Evaluation of OK-432 injection therapy as a possible primary treatment for intraoral ranula

Publication date: Available online 24 August 2016
Source:Journal of Oral and Maxillofacial Surgery
Author(s): Michihide Kono, Takafumi Satomi, Harutugi Abukawa, On Hasegawa, Masato Watanabe, Daichi Chikazu
A ranula is a pseudocyst caused by mucous extravasation from the sublingual gland. Recently, a sclerosing agent, OK-432 (Picibanil), has been reported to be highly effective for treating lymphangioma and cervical cystic lesions. This study aimed to assess the effectiveness of OK-432 injection therapy for intraoral ranula and to clarify whether it can be used as the primary treatment.Patients and methodsThis study was a retrospective clinical study of patients with intraoral ranula who were treated with OK-432 injection therapy from 2005 to 2015. Ranula size was measured by computed tomography or magnetic resonance imaging. We prepared 1 Klinische Einheit (KE) unit of OK-432 powder dissolved in normal saline equal to the aspiration volume. The primary endpoint was the treatment results. The secondary endpoint was the relation between the treatment results and the lesion length and aspiration volume.ResultsTwenty-three patients were treated for intraoral ranula by OK-432 injection therapy. The mean size of the lesions was 19.96 mm. The mean aspiration volume was 2.14 mL. The numbers of injections were 1 to 4 times (mean 1.70 times). Treatment results showed complete regression (CR) in 18 (78.2%), partial regression (PR) in 3 (13.0%), and no response (NR) in 2 (8%) patients after the last injection. The overall efficacy rate was 91.2% (21/23). There were no serious complications observed. The differences between the treatment results (CR vs PR/NR) and the lesion length and aspiration volume of the CR group showed 17.38 mm and 1.40 ml. The PR/NR group showed 29.20 mm and 4.80 ml. The PR/NR group lesion was significantly larger than the CR group lesion.ConclusionOK-432 injection therapy for intraoral ranula was found to be a safe and effective treatment compared with other surgical therapies. This therapy can potentially become a primary treatment for intraoral ranula.



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