Computer Guided Screw Holes Locating Guide and Custom-made Plates
NCT ID: NCT05647460
Last Updated: 2022-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
26 participants
INTERVENTIONAL
2022-10-06
2023-12-30
Brief Summary
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* 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
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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computer guided plates
computer guided screw holes locating guide and custom-made plates in management of parasymphseal mandibular fracture
computer guided screw holes locating guide and custom-made plates
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 plates
conventional plate osteosynthesis in management of parasymphseal mandibular fracture
conventional plates
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.
Interventions
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computer guided screw holes locating guide and custom-made plates
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 plates
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
* 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.
ALL
Yes
Sponsors
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Cairo University
OTHER
Responsible Party
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ahmed abd ellati tag eldin ahmed
master degree researcher
Principal Investigators
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Mohamed omara
Role: STUDY_DIRECTOR
Cairo University
mona el hadidy
Role: STUDY_DIRECTOR
Cairo University
Locations
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Cairo University
Cairo, , Egypt
Countries
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Central Contacts
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Hussien hatem
Role: CONTACT
Facility Contacts
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cairo university
Role: primary
Related Links
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Description Reginald H.B. Goodday/Management of Fractures of the Mandibular Body and Symphysis. Oral Maxillofacial Surg Clin North Am. 2013 Nov;25
Evaluation of the Accuracy of Computer-Guided Mandibular Fracture Reduction. 2015 Jul;26(5):1587-91.doi: 10.1097/ SCS.0000000000001773.
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):373-380
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 Aug
Other Identifiers
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3922
Identifier Type: -
Identifier Source: org_study_id