Virtual Surgical Planning in Mandibular Segmental Resection

Summary

Purpose: Odontogenic tumors, predominantly affecting the mandibular region, pose significant challenges in terms of treatment planning, particularly when requiring segmental mandibular resection. This study aims to evaluate the effectiveness of virtual planning and 3D modeling in comparison to traditional surgical methods for treating mandibular odontogenic tumors, focusing on aspects such as accuracy, clinical outcomes, and patient quality of life.

Method: The study is designed as a two-phase investigation. Phase 1 involves in vitro research to create high-precision 3D models and surgical support instruments. Phase 2 consists of a clinical trial with two groups: the Virtual Surgery Group using pre-bent reconstruction plates, 3D mandibular models and surgical guides and the Conventional Surgery Group. Data collection includes assessing model accuracy, comparing clinical outcomes, analyzing postoperative CT scans, and evaluating patient quality of life.

Expected Results: Investigators anticipate that the virtual planning and 3D modeling approach will yield more accurate surgical procedures, improved postoperative outcomes, and enhanced patient quality of life compared to traditional methods. This is expected to be particularly beneficial in maintaining the stability of the condyle at the postoperative site, reducing complications related to mandibular function, and potentially reducing the need for additional surgeries.

Conclusions: If the investigators study demonstrates the superiority of virtual planning and 3D modeling in treating mandibular odontogenic tumors, it could significantly impact the field of oral and maxillofacial surgery by offering a more precise and effective treatment approach. This could ultimately lead to improved patient outcomes and a reduction in the challenges associated with these complex surgical procedures.

Conditions

• Virtual Surgical Planning
• Benign Neoplasm
• Mandible

Interventions

PROCEDURE

Traditional Medthod

Before surgery, the patient's lower jawbone tumor is replicated using a 3D-printed original model without adjustments. Then, the model undergoes manual modification by drilling and adjusting the jawbone model at the tumor site using drills and manual instruments. Subsequently, the reconstructed model is formed preoperatively based on this modified model. During surgery, the patient isn't guided by surgical guides, and the incision lines are relatively dependent on the surgeon. Additionally, while fixing the remaining bone after the sectioning, the surgeon uses pre-bent fixation plates made earlier to assist in stabilizing the bone.

PROCEDURE

Virtual surgical planning

Before surgery, the patient's lower jawbone is 3D-printed, designed to remove the tumor mass, and create a suitable margin for reconstructive plate bending. Subsequently, the reconstruction plate is pre-bent preoperatively based on this model. During surgery, the patient is guided by specific surgical guiding tools: cutting guides. Additionally, while fixing the remaining bone after sectioning, the surgeon is assisted by bone fixation instruments to stabilize the alignment of the two bone fragments according to anatomical structure and then proceeds to use pre-bent reconstruction plates to secure the bone.

Sponsors & Collaborators

• University of Medicine and Pharmacy at Ho Chi Minh City

  lead OTHER

Principal Investigators

• Hung Tr Hoang, PhĐ · University of Medicine and Pharmacy at Ho Chi Minh City

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-12-27

Primary Completion

2025-11-30

Completion

2025-12-31

Countries

• Vietnam

Study Locations