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

N/ANot Yet RecruitingNCT06978530

Esraa Mosad Tawfik30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Mandibular Sub-condylar Fracture

Interventions

3D custom plateDEVICE

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

Standard titanium fixation platesDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Bite force

Bite force measured in Newtons at the molar region using a bite force recording device.

Time frame: 1 month, 3 months, and 6 months postoperatively

Secondary Outcomes

Maximum mouth opening

Distance in mm between incisal edges during maximal mouth opening.

Time frame: 1 month, 3 months, and 6 months postoperatively.

Mandibular deviation on opening

Deviation in mm measured using midline reference.

Time frame: 1 month, 3 months, and 6 months postoperatively.

Accuracy of fracture reduction

Evaluated by comparing preoperative CT with postoperative CT using 3D image superimposition analysis

Time frame: Immediately postoperative (within 1 week)

Central Contacts

Esraa Mosaad

CONTACT

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.