Background: The effectiveness of topical phenytoin has been reported for the treatment of oral biopsy ulcers, chemotherapy-induced oral mucositis, and chronic periodontitis. This study aimed to investigate the effects of topical phenytoin 2% on the prevention of fistula formation after cleft palate repair.
Method: This randomized clinical trial studied patients with nonsyndromic cleft palate who were referred to a tertiary center and underwent cleft palate repair from March 2010 to February 2015. Patients in the phenytoin group received phenytoin spray 2% for 8 weeks and were compared with an age- and sex-matched control group.
Results: A total of 160 patients in two phenytoin and control groups (n = 80 for each group) were recruited to the study. The mean ages of patients in the phenytoin and control groups were 11.42 ± 1.30 and 11.08 ± 1.25 months, respectively. The results showed that six patients (7.5%) in the phenytoin group and 15 patients (18.8%) in the control group formed fistulas during the 6-month follow-up period. There was a significant difference in fistula formation between the phenytoin and control groups (p = 0.035). Furthermore, fistula size was significantly smaller in the phenytoin group compared with the control group (p < 0.001).
Conclusion: More frequent use of phenytoin spray can be considered, although there is insufficient information on the long-term side-effects of the chosen drug.
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