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.
Investigators
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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