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

Phase 4Active Not RecruitingNCT07390734

Alexandria University18 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Mandibular Angle Fracture

Interventions

custom-made 3D titanium platesDEVICE

custom-made 3D titanium plates through intaoral and transbuccal approach .

standared two mini platesDEVICE

internal fixation with standared two mini plates through intaoral and transbuccal approach.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (1)

Faculty of dentistry, Alexandria university

Alexandria, Egypt

Outcomes

Primary Outcomes

Radiographic evaluation for the assessment of mean bone density at the fracture line

Mean bone density at the fracture line was assessed using Computed Tomography (CT) scan in Hounsfield Units (HU)

Time frame: 4 months

Secondary Outcomes

Post operative pain

\- Post operative pain This will be subjectively evaluated with a visual analogue scale (VAS) with values from 0 (no pain) to 10 (strongest pain).

Time frame: 3 months

Data from ClinicalTrials.gov

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