Phentolamine Mesylate as a Reversal of Local Anesthesics

November 10, 2018 updated by: alejandro gago garcia, León Formación

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post intervention pain
Time Frame: 1 day
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
Time Frame: 1 day
clinical assesment of post intervention bleeding when using phentolamine mesylate
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

León Formación

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

November 9, 2018

Study Completion (Actual)

November 9, 2018

Study Registration Dates

First Submitted

November 9, 2018

First Submitted That Met QC Criteria

November 10, 2018

First Posted (Actual)

November 14, 2018

Study Record Updates

Last Update Posted (Actual)

November 14, 2018

Last Update Submitted That Met QC Criteria

November 10, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LeonFormacion

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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