Anesthesia, Local
Conditions
Keywords
phentolamine mesylate, reverse local anesthesia
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.
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.
Interventions
DRUGPhentolamine Mesylate 0.235 MG/ML [OraVerse]
compare effect of phentolamine mesylate in three arms
Sponsors
León Formación
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
We use a program to randomize three groups. Double blind study No sham or placebo
Intervention model description
Three randomized groups
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| time lip recovery fron local anesthesia | 1 day | self reported lip sensitivity by questionaire marking every 15 minutes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post intervention pain | 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 | 1 day | clinical assesment of post intervention bleeding when using phentolamine mesylate |
Outcome results
None listed