Virtual Surgical Planning of Mandibular Reconstruction Using Custom Made Plate and Split Rib Bundle Bone Graf

April 18, 2026 updated by: Alexandria University

Effectiveness Of Virtual Surgical Planning of Mandibular Reconstruction Using Custom Made Plate and Split Rib Bundle Bone Graft

In mandibular reconstruction, computer-assisted procedures, including virtual surgical planning (VSP) and Custom-made implants, have become an integral part of routine clinical practice. Especially complex cases with extensive defects after ablative tumor surgery benefit from a computer-assisted approach. Various CAD/ CAM-manufactured tools such as surgical guides (guides for osteotomy, resection and predrilling) support the transition from virtual planning to surgery. Custom made implants are of particular value as they facilitate both osteosynthesis and the positioning of bone elements. Computer-based approaches may be associated with higher accuracy, efficiency, and superior patient outcomes. However, certain limitations should be considered, such as additional costs or restricted availability. In the future, automation of the planning process and augmented reality techniques, as well as MRI as a nonionizing imaging modality, have the potential to further improve the digital workflow.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Azarita
      • Alexandria, Azarita, Egypt, 00203
        • Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Benign mandibular tumors planned to be managed by segmental mandibulectomy.
  • Adequate soft tissue coverage after mandibular resection.

Exclusion Criteria:

  • Patients not suitable for general anesthesia because of severe systemic medical problems,
  • Soft Tissue deficiency after resection, which are better treated by free osseo-cutaneous flaps.
  • Planning to have postoperative radiotherapy or with history of head and neck radiotherapy.
  • Obvious preoperative infections at the site of surgical resection.
  • Recurrent lesions where wider resection will necessitate free composite flap reconstruction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: benign mandibular tumors planned to be managed by segmental mandibulectomy
Procedure: ustom made plate and split rib bundle bone graft using virtual surgical planning
the operation will be done through a combined intra-oral lower sulcus and extra-oral extended submandibular incisions for lateral mandibular resections and a combined intraoral lower sulcus and transverse collar incision for midline mandibular resections.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wound healing
Time Frame: 2 weeks
patients will be scored yes if healed and no for not healed wounds
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aesthetic deformity
Time Frame: 4 weeks
patients will be scored yes for presecne of aesthetic deformity and no for absence of deformity
4 weeks
Patient satisfaction
Time Frame: 3 days
The level of patient satisfaction will be measured using five-point Likert scale (1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied, and 5 = very satisfied
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2025

Primary Completion (Actual)

February 2, 2026

Study Completion (Actual)

February 2, 2026

Study Registration Dates

First Submitted

April 18, 2026

First Submitted That Met QC Criteria

April 18, 2026

First Posted (Actual)

April 24, 2026

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 18, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1240-01/2026

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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