Phentolamine Mesylate as a Reversal of Local Anesthesics

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-01

Study Completion Date

2018-11-09

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.

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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.

Conditions

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Anesthesia, Local

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Three randomized groups

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

We use a program to randomize three groups. Double blind study No sham or placebo

Study Groups

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lidocaine

lidocaine 2% 1:80000

Group Type EXPERIMENTAL

Phentolamine Mesylate 0.235 MG/ML [OraVerse]

Intervention Type DRUG

compare effect of phentolamine mesylate in three arms

articaine

articaine 4% 1:200000

Group Type EXPERIMENTAL

Phentolamine Mesylate 0.235 MG/ML [OraVerse]

Intervention Type DRUG

compare effect of phentolamine mesylate in three arms

bupivacaine

bupivacaine 0,5% 1:200000

Group Type EXPERIMENTAL

Phentolamine Mesylate 0.235 MG/ML [OraVerse]

Intervention Type DRUG

compare effect of phentolamine mesylate in three arms

Interventions

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Phentolamine Mesylate 0.235 MG/ML [OraVerse]

compare effect of phentolamine mesylate in three arms

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes