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Virtual Surgical PlanningNCT06174532

Virtual Surgical Planning in Mandibular Segmental Resection

A study testing Traditional Medthod and Virtual surgical planning in people with Virtual Surgical Planning and Benign Neoplasm, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Purpose: Odontogenic tumors, predominantly affecting the mandibular region, pose significant challenges in terms of treatment planning, particularly when requiring segmental mandibular resection. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
What is being tested?
Traditional Medthod and Virtual surgical planning
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteVietnam
Study dates
27 Dec 2023to Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Hung Tr Hoang, PhD contact

Vietnam1 site, 1 recruiting
  • National Hospital of Odonto-Stomatology in Ho Chi Minh City

    Ho Chi Minh City, Ho Chi Minh, 70000

    Phuc H Le, MSc, +84981913818, hoaiphuc1609@gmail.com

    Recruiting

Other trials in Vietnam

About this study

Official title: Application of Virtual Surgical Planning in Mandibular Segmental Resection With Reconstruction Plate

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.

Read more

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.

Read the detailed description

Introduction:

Odontogenic tumors predominantly affect the mandibular region, constituting approximately 99.1% of all benign tumors in the jawbone. Among these, odontogenic tumors, largely associated with teeth, account for a significant portion. Notably, in the mandibular bone make up 67.7% of all odontogenic tumors in the facial jaw region. Furthermore, benign odontogenic tumors of the mandible often exhibit slow progression, typically devoid of pain, and primarily manifest as bony swelling. As a result, tumors are often detected at later stages, potentially leading to severe complications such as complete mandibular destruction, facial deformities, malocclusion, and, in rare cases, malignant transformation.

The management of benign odontogenic tumors of the mandible remains a subject of debate and challenge. The ideal treatment approach must involve an appropriate level of bone resection while minimizing recurrence, thereby ensuring both aesthetic outcomes and functional restoration in the oral region. Two surgical methods are commonly employed: conservative approaches such as enucleation, curettage, with or without peripheral ostectomy, and radical surgical resection involving segmental bone removal. Segmental mandibular resection is chosen when tumors exhibit extensive bone destruction and do not respond to conservative treatments, particularly in cases of highly invasive tumors with less than 1 cm of remaining bone thickness beneath the lower mandible border.

Although segmental resection achieves high treatment efficacy with a low recurrence rate, it is an invasive approach associated with postoperative anatomical complications. Maintaining the correct alignment of the mandibular condyle within the glenoid fossa after segmental resection is a significant challenge. The natural articulation of the condyle and fossa plays a crucial role in mandibular function. Maintaining the original condylar position after resection remains challenging, leading to issues related to temporomandibular joint (TMJ) function, including joint clicking, pain, and limited mouth opening. Failure to address these issues promptly can result in severe complications such as ankylosis and dislocation, necessitating additional corrective surgery. Therefore, preserving the natural condylar-glenoid fossa relationship is crucial, and it requires special attention. Moreover, accurate alignment of the reconstructed segment with the desired orientation is essential.

With the advent of virtual surgical planning based on 3D modeling and 3D printing technology, tools to aid in the reconstruction of the mandible after segmental resection can be designed and manufactured before surgery, potentially yielding improved postoperative outcomes. The decision to perform immediate reconstruction with bone grafting simultaneously during segmental mandibular resection presents a significant challenge. While this approach may reduce the need for subsequent surgeries and shorten functional recovery time, it remains controversial due to the invasiveness and the strong likelihood of local tumor recurrence. Additionally, this technique may be unsuitable for large tumors or those diagnosed at a late stage. In such cases, grafting becomes challenging, especially when the extent of bone loss in the mandible exceeds 6 cm. Consequently, vascularized bone grafting is an option; however, it is associated with high costs and technical difficulties, limiting its accessibility to many patients. Therefore, segmental mandibular resection combined with reconstruction plate placement remains an effective method for treating benign mandibular odontogenic tumors, reducing the risk of recurrence, and ensuring treatment options for the majority of patients.

In Vietnam, alongside traditional surgical methods for the treatment of mandibular odontogenic tumors, involving manual intraoperative judgment for resection planning based on models of the mandible, there is a growing trend toward precision surgery. However, the limited number of studies related to surgical resection of mandibular odontogenic tumors using preoperative three-dimensional (3D) printed models with guiding instruments for accurate bone resection and condylar repositioning represents a knowledge gap in the field. Therefore, investigators initiated this research project titled "Application of Virtual Planning in the Surgical Treatment of Mandibular Odontogenic Tumors with Reconstruction Plate Placement" with the following research question and objectives:

Research Question: Is the virtual planning and 3D modeling approach superior to traditional surgical methods in the treatment of mandibular odontogenic tumors?

Method:

The study is conducted in two phases: an in vitro research phase and a clinical research phase.

Phase 1: In Vitro Research

  • Processing mandibular data and surgical support instruments from CT scan images using software.
  • 3D printing of mandibular models and surgical support instruments using plastic from mandibular CT scan images.
  • Bending the reconstruction plate according to the mandibular model.
  • Reconstruction Plate Bending: Precisely bending the reconstruction plate to fit snugly against the outer surface of the mandible (ensuring at least three holes for plate fixation on each remaining bone segment).
  • Placing the reconstruction plate onto mandibular model 2 with the guidance of a bone fragment fixation tool.
  • CT scanning of mandibular model 2 after the placement of the reconstruction plate.
  • Assessing the accuracy of the 3D model (mandibular model 2 with the plate and bone fragment fixation tool) compared to the real mandible (from the initial CT scan). Additionally, marking anatomical landmarks, measuring certain lines and angles on CT images of the bone model and mandibular CT images to calculate percentage errors.

Phase 2: Clinical Research with a Control

Group Virtual Surgery Group:

  1. Preparation of Necessary Instruments:
  • Utilizing the pre-bent reconstruction plate segment and surgical support instruments that were designed and printed, as well as the design and processing of mandibular models No.1 suitable for surgery.
  • Determining the cutting line on the mandibular model No.1 based on panoramic images, with the cutting position approximately 1 to 1.5 cm from the tumor's edge.
  1. Reconstruction Plate and Surgical Guide:
  • Sterilizing the reconstruction plate and screws.
  • Sterilizing the surgical support instruments using Ortho-phthalaldehyde 0.55% solution.
  1. In the Operating Room for Segmental Mandibular Resection and Reconstruction:
  2. Postoperative Treatment and Evaluation:

Conventional Surgery Group:

  1. Creating a 3D mandibular model using plastic from CT scan data. Determining the cutting line on the 3D mandibular model based on panoramic images, with the cutting position approximately 1 to 1.5 cm from the tumor's edge. The model has not undergone processing yet.
  2. Reconstruction Plate Bending:
  • Drawing the mandibular cutting line on the 3D reconstruction model.
  • Trimming the plastic to mimic the outer surface of the mandible on the 3D model. Processed manually.
  • Precisely bending the reconstruction plate to fit snugly against the outer surface of the 3D mandibular model (ensuring at least three holes for plate fixation on each remaining bone segment).
  • Sterilizing the reconstruction plate and screws.
  1. In the Operating Room for Segmental Mandibular Resection and Reconstruction following traditional technique.
  2. Postoperative Treatment and Evaluation:

Study Variables:

  • The predictor variable for this study is the supplemental method used to enhance the accuracy of the 3D printed surgical support instruments.
  • The primary outcome variable for this study is the assessment of the stability of the condyle at the postoperative segmental resection and reconstruction site.
  • The secondary outcome variable is the evaluation of the participants's occlusion after surgery.
  • Other variables collected for this study include age, sex, location (maxilla vs. mandible and anterior vs. posterior), and the assessment of the participants's postoperative quality of life. Statistical Analysis:
  • Descriptive statistics for the two groups were presented as means or proportions when appropriate.
  • Baseline comparisons between the two groups were conducted via t-tests and Fisher's exact tests as appropriate.
  • For the primary outcome, a multivariate Cox regression analysis was conducted to compare the time to recurrence between the two groups. Additionally, the comparison of time to recurrence was presented in an unadjusted manner as a Kaplan-Meier curve.
  • A comparison of the stability of the condyle at the postoperative segmental resection and reconstruction site was conducted via a multivariate logistic regression. The following potential confounders were controlled in both analyses: location of the tumor.
  • All evaluations were considered significant at p < 0.05. All statistical tests were conducted using SPSS 26.0 and Microsoft Excel 16.39.
Being tested
Traditional Medthod, Virtual surgical planning
Keywords
Virtual surgical planning, Benign Neoplasm, Mandible, Resection
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Traditional MedthodProcedure or surgery

    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.

  • Virtual surgical planningProcedure or surgery

    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.

Study groups in NCT06174532
Study groupRoleWhat they receive
Traditional methodPlacebo comparatorPatients with mandibular tumors will be treated by the traditional method
Receives: Procedure: Traditional Medthod
Virtual surgical planning methodActive comparatorPatients with mandibular tumors will be treated by traditional method with virtual surgical planning
Receives: Procedure: Virtual surgical planning

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Baseline, 1 week, 24 weeks

  2. 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

    Measured: Baseline, 1 week, 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2023
  2. Study start27 Dec 2023
  3. Primary completionNov 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06174532
Sponsor's protocol ID
VSP in mandibular segmental
Status last verified
Dec 2023
First submitted
21 Nov 2023
Last updated
27 Dec 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 34716904

Questions about this trial

What is this clinical trial studying?

A study testing Traditional Medthod and Virtual surgical planning in people with Virtual Surgical Planning and Benign Neoplasm, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Le (+84981913818, hoaiphuc1609@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Accuracy of Occlusion after surgery following virtual surgical planning (time frame: Baseline, 1 week, 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06174532, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2023.

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