Anesthetic Efficacy of Liposomal Prilocaine in Maxillary Infiltration Anesthesia

Dental Anesthesia Efficacy Clinical Trial

Official title:

Local Anesthetics New Formulations: From Development to Clinical Tests

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01073371
• Other study ID #: 131843/2008-7
• Status: Completed
• Phase: Phase 1
• First received: February 19, 2010
• Last updated: February 22, 2010
• Start date: July 2008
• Est. completion date: November 2009

Study information

• Verified date: June 2008
• Source: University of Campinas, Brazil
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: November 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Dental Anesthesia Efficacy

Intervention

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

Locations

Country	Name	City	State
Brazil	Piracicaba Dental School	Piracicaba	SP

Sponsors (3)

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

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anesthesia success, onset and duration of pulpal and gingival anesthesia.		10 minutes	No
Secondary	Injection pain - Visual Analogue Scale		1 minute after the injections	No