Comparison of a 2.0-mm locking system with conventional 2.0- and 2.4-mm systems in the treatment of mandibular fractures: a randomized controlled trial.

PURPOSE: A comparative study of the use of the 2.0-mm locking fixation system with conventional systems in the treatment of mandibular fractures was performed.

METHODS: For this study, 87 consecutive patients with 112 mandibular fractures were randomized to receive either 2.0-mm locking plates (n = 45) or conventional 2.0- or 2.4-mm plates (n = 42) and had a minimum follow-up of 6 months. Fractures were classified based on the degree of displacement and complexity. Statistical analyses were used to verify possible differences between the groups when separately compared unfavourable and favourable cases (p ≤ 0.050).

RESULTS: Despite randomization, systemic diseases were more frequent in the 2.0-mm locking group in favourable cases. Substance abuse occurred predominantly in the 2.0-mm locking group, in unfavourable and favourable fractures. There were more cases of complex fractures in the conventional group in unfavourable cases. One case involving a major postoperative complication occurred in the locking group (2.2%) and three cases occurred in the conventional group (7.1%) but with no significant difference between groups. In this study, there were no major differences between conventional and locking 2.0-mm locking systems with regard to the outcome of treated mandibular fractures, showing that both are adequate as long as the criteria of their indication and requirements for installation are met.

CONCLUSIONS: It was concluded that the 2.0-mm locking fixation system can replace conventional systems in the treatment of mandibular fractures; in addition, this approach was effective in the treatment of unfavourable fractures that typically require the 2.4-mm conventional system.