RANDOMIZED CONTROLLED TRIAL
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Open reduction and internal fixation versus closed treatment and mandibulomaxillary fixation of fractures of the mandibular condylar process: a randomized, prospective, multicenter study with special evaluation of fracture level.

PURPOSE: This randomized, clinical multicenter trial investigated the treatment outcomes of displaced condylar fractures, and whether radiographic fracture level was a prognostic factor in therapeutic decision-making between open reduction and internal fixation (ORIF) versus closed reduction and mandibulomaxillary fixation (CRMMF).

PATIENTS AND METHODS: Sixty-six patients with 79 displaced fractures (deviation of 10 degrees to 45 degrees, or shortening of the ascending ramus >or=2 mm) of the condylar process of the mandible at 7 clinical centers were enrolled. Patients were randomly allocated to CRMMF (n = 30 patients) or ORIF (n = 36 patients) treatment. The following parameters were measured 6 months after the trauma. Clinical parameters included mouth opening, protrusion, and laterotrusion. Radiographic parameters included level of the fracture, deviation of the fragment, and shortening of the ascending ramus. Subjective parameters included pain (according to a visual analogue scale), discomfort, and subjective functional impairment with a mandibular functional impairment questionnaire.

RESULTS: The difference in average mouth opening was 12 mm (P
CONCLUSION: Fractures with a deviation of 10 degrees to 45 degrees, or a shortening of the ascending ramus >or=2 mm, should be treated with ORIF, irrespective of level of the fracture.

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