Local Anesthetics New Formulations: From Development to Clinical Tests

Efficacy and Pharmacokinetics of Liposomal Mepivacaine Formulations in Dentistry

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01032798

Enrollment

Registered

2009-12-16

Start date

2007-05-31

Completion date

2008-05-31

Last updated

2010-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Local Anesthetic Effectiveness

Brief summary

This blinded cross-over study aim to evaluate the efficacy and the pharmacokinetics of a previously reported liposome-encapsulated mepivacaine formulations.

Interventions

DRUGmepivacaine

One intra-oral injection at four different sessions, of the following formulations: 2% mepivacaine with 1:100,000 epinephrine, 3% mepivacaine, 2% and 3% liposome-encapsulated mepivacaine.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy

Exclusion criteria

* Volunteers were free from cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal and haematological diseases, psychiatric disorders and allergy to local anesthetics

Design outcomes

Primary

Measure	Time frame
Latency period and duration of anesthesia were assessed by an electrical pulp tester	10 minutes

Secondary

Measure	Time frame
Plasma concentrations of mepivacaine	0 to 360 minutes after the injection

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026