Virtual Surgical Planning in Mandibular Segmental Resection

NCT06174532 | Unknown

• 1 other identifier: VSP in mandibular segmental
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Virtual surgical planning; Benign Neoplasm; Mandible; Resection

Outcome Measures

Primary Outcomes (2)

• The Accuracy of Occlusion after surgery following virtual surgical planning

  Assessment by Clinical Assessment involves observing three areas: the front teeth region, the right posterior teeth region, and the left posterior teeth region. The scoring scale is as follows: Posterior teeth group: Achieving interlocking: 2 points, achieving contact: 1 point, completely open: 0 points. Anterior teeth group achieving contact: 1 point, completely open: 0 points. Calculate the total score attained and classify the bite joint based on the criteria: Good: ≥ 4, Average: 2 - 3, Poor: \< 2

  Baseline, 1 week, 24 weeks

• The Accuracy of Condylar position after surgery following virtual surgical planning

  Assessment by CT scan the condylar position after surgery following the change anatomical lankmarks. Value of Condylar Deviation: The range between -12% to +12% is Center position, The range +12% is Forward position, and the range \< -12% is Rearward position

  Baseline, 1 week, 24 weeks

Study Arms (2)

Traditional method

PLACEBO COMPARATOR

Patients with mandibular tumors will be treated by the traditional method

Procedure: Traditional Medthod

Virtual surgical planning method

ACTIVE COMPARATOR

Patients with mandibular tumors will be treated by traditional method with virtual surgical planning

Procedure: Virtual surgical planning

Interventions

Traditional Medthod PROCEDURE

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.

Traditional method

Virtual surgical planning PROCEDURE

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.

Virtual surgical planning method

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients indicated for mandibular segment resection and reconstruction plate placement.
• Patients in overall good health suitable for undergoing anesthesia.
• Patients who consent to the surgery and agree to participate in the study.

You may not qualify if:

• Patients indicated for temporomandibular joint dislocation due to invasive tumor.
• Patients with infections in the mandible.
• Patients with a history of trauma or surgery in the concave region of the mandible.
• Patients with contraindications for surgery due to systemic diseases.
• Patients without the conditions for postoperative follow-up and re-examination.

Sponsors & Collaborators

• University of Medicine and Pharmacy at Ho Chi Minh City: lead

Study Sites (1)

National Hospital of Odonto-Stomatology in Ho Chi Minh City

Ho Chi Minh City, Ho Chi Minh, 70000, Vietnam

RECRUITING

Related Publications (1)

• Kokubun K, Yamamoto K, Nakajima K, Akashi Y, Chujo T, Takano M, Katakura A, Matsuzaka K. Frequency of Odontogenic Tumors: A Single Center Study of 1089 Cases in Japan and Literature Review. Head Neck Pathol. 2022 Jun;16(2):494-502. doi: 10.1007/s12105-021-01390-w. Epub 2021 Oct 30.

  PMID: 34716904 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Study Officials

• Hung Tr Hoang, PhĐ

  University of Medicine and Pharmacy at Ho Chi Minh City

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Le

CONTACT

+84981913818; hoaiphuc1609@gmail.com

Hung Tr Hoang, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator Le Hoai Phuc

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: December 18, 2023
• Study Start: December 27, 2023
• Primary Completion: November 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 27, 2023

Record last verified: 2023-12

Locations

VN (1)