Topical Phenytoin Enhancing Healing Process in Bisphosphonate-related Osteonecrosis of Mandible.

Objectives: The aim of this study is to evaluate the efficacy of Phenytoin on healing process in bisphosphonate-related Osteonecrosis (BRON) of the Mandible.
Methods: Twenty patients who had inclusion criteria (current or previous therapy with bisphosphonates, exposed necrotic bone in mandible lasting more than 8 weeks, absence of head and neck radiation therapy, radiographically a mouse eaten appearance and histoplacically proved osteonecrosis) were randomly allocated in 2 groups. Group 1 underwent debridement of necrotic bone and the involved area was closed primarily and in group 2 patients received topical phenytoin 5% after surgical debridement and surgical site was closed primarily. Patients were evaluated after 1, 6 and 12 months for wound dehiscence (Stage 0: No dehiscence, Stage 1: less than 10mm dehiscence, stage 2: more than 10mm dehiscence), infection (pus, sinus tract (Yes/NO)), pain (according to visual analog scale (VAS) 0-10). In the second and third follow-ups, the number of patients who experienced a time span of 3 months without clinical symptoms were documented in each group.
Results: In first and second follow-ups, 20% of patients in group 1 and 60% of patients in group 2 had complete healing. (P<0.05) In second and third follow-ups no significant difference was recorded between healin stages of 2 groups. (P>0.05) There was no significant difference for pain intensity in 3 follow-up times between the two groups. (P˃0.05) Furthermore, comparison of the number of patients with 3 months free of clinical symptoms did not show a significant difference between two groups. (P˃0.05)
Conclusions: It seems topical phenytoin may enhance soft tissue healing in short period (1 month). However, use of topical phenytoin has no effect on pain intensity or healing in long term.