An interventional study of Open Reduction & Internal Fixation and Closed Reduction & External Fixation in Mandibular Fractures, sponsored by King Edward Medical University. Completed. Open to participants aged 16 Years to 60 Years. Per ClinicalTrials.gov, last updated 2018-04-11.
Sponsored by King Edward Medical University · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
Open Reduction \& Internal Fixation
Procedure: Open Reduction & Internal Fixation
Closed Reduction \& External Fixation
Procedure: Closed Reduction & External Fixation
Patients underwent surgery and the fractures were reduced under direct vision followed by internal fixation with titanium plates and screws
Patients underwent closed reduction of the fracture and external fixation by arch bars \& guided elastics
Mouth Opening
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"
Time frame: 6 months
Occlusion
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.
Time frame: 6 months
Complications
The frequency of complications with either mode of treatment shall be recorded
Time frame: 6 months
Cost-Effectiveness
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.
Time frame: 6 months
Patient Satisfaction
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).
Time frame: 6 months
No study locations are listed for this record.
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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King Edward Medical University