Mandibular FracturesNCT07499726
Precision of Patient Specific 3D Printed Occlusal Stent, Surgical Guide, and Patient Specific Titanium Plates in Management of Mandibular Fracture (Case Series)
An observational study of Mandibular Fractures, run by Cairo University at 1 site in Egypt.
Trial summary
This study evaluates the accuracy of preoperative fully computerized occlusal stents, surgical guide, and patient-specific titanium plates in guided mandibular fracture reduction and fixation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mandibular Fractures
- What is being tested?
- Patient-Specific 3D Printed Occlusal Stent, Surgical Guide, and Titanium Plates
- Type of treatment
- Surgery or procedure
- How many people
- 6 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Jul 2024to 10 Jul 2025
- Phase
- Observational
- 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 to 65 years
- All sexes
- Adult, Older adult
Study population: Adult patients (18-65 years) presenting with isolated mandibular fractures requiring open reduction and internal fixation (ORIF) at the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Cairo University. All patients had displaced fractures requiring surgical intervention. Patients with systemic contraindications to surgery, uncontrolled diabetes, pregnancy, lactation, or history of head and neck radiation were excluded.
Who may be able to join
- Age 18 to 65 years
- Male or female patients
- Isolated mandibular fractures requiring open reduction and internal fixation (ORIF)
Who cannot join
- Severe cardiovascular, respiratory, or other systemic conditions presenting risk for anesthesia
- Head and neck radiation therapy within the past year
- Uncontrolled diabetes (glycated hemoglobin HbA1c > 8%)
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates the accuracy of preoperative fully computerized occlusal stents, surgical guide, and patient-specific titanium plates in guided mandibular fracture reduction and fixation. The research question is: Does the use of patient-specific three-dimensional (3D) printed occlusal stents, surgical guides, and titanium plates accurately reduce mandibular fractures regarding guided fracture reduction, fixation, and occlusion? Mandibular fractures are among the most common maxillofacial fractures observed in the emergency room. The evaluation, diagnosis, and management of these fractures remain challenging despite improved imaging technology and fixation techniques. Depending on the type and location of the fractures, various open and closed surgical reduction techniques can be utilized. There are several critical and inherent limitations to the current standard approach of mandibular fracture reduction and fixation.
The anatomical term "body fractures" is used in the present study. It refers to the tooth-bearing area of the mandible including symphyseal, parasymphyseal, and body fractures. Anatomically, the mandible consists of a curved horizontal portion (the body) with the alveolar process on top, and two perpendicular portions (the rami), which unite with the ends of the body nearly at right angles.
Read more
Conventionally, surgical plates are mass-produced with universal configurations that must be manually bent to match individual bone anatomy. The plate bending procedure can be time-consuming and technically demanding, especially for inexperienced surgeons. In complex cases, surgical plates may need to be bent repeatedly, which induces internal stress concentration. The stressed plates may suffer from fatigue under in vivo masticatory loading, resulting in complications including plate fracture, corrosion, screw loosening, and bone resorption.
Three-dimensional (3D) printing involves additive manufacturing techniques used to build structures layer by layer. This technology has been adapted to a wide range of surgical applications. It has been used to print patient-specific anatomic models, implants, prosthetics, external fixators, splints, surgical instrumentation, and surgical cutting guides. The utility of this technology in surgery explains its rapid adoption.
There are no comparators in this study because it is a case series. Objectives: This study aims to evaluate the accuracy of preoperative fully computerized occlusal stents, surgical guides, and patient-specific titanium plates in guided mandibular fracture reduction and fixation.
Primary Objectives:
- To achieve anatomical reduction with accurate post-operative occlusion
- To reduce intra-operative time with subsequent reduction in post-operative pain and edema Hypothesis: We hypothesize that preoperative fully computerized occlusal stents, surgical guides, and patient-specific titanium plates are an accurate method for mandibular fracture reduction and fixation.
Trial Design: This is a prospective case series study conducted on adult patients with mandibular fractures.
PIO:
- Population: Patients with mandibular fracture requiring open reduction internal fixation (ORIF)
- Intervention: Preoperative fully computerized occlusal stents, surgical guides, and patient-specific titanium plates
- Outcome: Accuracy of reduction and occlusion
- Conditions
- Mandibular Fractures
- Being tested
- Patient-Specific 3D Printed Occlusal Stent, Surgical Guide, and Titanium Plates
- Keywords
- Mandibular Fracture, Patient-Specific Plates, Surgical Guide, Open Reduction Internal Fixation (ORIF), Virtual Surgical Planning
- Medical subject headings
- Mandibular Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-Specific 3D Printed Occlusal Stent, Surgical Guide, and Titanium PlatesProcedure or surgery
Patients underwent preoperative virtual surgical planning using Mimics software. Patient-specific three-dimensional (3D) printed occlusal stents, surgical guides, and titanium plates (2.0 mm thickness, Grade 4 titanium) were fabricated. Surgical procedure included intraoral or extraoral approach as indicated, fracture reduction using custom guides, fixation with patient-specific plates, and standard postoperative care including antibiotics and soft diet for 4-6 weeks. Postoperative computed tomography (CT) scan was obtained at 4 weeks for accuracy assessment via superimposition analysis.
| Study group | Role | What they receive |
|---|---|---|
| Case Series | Six adult patients with isolated mandibular fractures requiring open reduction and internal fixation (ORIF). All patients underwent surgical fixation using patient-specific Three-Dimensional (3D) printed occlusal stents, surgical guides, and titanium plates (2.0 mm thickness) designed via virtual surgical planning. Receives: Procedure: Patient-Specific 3D Printed Occlusal Stent, Surgical Guide, and Titanium Plates |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dimensional Accuracy of Mandibular Fracture Reduction
Absolute error between planned (virtual surgical planning) and post-operative measurements across 12 standardized mandibular measurements (Lateral Intercondylar Length, Medial Intercondylar Length, Bicoronoid Length, Bigonial Width, Bimental Length, Maximum Mandibular Length Right, Maximum Mandibular Length Left, Intercanine Length, Maximum Ramus Height Right, Maximum Ramus Height Left, Mandibular Angle Right, Mandibular Angle Left) assessed via computed tomography (CT) superimposition analysis at 4 weeks post-operative.
Measured: 4 weeks post-operative
Secondary outcomes (2)
Clinical Acceptability Rate
Proportion of measurements achieving absolute error < 2.0 mm (clinically acceptable threshold) and < 1.0 mm (excellent accuracy threshold) based on computed tomography (CT) superimposition analysis.
Measured: 4 weeks post-operative
Rotational Movement Pattern
Identification and quantification of rotational movement characterized by anterior widening (intercanine length change) and posterior narrowing (bicoronoid and bigonial width changes) measured by Rotational Divergence Index (RDI) from computed tomography (CT) superimposition analysis.
Measured: 4 weeks post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start6 Jul 2024
- Primary completion9 Jul 2025
- Study completion10 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mandibular FracturesStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Riad Kamal Riad Ali, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07499726
- Sponsor's protocol ID
- 22624
- Status last verified
- Mar 2026
- First submitted
- 24 Mar 2026
- Last updated
- 3 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to protect patient confidentiality. Only aggregated and de-identified summary data are presented in the thesis.
Publications
Riad RK, Shalaby E, ElHawary H. Assessment of plan-execution fidelity in a fully digital workflow using custom-made plates for mandibular fracture repair: a prospective pilot study. BMC Oral Health. 2026 Jul 22;26(1):1331. doi: 10.1186/s12903-026-09349-5.
PubMed 42482012
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision of Patient Specific 3D Printed Occlusal Stent, Surgical Guide, and Patient Specific Titanium Plates in Management of Mandibular Fracture (Case Series)
- ClinicalTrials.gov ID
- NCT07499726
- Acronym / sponsor ID
- 22624
- Conditions
- Mandibular Fractures
- Keywords
- Mandibular Fracture, Patient-Specific Plates, Surgical Guide, Open Reduction Internal Fixation (ORIF), Virtual Surgical Planning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 6 Jul 2024 (actual)
- Primary completion
- 9 Jul 2025 (actual)
- Study completion
- 10 Jul 2025 (actual)
- First posted
- 30 Mar 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.
This study evaluates the accuracy of preoperative fully computerized occlusal stents, surgical guide, and patient-specific titanium plates in guided mandibular fracture reduction and fixation. The research question is: Does the use of patient-specific three-dimensional (3D) printed occlusal stents, surgical guides, and titanium plates accurately reduce mandibular fractures regarding guided fracture reduction, fixation, and occlusion? Mandibular fractures are among the most common maxillofacial fractures observed in the emergency room. The evaluation, diagnosis, and management of these fractures remain challenging despite improved imaging technology and fixation techniques. Depending on the type and location of the fractures, various open and closed surgical reduction techniques can be utilized. There are several critical and inherent limitations to the current standard approach of mandibular fracture reduction and fixation.
The anatomical term "body fractures" is used in the present study. It refers to the tooth-bearing area of the mandible including symphyseal, parasymphyseal, and body fractures. Anatomically, the mandible consists of a curved horizontal portion (the body) with the alveolar process on top, and two perpendicular portions (the rami), which unite with the ends of the body nearly at right angles.
Conventionally, surgical plates are mass-produced with universal configurations that must be manually bent to match individual bone anatomy. The plate bending procedure can be time-consuming and technically demanding, especially for inexperienced surgeons. In complex cases, surgical plates may need to be bent repeatedly, which induces internal stress concentration. The stressed plates may suffer from fatigue under in vivo masticatory loading, resulting in complications including plate fracture, corrosion, screw loosening, and bone resorption.
Three-dimensional (3D) printing involves additive manufacturing techniques used to build structures layer by layer. This technology has been adapted to a wide range of surgical applications. It has been used to print patient-specific anatomic models, implants, prosthetics, external fixators, splints, surgical instrumentation, and surgical cutting guides. The utility of this technology in surgery explains its rapid adoption.
There are no comparators in this study because it is a case series. Objectives: This study aims to evaluate the accuracy of preoperative fully computerized occlusal stents, surgical guides, and patient-specific titanium plates in guided mandibular fracture reduction and fixation.
Primary Objectives:
- To achieve anatomical reduction with accurate post-operative occlusion
- To reduce intra-operative time with subsequent reduction in post-operative pain and edema Hypothesis: We hypothesize that preoperative fully computerized occlusal stents, surgical guides, and patient-specific titanium plates are an accurate method for mandibular fracture reduction and fixation.
Trial Design: This is a prospective case series study conducted on adult patients with mandibular fractures.
PIO:
- Population: Patients with mandibular fracture requiring open reduction internal fixation (ORIF)
- Intervention: Preoperative fully computerized occlusal stents, surgical guides, and patient-specific titanium plates
- Outcome: Accuracy of reduction and occlusion
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Case Series | – | Procedure: Patient-Specific 3D Printed Occlusal Stent, Surgical Guide, and Titanium PlatesSix adult patients with isolated mandibular fractures requiring open reduction and internal fixation (ORIF). All patients underwent surgical fixation using patient-specific Three-Dimensional (3D) printed occlusal stents, surgical guides, and titanium plates (2.0 mm thickness) designed via virtual surgical planning. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients (18-65 years) presenting with isolated mandibular fractures requiring open reduction and internal fixation (ORIF) at the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Cairo University. All patients had displaced fractures requiring surgical intervention. Patients with systemic contraindications to surgery, uncontrolled diabetes, pregnancy, lactation, or history of head and neck radiation were excluded.
Key inclusion criteria (3 listed)
- Age 18 to 65 years
- Male or female patients
- Isolated mandibular fractures requiring open reduction and internal fixation (ORIF)
Key exclusion criteria (4 listed)
- Severe cardiovascular, respiratory, or other systemic conditions presenting risk for anesthesia
- Head and neck radiation therapy within the past year
- Uncontrolled diabetes (glycated hemoglobin HbA1c > 8%)
- Pregnancy or lactation
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 3D Printed Occlusal Stent, Surgical Guide, and Titanium PlatesPatients underwent preoperative virtual surgical planning using Mimics software. Patient-specific three-dimensional (3D) printed occlusal stents, surgical guides, and titanium plates (2.0 mm thickness, Grade 4 titanium) were fabricated. Surgical procedure included intraoral or extraoral approach as indicated, fracture reduction using custom guides, fixation with patient-specific plates, and standard postoperative care including antibiotics and soft diet for 4-6 weeks. Postoperative computed tomography (CT) scan was obtained at 4 weeks for accuracy assessment via superimposition analysis. | Procedure or surgery | Case Series |
Primary outcome
Dimensional Accuracy of Mandibular Fracture Reduction
Time frame: 4 weeks post-operative
Absolute error between planned (virtual surgical planning) and post-operative measurements across 12 standardized mandibular measurements (Lateral Intercondylar Length, Medial Intercondylar Length, Bicoronoid Length, Bigonial Width, Bimental Length, Maximum Mandibular Length Right, Maximum Mandibular Length Left, Intercanine Length, Maximum Ramus Height Right, Maximum Ramus Height Left, Mandibular Angle Right, Mandibular Angle Left) assessed via computed tomography (CT) superimposition analysis at 4 weeks post-operative.
2 secondary outcomes
Clinical Acceptability Rate
Time frame: 4 weeks post-operative
Rotational Movement Pattern
Time frame: 4 weeks post-operative
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 3 Apr 2026.
- Derived from this study: PubMed 42482012Riad RK, Shalaby E, ElHawary H. Assessment of plan-execution fidelity in a fully digital workflow using custom-made plates for mandibular fracture repair: a prospective pilot study. BMC Oral Health. 2026 Jul 22;26(1):1331. doi: 10.1186/s12903-026-09349-5.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to protect patient confidentiality. Only aggregated and de-identified summary data are presented in the thesis.
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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. 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?
An observational study of Mandibular Fractures, run by Cairo 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 3 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: finished, as of the sponsor's last update on 3 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?
Dimensional Accuracy of Mandibular Fracture Reduction (time frame: 4 weeks post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07499726, which also lists 1 linked publication.
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 3 Apr 2026.