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

NCT ID: NCT06978530

Last Updated: 2025-08-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2026-07-01

Brief Summary

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.

Conditions

Mandibular Sub-condylar Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

3D Custom Plate group

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.

Group Type: EXPERIMENTAL

3D custom plate

Intervention Type: DEVICE

Custom 3D plate will be designed using preoperative CT and virtual surgical planning.

Standard titanium plates group

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.

Group Type: ACTIVE_COMPARATOR

Standard titanium fixation plates

Intervention Type: DEVICE

The fixation will be performed according to established surgical principles for managing displaced mandibular sub-condylar fractures without patient-specific planning or customization.

Interventions

3D custom plate

Custom 3D plate will be designed using preoperative CT and virtual surgical planning.

Intervention Type: DEVICE

Standard titanium fixation plates

The fixation will be performed according to established surgical principles for managing displaced mandibular sub-condylar fractures without patient-specific planning or customization.

Intervention Type: DEVICE

Other Intervention Names

patient specific plate

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Esraa Mosad Tawfik

OTHER

Sponsor Role: lead

Responsible Party

Esraa Mosad Tawfik

Resident, Oral and Maxillofacial Surgery

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Esraa Mosaad

Role: CONTACT

esraa.tawfik@dentistry.cu.edu.eg

+201153918930

Other Identifiers

3D-SCF-RCT-2025

Identifier Type: -

Identifier Source: org_study_id