Phentolamine Mesylate as a Reversal of Local Anesthesics

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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Key information

Conditions

Anesthesia, Local

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Phentolamine Mesylate 0.235 MG/ML [OraVerse]

Drug

compare effect of phentolamine mesylate in three arms

Primary outcomes

time lip recovery fron local anesthesia

Time frame: 1 day

self reported lip sensitivity by questionaire marking every 15 minutes

Secondary outcomes

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
post intervention bleeding

Time frame: 1 day

clinical assesment of post intervention bleeding when using phentolamine mesylate

Sponsors and collaborators

Lead sponsor

León Formación

Other

Registry information

Important dates

Study start: 2016
Primary completion: 2018
Study completion: 2018
First posted: Nov 14, 2018
Registry last updated: Nov 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed