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

NCT07499726 | Completed

• 1 other identifier: 22624
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

1\. Title: Precision of patient specific 3D printed occlusal stent, surgical guide, and patient specific titanium plates in management of mandibular fracture (case series). a: Research question: Does the use of patient specific 3D printed occlusal stent, surgical guide, and patient specific titanium plates accurately reduce mandibular fractures regarding guided fracture reduction fixation and occlusion? Statement of the problem: Mandibular fractures are among the most common maxillofacial fractures observed in emergency room and within the maxillofacial injuries. The evaluation, diagnosis, and management of these fractures remain challenging despite improved imaging technology and fixation techniques (EL-GENGEHI; SEIF, 2015). 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 (YANG, W. F.; CHOI, W. S.; LEUNG, Y. Y.; CURTIN, J. P. et al., 2018). The anatomical term of body fractures has been used in the present study. It refers to the teeth bearing area of the mandible including the symphyseal, parasymphyseal and the body fractures of the mandible. This anatomical term has been used after Warwick et al (ODOM; SNYDER-WARWICK, 2016) who stated that "anatomically the mandible consists of a curved, horizontal portion, the body with the alveolar process on top of it, 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 should be manually bended to match the individual bone anatomy. The plate bending procedure could be time- and energy-consuming, especially for inexperienced surgeons. In order to achieve the desired contour in some complicated cases, surgical plates need to be bended repeatedly, which induces internal stress concentration (MURTEZANI; SHARMA; THIERINGER, 2022). The stressed plates may suffer from fatigue under in vivo masticatory loading, resulting in various complications including plate fracture, corrosion, screw loosening and bone resorption (YANG, W.-F.; CHOI, W. S.; LEUNG, Y. Y.; CURTIN, J. P. et al., 2018). Three-dimensional (3D) printing involves a number of additive manufacturing techniques that are used to build structures from the ground up (HOANG; PERRAULT; STEVANOVIC; GHIASSI, 2016). This technology has been adapted to a wide range of surgical applications at an impressive rate. It has been used to print patient-specific anatomic models, implants, prosthetics, external fixators, splints, surgical instrumentation, and surgical cutting guides. The profound utility of this technology in surgery explains the exponential growth (MEYER-SZARY; LUIS; MIKULSKI; PATEL et al., 2022). 6 a: Rationale for conducting the research: The use of pre-operative 3D planning has the potential to drastically reduce operating room time and costs and reducing fractures of completely and partially edentulous mandibles. Currently, several corporations are contracted with maxillofacial plating companies to provide 3D planning and printing of surgical models, stents and guides to facilitate surgery (KING; PARK; CHRISTENSEN; DANRAD, 2018). To overcome disadvantages of conventional surgical plates, our study is designed to evaluate the effectiveness of preoperative fully computerized occlusal stents, surgical guide, and patient specific titanium plates on guided mandibular fracture reduction fixation. 6 b: Explanation for choice of comparators: There are no comparators in our study because it is a case series study. B. Objectives: Our study aims to evaluate the accuracy of preoperative fully computerized occlusal stents, surgical guide, and patient specific titanium plates on guided mandibular fracture reduction fixation. 7. Primary objective: The function, anatomical reduction with accurate post-operative occlusion. Intra-operative time with subsequent reduction post-operative pain and edema. 7. Hypothesis: We hypothesized that preoperative fully computerized occlusal stents, surgical guide, and patient specific titanium plates are accurate method for mandibular fracture reduction fixation. 8\. Trial design: This is a case series study will be conducted on adult patients with mandibular fracture. PICO (P): Populations: Patients with mandibular fracture needs open reduction and internal fixation. (I): Intervention: preoperative fully computerized occlusal stents, surgical guide, and titanium plates. O): Outcome: accuracy of reduction and occlusion.

Conditions

Mandibular Fractures

Keywords

Mandibular Fracture; Patient-Specific Plates; Surgical Guide; Open Reduction Internal Fixation (ORIF); Virtual Surgical Planning

Outcome Measures

Primary Outcomes (1)

• 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 CT superimposition analysis at 4 weeks post-operative.

  4 weeks post-operative

Secondary Outcomes (2)

• Clinical Acceptability Rate

  4 weeks post-operative

• Rotational Movement Pattern

  4 weeks post-operative

Study Arms (1)

Case Series

Six adult patients with isolated mandibular fractures requiring open reduction and internal fixation (ORIF). All patients underwent surgical fixation using patient-specific 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

Interventions

Patient-Specific 3D Printed Occlusal Stent, Surgical Guide, and Titanium Plates PROCEDURE

Patients underwent preoperative virtual surgical planning using Mimics software. Patient-specific 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 CT scan was obtained at 4 weeks for accuracy assessment via superimposition analysis.

Case Series

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Riad Kamal Riad Ali: lead

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Mandibular Fractures

Condition Hierarchy (Ancestors)

Jaw Fractures; Maxillofacial Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Skull Fractures; Fractures, Bone; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: RIAD KAMAL RIAD ALI

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: March 30, 2026
• Study Start: July 6, 2024
• Primary Completion: July 9, 2025
• Study Completion: July 10, 2025
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)