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Completed

NCT Number: NCT01073371

Anesthetic Efficacy of Liposomal Prilocaine in Maxillary Infiltration Anesthesia

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.

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Key information

Conditions

Dental Anesthesia Efficacy

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Piracicaba Dental School

Piracicaba, São Paulo, 13414903, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prilocaine

Drug

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 names: Citocaína®

Primary outcomes

  1. Anesthesia success, onset and duration of pulpal and gingival anesthesia.

    Time frame: 10 minutes

Secondary outcomes

  1. Injection pain - Visual Analogue Scale

    Time frame: 1 minute after the injections

Sponsors and collaborators

Lead sponsor

University of Campinas, Brazil

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

Local Anesthetics New Formulations: From Development to Clinical Tests

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Feb 23, 2010
Registry last updated
Feb 23, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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