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

NCT07499726 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 6

Last updated 2026-04-03

No results posted yet for this study

Summary

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

Conditions

  • Mandibular Fractures

Interventions

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.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-06
Primary Completion
2025-07-09
Completion
2025-07-10

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07499726 on ClinicalTrials.gov