Phentolamine Mesylate as a Reversal of Local Anesthesics

NCT03740386 | Completed DMC

• 1 other identifier: LeonFormacion
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anesthesia, Local

Keywords

phentolamine mesylate; reverse local anesthesia

Outcome Measures

Primary Outcomes (1)

• time lip recovery fron local anesthesia

  self reported lip sensitivity by questionaire marking every 15 minutes

  1 day

Secondary Outcomes (2)

• Post intervention pain

  1 day

• post intervention bleeding

  1 day

Study Arms (3)

lidocaine

EXPERIMENTAL

lidocaine 2% 1:80000

Drug: Phentolamine Mesylate 0.235 MG/ML [OraVerse]

articaine

EXPERIMENTAL

articaine 4% 1:200000

Drug: Phentolamine Mesylate 0.235 MG/ML [OraVerse]

bupivacaine

EXPERIMENTAL

bupivacaine 0,5% 1:200000

Drug: Phentolamine Mesylate 0.235 MG/ML [OraVerse]

Interventions

Phentolamine Mesylate 0.235 MG/ML [OraVerse] DRUG

compare effect of phentolamine mesylate in three arms

articaine; bupivacaine; lidocaine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Previously diagnosticated to receive dental treatment according to Leonformacion's criteria

You may not qualify if:

• 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

Sponsors & Collaborators

• León Formación: lead

Related Publications (9)

• 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.

  PMID: 26409985 RESULT

• 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.

  PMID: 18682623 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.

  PMID: 18573982 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.

  PMID: 21924181 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.

  PMID: 18682624 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.

  PMID: 18547152 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.

  PMID: 20831927 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.

  PMID: 23522530 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.

  PMID: 28126226 RESULT

MeSH Terms

Interventions

Phentolamine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: We use a program to randomize three groups. Double blind study No sham or placebo
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assintant professor

Model Details: Three randomized groups

Study Record Dates

• First Submitted: November 9, 2018
• First Posted: November 14, 2018
• Study Start: January 1, 2016
• Primary Completion: November 9, 2018
• Study Completion: November 9, 2018
• Last Updated: November 14, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share