Patient Specific Plates Versus Conventional Miniplates for Treatment of Mandibular Body Fractures

Cairo University (CU)

Status: Unknown

Conditions: Mandibular Fractures

Treatments: Device: Computer guided patient specific 3D titanium plate; Device: Conventional titanium miniplates

Study type: Interventional

Funder types: Other

Identifiers

NCT03608891

Patient specific plate

Details and patient eligibility

About

The aim of the current study is to evaluate and assess the clinical stability and efficacy of patient specific computer guided titanium plates versus the conventional titanium mini plates regarding accurate reduction and fixation of mandibular body fractures, reducing the operating time, achieving precise bone alignment and reducing the plate palpability.

Full description

The study will be conducted on two groups:

Intervention group: patient specific three-dimensional titanium plates CBCT or CT scan will be performed for the patient, the dicom files will be imported into a surgical planning software , plates will then be designed virtually and sent for three-dimensional (3D) printing.

Control group: Conventional miniplates:

In this group two miniplates of titanium Mini-System 2.0 mm will be used. The plate has profile height 1.0 mm whereas the screw length varies according to the site of the plate. According to Champy osteosynthesis lines for fixation of the posterior mandibular fracture ,the first plate will be placed at the inferior border from the buccal side, using bicortical screws engaging the buccal and lingual cortices to achieve rigid fixation, while the second plate will be placed at about 5mm superior to the inferior plate in the subapical region, using monocortical screws engaging only the buccal cortex to avoid injuring the teeth roots.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients with unilateral mandibular body fractures, not associated with other mandibular and maxillofacial fractures

Exclusion criteria

• Patients with bilateral mandibular fractures
• Patients with other mandibular or maxillofacial fractures
• Comminuted fractures
• Medical problem that may interfere with the procedure such as bleeding disorder and pregnancy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

Control Arm

Active Comparator group

Description:

Conventional titanium miniplates

Treatment:

Device: Conventional titanium miniplates

Intervention arm

Experimental group

Description:

Patient specific 3D plates

Treatment:

Device: Computer guided patient specific 3D titanium plate