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Anesthetic Efficacy of Liposomal Prilocaine in Maxillary Infiltration Anesthesia

This study has been completed.
Sponsor:
Collaborators:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by:
University of Campinas, Brazil
ClinicalTrials.gov Identifier:
NCT01073371
First received: February 19, 2010
Last updated: February 22, 2010
Last verified: June 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Dental Anesthesia Efficacy
 Drug: Prilocaine
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Local Anesthetics New Formulations: From Development to Clinical Tests

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Campinas, Brazil:

Primary Outcome Measures:
  • Anesthesia success, onset and duration of pulpal and gingival anesthesia. [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Injection pain - Visual Analogue Scale [ Time Frame: 1 minute after the injections ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: July 2008
Study Completion Date: November 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: liposome-encapsulated 3% prilocaine Drug: Prilocaine
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
Other Name: Citocaína®
Active Comparator: 3% plain prilocaine Drug: Prilocaine
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
Other Name: Citocaína®
Active Comparator: 3% prilocaine with 0,03IU/mL felypressin Drug: Prilocaine
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
Other Name: Citocaína®

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01073371

Locations
Brazil
Piracicaba Dental School
Piracicaba, SP, Brazil, 13414903
Sponsors and Collaborators
University of Campinas, Brazil
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
Study Director: Eneida de Paula, PhD University of Campinas, Brazil
  More Information

No publications provided

Responsible Party: Patrícia Maria Wiziack Zago, University of Campinas, Brazil
ClinicalTrials.gov Identifier: NCT01073371     History of Changes
Other Study ID Numbers: 131843/2008-7
Study First Received: February 19, 2010
Last Updated: February 22, 2010
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Campinas, Brazil:
Liposome
Prilocaine
Dental anesthesia

Additional relevant MeSH terms:
Anesthetics
Prilocaine
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 21, 2013