A Case-and-Control, Multisite, Positive Controlled, Prospective Study of the Safety and Effectiveness of Immediate Inferior Alveolar Nerve Processed Nerve Allograft Reconstruction With Ablation of the Mandible for Benign Pathology

Purpose: This study determined whether immediate reconstruction of the inferior alveolar nerve with a long (>4.5 cm) processed nerve allograft (PNA) in conjunction with simultaneous ablation and reconstruction of the mandible would be effective in safely restoring subjective sensation and achieving functional sensory recovery. Materials and Methods: Patients (5 to 70 yr old) requiring resection of the unilateral or bilateral mandible for benign pathology were included. The graft had to be longer than 4.5 cm. Results of sensory nerve tests and 3 different surveys (Direct Path, Numerical Rating Scale, Word Choice) were collected before surgery and at 3, 6, and 12 months after surgery. Safety data were recorded. Results: Twenty-six patients participated in this study. Three patients served as positive controls (no nerve repair). Five in the repair group and 1 in the positive control group were lost to follow-up. Data during a 1-year period were collected on 18 patients (7 male and 11 female; mean age, 26.4 yr; range, 10 to 64 yr). The mean length of the PNA was 62.7 mm (range, 45 to 70 mm). Seventeen of 18 patients had S4 sensory scores preoperatively and the postoperative score was S4 at 3 months in 3, at 6 months in 3, and at 1 year in 12. Scores for positive control patients never exceeded S2. Numerical rating scales and word choices were not statistically different from presurgical scores at 6 and 12 months. There were no adverse events. Conclusions: The PNA is safe and effective when immediately inserted with resection and reconstruction of the mandible: 90% of patients achieved functional sensory recovery and reported similar sensations to preoperative subjective values.