An interventional study of 3D-Printed Patient-Specific Titanium Plates and Milled Patient-Specific Titanium Plates in Malocclusion, Angle Class II, Malocclusion, Angle Class III and Dentofacial Deformities, sponsored by Future University in Egypt. Recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Future University in Egypt · Not applicable, Interventional, and Treatment
The purpose of this study is to find out if 3D printed patient-specific titanium plates improve surgical accuracy and decrease operative time compared to milled patient-specific titanium plates in patients having Le Fort I osteotomy for jaw correction. The main questions it aims to answer are:
All participants in the study will:
Preoperative Diagnostic Protocol \& 3D Virtual Surgical Planning
Surgical Guides: Exported in stereolithography (STL) file format and printed in white polyamide (PA2200; EOS e-manufacturing solutions, Munich, Germany) via fused deposition modeling (FDM) on an additive CAM machine (FORMIGA P 110 printer; EOS e-manufacturing solutions, Munich, Germany). The guides are cold-sterilized by overnight immersion in 2% glutaraldehyde.
Patient-Specific Osteosynthesis Plates: Designed to fix the maxilla in the desired position making use of the previously established reference holes. The designed plates will be exported in STL file format to be manufactured in grade 5 titanium alloy using either 3D printing or milling according to randomized allocation .
Intraoperative Protocol \& Interventions Surgical procedures are performed under general anesthesia then intraoral local anesthetic infiltration along incision line with (lidocaine 2%, 1/100,000 adrenaline) for hemostasis. Access is established via intraoral vestibular maxillary and sagittal split mandibular incisions.
Osteotomy \& Reference Hole Drilling: The maxillary cutting guide is seated on the exposed bone, verified for passive fit, and secured using four 2.0-mm screws. Sixteen reference holes (8 per side) are established through the guide. A reciprocating saw is used to perform the Le Fort I osteotomy, followed by maxillary mobilization and removal of bony interferences. Bilateral sagittal split osteotomies of the mandible are subsequently performed using a mandibular guide.
Fixation Protocol (Randomized Allocation):
Study Arm (Group 1): Maxillary repositioning and fixation are executed using 3D-printed patient-specific titanium plates, aligned with the pre-established reference holes and secured with 2.0-mm screws.
Control Arm (Group 2): Maxillary repositioning and fixation are executed using milled patient-specific titanium plates, aligned with the pre-established reference holes and secured with 2.0-mm screws.
Mandibular Fixation \& Closure: In both arms, the mandible is repositioned and fixated relative to the maxilla using traditional tri-poding bi-cortical screws. Incisions are sutured using 4-0 resorbable sutures in a continuous running fashion.
Postoperative Care \& Evaluation Schedule Postoperative Medications: Systemic antibiotic coverage (Amoxicillin / Clavulanic acid 625 mg every 8 hours) is initiated 4 hours postoperatively and continued for 5 days. Analgesics (NSAIDs every 6 hours) are provided for 3 days, and 0.12% Chlorhexidine mouthwash is prescribed for 2 weeks.
Follow-Up Schedule: Clinical evaluations occur weekly for the first month, followed by monthly visits for 5 additional months.
Radiographic Evaluation \& Orthodontics: A postoperative CT scan is acquired within the first postoperative week using parameters identical to the baseline scan to analyze 3D plan transfer accuracy. Post-surgical orthodontic treatment resumes 4 to 6 weeks postoperatively.
Quality Assurance, Monitoring, and Auditing Supervision \& Governance: All CAD/CAM virtual planning and surgical procedures are conducted under the direct supervision of senior academic staff (Prof. Lobna Abdelaziz Aly and Dr. Aya Magdy AbdelRady) at the Oral and Maxillofacial Surgery Department, Future University in Egypt.
Harms: Any temporary or permanent adverse effect will be recorded and documented.
Auditing: Auditing of the study design will be done by the Research Ethics Council, Future University in Egypt.
Protocol Amendments: Any modifications impacting study conduct, patient safety, or benefits require formal approval by the Council of the Oral and Maxillofacial Surgery Department, Future University in Egypt.
Discontinuation Criteria: Interventions are discontinued if technical difficulty with cutting guides/plates arises or if inaccurate translation of the surgical plan occurs intraoperatively.
Confidentiality: All study-related information will be stored securely. All participant information will be stored in locked file cabinets in areas with limited access. All patients' records will be digitized and stored securely on personal computer.
Ancillary and Post Trial Care: All patients will be followed up until complete healing and satisfactory results occur.
Declaration of interests: The study is self-funded. No conflict of interest Consent: The entire procedure will be explained to the patients and a written consent will be obtained.
Standard Operating Procedures \& Protocol Workflows
Patient Recruitment \& Consent:
Inclusion criteria target skeletally mature patients requiring Le Fort I osteotomy for Class II/III malocclusion with good oral hygiene and no active TMDs.
Fully informed written consent is obtained prior to enrollment.
CAD/CAM \& Manufacturing:
Preoperative CT scans and digitized dental models. Cutting guides and Patient-specific titanium plates (Grade 5 titanium alloy) are manufactured.
Any temporary or permanent adverse effects occurring during the trial are documented and recorded in patient files.
Plan for Missing Data \& Participant Retention Participant Retention Strategies: Patient phone numbers are recorded during written consent, and structured telephone reminders are made prior to every follow-up visit.
Adherence Verification: Patients are recalled at 1-week intervals and instructed to bring their medication packaging to verify postoperative drug compliance.
Statistical Analysis Plan Statistical analysis will be carried out. Data will be analyzed using IBM SPSS advanced statistics (Statistical Package for Social Sciences), version 21 (SPSS Inc., Chicago, IL). Numerical data will be described as mean and standard deviation or median and range, as appropriate. Because of the small sample size, the comparisons between pre and post treatment will be done by Wilcoxon signed rank test. A p-value less than or equal to 0.05 will be considered statistically significant. All tests will be two tailed.
124 studies on the registry are indexed under Malocclusion, Angle Class II; 19 are open to participants now.
This study's planned enrollment of 12 is below the median of 34 across 115 interventional studies indexed under Malocclusion, Angle Class II.
Browse Malocclusion, Angle Class II studies →Future University in Egypt is the lead sponsor of 104 studies on the registry; 31 are open to participants now.
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Exclusion Criteria:
Participants in this group undergo Le Fort I osteotomy with maxillary repositioning and fixation using 3D-printed (additive manufactured) patient-specific grade 5 titanium alloy plates. Plate placement is guided by pre-drilled reference holes established via CAD/CAM cutting guides and secured with 2.0-mm screws.
Device: 3D-Printed Patient-Specific Titanium Plates
Participants in this group undergo Le Fort I osteotomy with maxillary repositioning and fixation using milled (subtractive manufactured) patient-specific grade 5 titanium alloy plates. Plate placement is guided by pre-drilled reference holes established via CAD/CAM cutting guides and secured with 2.0-mm screws.
Device: Milled Patient-Specific Titanium Plates
Following a Le Fort I osteotomy performed with a reciprocating saw, the maxilla is repositioned and rigidly fixated using the 3D-printed patient-specific plates. Plate alignment is guided by 16 pre-drilled reference holes (8 per side) established using a customized cutting guide, and plates are secured using 2.0-mm screws
Following a Le Fort I osteotomy performed with a reciprocating saw, the maxilla is repositioned and rigidly fixated using the milled patient-specific plates. Plate alignment is guided by the same 16 pre-drilled reference holes (8 per side) established via a customized cutting guide, and plates are secured using 2.0-mm screws
Accuracy of Surgical Transfer
The primary outcome measures the precision with which the virtual surgical plan (P0/T0) is transferred to the actual surgical outcome (P1/T1). * Image Registration: The virtual surgical plan is superimposed onto the postoperative Computed Tomography (CT) scan using point-based matching Iterative Closest Point (ICP) registration, followed by manual surface-based best-fit registration targeting the stable skull base in Mimics 19.0 software. * Linear Measurement: Discrepancies between the planned and actual positions are measured from hard tissue reference points specifically the upper central incisor (U1) and upper first molars (16, 26): Vertical Deviation: Distance measured relative to the Frankfort Horizontal Plane (FHP). Anteroposterior Deviation: Distance measured relative to the Coronal Plane (CP). Mediolateral Deviation: Distance measured relative to the Mid-Facial Plane (MFP).
Time frame: Immediate postoperative period (within the first week postoperatively)
Operative Time
Operative time is defined as the total intraoperative duration required for all surgical procedures, including the positioning and fixation of the patient-specific titanium plate on the maxilla during Le Fort I osteotomy. The time is measured and recorded in minutes for each participant using a digital stopwatch, starting when the surgeon performs the first surgical incision and ending when the surgeon completes final closure suturing
Time frame: Intraoperatively (from initial surgical incision to final suture closure)
Postoperative Stability
Evaluates the extent to which skeletal structures maintain their corrected position relative to the virtual surgical plan following Le Fort I osteotomy. Postoperative CT scans obtained within 1 week are imported into Mimics software and superimposed onto the virtual plan using stable skull base reference points. Linear deviations are evaluated at key hard tissue landmarks (central incisor U1, first molars 16 and 26) across three spatial dimensions
Time frame: Immediate postoperative period (within 1 week postoperatively)
Plan to share: Undecided
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Malocclusion, Angle Class II →