3D Custom Plate vs. Standard Titanium Plates for Mandibular Sub-condylar Fractures Fixation

Esraa Mosad Tawfik

Status: Not yet enrolling

Conditions: Mandibular Sub-condylar Fracture

Treatments: Device: Standard titanium fixation plates; Device: 3D custom plate

Study type: Interventional

Funder types: Other

Identifiers

NCT06978530

3D-SCF-RCT-2025

Details and patient eligibility

About

This randomized clinical trial aims to conduct a comprehensive clinical and radiographic evaluation by comparing the efficacy of standard titanium fixation plates with three dimensional custom plate in the management of sub-condylar fractures. By assessing the clinical outcomes, accuracy of reduction of the fracture segments, and bite force promoted by both fixation modalities.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Displaced sub condylar fractures, requiring open reduction and rigid internal fixation
• Age ranges from 18 to 60 years
• Fracture duration less than 2 weeks
• Patients with adequate follow up duration for outcome assessment

Exclusion criteria

• Comminuted sub condylar fractures
• Patients with severe systemic diseases that may affect fracture healing
• Presence of any pathology at the fracture site
• Patients with previous history of mandibular surgery
• Medically compromised patients who are not fit to undergo surgery under general anesthesia
• Patients with in complete medical records or missing follow up data

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

3D Custom Plate group

Experimental group

Description:

Patients in this group will undergo open reduction and internal fixation of displaced mandibular sub-condylar fractures using preoperatively designed and 3D-printed patient-specific titanium plates.

Treatment:

Device: 3D custom plate

Standard titanium plates group

Active Comparator group

Description:

Patients in this group will undergo open reduction and internal fixation of displaced mandibular sub-condylar fractures using the conventional technique, involving either two standard titanium miniplates or a single 2.3 mm titanium plate.

Treatment:

Device: Standard titanium fixation plates