Mandibular Sub-condylar Fracture
Conditions
Keywords
Mandibular fracture, 3D custom plate, titanium miniplates, sub-condylar fractures
Brief 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.
Interventions
DEVICE3D custom plate
Custom 3D plate will be designed using preoperative CT and virtual surgical planning.
DEVICEStandard 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.
Sponsors
Esraa Mosad Tawfik
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mandibular deviation on opening | 1 month, 3 months, and 6 months postoperatively. | Deviation in mm measured using midline reference. |
| Maximum mouth opening | 1 month, 3 months, and 6 months postoperatively. | Distance in mm between incisal edges during maximal mouth opening. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bite force | 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 | Immediately postoperative (within 1 week) | Evaluated by comparing preoperative CT with postoperative CT using 3D image superimposition analysis |
Contacts
CONTACTEsraa Mosaad
Outcome results
None listed