Anesthetic Efficacy of Liposomal Prilocaine in Maxillary Infiltration Anesthesia

Phase 1

Completed

• Conditions: Dental Anesthesia Efficacy
• Interventions: Drug: Prilocaine

• Registration Number: NCT01073371
• Lead Sponsor: University of Campinas, Brazil

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2008-06
• Study Start: 2008-07
• Primary Completion: 2009-08
• Study Completion: 2009-11
• Study First Submitted: 2010-02-19
• Study First Submitted QC: 2010-02-22
• Last Update Submitted: 2010-02-22
• Study First Posted: 2010-02-23
• Last Update Posted: 2010-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
liposome-encapsulated 3% prilocaine	Prilocaine	-
3% plain prilocaine	Prilocaine	-
3% prilocaine with 0,03IU/mL felypressin	Prilocaine	-

Primary Outcome Measures

Name	Time	Method
Anesthesia success, onset and duration of pulpal and gingival anesthesia.	10 minutes

Secondary Outcome Measures

Name	Time	Method
Injection pain - Visual Analogue Scale	1 minute after the injections

Trial Locations

Locations (1)

Piracicaba Dental School; 🇧🇷 Piracicaba, SP, Brazil