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Formulations of Liposomal Local Anesthetics

This study has been completed.
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
University of Campinas, Brazil
ClinicalTrials.gov Identifier:
NCT01307969
First received: February 16, 2011
Last updated: March 2, 2011
Last verified: February 2011
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Formulations of Liposomal Local Anesthetics for Dental Anesthesia

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years to 44 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01307969

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

No publications provided by University of Campinas, Brazil

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Michelle Franz-Montan, Unicamp
ClinicalTrials.gov Identifier: NCT01307969     History of Changes
Other Study ID Numbers: 164/2006
Study First Received: February 16, 2011
Last Updated: March 2, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Campinas, Brazil:
liposomes
ropivacaine
dental anesthesia
dentistry

Additional relevant MeSH terms:
Epinephrine
Ropivacaine
Anesthetics, Local
Anesthetics
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
 Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Mydriatics
Adrenergic alpha-Agonists
Sympathomimetics
Vasoconstrictor Agents
Cardiovascular Agents
Central Nervous System Depressants
Sensory System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on June 18, 2013