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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lidocaine | Experimental | lidocaine 2% 1:80000 |
|
| articaine | Experimental | articaine 4% 1:200000 |
|
| bupivacaine | Experimental | bupivacaine 0,5% 1:200000 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phentolamine Mesylate 0.235 MG/ML [OraVerse] | Drug | compare effect of phentolamine mesylate in three arms |
|
| Measure | Description | Time Frame |
|---|---|---|
| time lip recovery fron local anesthesia | self reported lip sensitivity by questionaire marking every 15 minutes | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Post intervention pain | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26409985 | Result | Prados-Frutos JC, Rojo R, Gonzalez-Serrano J, Gonzalez-Serrano C, Sammartino G, Martinez-Gonzalez JM, Sanchez-Monescillo A. Phentolamine mesylate to reverse oral soft-tissue local anesthesia: A systematic review and meta-analysis. J Am Dent Assoc. 2015 Oct;146(10):751-9.e3. doi: 10.1016/j.adaj.2015.04.018. | |
| 18682623 | Result |
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| ID | Term |
|---|---|
| D010646 | Phentolamine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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Three randomized groups
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We use a program to randomize three groups. Double blind study No sham or placebo
clinical assesment of post intervention bleeding when using phentolamine mesylate
| 1 day |
| Hersh EV, Moore PA, Papas AS, Goodson JM, Navalta LA, Rogy S, Rutherford B, Yagiela JA; Soft Tissue Anesthesia Recovery Group. Reversal of soft-tissue local anesthesia with phentolamine mesylate in adolescents and adults. J Am Dent Assoc. 2008 Aug;139(8):1080-93. doi: 10.14219/jada.archive.2008.0311. |
| 18573982 | Result | Laviola M, McGavin SK, Freer GA, Plancich G, Woodbury SC, Marinkovich S, Morrison R, Reader A, Rutherford RB, Yagiela JA. Randomized study of phentolamine mesylate for reversal of local anesthesia. J Dent Res. 2008 Jul;87(7):635-9. doi: 10.1177/154405910808700717. |
| 21924181 | Result | Fowler S, Nusstein J, Drum M, Reader A, Beck M. Reversal of soft-tissue anesthesia in asymptomatic endodontic patients: a preliminary, prospective, randomized, single-blind study. J Endod. 2011 Oct;37(10):1353-8. doi: 10.1016/j.joen.2011.06.019. Epub 2011 Aug 5. |
| 18682624 | Result | Tavares M, Goodson JM, Studen-Pavlovich D, Yagiela JA, Navalta LA, Rogy S, Rutherford B, Gordon S, Papas AS; Soft Tissue Anesthesia Reversal Group. Reversal of soft-tissue local anesthesia with phentolamine mesylate in pediatric patients. J Am Dent Assoc. 2008 Aug;139(8):1095-104. doi: 10.14219/jada.archive.2008.0312. |
| 18547152 | Result | Moore PA, Hersh EV, Papas AS, Goodson JM, Yagiela JA, Rutherford B, Rogy S, Navalta L. Pharmacokinetics of lidocaine with epinephrine following local anesthesia reversal with phentolamine mesylate. Anesth Prog. 2008 Summer;55(2):40-8. doi: 10.2344/0003-3006(2008)55[40:POLWEF]2.0.CO;2. |
| 20831927 | Result | Hersh EV, Lindemeyer RG. Phentolamine mesylate for accelerating recovery from lip and tongue anesthesia. Dent Clin North Am. 2010 Oct;54(4):631-42. doi: 10.1016/j.cden.2010.06.004. |
| 23522530 | Result | Elmore S, Nusstein J, Drum M, Reader A, Beck M, Fowler S. Reversal of pulpal and soft tissue anesthesia by using phentolamine: a prospective randomized, single-blind study. J Endod. 2013 Apr;39(4):429-34. doi: 10.1016/j.joen.2012.12.024. Epub 2013 Feb 11. |
| 28126226 | Result | Daublander M, Liebaug F, Niedeggen G, Theobald K, Kurzinger ML. Effectiveness and safety of phentolamine mesylate in routine dental care. J Am Dent Assoc. 2017 Mar;148(3):149-156. doi: 10.1016/j.adaj.2016.11.017. Epub 2017 Jan 23. |