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

NCT07551154 | Completed

• 1 other identifier: 1240-01/2026
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mandibular Injuries

Outcome Measures

Primary Outcomes (1)

• Wound healing

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

  2 weeks

Secondary Outcomes (2)

• Aesthetic deformity

  4 weeks

• Patient satisfaction

  3 days

Study Arms (1)

benign mandibular tumors planned to be managed by segmental mandibulectomy

EXPERIMENTAL

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

Interventions

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.

benign mandibular tumors planned to be managed by segmental mandibulectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

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

Alexandria, Azarita, 00203, Egypt

Location

MeSH Terms

Conditions

Mandibular Injuries

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2026
• First Posted: April 24, 2026
• Study Start: January 2, 2025
• Primary Completion: February 2, 2026
• Study Completion: February 2, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

EG (1)