Mandibular FracturesNCT05647460
Computer Guided Screw Holes Locating Guide and Custom-made Plates
A study testing computer guided screw holes locating guide and custom-made plates and conventional plates in people with Mandibular Fractures, run by Cairo University at 1 site in Egypt.
Trial summary
Preoperative CT. Virtual reduction of broken segments on software. Gain occlusion. Design surgical screw holes locating guide. Design the custom-made plates. Print the screw holes locating guide and the custom-made plate. 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?
- computer guided screw holes locating guide and custom-made plates and conventional plates
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Oct 2022to 30 Dec 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 parasymphseal mandibular class 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
1 site in 1 country.
Hussien hatem contact
About this study
Official title: Precision of Computer Guided Screw Holes Locating Guide and Custom-made Plates vs Conventional Plate Osteosynthesis in Management of Parasymphseal Mandibular Fracture
- Preoperative CT.
- Virtual reduction of broken segments on software.
- Gain occlusion.
- Design surgical screw holes locating guide.
- Design the custom-made plates.
- Print the screw holes locating guide and the custom-made plate. under general anesthesia the parasymphseal fracture will be reduced using screw holes locating guide and the custom-made plates.
Read the detailed description
Interventions 26 patients involved in this study will be divided in to two different groups, first group will be reduced using patient computer guided specific screw holes locating guide and custom-made plates.
Second group fractures will be reduced by conventional work flow.
Clinical evaluation:
A through medical and dental history followed by clinical examination was carried out for all patients. Clinical measurements were taken to ensure patient adherence to our initial inclusion criteria prior to further investigations.
A preoperative digital panoramic radiograph with 1:1 magnification was taken for each patient as a primary survey in order to exclude the presence of any lesion at the area of interest nor segment loss followed by A pre-operative CT.
Virtual planning and guide fabrication for the study group:
- Preoperative CT.
- Virtual reduction of broken segments on software.
- Gain occlusion.
- Design surgical screw holes locating guide.
- Design the custom-made plates.
- Print the screw holes locating guide and the custom-made plate.
- Surgical guiding tools: screw holes locating guide and custom-made plates.
Intra operative procedures for both groups:
- In both group: the operation will under general anesthesia with nasal intubation and oral pack, Injection of 20 cc saline adrenaline 1:00000 to 0 in the sulcus for hemostasis, Vestibular mucosal incision followed by mentalis incision in 2 planes and ensure enough cough for latter muscle suturing, Reflect the flap to visualize the broken segments.
In first group:
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 custom-made plates and fix it with screw for passive reduction of the segments. Then suture the mentalis muscle then the mucosa.
In second group:
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.
- Conditions
- Mandibular Fractures
- Being tested
- computer guided screw holes locating guide and custom-made plates, conventional plates
- Keywords
- parasymphseal mandibular fractures
- Medical subject headings
- Mandibular Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computer guided screw holes locating guide and custom-made platesProcedure or surgery
Virtual planning and guide fabrication for the study group:
- Preoperative CT.
- Virtual reduction of broken segments on software.
- Gain occlusion.
- Design surgical screw holes locating guide.
- Design the custom-made plates.
- Print the screw holes locating guide and the custom-made plate.
- Surgical guiding tools: screw holes locating guide and custom-made plates.
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 custom-made plates and fix it with screw for passive reduction of the segments. Then suture the mentalis muscle then the mucosa.
conventional platesProcedure or surgery
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 |
|---|---|---|
| computer guided plates | Active comparator | computer guided screw holes locating guide and custom-made plates in management of parasymphseal mandibular fracture Receives: Procedure: computer guided screw holes locating guide and custom-made plates |
| conventional plates | Active comparator | conventional plate osteosynthesis in management of parasymphseal mandibular fracture Receives: Procedure: conventional plates |
What is being measured
The primary outcome is the main question the study is designed to answer.
computer tomoghraphy
the Computer Tomography Will calculate the segments deviation in mm.
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 posted12 Dec 2022
- Study start6 Oct 2022
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Dec 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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ahmed abd ellati tag eldin ahmed, Cairo University
- Investigators
- Mohamed omara, Study director, Cairo Universitymona el hadidy, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05647460
- Sponsor's protocol ID
- 3922
- Status last verified
- Sep 2022
- First submitted
- 5 Dec 2022
- Last updated
- 12 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Abdellatif A, Hatem H, Elhadidy M, Omara M. Precision of virtual surgical planning employing screw-holes locator and patient-specific implants versus conventional plate osteosynthesis for parasymphyseal mandibular fracture: a double-blinded randomized control trial. BMC Oral Health. 2026 Jul 23;26(1):1348. doi: 10.1186/s12903-026-09303-5.
PubMed 42498926
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision of Computer Guided Screw Holes Locating Guide and Custom-made Plates vs Conventional Plate Osteosynthesis in Management of Parasymphseal Mandibular Fracture
- ClinicalTrials.gov ID
- NCT05647460
- Acronym / sponsor ID
- 3922
- Conditions
- Mandibular Fractures
- Keywords
- parasymphseal mandibular fractures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 6 Oct 2022 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 12 Dec 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.
- Preoperative CT.
- Virtual reduction of broken segments on software.
- Gain occlusion.
- Design surgical screw holes locating guide.
- Design the custom-made plates.
- Print the screw holes locating guide and the custom-made plate. under general anesthesia the parasymphseal fracture will be reduced using screw holes locating guide and the custom-made plates.
Detailed description
Interventions 26 patients involved in this study will be divided in to two different groups, first group will be reduced using patient computer guided specific screw holes locating guide and custom-made plates.
Second group fractures will be reduced by conventional work flow.
Clinical evaluation:
A through medical and dental history followed by clinical examination was carried out for all patients. Clinical measurements were taken to ensure patient adherence to our initial inclusion criteria prior to further investigations.
A preoperative digital panoramic radiograph with 1:1 magnification was taken for each patient as a primary survey in order to exclude the presence of any lesion at the area of interest nor segment loss followed by A pre-operative CT.
Virtual planning and guide fabrication for the study group:
- Preoperative CT.
- Virtual reduction of broken segments on software.
- Gain occlusion.
- Design surgical screw holes locating guide.
- Design the custom-made plates.
- Print the screw holes locating guide and the custom-made plate.
- Surgical guiding tools: screw holes locating guide and custom-made plates.
Intra operative procedures for both groups:
- In both group: the operation will under general anesthesia with nasal intubation and oral pack, Injection of 20 cc saline adrenaline 1:00000 to 0 in the sulcus for hemostasis, Vestibular mucosal incision followed by mentalis incision in 2 planes and ensure enough cough for latter muscle suturing, Reflect the flap to visualize the broken segments.
In first group:
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 custom-made plates and fix it with screw for passive reduction of the segments. Then suture the mentalis muscle then the mucosa.
In second group:
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| computer guided plates | Active comparator | Procedure: computer guided screw holes locating guide and custom-made platescomputer guided screw holes locating guide and custom-made plates in management of parasymphseal mandibular fracture |
| conventional plates | Active comparator | Procedure: conventional platesconventional plate osteosynthesis in management of parasymphseal mandibular fracture |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with parasymphseal mandibular class 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 |
|---|---|---|
| computer guided screw holes locating guide and custom-made platesVirtual planning and guide fabrication for the study group: * Preoperative CT. * Virtual reduction of broken segments on software. * Gain occlusion. * Design surgical screw holes locating guide. * Design the custom-made plates. * Print the screw holes locating guide and the custom-made plate. * Surgical guiding tools: screw holes locating guide and custom-made plates. 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 custom-made plates and fix it with screw for passive reduction of the segments. Then suture the mentalis muscle then the mucosa. | Procedure or surgery | computer guided plates |
| conventional platesmobilize 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. | Procedure or surgery | conventional plates |
Primary outcome
computer tomoghraphy
Time frame: 3 months .
the Computer Tomography Will calculate the segments deviation in mm.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2022.
- Derived from this study: PubMed 42498926Abdellatif A, Hatem H, Elhadidy M, Omara M. Precision of virtual surgical planning employing screw-holes locator and patient-specific implants versus conventional plate osteosynthesis for parasymphyseal mandibular fracture: a double-blinded randomized control trial. BMC Oral Health. 2026 Jul 23;26(1):1348. doi: 10.1186/s12903-026-09303-5.
- Description 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.
- Description 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.
Hussien hatem contact
Mohamed omara study director
Cairo University
mona el hadidy study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing computer guided screw holes locating guide and custom-made plates and conventional plates in people with 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 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 12 Dec 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ahmed abdellatif tageldin ahmed (00201119720141, ahmed.tageldeen@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 tomoghraphy (time frame: 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 NCT05647460, 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 12 Dec 2022.