Mandibular InjuriesNCT07551154
Virtual Surgical Planning of Mandibular Reconstruction Using Custom Made Plate and Split Rib Bundle Bone Graf
A study testing ustom made plate and split rib bundle bone graft using virtual surgical planning in people with Mandibular Injuries, run by Alexandria University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mandibular Injuries
- What is being tested?
- ustom made plate and split rib bundle bone graft using virtual surgical planning
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Jan 2025to 2 Feb 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Benign mandibular tumors planned to be managed by segmental mandibulectomy.
- Adequate soft tissue coverage after mandibular resection.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt
Alexandria, Azarita, 00203
About this study
Official title: 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.
- Conditions
- Mandibular Injuries
- Being tested
- ustom made plate and split rib bundle bone graft using virtual surgical planning
- Medical subject headings
- Mandibular Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ustom made plate and split rib bundle bone graft using virtual surgical planningProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| benign mandibular tumors planned to be managed by segmental mandibulectomy | Experimental | Not described Receives: Procedure: ustom made plate and split rib bundle bone graft using virtual surgical planning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound healing
patients will be scored yes if healed and no for not healed wounds
Measured: 2 weeks
Secondary outcomes (2)
Aesthetic deformity
patients will be scored yes for presecne of aesthetic deformity and no for absence of deformity
Measured: 4 weeks
Patient satisfaction
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
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start2 Jan 2025
- Primary completion2 Feb 2026
- Study completion2 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mandibular InjuriesStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07551154
- Sponsor's protocol ID
- 1240-01/2026
- Status last verified
- Apr 2026
- First submitted
- 18 Apr 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness Of Virtual Surgical Planning of Mandibular Reconstruction Using Custom Made Plate and Split Rib Bundle Bone Graft
- ClinicalTrials.gov ID
- NCT07551154
- Acronym / sponsor ID
- 1240-01/2026
- Conditions
- Mandibular Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 2 Jan 2025 (actual)
- Primary completion
- 2 Feb 2026 (actual)
- Study completion
- 2 Feb 2026 (actual)
- First posted
- 24 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Benign mandibular tumors planned to be managed by segmental mandibulectomy.
- Adequate soft tissue coverage after mandibular resection.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ustom made plate and split rib bundle bone graft using virtual surgical planningthe 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. | Procedure or surgery | benign mandibular tumors planned to be managed by segmental mandibulectomy |
Primary outcome
Wound healing
Time frame: 2 weeks
patients will be scored yes if healed and no for not healed wounds
2 secondary outcomes
Aesthetic deformity
Time frame: 4 weeks
Patient satisfaction
Time frame: 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
Related trials for Mandibular Injuries
RecruitingObservational study
Predictive Factors for Occlusal Changes in Obstructive Sleep Apnea Treatment With Mandibular Advancement Appliance
Obstructive Sleep Apnea Syndrome
Recruiting
Optimized Osteosynthesis: Bone Mineral Density Recovery in Mandibular Body Fractures Using Patient-Specific Versus Conventional Plates
Mandibular Fractures
Active, not recruiting
Fixation of Mandibular Angle Fracture Using 3D Titanium Miniplate Versus Standard Two Plate Fixation
Mandible Fracture, Force Measurement
Not yet recruiting
Antibacterial Effect and Soft Tissue Healing of Chlorhexidine-Coated Polyglactin 910 Sutures After Impacted Lower Third Molar Surgery
Impacted Third Molar Tooth, Surgical Wound Healing
Recruiting
Custom-Made Titanium Plates Versus Custom-Made Polyether Ether Ketone (PEEK) Plates
Mandibular Fractures
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ustom made plate and split rib bundle bone graft using virtual surgical planning in people with Mandibular Injuries, run by Alexandria University at 1 site in Egypt.
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 2 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: finished, as of the sponsor's last update on 24 Apr 2026. 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 Egypt. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound healing (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Apr 2026.