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CompletedNCT01073371Updated Feb 23, 2010

Anesthetic Efficacy of Liposomal Prilocaine in Maxillary Infiltration Anesthesia

A Phase 1 interventional study of Prilocaine in Dental Anesthesia Efficacy, sponsored by University of Campinas, Brazil. Completed at 1 site in Brazil. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-02-23.

Sponsored by University of Campinas, Brazil · Phase 1, Interventional, and Supportive care

Phase
Phase 1
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Dental Anesthesia Efficacy

Keywords

  • Liposome
  • Prilocaine
  • Dental anesthesia
03

In context

Lead sponsor

University of Campinas, Brazil is the lead sponsor of 166 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Phase 1
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
32 participants (actual)

Study arms

  • Active comparator
    liposome-encapsulated 3% prilocaine

    Drug: Prilocaine

  • Active comparator
    3% plain prilocaine

    Drug: Prilocaine

  • Active comparator
    3% prilocaine with 0,03IU/mL felypressin

    Drug: Prilocaine

Interventions

  • DrugPrilocaine

    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

    Also known as: Citocaína®

06

What researchers measure

Primary outcomes

  1. Anesthesia success, onset and duration of pulpal and gingival anesthesia.

    Time frame: 10 minutes

Secondary outcomes

  1. Injection pain - Visual Analogue Scale

    Time frame: 1 minute after the injections

07

Study locations

1 site
  • Piracicaba Dental School
    Piracicaba, SP 13414903, Brazil
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 23, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01073371
Lead sponsor
University of Campinas, Brazil
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted
Feb 23, 2010
Start date
Jul 2008
Primary completion
Aug 2009
Completion
Nov 2009
Last update
Feb 23, 2010

Study contacts

Eneida de Paula, PhD
study director · University of Campinas, Brazil

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2008. You cannot join it, but the record below documents what was studied.

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