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Topical 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:
NCT01054547
First received: January 20, 2010
Last updated: January 21, 2010
Last verified: May 2006
History of Changes
  Purpose

This blinded cross-over study aim to evaluate the efficacy of topical liposome-encapsulated ropivacaine formulations.


Condition Intervention Phase
Administration, Topical Drug
Administration, Topical
Anesthetic Drugs
 Drug: Ropivacaine
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Health Services Research
Official Title: Local Anesthetic Activity of Liposomal Formulations in Dentistry

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • After topical application of the local anesthetic formulations at the oral mucosa, their influence on pulpal response was assessed by an electrical pulp tester. [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The efficacy of the topical anesthetics was measured after a simulation of a local anesthesia in the application site (insertion of a 30 gauge needle until periosteum contact). [ Time Frame: 10 seconds after removal of topical formulation ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: September 2006
Study Completion Date: April 2007
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Liposomal ropivacaine, topical
The topical anesthetics were applied at the region of right and left maxillary lateral incisors at the buccal mucosa.
 Drug: Ropivacaine
100 mg of the following formulations: Liposome-encapsulated 1 and 2% ropivacaine gel, liposome placebo gel and 20% benzocaine gel were applied once during 30 minutes.
Other Name: Topical anesthesia in the buccal mucosa.
Placebo Comparator: Liposomal ropivacaine, palatal mucosa
Topical formulations were applied at the palatal mucosa at the right canine region and efficacy of topical formulations was accessed through insertion of a 30 gauge needle and injection of anesthetic solution.
 Drug: Ropivacaine
100 mg of the following formulations: Liposome-encapsulated 1 and 2% ropivacaine gel, liposome placebo gel and 2.5% lidocaine and 2.5% prilocaine cream were applied once during 5 minutes.
Other Name: Topical anesthesia in the palatal mucosa

Detailed Description:

This blinded cross-over study aim to evaluate the efficacy of topical liposome-encapsulated 1 and 2% ropivacaine gel formulations.

  Eligibility

Ages Eligible for Study:   18 Years to 43 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: NCT01054547

Locations
Brazil
Piracicaba Dental School
Piracicaba, Sao Paulo, Brazil, 13414903
Sponsors and Collaborators
University of Campinas, Brazil
Fundação de Amparo à Pesquisa do Estado de São Paulo
  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: NCT01054547     History of Changes
Other Study ID Numbers: 093/2006
Study First Received: January 20, 2010
Last Updated: January 21, 2010
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Campinas, Brazil:
topical anesthetic
liposomal ropivacaine
dentistry

Additional relevant MeSH terms:
Anesthetics
Ropivacaine
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 23, 2013