Skip to content

Anesthetic Efficacy of Liposomal Prilocaine in Maxillary Infiltration Anesthesia

Local Anesthetics New Formulations: From Development to Clinical Tests

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01073371
Enrollment
32
Registered
2010-02-23
Start date
2008-07-31
Completion date
2009-11-30
Last updated
2010-02-23

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

Conditions

Dental Anesthesia Efficacy

Keywords

Liposome, Prilocaine, Dental anesthesia

Brief summary

This blinded randomized, crossover, three period study aim to evaluate the anesthetic efficacy of liposome-encapsulated 3% prilocaine compared to 3% plain prilocaine and 3% prilocaine with 0,03IU/mL felypressin, after 1.8mL infiltration in the buccal sulcus of the maxillary right canine, in 32 volunteers.

Interventions

1.8mL infiltration of liposome-encapsulated 3% prilocaine, 3% plain prilocaine or 3% prilocaine with 0,03IU/mL felypressin in the buccal sulcus of the maxillary right canine

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo
CollaboratorOTHER_GOV
Conselho Nacional de Desenvolvimento Científico e Tecnológico
CollaboratorOTHER_GOV
University of Campinas, Brazil
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes

Inclusion criteria

* good health * no history of allergy to the components of the local anesthetic formulations tested * maxillary canine, lateral incisor, and first premolar responsible to electric stimulation

Exclusion criteria

* intake of any medication that would alter pain perception * history of trauma or sensitivity, caries, restorations, periodontal disease and endodontic treatment in the maxillary canine, lateral incisor, and first premolar * systemic disease

Design outcomes

Primary

MeasureTime frame
Anesthesia success, onset and duration of pulpal and gingival anesthesia.10 minutes

Secondary

MeasureTime frame
Injection pain - Visual Analogue Scale1 minute after the injections

Countries

Brazil

Outcome results

None listed

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