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Phentolamine Mesylate as a Reversal of Local Anesthesics

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ClinicalTrials.gov Identifier: NCT03740386
Recruitment Status : Completed
First Posted : November 14, 2018
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
alejandro gago garcia, León Formación

Brief 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.


Condition or disease Intervention/treatment Phase
Anesthesia, Local Drug: Phentolamine Mesylate 0.235 MG/ML [OraVerse] Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Three randomized groups
Masking: Double (Participant, Investigator)
Masking Description: We use a program to randomize three groups. Double blind study No sham or placebo
Primary Purpose: Treatment
Official Title: Phentolamine Mesylate as a Reversal of Local Anesthesics
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : November 9, 2018
Actual Study Completion Date : November 9, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. time lip recovery fron local anesthesia [ Time Frame: 1 day ]
    self reported lip sensitivity by questionaire marking every 15 minutes


Secondary Outcome Measures :
  1. 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

  2. post intervention bleeding [ Time Frame: 1 day ]
    clinical assesment of post intervention bleeding when using phentolamine mesylate



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Publications of Results:

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Responsible Party: alejandro gago garcia, Assintant professor, León Formación
ClinicalTrials.gov Identifier: NCT03740386     History of Changes
Other Study ID Numbers: LeonFormacion
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Keywords provided by alejandro gago garcia, León Formación:
phentolamine mesylate
reverse local anesthesia

Additional relevant MeSH terms:
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Phentolamine
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antihypertensive Agents