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Anesthetic Efficacy of Liposomal Prilocaine in Maxillary Infiltration Anesthesia

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ClinicalTrials.gov Identifier: NCT01073371
Recruitment Status : Completed
First Posted : February 23, 2010
Last Update Posted : February 23, 2010
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Dental Anesthesia Efficacy Drug: Prilocaine Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Local Anesthetics New Formulations: From Development to Clinical Tests
Study Start Date : July 2008
Actual Primary Completion Date : August 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Prilocaine

Arms and Interventions
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Arm Intervention/treatment
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®


Outcome Measures
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Primary Outcome Measures :
  1. Anesthesia success, onset and duration of pulpal and gingival anesthesia. [ Time Frame: 10 minutes ]

Secondary Outcome Measures :
  1. Injection pain - Visual Analogue Scale [ Time Frame: 1 minute after the injections ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01073371


Locations
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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
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Study Director: Eneida de Paula, PhD University of Campinas, Brazil
More Information
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Responsible Party: Patrícia Maria Wiziack Zago, University of Campinas, Brazil
ClinicalTrials.gov Identifier: NCT01073371    
Other Study ID Numbers: 131843/2008-7
First Posted: February 23, 2010    Key Record Dates
Last Update Posted: February 23, 2010
Last Verified: June 2008
Keywords provided by University of Campinas, Brazil:
Liposome
Prilocaine
Dental anesthesia
Additional relevant MeSH terms:
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Prilocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
 Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents