Anesthetic Efficacy of Liposomal Prilocaine in Maxillary Infiltration Anesthesia

University of Campinas, Brazil

Status and phase: Completed; Phase 1

Conditions: Dental Anesthesia Efficacy

Treatments: Drug: Prilocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT01073371

131843/2008-7

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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32 participants in 3 patient groups

liposome-encapsulated 3% prilocaine

Active Comparator group

Treatment:

Drug: Prilocaine

3% plain prilocaine

Active Comparator group

Treatment:

Drug: Prilocaine

3% prilocaine with 0,03IU/mL felypressin

Active Comparator group

Treatment:

Drug: Prilocaine