Precision of Patient Specific 3D Printed Occlusal Stent, Surgical Guide, and Patient Specific Titanium Plates in Management of Mandibular Fracture (Case Series)

This study evaluates the accuracy of preoperative fully computerized occlusal stents, surgical guide, and patient-specific titanium plates in guided mandibular fracture reduction and fixation. The research question is: Does the use of patient-specific three-dimensional (3D) printed occlusal stents, surgical guides, and titanium plates accurately reduce mandibular fractures regarding guided fracture reduction, fixation, and occlusion? Mandibular fractures are among the most common maxillofacial fractures observed in the emergency room. The evaluation, diagnosis, and management of these fractures remain challenging despite improved imaging technology and fixation techniques. Depending on the type and location of the fractures, various open and closed surgical reduction techniques can be utilized. There are several critical and inherent limitations to the current standard approach of mandibular fracture reduction and fixation.

The anatomical term "body fractures" is used in the present study. It refers to the tooth-bearing area of the mandible including symphyseal, parasymphyseal, and body fractures. Anatomically, the mandible consists of a curved horizontal portion (the body) with the alveolar process on top, and two perpendicular portions (the rami), which unite with the ends of the body nearly at right angles.

Conventionally, surgical plates are mass-produced with universal configurations that must be manually bent to match individual bone anatomy. The plate bending procedure can be time-consuming and technically demanding, especially for inexperienced surgeons. In complex cases, surgical plates may need to be bent repeatedly, which induces internal stress concentration. The stressed plates may suffer from fatigue under in vivo masticatory loading, resulting in complications including plate fracture, corrosion, screw loosening, and bone resorption.

Three-dimensional (3D) printing involves additive manufacturing techniques used to build structures layer by layer. This technology has been adapted to a wide range of surgical applications. It has been used to print patient-specific anatomic models, implants, prosthetics, external fixators, splints, surgical instrumentation, and surgical cutting guides. The utility of this technology in surgery explains its rapid adoption.

There are no comparators in this study because it is a case series. Objectives: This study aims to evaluate the accuracy of preoperative fully computerized occlusal stents, surgical guides, and patient-specific titanium plates in guided mandibular fracture reduction and fixation.

Primary Objectives:

• To achieve anatomical reduction with accurate post-operative occlusion
• To reduce intra-operative time with subsequent reduction in post-operative pain and edema Hypothesis: We hypothesize that preoperative fully computerized occlusal stents, surgical guides, and patient-specific titanium plates are an accurate method for mandibular fracture reduction and fixation.

Trial Design: This is a prospective case series study conducted on adult patients with mandibular fractures.

PIO:

• Population: Patients with mandibular fracture requiring open reduction internal fixation (ORIF)
• Intervention: Preoperative fully computerized occlusal stents, surgical guides, and patient-specific titanium plates
• Outcome: Accuracy of reduction and occlusion

Study Overview

• Status: Completed
• Conditions: Mandibular Fractures
• Intervention / Treatment: Procedure: Patient-Specific 3D Printed Occlusal Stent, Surgical Guide, and Titanium Plates

• Study Type: Observational
• Enrollment (Actual): 6

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of Dentistry, Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Adult patients (18-65 years) presenting with isolated mandibular fractures requiring open reduction and internal fixation (ORIF) at the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Cairo University. All patients had displaced fractures requiring surgical intervention. Patients with systemic contraindications to surgery, uncontrolled diabetes, pregnancy, lactation, or history of head and neck radiation were excluded.

Description

Inclusion Criteria:

• Age 18 to 65 years
• Male or female patients
• Isolated mandibular fractures requiring open reduction and internal fixation (ORIF)

Exclusion Criteria:

• Severe cardiovascular, respiratory, or other systemic conditions presenting risk for anesthesia
• Head and neck radiation therapy within the past year
• Uncontrolled diabetes (glycated hemoglobin HbA1c > 8%)
• Pregnancy or lactation

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Case Series; Six adult patients with isolated mandibular fractures requiring open reduction and internal fixation (ORIF). All patients underwent surgical fixation using patient-specific Three-Dimensional (3D) printed occlusal stents, surgical guides, and titanium plates (2.0 mm thickness) designed via virtual surgical planning.

Procedure: Patient-Specific 3D Printed Occlusal Stent, Surgical Guide, and Titanium Plates; Patients underwent preoperative virtual surgical planning using Mimics software. Patient-specific three-dimensional (3D) printed occlusal stents, surgical guides, and titanium plates (2.0 mm thickness, Grade 4 titanium) were fabricated. Surgical procedure included intraoral or extraoral approach as indicated, fracture reduction using custom guides, fixation with patient-specific plates, and standard postoperative care including antibiotics and soft diet for 4-6 weeks. Postoperative computed tomography (CT) scan was obtained at 4 weeks for accuracy assessment via superimposition analysis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dimensional Accuracy of Mandibular Fracture Reduction	Absolute error between planned (virtual surgical planning) and post-operative measurements across 12 standardized mandibular measurements (Lateral Intercondylar Length, Medial Intercondylar Length, Bicoronoid Length, Bigonial Width, Bimental Length, Maximum Mandibular Length Right, Maximum Mandibular Length Left, Intercanine Length, Maximum Ramus Height Right, Maximum Ramus Height Left, Mandibular Angle Right, Mandibular Angle Left) assessed via computed tomography (CT) superimposition analysis at 4 weeks post-operative.	4 weeks post-operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Acceptability Rate	Proportion of measurements achieving absolute error < 2.0 mm (clinically acceptable threshold) and < 1.0 mm (excellent accuracy threshold) based on computed tomography (CT) superimposition analysis.	4 weeks post-operative
Rotational Movement Pattern	Identification and quantification of rotational movement characterized by anterior widening (intercanine length change) and posterior narrowing (bicoronoid and bigonial width changes) measured by Rotational Divergence Index (RDI) from computed tomography (CT) superimposition analysis.	4 weeks post-operative

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2024
• Primary Completion (Actual): July 9, 2025
• Study Completion (Actual): July 10, 2025

Study Registration Dates

• First Submitted: March 24, 2026
• First Submitted That Met QC Criteria: March 24, 2026
• First Posted (Actual): March 30, 2026

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Surgical Guide; Virtual Surgical Planning; Mandibular Fracture; Patient-Specific Plates; Open Reduction Internal Fixation (ORIF)
• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Fractures, Bone; Craniocerebral Trauma; Trauma, Nervous System; Facial Injuries; Jaw Fractures; Maxillofacial Injuries; Skull Fractures; Mandibular Fractures
• Other Study ID Numbers: 22624 (Other Identifier: City of Hope Medical Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared to protect patient confidentiality. Only aggregated and de-identified summary data are presented in the thesis.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No