Intralesional Injection of Ethanolamine Oleate Alone or Mixed with Bupivacaine in Oral Venous Malformation (Randomized Controlled Trial) - Trial PACTR202209738652499

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Summary

Vascular anomalies (VAs) arise from blood vessel abnormalities or during endothelial proliferation and are classically distinguished according to the classifications of Mulliken and Glowacki, based on their clinical, histological, and histochemical findings, in hemangiomas and vascular malformations. VMs can be divided into low-flow (venous, capillary, or lymphatic component) and high-flow (arterial or arteriovenous component) The majority of VMs in the oral cavity are venous and slow flow in nature. The main affected areas are the lips, tongue, buccal mucosa, and palate. VMs in the oral cavity may lead to esthetic disorders, pain, and bleeding. Different treatment modalities were proposed, including surgery, laser, embolization, cryotherapy, sclerotherapy, and corticosteroids. Sclerotherapy is an efficient and conservative method for the treatment of VMs. It is a simple procedure that consists of intralesional injection with a low recurrence rate, good esthetic results, and reasonable morbidity. Ethanolamine oleate is a sclerosing agent that causes an acute, dose-related inflammatory reaction of the intimal endothelium of the vein leading to scarring at the inner wall of the veins and possible occlusion of the veins. Adverse reactions related to ethanolamine oleate (EO) include pain during and after injection. Since Ethanolamine Oleate causes post-operative pain, the purpose of this study is to introduce a novel approach of intralesional injection with both Ethanolamine Oleate with Bupivacaine to reduce post-operative pain and com pare both clinically and radiographically the effect on oral venous malformation.

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