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Formulations of Liposomal Local Anesthetics

This study has been completed.
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
University of Campinas, Brazil Identifier:
First received: February 16, 2011
Last updated: March 2, 2011
Last verified: February 2011
This blinded cross-over study aim to evaluate the efficacy of liposome-encapsulated ropivacaine formulation for dental anesthesia.

Condition Intervention Phase
Underdosing of Local Anesthetics, Initial Encounter
Drug: Ropivacaine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Formulations of Liposomal Local Anesthetics for Dental Anesthesia

Resource links provided by NLM:

Further study details as provided by University of Campinas, Brazil:

Primary Outcome Measures:
  • After anesthetic injection the pulpal response was assessed by an electrical pulp tester. [ Time Frame: 100 minutes ]

Secondary Outcome Measures:
  • Duration of soft tissue anesthesia was measured as the time from beginning to end of lip and gingival numbness. [ Time Frame: 240 minutes ]

Enrollment: 40
Study Start Date: February 2007
Study Completion Date: June 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Anesthetic efficacy
Local anesthetics were injected at the apex of the maxillary right canine.
Drug: Ropivacaine
1,8 mL of the local anesthetic formulations were injected at the apex of the maxillary right canine.
Other Names:
  • 0,5% ropivacaine encapsulated in liposomes
  • 0,5% ropivacaine with epinephrine 1:200.000
  • 2% lidocaine with epinephrine 1:100.000

Detailed Description:
This blinded cross-over study aim to evaluate the efficacy of liposome-encapsulated 0, 5% ropivacaine for dental anesthesia after maxillary infiltration.

Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy

Exclusion Criteria:

  • Volunteers were free from cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal and haematological diseases, psychiatric disorders and allergy to local anesthetics
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Please refer to this study by its identifier: NCT01307969

Piracicaba Dental School
Piracicaba, São Paulo, Brazil
Sponsors and Collaborators
University of Campinas, Brazil
Fundação de Amparo à Pesquisa do Estado de São Paulo
Principal Investigator: Michelle Franz-Montan, PhD Researcher at Unicamp
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Michelle Franz-Montan, Unicamp Identifier: NCT01307969     History of Changes
Other Study ID Numbers: 164/2006
Study First Received: February 16, 2011
Last Updated: March 2, 2011

Keywords provided by University of Campinas, Brazil:
dental anesthesia

Additional relevant MeSH terms:
Anesthetics, Local
Epinephryl borate
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Vasoconstrictor Agents processed this record on May 25, 2017