Anesthesia, LocalNCT03740386
Phentolamine Mesylate as a Reversal of Local Anesthesics
A study testing Phentolamine Mesylate 0.235 MG/ML [OraVerse] in people with Anesthesia, Local, run by León Formación.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Local
- What is being tested?
- Phentolamine Mesylate 0.235 MG/ML [OraVerse]
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 9 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Previously diagnosticated to receive dental treatment according to Leonformacion's criteria
Who cannot join
- 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
About this study
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.
Read the 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.
- Conditions
- Anesthesia, Local
- Being tested
- Phentolamine Mesylate 0.235 MG/ML [OraVerse]
- Keywords
- phentolamine mesylate, reverse local anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phentolamine Mesylate 0.235 MG/ML [OraVerse]Drug
compare effect of phentolamine mesylate in three arms
| Study group | Role | What they receive |
|---|---|---|
| lidocaine | Experimental | lidocaine 2% 1:80000 Receives: Drug: Phentolamine Mesylate 0.235 MG/ML [OraVerse] |
| articaine | Experimental | articaine 4% 1:200000 Receives: Drug: Phentolamine Mesylate 0.235 MG/ML [OraVerse] |
| bupivacaine | Experimental | bupivacaine 0,5% 1:200000 Receives: Drug: Phentolamine Mesylate 0.235 MG/ML [OraVerse] |
What is being measured
The primary outcome is the main question the study is designed to answer.
time lip recovery fron local anesthesia
self reported lip sensitivity by questionaire marking every 15 minutes
Measured: 1 day
Secondary outcomes (2)
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
Measured: 1 day
post intervention bleeding
clinical assesment of post intervention bleeding when using phentolamine mesylate
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2018
- Study start1 Jan 2016
- Primary completion9 Nov 2018
- Study completion9 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, LocalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Three randomized groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- León Formación
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, alejandro gago garcia, León Formación
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03740386
- Sponsor's protocol ID
- LeonFormacion
- Status last verified
- Nov 2018
- First submitted
- 9 Nov 2018
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26409985Hersh 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.
PubMed 18682623Laviola 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.
PubMed 18573982Fowler 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.
PubMed 21924181Tavares 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.
PubMed 18682624Moore 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.
PubMed 18547152Hersh 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.
PubMed 20831927Elmore 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.
PubMed 23522530Daublander 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.
PubMed 28126226
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phentolamine Mesylate as a Reversal of Local Anesthesics
- ClinicalTrials.gov ID
- NCT03740386
- Acronym / sponsor ID
- LeonFormacion
- Conditions
- Anesthesia, Local
- Keywords
- phentolamine mesylate, reverse local anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- León FormaciónUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 9 Nov 2018 (actual)
- Study completion
- 9 Nov 2018 (actual)
- First posted
- 14 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Three randomized groups
| Arm | Type | Receives |
|---|---|---|
| lidocaine | Experimental | Drug: Phentolamine Mesylate 0.235 MG/ML [OraVerse]lidocaine 2% 1:80000 |
| articaine | Experimental | Drug: Phentolamine Mesylate 0.235 MG/ML [OraVerse]articaine 4% 1:200000 |
| bupivacaine | Experimental | Drug: Phentolamine Mesylate 0.235 MG/ML [OraVerse]bupivacaine 0,5% 1:200000 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Previously diagnosticated to receive dental treatment according to Leonformacion's criteria
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phentolamine Mesylate 0.235 MG/ML [OraVerse]compare effect of phentolamine mesylate in three arms | Drug | articaine, bupivacaine, lidocaine |
Primary outcome
time lip recovery fron local anesthesia
Time frame: 1 day
self reported lip sensitivity by questionaire marking every 15 minutes
2 secondary outcomes
Post intervention pain
Time frame: 1 day
post intervention bleeding
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2018.
- Results publication: PubMed 26409985Prados-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.
- Results publication: PubMed 18682623Hersh 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.
- Results publication: PubMed 18573982Laviola 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.
- Results publication: PubMed 21924181Fowler 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.
- Results publication: PubMed 18682624Tavares 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.
- Results publication: PubMed 18547152Moore 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.
- Results publication: PubMed 20831927Hersh 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.
- Results publication: PubMed 23522530Elmore 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.
- Results publication: PubMed 28126226Daublander 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Phentolamine Mesylate 0.235 MG/ML [OraVerse] in people with Anesthesia, Local, run by León Formación.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time lip recovery fron local anesthesia (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03740386, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2018.