Phentolamine Mesylate as a Reversal of Local Anesthesics

Study Overview
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Brief Summary
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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.

Detailed Description
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PURPOSE OF THE STUDY: To analyze the response of Oraverse in patients receiving complete oral disinfection treatment, after administration of Lidocaine 2% 1/80000, Articaine 4% 1/200000 or Bupivacaine 0,5% 1:200000 in mandible, in comparison with the contralateral control side.

Official Title
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Phentolamine Mesylate as a Reversal of Local Anesthesics

Conditions
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Anesthesia, Local

Intervention / Treatment
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* Drug: Phentolamine Mesylate 0.235 MG/ML [OraVerse]


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Three randomized groups
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lidocaine<br>lidocaine 2% 1:80000 | Drug: Phentolamine Mesylate 0.235 MG/ML [OraVerse]<br>* compare effect of phentolamine mesylate in three arms<br>|
| Experimental: articaine<br>articaine 4% 1:200000 | Drug: Phentolamine Mesylate 0.235 MG/ML [OraVerse]<br>* compare effect of phentolamine mesylate in three arms<br>|
| Experimental: bupivacaine<br>bupivacaine 0,5% 1:200000 | Drug: Phentolamine Mesylate 0.235 MG/ML [OraVerse]<br>* compare effect of phentolamine mesylate in three arms<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time lip recovery fron local anesthesia | self reported lip sensitivity by questionaire marking every 15 minutes | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post intervention pain | visual analogue scale to measure pain: Line ranged from 1 to 10 units where 1 means no pain at all and 10 means the worst imaginable pain. Lower levels are good outcomes | 1 day | 
| post intervention bleeding | clinical assesment of post intervention bleeding when using phentolamine mesylate | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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phentolamine mesylate, reverse local anesthesia