Objectives: this study proposed to evaluate the eficacy of the use of 13-cis retinoic acid 0.05% in the form of gel in oral leukoplakias when compared to placebo.
Methods: a total of 40 patients were screened and selected for this purpose, and 23 patients concluded the whole research protocol. The sample was composed more by women (56,5%), with mean age of 58,9 years (sd = 13,5). A calibrated examiner (Kappa test > 0.896) analyzed the progression of the lesions, using three criteria to rank them.
Results: The patients who received the retinoic acid (n=10), 50% kept the clinical characteristics of the leukoplasia, 20% healed part of the lesion and 30% healed almost completely. The patients who received placebo (n=13), 69.2% kept the clinical characteristics of the leukoplasia, 30.8% healed part of the lesion and none of them (0%) healed almost completely. The results showed that the patients, who healed almost completed, were treated with retinoic acid, showing the eficacy of the medication in relation to placebo.
Conclusions: there was a good therapeutic effect of the retinoic acid in oral leukoplasias, especially when compared with the results of those who receive placebo. Further studies are need to test it in higher concentrations of the retinoic acid, with more prolonged therapy and also in a bigger sample. It was also concluded that before using this medication as a protocol in Brazilian public health, the Dental Surgeons need to specialize in diagnostic of oral lesions and early detection of leukoplasias.
Grant: FAPES/PPSUS 01_2005