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Formulations of Liposomal Local Anesthetics

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01307969
First Posted: March 3, 2011
Last Update Posted: March 3, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
University of Campinas, Brazil
  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
Intervention Model: Crossover Assignment
Masking: Triple (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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: February 16, 2011
First Posted: March 3, 2011
Last Update Posted: March 3, 2011
Last Verified: February 2011

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

Additional relevant MeSH terms:
Anesthetics
Ropivacaine
Anesthetics, Local
Epinephrine
Racepinephrine
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
Mydriatics
Sympathomimetics
Vasoconstrictor Agents