Virtual Plan of Mandibular FractureNCT06898736
Three-Dimensional Printing and Three-Dimensional Miniplates in Treatment of Anterior Mandibular Fractures
A study testing 3d miniplate in people with Virtual Plan of Mandibular Fracture, run by Mansoura University at 3 sites in Egypt.
Trial summary
The primary objective of this study was to evaluate the accuracy of virtual reduction and the prebending of the 3D miniplates on printed models for fixation of anterior mandibular fractures. The secondary objective is to evaluate the bone healing of anterior mandibular reduction. Read more about this study
- Who is it for?
- Ages 15 to 50 years
- Conditions the study is for
- Virtual Plan of Mandibular Fracture
- What is being tested?
- 3d miniplate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 3 sitesEgypt
- Study dates
- 10 Oct 2021to 10 Mar 2025
- 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 15 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Recent anterior mandibular fractures (within one week).
- Adult patients of both genders (18-50 years old).
- Systematic healthy patients.
- Radiographic evidence of anterior mandibular fracture.
Who cannot join
- Medically compromised patients contraindicated for general anaesthesia and bone surgery.
- Comminuted fractures.
- Bilateral anterior mandibular fractures.
- Previously treated fractures.
- Pathological fractures and bone diseases.
Trial locations and contacts
3 sites in 1 country.
Egypt3 sites
oral and maxillofacial department , faculty of dentistry, Alexandria university
Alexandria, Alexandria Governorate, 21526
oral and maxillofacial department, faculty of dentistry,Alexandria
Alexandria, Alexandria Governorate, 21526
Oral and Maxillofacial Department
Alexandria, Alexandria Governorate, 21526
About this study
Official title: Evaluation of Accuracy of Three-Dimensional Printing and Three-Dimensional Miniplates in Treatment of Anterior Mandibular Fractures: A Prospective Clinical Study
The primary objective of this study was to evaluate the accuracy of virtual reduction and the prebending of the 3D miniplates on printed models for fixation of anterior mandibular fractures. The secondary objective is to evaluate the bone healing of anterior mandibular reduction.
Read the detailed description
The mandible is the largest and most prominent bone in the maxillofacial region. Facial fractures frequently involve the mandible. Rigid internal fixation combined with maxillomandibular fixation is the standard surgical procedure for treating mandibular fractures. Maxillofacial surgery currently makes extensive use of digital technology in areas like surgical navigation, titanium plate preforming technology, and 3D digital guide plate technology.
Monocortical miniplates that are easily adaptable are used in Champy's semi-rigid fixation technique, along with an "ideal osteosynthesis line" to counteract the developing masticatory forces. The location of the bone plate fixation must provide the fixation method that is most stable in relation to the line of tension at the base of the alveolar process. One plate is often used for fractures that are posterior to the foramen, and two plates are typically used for fractures anterior to the foramen.
Due to muscles working against each other, the anterior mandible fractures are subject to strong torsional forces. Some researchers have suggested using the three-dimensional (3D) miniplates as a viable option for fixation.
To ensure successful osteosynthesis with a minimally invasive approach, three-dimensional (3D) miniplate systems can be used. The system comprises two miniplates joined by interconnecting crossbars and fixed to the bone with monocortical screws. When placed in the fracture line, the 3D miniplate system ensures fracture stabilization, regardless of plate thickness and geometry. The placement of screws in a square pattern on either side of the fracture creates a solid platform that increases resistance to twisting and rotation of the longitudinal axis of the plate.
The stability of occlusion after using 3D miniplates may be due to the box-like configuration, providing rigid fixation of fractures that prevent Buccolingual splaying and gap formation at the fracture site and subsequent occlusal discrepancy; this is the advantage of 3D miniplates over 2D miniplates.
The surgeon is now able to use 3D segmentation and mirroring methods, which are highly effective in simulating the pre-traumatized anatomy at a minimal cost, using advanced open-source software programs.
The idea behind 3D printing in the medical industry is to take anatomical scans utilizing imaging methods like computed tomography (CT) and magnetic resonance imaging (MRI). The images from these methods will be saved in a common format, such as the Digital Imaging and Communications in Medicine (DICOM) format, and then with the aid of computer-aided design (CAD) software, a virtual 3D prototype with Standard Tessellation Language (STL) format will be created to enable 3D printing and the deposition of the material layer by layer to achieve the final structure.
Thus, in the present study, the goal was to assess the accuracy of virtual planning and pre-bent 3D miniplates in anterior mandibular fixation by comparing postoperative outcomes with preoperative virtual reduction and to evaluate the clinical outcomes and bone density after fixation with 3D miniplates.
- Conditions
- Virtual Plan of Mandibular Fracture
- Being tested
- 3d miniplate
- Keywords
- Virtual plan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3d miniplateDevice
3d miniplate was used for mandibular fracture fixation
| Study group | Role | What they receive |
|---|---|---|
| virual plan before and after mandibular fracture fixation | Experimental | virual plan before and after mandibular fracture fixation and 3D miniplate fixation Receives: Device: 3d miniplate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone density was measured by Hounsfield units (HU) measured on CT images
The length and width of the mandible were measured using 3D CT scan with digital callipers in millimetres.
Measured: 3 months
mandible dimensions
Mandibular length and width were measured using 3D CT scan with digital callipers in millimetres.
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 posted27 Mar 2025
- Study start10 Oct 2021
- Primary completion10 Oct 2024
- Study completion10 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Virtual Plan of Mandibular FractureStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Collaborators
- Alexandria University
- Responsible party
- Principal investigator, Mazen Tharwat Abou Elkhier, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06898736
- Sponsor's protocol ID
- 3D printing and virtual plan
- Status last verified
- Mar 2025
- First submitted
- 20 Mar 2025
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to \[privacy/ethical/confidentiality\] reasons, the research data are not publicly available.
Publications
https://pmc.ncbi.nlm.nih.gov/articles/PMC10709695/
Ponvel K, Panneerselvam E, Balasubramanian S, Krishna Kumar Raja VB. Evaluation of labial versus labio-inferior lines of osteosynthesis using 3D miniplate for fractures of anterior mandible: A finite element analysis with a pilot clinical trial. Chin J Traumatol. 2019 Oct;22(5):261-269. doi: 10.1016/j.cjtee.2019.08.001. Epub 2019 Aug 9.
PubMed 31493976Macdonald B, McAleer S, Kelly S, Chakraverty R, Johnston M, Pollock N. Hamstring rehabilitation in elite track and field athletes: applying the British Athletics Muscle Injury Classification in clinical practice. Br J Sports Med. 2019 Dec;53(23):1464-1473. doi: 10.1136/bjsports-2017-098971. Epub 2019 Jul 12.
PubMed 31300391Abou Elkhier MT, Saber ME, Sweedan AO, Elashwah A. Evaluation of accuracy of three-dimensional printing and three-dimensional miniplates in treatment of anterior mandibular fractures: a prospective clinical study. BMC Oral Health. 2025 Apr 28;25(1):649. doi: 10.1186/s12903-025-05935-1.
PubMed 40296061
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Accuracy of Three-Dimensional Printing and Three-Dimensional Miniplates in Treatment of Anterior Mandibular Fractures: A Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT06898736
- Acronym / sponsor ID
- 3D printing and virtual plan
- Conditions
- Virtual Plan of Mandibular Fracture
- Keywords
- Virtual plan
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Collaborators
- Alexandria University
- Study start
- 10 Oct 2021 (actual)
- Primary completion
- 10 Oct 2024 (actual)
- Study completion
- 10 Mar 2025 (actual)
- First posted
- 27 Mar 2025 (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 primary objective of this study was to evaluate the accuracy of virtual reduction and the prebending of the 3D miniplates on printed models for fixation of anterior mandibular fractures. The secondary objective is to evaluate the bone healing of anterior mandibular reduction.
Detailed description
The mandible is the largest and most prominent bone in the maxillofacial region. Facial fractures frequently involve the mandible. Rigid internal fixation combined with maxillomandibular fixation is the standard surgical procedure for treating mandibular fractures. Maxillofacial surgery currently makes extensive use of digital technology in areas like surgical navigation, titanium plate preforming technology, and 3D digital guide plate technology.
Monocortical miniplates that are easily adaptable are used in Champy's semi-rigid fixation technique, along with an "ideal osteosynthesis line" to counteract the developing masticatory forces. The location of the bone plate fixation must provide the fixation method that is most stable in relation to the line of tension at the base of the alveolar process. One plate is often used for fractures that are posterior to the foramen, and two plates are typically used for fractures anterior to the foramen.
Due to muscles working against each other, the anterior mandible fractures are subject to strong torsional forces. Some researchers have suggested using the three-dimensional (3D) miniplates as a viable option for fixation.
To ensure successful osteosynthesis with a minimally invasive approach, three-dimensional (3D) miniplate systems can be used. The system comprises two miniplates joined by interconnecting crossbars and fixed to the bone with monocortical screws. When placed in the fracture line, the 3D miniplate system ensures fracture stabilization, regardless of plate thickness and geometry. The placement of screws in a square pattern on either side of the fracture creates a solid platform that increases resistance to twisting and rotation of the longitudinal axis of the plate.
The stability of occlusion after using 3D miniplates may be due to the box-like configuration, providing rigid fixation of fractures that prevent Buccolingual splaying and gap formation at the fracture site and subsequent occlusal discrepancy; this is the advantage of 3D miniplates over 2D miniplates.
The surgeon is now able to use 3D segmentation and mirroring methods, which are highly effective in simulating the pre-traumatized anatomy at a minimal cost, using advanced open-source software programs.
The idea behind 3D printing in the medical industry is to take anatomical scans utilizing imaging methods like computed tomography (CT) and magnetic resonance imaging (MRI). The images from these methods will be saved in a common format, such as the Digital Imaging and Communications in Medicine (DICOM) format, and then with the aid of computer-aided design (CAD) software, a virtual 3D prototype with Standard Tessellation Language (STL) format will be created to enable 3D printing and the deposition of the material layer by layer to achieve the final structure.
Thus, in the present study, the goal was to assess the accuracy of virtual planning and pre-bent 3D miniplates in anterior mandibular fixation by comparing postoperative outcomes with preoperative virtual reduction and to evaluate the clinical outcomes and bone density after fixation with 3D miniplates.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| virual plan before and after mandibular fracture fixation | Experimental | Device: 3d miniplatevirual plan before and after mandibular fracture fixation and 3D miniplate fixation |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Recent anterior mandibular fractures (within one week).
- Adult patients of both genders (18-50 years old).
- Systematic healthy patients.
- Radiographic evidence of anterior mandibular fracture.
Key exclusion criteria (5 listed)
- Medically compromised patients contraindicated for general anaesthesia and bone surgery.
- Comminuted fractures.
- Bilateral anterior mandibular fractures.
- Previously treated fractures.
- Pathological fractures and bone diseases.
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 |
|---|---|---|
| 3d miniplate3d miniplate was used for mandibular fracture fixation | Device | virual plan before and after mandibular fracture fixation |
Primary outcome
Bone density was measured by Hounsfield units (HU) measured on CT images
Time frame: 3 months
The length and width of the mandible were measured using 3D CT scan with digital callipers in millimetres.
mandible dimensions
Time frame: 3 months
Mandibular length and width were measured using 3D CT scan with digital callipers in millimetres.
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 1 Apr 2025.
- Results publicationhttps://pmc.ncbi.nlm.nih.gov/articles/PMC10709695/
- Results publication: PubMed 31493976Ponvel K, Panneerselvam E, Balasubramanian S, Krishna Kumar Raja VB. Evaluation of labial versus labio-inferior lines of osteosynthesis using 3D miniplate for fractures of anterior mandible: A finite element analysis with a pilot clinical trial. Chin J Traumatol. 2019 Oct;22(5):261-269. doi: 10.1016/j.cjtee.2019.08.001. Epub 2019 Aug 9.
- Results publication: PubMed 31300391Macdonald B, McAleer S, Kelly S, Chakraverty R, Johnston M, Pollock N. Hamstring rehabilitation in elite track and field athletes: applying the British Athletics Muscle Injury Classification in clinical practice. Br J Sports Med. 2019 Dec;53(23):1464-1473. doi: 10.1136/bjsports-2017-098971. Epub 2019 Jul 12.
- Derived from this study: PubMed 40296061Abou Elkhier MT, Saber ME, Sweedan AO, Elashwah A. Evaluation of accuracy of three-dimensional printing and three-dimensional miniplates in treatment of anterior mandibular fractures: a prospective clinical study. BMC Oral Health. 2025 Apr 28;25(1):649. doi: 10.1186/s12903-025-05935-1.
- Individual participant dataSharing planned: No. Due to [privacy/ethical/confidentiality] reasons, the research data are not publicly available.
Related trials for Virtual Plan of Mandibular Fracture
Not yet recruiting
Virtual Surgical Planning and Preoperative Plate Bending for Maxillofacial Fractures
Mandibular Fractures, Maxillofacial Injuries
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3d miniplate in people with Virtual Plan of Mandibular Fracture, run by Mansoura University at 3 sites 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 4 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 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Bone density was measured by Hounsfield units (HU) measured on CT images (time frame: 3 months). The study lists 2 primary outcomes in all. 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 NCT06898736, which also lists 4 linked publications.
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 1 Apr 2025.