Customized z Shaped Miniplate Versus Standard 2 Miniplates for Fixation of Parasymphyseal/Body Mandibular Fractures

Hams Hamed Abdelrahman

Status: Completed

Conditions: Mandibular Fractures

Treatments: Other: conventional two miniplates; Other: customized Z shaped miniplate

Study type: Interventional

Funder types: Other

Identifiers

NCT07094867

0866-02/2024

Details and patient eligibility

About

Mandibular fractures are a common type of facial fractures. The surgical treatment has developed over the years due to improved understanding of biomechanics, biomaterials and scientifically based treatment outcomes. since customized fixation mechanism is more suited to the bone surface which helps to meet the requirements of a semirigid fixation. Customized Z plate is a new geometry of miniplates that may provide superior preservation of mental nerve, stability, support and easier in adaptation compared to the standard 2 miniplates system for fixation of parasymhyseal/body mandibular fractures.

Enrollment: 22 patients

Sex: All

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients suffering from recent fractures at the parasymphysis/body of the mandible presented within 2 weeks of the date of trauma.
• Radiographic evidence of parasymphyseal/body mandibular fracture that demands open reduction and internal fixation.
• The patient is medically fit for general anesthesia

Exclusion criteria

• comminuted fracture.
• Pathological fracture.
• Presence of infection

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

Test Group "Customzied z Plate"

Experimental group

Treatment:

Other: customized Z shaped miniplate

Conventional treatment "Miniplates"

Active Comparator group

Treatment:

Other: conventional two miniplates