An interventional study of 3D custom plate and Standard titanium fixation plates in Mandibular Sub-condylar Fracture, sponsored by Esraa Mosad Tawfik. Not yet recruiting. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-03-19.
Sponsored by Esraa Mosad Tawfik · Not applicable, Interventional, and Treatment
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.
91 studies on the registry are indexed under Mandibular Fractures; 24 are open to participants now.
This study's planned enrollment of 30 is above the median of 21 across 72 interventional studies indexed under Mandibular Fractures.
Browse Mandibular Fractures studies →This is the only study on the registry with Esraa Mosad Tawfik as lead sponsor.
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Exclusion Criteria:
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. The custom plate is designed based on patient CT data and includes extensions along the posterior border of the mandibular ramus and above the sigmoid notch to facilitate accurate fracture reduction and stable fixation.
Device: 3D custom plate
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.
Device: Standard titanium fixation plates
Custom 3D plate will be designed using preoperative CT and virtual surgical planning.
Also known as: patient specific plate
The fixation will be performed according to established surgical principles for managing displaced mandibular sub-condylar fractures without patient-specific planning or customization.
Mandibular deviation on opening
Deviation in mm measured using midline reference.
Time frame: 1 month, 3 months, and 6 months postoperatively.
Maximum mouth opening
Distance in mm between incisal edges during maximal mouth opening.
Time frame: 1 month, 3 months, and 6 months postoperatively.
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
Accuracy of fracture reduction
Evaluated by comparing preoperative CT with postoperative CT using 3D image superimposition analysis
Time frame: Immediately postoperative (within 1 week)
No study locations are listed for this record.
Start is estimated for Apr 2026; primary completion for Oct 2026, 6 months later.
Of 38 non-industry interventional studies with no phase under Mandibular Fractures, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 24. This study's planned 6 months is below that.
Counting every sponsor, half of 38 studies reached it within 13 months; a quarter within 9 and three quarters within 24.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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