Skip to main content
OpenTrials
Completed

NCT Number: NCT07551154

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Mandibular Injuries Craniocerebral Trauma Facial Injuries Maxillofacial Injuries Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Alexandria, Azarita, 00203, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ustom made plate and split rib bundle bone graft using virtual surgical planning

Procedure

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.

Primary outcomes

  1. Wound healing

    Time frame: 2 weeks

    patients will be scored yes if healed and no for not healed wounds

Secondary outcomes

  1. Aesthetic deformity

    Time frame: 4 weeks

    patients will be scored yes for presecne of aesthetic deformity and no for absence of deformity

  2. 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

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 24, 2026
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.