Mandibular ResectionNCT07320924
Patient-specific Reconstruction Plate for Segmental Mandibular Defects
A study testing Patient specific reconstruction plate in people with Mandibular Resection and Mandibular Reconstruction* / Methods, run by Alexandria University at 1 site in Egypt.
Trial summary
The mandible's horseshoe-shaped anatomy makes the reconstruction of segmental defects a challenging procedure. Conventional reconstruction typically relies on alloplastic plates to bridge bony stumps; however, these require extensive intraoperative bending, often resulting in imperfect adaptation, press-to-contact… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mandibular Resection, Mandibular Reconstruction* / Methods, Mandibular Reconstruction
- What is being tested?
- Patient specific reconstruction plate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2025to 30 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with a segmental mandibular continuity defect, not involving the condyle.
- Patients suffering from benign, locally invasive or malignant lesions that involving the lower border of the mandible.
- Patients with recurrent lesions after resection.
- Patients dealing with osteomyelitis or jaw osteonecrosis that is indicated for sequestrectomy.
- Stage-III jaw osteonecrosis.
- Patients with traumatic defects.
- Patients with post-gunshot mandibular defects.
Who cannot join
- Medically compromised patients contradict the operation.
- Patients with segmental mandibular defects that require condylar process resection
- Patients with lateral segmental mandibular defects involving the condyle that require reconstruction using an alloplastic total joint.
- Patients with an active infection at the site of resection.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, Alexandria University
Alexandria, Alexandria Governorate, 21523
Yehia A El-Mahallawy, PhD, +201007217014, yehia.el-mahallawy@alexu.edu.eg
About this study
Official title: Patient-specific Reconstruction Plate for Alloplastic Bridging of Segmental Mandibular Defects. A Clinical and Radiographic Study.
The mandible's horseshoe-shaped anatomy makes the reconstruction of segmental defects a challenging procedure. Conventional reconstruction typically relies on alloplastic plates to bridge bony stumps; however, these require extensive intraoperative bending, often resulting in imperfect adaptation, press-to-contact fixation, and residual stresses that increase the risk of hardware fatigue and fracture. Recent advances in computer-aided design and manufacturing (CAD/CAM) and virtual surgical planning (VSP) have improved precision in maxillofacial reconstruction. Patient-Specific Reconstruction Plates (PSRP), developed from virtual planning and patient-specific anatomical data, offer a bespoke contour adaptation, predictable screw positioning, and elimination of press-fit deformation. This customization improves alignment, mechanical stability, and long-term outcomes.
Read the detailed description
The study aims to assess the clinical performance and morbidity rate of computer-guided PSRP in the management of mandibular segmental defects.
This prospective interventional clinical trial will be conducted on a total of 14 patients with a segmental mandibular defect, recruited from Alexandria University Teaching Hospital. All patients will be reconstructed using a PSRP alloplastic bridging plate, utilizing a preoperative virtual surgical planning and design. Patients will be evaluated clinically for the rate of morbidity and range of mandibular excursions. Furthermore, postoperative radiographic 3D analysis will evaluate the accuracy of the computer-guided procedure.
- Being tested
- Patient specific reconstruction plate
- Keywords
- mandibular resection, surgery, computer-assisted, computer-aided design, computer-aided manufacturing, software
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient specific reconstruction plateDevice
Patient specific reconstruction plate
| Study group | Role | What they receive |
|---|---|---|
| Patient specific reconstruction plate | Experimental | patient with mandibular ablation defect managed with patient specific reconstruction plate Receives: Device: Patient specific reconstruction plate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications and degree of morbidity
All patients will be assessed immediately post-operative, at 1 and 3 months. Any complication that arises during the clinical follow-up period will be monitored and reported. Complications include prolonged hospital stay, prolonged drug administration, signs of screw or PSRP loosening, PSRP fracture, wound dehiscence or tissue necrosis, Intra/extraoral PSRP exposure, and fistulae.
Measured: 3 months
Secondary outcomes (1)
Functional Range of Mandibular Excursions
The range of mandibular excursions will be objectively recorded using a caliper measurement during the clinical follow-up periods. The following excursions will be recorded:
Intra-Incisal Mouth Opening (I-IMO) Dental Midline Deflection on Opening (DMD-O) Chin Midline Deflection on Opening (CMD-O)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start1 Jan 2025
- Primary completion30 May 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mandibular ResectionStudies of the same condition, open and under way.
- 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
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- yehia M El-Mahallawy, Phd, Principal investigator, Faculty of Dentistry, Alexandria University, Alexandria, Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07320924
- Sponsor's protocol ID
- 20-12-25/PSRP
- Status last verified
- Dec 2025
- First submitted
- 20 Dec 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data will be de-identified to protect the participant data. patients signed an informed consent for the use of their medical records and data for study.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-specific Reconstruction Plate for Alloplastic Bridging of Segmental Mandibular Defects. A Clinical and Radiographic Study.
- ClinicalTrials.gov ID
- NCT07320924
- Acronym / sponsor ID
- 20-12-25/PSRP
- Keywords
- mandibular resection, surgery, computer-assisted, computer-aided design, computer-aided manufacturing, software
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 6 Jan 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.
The mandible's horseshoe-shaped anatomy makes the reconstruction of segmental defects a challenging procedure. Conventional reconstruction typically relies on alloplastic plates to bridge bony stumps; however, these require extensive intraoperative bending, often resulting in imperfect adaptation, press-to-contact fixation, and residual stresses that increase the risk of hardware fatigue and fracture. Recent advances in computer-aided design and manufacturing (CAD/CAM) and virtual surgical planning (VSP) have improved precision in maxillofacial reconstruction. Patient-Specific Reconstruction Plates (PSRP), developed from virtual planning and patient-specific anatomical data, offer a bespoke contour adaptation, predictable screw positioning, and elimination of press-fit deformation. This customization improves alignment, mechanical stability, and long-term outcomes.
Detailed description
The study aims to assess the clinical performance and morbidity rate of computer-guided PSRP in the management of mandibular segmental defects.
This prospective interventional clinical trial will be conducted on a total of 14 patients with a segmental mandibular defect, recruited from Alexandria University Teaching Hospital. All patients will be reconstructed using a PSRP alloplastic bridging plate, utilizing a preoperative virtual surgical planning and design. Patients will be evaluated clinically for the rate of morbidity and range of mandibular excursions. Furthermore, postoperative radiographic 3D analysis will evaluate the accuracy of the computer-guided procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient specific reconstruction plate | Experimental | Device: Patient specific reconstruction platepatient with mandibular ablation defect managed with patient specific reconstruction plate |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with a segmental mandibular continuity defect, not involving the condyle.
- Patients suffering from benign, locally invasive or malignant lesions that involving the lower border of the mandible.
- Patients with recurrent lesions after resection.
- Patients dealing with osteomyelitis or jaw osteonecrosis that is indicated for sequestrectomy.
- Patients with traumatic defects.
Key exclusion criteria (4 listed)
- Medically compromised patients contradict the operation.
- Patients with segmental mandibular defects that require condylar process resection
- Patients with lateral segmental mandibular defects involving the condyle that require reconstruction using an alloplastic total joint.
- Patients with an active infection at the site of resection.
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 |
|---|---|---|
| Patient specific reconstruction platePatient specific reconstruction plate | Device | Patient specific reconstruction plate |
Primary outcome
Postoperative complications and degree of morbidity
Time frame: 3 months
All patients will be assessed immediately post-operative, at 1 and 3 months. Any complication that arises during the clinical follow-up period will be monitored and reported. Complications include prolonged hospital stay, prolonged drug administration, signs of screw or PSRP loosening, PSRP fracture, wound dehiscence or tissue necrosis, Intra/extraoral PSRP exposure, and fistulae.
1 secondary outcome
Functional Range of Mandibular Excursions
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Individual participant dataSharing planned: No. All data will be de-identified to protect the participant data. patients signed an informed consent for the use of their medical records and data for study.
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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.
yehia M El-Mahallawy, Phd principal investigator
Faculty of Dentistry, Alexandria University, Alexandria, Alexandria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient specific reconstruction plate in people with Mandibular Resection and Mandibular Reconstruction* / Methods, 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 7 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 6 Jan 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact yehia A El-Mahallawy., PhD (+201007217014. ext. 002, yehia.el-mahallawy@alexu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative complications and degree of morbidity (time frame: 3 months). 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 6 Jan 2026.