Intralesional Injection of Ethanolamine Oleate Alone or Mixed with Bupivacaine in Oral Venous Malformation (Randomized Controlled Trial)
- Disease/Condition
- Oral Health
- Intervention type
- drug
- Primary sponsor
- Oral and Maxillofacial Surgery Department Faculty of Dentistry Alexandria University
- Funder
- Omneya Mashaly
- Location
- Egypt
- Phase
- Not Applicable
- Start date
- Nov 01, 2021
- End date
- Jan 01, 1900
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.
- Registry
- Pan Africa Clinical Trials Registry
- Trial ID
- PACTR202209738652499
- Type
- Non-Device Trial
Access comprehensive clinical trial information for PACTR202209738652499 through Pure Global AI's free database. This Not Applicable trial is sponsored by Oral and Maxillofacial Surgery Department Faculty of Dentistry Alexandria University and is currently Recruitment Completed. The study focuses on Oral Health.
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