conditions":212,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":114},"100580521","accuracy-of-computer-guided-screw-holes-locating-guide-and-patient-specific-champy-plate-vs-conventional-champy-plate-osteosynthesis-in-management-of-mandibular-angle-fracture-randomized-controlled-trial-100580521","NCT06838377","Accuracy of Computer Guided Screw Holes Locating Guide and Patient Specific Champy Plate vs Conventional Champy Plate Osteosynthesis in Management of Mandibular Angle Fracture: Randomized Controlled Trial","Inclusion Criteria:\n\n* Patients with isolated mandibular angle fracture needs open reduction and internal fixation.\n* Patients with medical history that did not hinder plate placement and adequate proper oral hygiene.\n* Both genders males and females will be included.\n\nExclusion Criteria:\n\n* General contraindications to surgery. .\n* Patients with comminuted fractures.\n* Subjected to irradiation in the head and neck area less than 1 year before fixation.\n* Untreated periodontitis.\n* Poor oral hygiene and motivation.\n* Uncontrolled diabetes.\n* Pregnant or nursing.\n* Substance abuse.\n* Psychiatric problems or unrealistic expectations.\n* Severe bruxism or clenching.\n* Immunosuppressed or immunocompromised.\n* Treated or under treatment with intravenous amino-bisphosphonates.\n* Patients participating in other studies, if the present protocol could not be properly followed.","16 Years","60 Years",{"count":20,"type":21},[24],"the aim of our study is to assess computer guided mandibular fracture reduction and to prove its lower rate of complications and higher accuracy of reduction compared to the conventional approach in management of mandibular angle fracture.",[27],"2025-02-16",{"date":215,"type":41},"2025-02-20",{"date":217,"type":21},"2025-02-25",{"date":219,"type":21},"2025-06-30",{"name":47,"class":48}]