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Clinical Trials/NCT01073371
NCT01073371
Completed
Phase 1

Local Anesthetics New Formulations: From Development to Clinical Tests

University of Campinas, Brazil1 site in 1 country32 target enrollmentJuly 2008

Overview

Phase
Phase 1
Intervention
Prilocaine
Conditions
Dental Anesthesia Efficacy
Sponsor
University of Campinas, Brazil
Enrollment
32
Locations
1
Primary Endpoint
Anesthesia success, onset and duration of pulpal and gingival anesthesia.
Status
Completed
Last Updated
16 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2008
End Date
November 2009
Last Updated
16 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
University of Campinas, Brazil

Eligibility 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

Arms & Interventions

liposome-encapsulated 3% prilocaine

Intervention: Prilocaine

3% plain prilocaine

Intervention: Prilocaine

3% prilocaine with 0,03IU/mL felypressin

Intervention: Prilocaine

Outcomes

Primary Outcomes

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

Time Frame: 10 minutes

Secondary Outcomes

  • Injection pain - Visual Analogue Scale(1 minute after the injections)

Study Sites (1)

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