Fixation of Mandibular Angle Fracture Using 3D Titanium Miniplate Versus Standard Two Plate Fixation

Cairo University (CU)

Status: Active, not recruiting

Conditions: Force Measurement; Mandible Fracture

Treatments: Device: 3D Titanium Miniplate (2.0 mm, 8-hole).; Device: Two Standard Plate Fixation

Study type: Interventional

Funder types: Other

Identifiers

NCT07574554

angle frcture ,Truma

Details and patient eligibility

About

Hypothesis The investigators hypothesis that fixation of mandibular angle fractures using a 3D titanium miniplate will provide better occlusal bite force than intraoral fixation using the standard two-plate technique.

The investigators expect that this method will facilitate a faster recovery time for participants to regain baseline occlusion force.

Enrollment: 20 estimated patients

Sex: Male

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• • Age from 20 to 50years.

  • Male .
  • Patients with mandibular angle fractures.

Exclusion criteria

• • Patients with contraindication to general anesthesia

  • Patients with comminuted angle fractures.
  • Patients with relevant systemic diseases contraindicating surgery or affecting bone healing.
  • Patients with infected condyle and coronoid fractures.
  • Gun-shot injuries.
  • Edentulous fractures.
  • Pathological fractures.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 2 patient groups

fixation using standard Two plate titanium.

Active Comparator group

Description:

Intervention Name: Two Standard plat titanium system . Intervention Type: Device Assigned Intervention: Fixation using two titanium miniplates. The first plate is placed at the inferior border of the mandible from the buccal side, fixed with bicortical screws engaging both cortices. The second plate is positioned \~5 mm superior or at the external oblique ridge, fixed with monocortical screws to avoid dental root injury.

Treatment:

Device: Two Standard Plate Fixation

Device: 3D Titanium Miniplate (2.0 mm, 8-hole).

3D titanium miniplate

Experimental group

Description:

Intervention Name: 3D Titanium Miniplate (2.0 mm, 8-hole) Intervention Type: Device Assigned Intervention: Fixation with a single rectangular 2.0 mm 9-hole 3D titanium miniplate. Two diagonally opposite monocortical screws placed first, followed by the remaining two. The plate is contoured with crossbars perpendicular and struts parallel to the fracture line. The upper crossbar is positioned subapically. Fixation is on the lateral cortex or external oblique ridge with proper adaptation.

Treatment:

Device: Two Standard Plate Fixation

Device: 3D Titanium Miniplate (2.0 mm, 8-hole).