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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ORIF | Experimental | Open Reduction & Internal Fixation |
|
| CREF | Active Comparator | Closed Reduction & External Fixation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Open Reduction & Internal Fixation | Procedure | Patients underwent surgery and the fractures were reduced under direct vision followed by internal fixation with titanium plates and screws |
| Measure | Description | Time Frame |
|---|---|---|
| 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" | 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Complications | The frequency of complications with either mode of treatment shall be recorded | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D008337 | Mandibular Fractures |
| ID | Term |
|---|---|
| D007572 | Jaw Fractures |
| D008446 | Maxillofacial Injuries |
| D005151 | Facial Injuries |
| D006259 | Craniocerebral Trauma |
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| ID | Term |
|---|---|
| D000070799 | Open Fracture Reduction |
| D005593 | Fracture Fixation, Internal |
| ID | Term |
|---|---|
| D005592 | Fracture Fixation |
| D019637 | Orthopedic Procedures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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| Closed Reduction & External Fixation | Procedure | Patients underwent closed reduction of the fracture and external fixation by arch bars & guided elastics |
|
| 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). | 6 months |
| D020196 |
| Trauma, Nervous System |
| D009422 | Nervous System Diseases |
| D012887 | Skull Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |