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Not yet recruiting NCT06978530

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

No phase Interventional Mandibular Sub-condylar Fracture

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 3D custom plate, Standard titanium fixation plates.
Who it may be relevant to
Registry conditions: Mandibular Sub-condylar Fracture. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

Interventions

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

Primary outcome measures

  • Mandibular deviation on opening [Time frame: 1 month, 3 months, and 6 months postoperatively.]
  • Maximum mouth opening [Time frame: 1 month, 3 months, and 6 months postoperatively.]
Secondary outcome measures (2)
  • Bite force [Time frame: 1 month, 3 months, and 6 months postoperatively]
  • Accuracy of fracture reduction [Time frame: Immediately postoperative (within 1 week)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06978530 · 3D-SCF-RCT-2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗