Clinical trial · Interventional
Virtual Surgical Planning in Mandibular Segmental Resection
Application of Virtual Surgical Planning in Mandibular Segmental Resection With Reconstruction Plate
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Benign Neoplasm | Benign Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Mandible | — | UNRESOLVED | — |
| Virtual Surgical Planning | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Traditional Medthod | Procedure | — | UNRESOLVED |
| Virtual surgical planning | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Traditional method
- description
- Patients with mandibular tumors will be treated by the traditional method
- interventionNames
- Procedure: Traditional Medthod
- type
- ACTIVE_COMPARATOR
- label
- Virtual surgical planning method
- description
- Patients with mandibular tumors will be treated by traditional method with virtual surgical planning
- interventionNames
- Procedure: Virtual surgical planning
Primary outcomes (2)
- measure
- The Accuracy of Occlusion after surgery following virtual surgical planning
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (1)
- BACKGROUNDKokubun 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