Patient Specific 3d Titanium Plate Versus Standard Two Mini Plates in the Fixation of Mandibular Angle Fractures (a Randomized Controlled Clinical Trial)

Alexandria University

Status and phase: Active, not recruiting; Phase 4

Conditions: Mandibular Angle Fracture

Treatments: Device: custom-made 3D titanium plates; Device: standared two mini plates

Study type: Interventional

Funder types: Other

Identifiers

NCT07390734

1023-01/2025

Details and patient eligibility

About

To compare the effectiveness of custom-made (3D) titanium plates to standard two titanium mini plates in fixation of mandibular angle fracture.

Full description

Eighteen patients with mandibular angle fractures will be selected. In nine fractures, custom-made three dimensional titanium plates will be used for fracture fixation (study group); while in the other nine, conventional two mini plates will be used (control group),via intra oral approach (combined with transbuccal approach) for both groups. Patients will be evaluated clinically, and radiographically (immediate and four months post operative) to evaluate the bone density at the fracture line.

Enrollment: 18 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients suffering from mandibular angle fracture indicated for open reduction and fixation.
2. Non infected mandibular angle fractures present less than two weeks. 3. Good oral hygiene.

Exclusion criteria

1. Medically compromised patients contradicting operation (ASA III, IV & V).
2. Patients receiving radiotherapy or chemotherapy. 3- Bone diseases (Osteoporosis, Osteopetrosis, Osteomalacia…etc.) 4- Pathological fracture. 5- Old untreated fracture.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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18 participants in 2 patient groups

patients with recent mandibular angle fractures managed with custom-made 3D titanium plates

Experimental group

Description:

patients that will undergo internal fixation with custom-made 3D titanium plates through intaoral and transbuccal approach .

Treatment:

Device: custom-made 3D titanium plates

patients with recent mandibular angle fractures managed with standared two mini plates

Experimental group

Description:

patient that will undergo internal fixation with standared two mini plates through intaoral and transbuccal approach.

Treatment:

Device: standared two mini plates