Mandibular FracturesNCT05444829
Specific Screw Holes Locating Surgical Guide and Pre-bent Plates
A study testing specific screw holes locating surgical guide and pre-bent plates and classical reduction and internal fixation. in people with Mandibular Fractures, run by Abdallah Gaber Ali Mohamed.
Trial summary
The aim of the current study was to evaluate the accuracy of computer-guided mandibular fracture reduction versus the classical work flow Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Mandibular Fractures
- What is being tested?
- specific screw holes locating surgical guide and pre-bent plates and classical reduction and internal fixation.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2022to Sep 2023
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with delayed and isolated mandibular class III fracture needs open reduction and internal fixation.
- Patients with medical history that did not hinder plate placement (uncontrolled diabetes) and adequate proper oral hygiene.
- Both genders males and females will be included.
Who cannot join
- • General contraindications to surgery.
- Patients with fresh fractures (mobile segments).
- Patients with unfavourable nor comminuted fractures.
- Subjected to irradiation in the head and neck area less than 1 year before fixation.
- Untreated periodontitis.
- Poor oral hygiene and motivation.
Show all 14Show fewer
- Uncontrolled diabetes.
- Pregnant or nursing.
- Substance abuse.
- Psychiatric problems or unrealistic expectations.
- Severe bruxism or clenching.
- Immunosuppressed or immunocompromised.
- Treated or under treatment with intravenous amino-bisphosphonates.
- Patients participating in other studies, if the present protocol could not be properly followed.
Trial locations and contacts
No sites are listed yet.
Hussein Hatem contact
About this study
Official title: Precision of Patient Specific Screw Holes Locating Surgical Guide and Pre-bent Plates Osteosynthesis Versus Classical Work-flow in Management of Class III Mandibular Fractures
The aim of the current study was to evaluate the accuracy of computer-guided mandibular fracture reduction versus the classical work flow
Read the detailed description
Research question:
Does the use of screw holes locating surgical guide \& pre-bent plates osteosynthesis accurately reduce class III mandibular fractures regarding segments integrity and occlusion more than the classical reduction and fixation?
Statement of the problem:
Mandibular fractures are the most frequently occurring fractures within the maxillofacial injuries. 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 includes : (improper alignment of segments ,malocclusion ,nerve affections and related teeth roots injury).
There is a possibility to overcome these limitations with the help of computer-guided surgery . The introduction of CAD/CAM software has provided surgeons with an opportunity to perform virtual manipulations of CT datasets preoperatively and production of corrected mandibular model for plate pre-bending and fabrication of plate locating surgical guide which provide accurate segment reduction and fixation with accurate post-operative occlusion and minimal post-operative complication . The aim of the current study was to evaluate the accuracy of computer-guided mandibular fracture reduction versus the conventional work flow
Rationale for conducting the research:
Through computer guided mandibular fracture reduction investigators can provide proper segment alignment with subsequent accurate post-operative occlusion in addition reduce intra-operative time , post-operative pain and edema
- Conditions
- Mandibular Fractures
- Being tested
- specific screw holes locating surgical guide and pre-bent plates, classical reduction and internal fixation.
- Keywords
- class III
- Medical subject headings
- Mandibular Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
specific screw holes locating surgical guide and pre-bent platesDevice
Put the specific screw holes locating device in place and drill the screw holes, remove the screw holes locating device and mobilize the segments then apply the pre-bent plates and fix it with screw for passive reduction of the segments. Then suture the mentalis muscle then the mucosa.
classical reduction and internal fixation.Device
mobilize the broken segment first, Arch bar was made to achieve proper occlusion put the compression plate on the inferior border and remove it for further bending using plate pliers for further accommodation of the plate on the inferior border the fix it in place using compression and tension plate.
| Study group | Role | What they receive |
|---|---|---|
| specific screw holes locating surgical guide and pre-bent plates | Experimental | Put the specific screw holes locating device in place and drill the screw holes, remove the screw holes locating device and mobilize the segments then apply the pre-bent plates and fix it with screw for passive reduction of the segments. Then suture the mentalis muscle then the mucosa. Receives: Device: specific screw holes locating surgical guide and pre-bent plates |
| classical reduction and fixation | Other | mobilize the broken segment first, Arch bar was made to achieve proper occlusion put the compression plate on the inferior border and remove it for further bending using plate pliers for further accommodation of the plate on the inferior border the fix it in place using compression and tension plate. Receives: Device: classical reduction and internal fixation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
computer tomography
the Computer Tomography Will calculate the segments deviation in mm. after 3 month .
Measured: after 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 Jul 2022
- Study start1 Jul 2022 (estimated)
- Primary completionJul 2023 (estimated)
- Study completionSep 2023 (estimated)
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.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abdallah Gaber Ali Mohamed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Abdallah Gaber Ali Mohamed, Cairo University
- Investigators
- Mohammed Omara, Study director, Cairo Universitymona el hadidy, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05444829
- Sponsor's protocol ID
- class III mandibular fractures
- Status last verified
- Jul 2022
- First submitted
- 22 Jun 2022
- Last updated
- 6 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gaber A, Hatem H, El M, Omara M. Precision of patient specific screw holes locating surgical guide and pre-bent plates osteosynthesis versus classical workflow in management of class III mandibular fracture. Maxillofac Plast Reconstr Surg. 2025 Dec 19;47(1):43. doi: 10.1186/s40902-025-00495-4.
PubMed 41417183
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision of Patient Specific Screw Holes Locating Surgical Guide and Pre-bent Plates Osteosynthesis Versus Classical Work-flow in Management of Class III Mandibular Fractures
- ClinicalTrials.gov ID
- NCT05444829
- Acronym / sponsor ID
- class III mandibular fractures
- Conditions
- Mandibular Fractures
- Keywords
- class III
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Abdallah Gaber Ali MohamedUniversity, hospital or other
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 6 Jul 2022 (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 aim of the current study was to evaluate the accuracy of computer-guided mandibular fracture reduction versus the classical work flow
Detailed description
Research question:
Does the use of screw holes locating surgical guide \& pre-bent plates osteosynthesis accurately reduce class III mandibular fractures regarding segments integrity and occlusion more than the classical reduction and fixation?
Statement of the problem:
Mandibular fractures are the most frequently occurring fractures within the maxillofacial injuries. 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 includes : (improper alignment of segments ,malocclusion ,nerve affections and related teeth roots injury).
There is a possibility to overcome these limitations with the help of computer-guided surgery . The introduction of CAD/CAM software has provided surgeons with an opportunity to perform virtual manipulations of CT datasets preoperatively and production of corrected mandibular model for plate pre-bending and fabrication of plate locating surgical guide which provide accurate segment reduction and fixation with accurate post-operative occlusion and minimal post-operative complication . The aim of the current study was to evaluate the accuracy of computer-guided mandibular fracture reduction versus the conventional work flow
Rationale for conducting the research:
Through computer guided mandibular fracture reduction investigators can provide proper segment alignment with subsequent accurate post-operative occlusion in addition reduce intra-operative time , post-operative pain and edema
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| specific screw holes locating surgical guide and pre-bent plates | Experimental | Device: specific screw holes locating surgical guide and pre-bent platesPut the specific screw holes locating device in place and drill the screw holes, remove the screw holes locating device and mobilize the segments then apply the pre-bent plates and fix it with screw for passive reduction of the segments. Then suture the mentalis muscle then the mucosa. |
| classical reduction and fixation | Other | Device: classical reduction and internal fixation.mobilize the broken segment first, Arch bar was made to achieve proper occlusion put the compression plate on the inferior border and remove it for further bending using plate pliers for further accommodation of the plate on the inferior border the fix it in place using compression and tension plate. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with delayed and isolated mandibular class III fracture needs open reduction and internal fixation.
- Patients with medical history that did not hinder plate placement (uncontrolled diabetes) and adequate proper oral hygiene.
- Both genders males and females will be included.
Key exclusion criteria (14 listed)
- • General contraindications to surgery.
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 |
|---|---|---|
| specific screw holes locating surgical guide and pre-bent platesPut the specific screw holes locating device in place and drill the screw holes, remove the screw holes locating device and mobilize the segments then apply the pre-bent plates and fix it with screw for passive reduction of the segments. Then suture the mentalis muscle then the mucosa. | Device | specific screw holes locating surgical guide and pre-bent plates |
| classical reduction and internal fixation.mobilize the broken segment first, Arch bar was made to achieve proper occlusion put the compression plate on the inferior border and remove it for further bending using plate pliers for further accommodation of the plate on the inferior border the fix it in place using compression and tension plate. | Device | classical reduction and fixation |
Primary outcome
computer tomography
Time frame: after 3 months
the Computer Tomography Will calculate the segments deviation in mm. after 3 month .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
- Derived from this study: PubMed 41417183Gaber A, Hatem H, El M, Omara M. Precision of patient specific screw holes locating surgical guide and pre-bent plates osteosynthesis versus classical workflow in management of class III mandibular fracture. Maxillofac Plast Reconstr Surg. 2025 Dec 19;47(1):43. doi: 10.1186/s40902-025-00495-4.
- Reginald H.B. Goodday/Management of Fractures of the Mandibular Body and Symphysis. Oral Maxillofacial Surg Clin North Am. 2013 Nov;25Link provided by the sponsor.
- Evaluation of the Accuracy of Computer-Guided Mandibular Fracture Reduction. 2015 Jul;26(5):1587-91.doi: 10.1097/SCS.0000000000001773.Link provided by the sponsor.
- Parul Sinha , Gary Skolnick , Kamlesh B Patel , Gregory H Branham , John J Chi /A 3-Dimensional-Printed Short-Segment Template Prototype for Mandibular Fracture Repair. 2018 Sep 1;20(5):373-380Link provided by the sponsor.
- Comparison of 3D plate and locking plate in treatment of mandibular fracture-a clinical study. Oral Maxillofacial Surg 2017 Dec;21(4)Link provided by the sponsor.
- Scott Lovald , Bret Baack, Curtis Gaball, Garth Olson, Anna 31 Hoard/Biomechanical optimization of bone plates used in rigid fixation of mandibular symphysis fractures. 2010 AugLink provided by the sponsor.
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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.
Hussein Hatem contact
Mohammed Omara study director
Cairo University
mona el hadidy study director
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing specific screw holes locating surgical guide and pre-bent plates and classical reduction and internal fixation. in people with Mandibular Fractures, run by Abdallah Gaber Ali Mohamed.
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 14 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: status not confirmed, as of the sponsor's last update on 6 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact abdallah gaber (01155778958, abdallahgaber@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
computer tomography (time frame: after 3 months). 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 NCT05444829, 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 6 Jul 2022.