Equivalence randomized controlled trial of bioresorbable versus titanium miniplates in treatment of mandibular fracture: a pilot study.

PURPOSE: The present study was undertaken to test bioresorbable fixation versus titanium for equivalence in terms of clinical union and complications using the American Association of Oral and Maxillofacial Surgeons parameters of care. The study design was a randomized, controlled, equivalence trial.

MATERIALS AND

METHODS

A total of 40 patients were enrolled and allocated to the titanium group and bioresorbable group using a computerized randomization table. All were plated using standard plating principles. In the bioresorbable group, 2 weeks of maxillomandibular fixation was also used. Evaluation of the study endpoint was done at 8 weeks postoperatively. For statistical analysis, the upper limit of the 95% confidence interval was calculated for failure to achieve the primary outcome variable and compared with the maximal clinically acceptable difference between the standard and test modalities in the failure to achieve clinical union (delta). Delta was predetermined as 2%. The other complications were tested for significance using Fisher's exact test.

RESULTS

Of the 40 patients, 21 were in the titanium group and 19 were in the bioresorbable group, with 20 men and 1 woman in the titanium group and 18 men and 1 woman in the bioresorbable group. The mean age was 28.7 years in the titanium group and 26.6 years in the bioresorbable group. In the titanium group, the complications noted were nonunion in 0%, malocclusion in 7.7%, continued postoperative swelling in 0%, chronic pain in 2%, infection in 5.2%, an inability to chew hard food after 8 weeks in 7.7%, the need for alternative treatment in 0%, and the need for reoperation in 31%. In the bioresorbable group, the complications were nonunion in 4.17%, malocclusion in 11.1%, swelling in 8.3%, chronic pain in 37.5%, infection in 0%, an inability to chew hard food in 11.1%, the need for alternative treatment in 11.1%, and need for reoperation for plate removal in 0%.

CONCLUSIONS

The small sample size did not allow any meaningful conclusion to be drawn from the present study in terms of the primary question of achieving union. Both groups matched in outcomes when evaluated only on a clinical basis. The avoidance of repeat surgery for plate removal is a definite advantage of using resorbable plates. However, the results are inconclusive in favor of any particular plating system.