Clinical Research Directory

Stryker Facial iD Universal Plate Configurator: A Retrospective Post Market Follow Up

A retrospective post market follow up to confirm safety and performance of Stryker's Facial iD Universal Plate Configurator (UPC) implants in the clinical setting. The study is performed to confirm the product's performance and safety by systematically collecting clinical data on its use.

Facial iD Customized Mandible Reconstruction Plates

A retrospective post market follow up to confirm the safety and performance of Stryker's Customized Plates for Mandibular Reconstruction. The study is performed to confirm the product's performance and safety by systematically collecting clinical data on its use.

Piezosurgery Versus Conventional Techniques in Orthognathic Surgery

The goal of this randomized double-blinded controlled clinical trial is to determine whether piezosurgery can reduce complications and improve outcomes compared to conventional osteotomy techniques in patients undergoing bilateral sagittal split osteotomy (BSSO), with or without concurrent Le Fort I osteotomy (bimaxillary surgery). The main questions this study aims to answer are: * Does piezosurgery reduce inferior alveolar nerve impairment following BSSO compared to conventional techniques? * Does piezosurgery affect surgical duration, intraoperative blood loss, rates of bad splits, postoperative infections, costs, and environmental sustainability compared to conventional techniques? Researchers will compare BSSO performed with piezosurgery versus BSSO performed with conventional oscillating saw and burr techniques to see if piezosurgery leads to better sensory outcomes, reduced morbidity, and improved cost-effectiveness and sustainability. Participants will be: * Dutch or English-speaking adults aged 18-65 scheduled for BSSO or BIMAX surgery at Erasmus Medical Centre (Rotterdam) or St. Anna Hospital (Geldrop, Netherlands). * Exclusions include bone healing disorders, coagulation issues, facial trauma history, smoking, craniofacial anomalies, and planned simultaneous genioplasty. Participants will: * Undergo preoperative assessment of inferior alveolar nerve function (two-point discrimination test, validated questionnaire). * Be randomized into: * Intervention group: BSSO performed entirely using piezosurgery. * Control group: BSSO performed with conventional burr and saw techniques. * Have their surgery performed by experienced maxillofacial surgeons following standardized protocols. * Have operative time and blood loss recorded during surgery. * Be followed up at 1 week, 3 months, 6 months, and 1 year for nerve function, sensory recovery, and infection assessment. * Complete postoperative questionnaires on sensory changes at 3 months and 1 year. * Have surgical outcomes evaluated by blinded examiners. * Contribute to a life cycle cost analysis (LCC) and life cycle assessment (LCA) comparing equipment cost, maintenance, energy use, waste generation, and environmental impact between techniques.

Impact of 3D-Printed Anatomical Model on Patient Understanding in Orthognathic Surgery

The goal of this clinical trial is to learn whether using three dimensional (3D)-printed anatomical models improves the informed consent process for participants undergoing orthognathic surgery. The trial also explores how these models affect participants understanding, anxiety, satisfaction, and communication with the surgeon. The main questions it aims to answer are: * Do 3D-printed anatomical models improve participants understanding of their jaw condition and the surgical procedure? * Do they reduce participants anxiety before surgery? * Do they enhance overall participants satisfaction and the physician-patient relationship? Researchers compares participants who received standard two dimensional (2D) imaging and verbal explanations with those who received the same information plus 3D-printed jaw models. Participants: * Scheduled for double- or triple-jaw orthognathic surgery * Randomly assigned to receive either traditional 2D education or the 3D-printed model intervention * Complete a validated questionnaires assessing understanding, anxiety, satisfaction, and doctor-patient communication

Comparison of Accuracy of Maxilla Between Virtual and Conventional Surgical Planning in Bimaxillary Orthognathic Surgery

Study Title Comparison of Maxillary Accuracy Between Virtual and Conventional Surgical Planning in Bimaxillary Orthognathic Surgery: A Randomized Controlled Trial Study Design * Type: Prospective, single-center, randomized, blinded, case-controlled trial * Location: National Hospital of Odonto-Stomatology, Ho Chi Minh City * Period: August 2023 - February 2025 * Sample size: 20 patients * Ethical approval: Granted by the University of Medicine and Pharmacy at HCMC (Approval No. 647/HĐĐĐ-ĐHYD) Inclusion Criteria * Patients aged 18-30 years * Diagnosed with malocclusion requiring bimaxillary orthognathic surgery * Completed presurgical orthodontic treatment Exclusion Criteria * Cleft lip/palate, craniofacial syndromes * Deformities due to trauma, tumors, or iatrogenic causes * TMJ disorders * History of previous orthognathic surgery * Planned multipiece Le Fort I osteotomy Randomization and Blinding * All patients underwent both 2D and 3D surgical planning. * Two splints (CSP and VSP) were fabricated for each patient. * Intraoperative randomization was performed by an OR nurse. * The surgical team and data analysts were blinded to group allocation. * Groups were revealed only after data analysis. Groups * Test group (VSP): 3D virtual planning, simulation, and 3D-printed splints * Control group (CSP): 2D cephalometric planning, model surgery, conventional resin splints Surgical Procedure * All patients underwent Le Fort I and BSSO * Maxilla-first approach with fixation using 4 miniplates * Mandibular repositioning using final splint and fixed with 2 miniplates per side * All surgeries performed by a single experienced surgeon Data Collection \& Measurements * CT scans before and 2 weeks after surgery * Superimposition using Invivo 7.0 software (voxel-based registration) * Measured landmark changes (A point, ANS, U1, U3, U6) in X (medial-lateral), Y (anterior-posterior), and Z (vertical) directions * Compared: * 2D plan (P2D) vs. 3D plan (P3D) * P3D vs. actual postoperative result * VSP vs. CSP accuracy Statistical Analysis * ICC used to test measurement reliability (10 patients, remeasured after 2 weeks) * Normality tested * Paired t-test/Wilcoxon for planned vs. actual * Independent t-test/Mann-Whitney for between-group comparisons * Significance set at p \< 0.05

Facial Conformation Meshes for Orthognathic Surgery

This study is a retrospective analysis that evaluates the accuracy of 3D soft tissue simulation in bimaxillary orthognathic surgery for Class III dentofacial deformities. The study integrates segmented 3D facial conformation meshes and regional aesthetic subunits to enhance soft tissue prediction accuracy. Key Aspects of the Study: Study Design: Retrospective analysis based on existing CBCT scans of patients who have undergone maxillary advancement and mandibular setback surgery. Objective: To assess the accuracy of soft tissue predictions using Dolphin software in different facial regions, particularly in midline vs. lateral regions. Methodology: .CBCT superimposition using voxel-based registration. .Soft tissue surface analysis via generic mesh conformation and dense correspondence analysis. .Error assessment in X, Y, Z dimensions rather than Euclidean distance. .Color-coded maps for visualizing prediction accuracy. Clinical Relevance: The study aims to refine 3D prediction models for orthognathic surgery planning, making them more precise and reliable. Key innovation: Modifying the aesthetic unit segmentation approach for a clinically and statistically relevant assessment of soft tissue changes. Findings will contribute to improving surgical outcome predictability and optimizing treatment planning in maxillofacial surgery. Ethical Considerations: No patient recruitment; the study relies solely on existing anonymized CBCT scans. Ethical approval and waiver of informed consent will be sought from the Institutional Review Board (IRB). This research aligns with modern advancements in 3D facial prediction technology, aiming to enhance precision and clinical applicability in orthognathic surgery.

Incidence of Body Dysmorphic Disorder (BDD) in a Population of Patients Undergoing Orthognathic Surgery

Assessment of the incidence of Body dismorphic disorder in a population candidated to orthognathic surgery

Biodegradable Magnesium Bone Plate and Screw Fixation in Jaw Surgery

The purpose of this study is to evaluate the efficacy and safety of using high-purity magnesium bone plates and screws for internal fixation in jaw surgery. The investigators aim to assess whether these biodegradable magnesium devices promote normal bone healing and functional recovery while ensuring the safety of patients undergoing dentoalveolar surgery, fracture fixation, orthognathic surgery, or craniofacial reconstruction. The hypotheses are: 1. High-purity magnesium bone plates and screws are effective in bone fixation, promoting normal bone healing and functional recovery in jaw surgery. 2. High-purity magnesium bone plates and screws are safe in jaw surgery in terms of local side effects and systemic safety. Participants will undergo jaw surgery based on the clinical indications. High-purity magnesium bone plates and screws will be used for internal fixation during the surgical procedure. Participants will be followed up at 1 week, 3 weeks, 6 weeks, 3 months, 6 months, 1 year, and 2 years after surgery to assess wound healing, functional recovery, and any side effects. If any side effects occur or deemed necessary, participants may be followed up for a longer period. During postoperative follow-up visits, X-ray or CBCT/CT imaging will be conducted routinely or when clinically indicated.