Mandibular Fractures
Conditions
Keywords
Mandibular Subcondylar Fractures, Mouth Opening, Open Reduction and Internal Fixation, Closed Reduction with External Fixation
Brief summary
Patients with mandibular sub-condylar fractures underwent either either open reduction with internal fixation (ORIF) or closed reduction with external fixation (CREF) and were followed up for 6 months to assess treatment adequacy with the hypothesis that ORIF is superior to CREF.
Interventions
PROCEDUREOpen Reduction & Internal Fixation
Patients underwent surgery and the fractures were reduced under direct vision followed by internal fixation with titanium plates and screws
PROCEDUREClosed Reduction & External Fixation
Patients underwent closed reduction of the fracture and external fixation by arch bars & guided elastics
Sponsors
King Edward Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Age 16-60 years * Displaced Mandibular Subcondylar Fractures(MCFs) irrespective of multiple mandibular fractures.
Exclusion criteria
* Bilateral MCFs * MCF with mid-facial fractures * Insufficient bilateral dentition * Medically unfit for surgery * Old healed mandibular fractures * History of previous mandibular surgery for the same indication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mouth Opening | 6 months | Mouth Opening shall be determined by measuring the maximal distance between the edges of upper and lower incisors with fully opened mouth; the measurement shall be made in millimeters (mm) using vernier caliper and mouth opening of 35 mm or more shall be classified as adequate |
| Occlusion | 6 months | Occlusion shall be determined by maximum inter-cuspation as observed by the surgeon and patient self-reporting and will be classified as fine or deranged. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complications | 6 months | The frequency of complications with either mode of treatment shall be recorded |
| Cost-Effectiveness | 6 months | Cost-Effectiveness shall be determined as the ratio of the cost of treatment and achievement of both adequate mouth opening and fine occlusion. The cost of treatment shall include the cost of surgical items (wires, elastics, arch bars, plates, screws etc), cost of anesthesia and surgery, cost of hospital stay and cost of follow up. |
| Patient Satisfaction | 6 months | Participants shall be requested to report their satisfaction after treatment with regards to ease of chewing, mouth opening & closing and achievement of pre0traumatic facial symmetry/orientation. This parameter shall be recorded on a 4-point Likert scale (not satisfied, somewhat dissatisfied, somewhat satisfied, satisfied). |
Outcome results
None listed