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

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.

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Key information

Conditions

Mandibular Sub-condylar Fracture Craniocerebral Trauma Facial Injuries Fractures, Bone Jaw Fractures Mandibular Fractures Maxillofacial Injuries Nervous System Diseases Skull Fractures Trauma, Nervous System Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3D custom plate

Device

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

Other names: patient specific plate

Standard titanium fixation plates

Device

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

Primary outcomes

Mandibular deviation on opening

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

Deviation in mm measured using midline reference.
Maximum mouth opening

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

Distance in mm between incisal edges during maximal mouth opening.

Secondary outcomes

Bite force

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

Bite force measured in Newtons at the molar region using a bite force recording device.
Accuracy of fracture reduction

Time frame: Immediately postoperative (within 1 week)

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

Study contacts

Contact information is provided by the study sponsor or research team.

Esraa Mosaad

CONTACT

[email protected]

+201153918930

Sponsors and collaborators

Lead sponsor

Esraa Mosad Tawfik

Other

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: May 18, 2025
Registry last updated: Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed