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

Mandibular Sub-condylar Fractures Fixation Using Three-dimensional Custom Plate Versus Standard Titanium Fixation Plates: Randomized Clinical Trial

NCT06978530•Esraa Mosad Tawfik

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 60 years

Sex

ALL

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

Key Dates

Start Date

April 10, 2026

Primary Completion Date

October 10, 2026

Completion Date

November 1, 2026

Last Updated

March 19, 2026

Enrollment

ESTIMATED participants

Conditions

Mandibular Sub-condylar Fracture

Interventions

3D custom plate

DEVICE

Standard titanium fixation plates

DEVICE

Contacts

Esraa Mosaad

CONTACT

+201153918930 esraa.tawfik@dentistry.cu.edu.eg