Phentolamine Mesylate as a Reversal of Local Anesthesics

• Status: Completed
• Trial end date: 2018-11-09
• Target enrollment: 0
• Participant gender: All

Summary

Oraverse © (Phentolamine mesylate) is a product designed to reverse the effect of local anesthetics used in dentistry. Its main objective is to reduce the postoperative period during which the patient suffers from the lack of sensitivity in the perioral soft tissues, it is an obvious discomfort, a difficulty to speak or eat, and sometimes a risk of self-injury in the lips and / or tongue .

The product was approved by the FDA in 2008 although the introduction in Spain has not occurred until December 2015. There are numerous studies that support its use, its effectiveness and safety, although none of the Spanish population, who have not yet had the opportunity to experience it.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: León Formación
• Treatments: Phentolamine

Criteria

Inclusion Criteria:

• Previously diagnosticated to receive dental treatment according to Leonformacion's criteria

Exclusion Criteria:

• Hepatic or renal patient

• Fertility treatment, pregnancy or lactation

• Treatment with oral anticoagulants

• Patients with known allergies to anesthetics, excipients or phentolamine mesylate

• Patients with previous facial paresthesia

• Patients who had taken any painkiller or anti-inflammatory the day before

• Patients in which the anesthetic technique fails or has to be reinforced with more than two carpules