Liposomal Lidocaine Gel for Oral Topical Anesthesia

This study has been completed.
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
University of Campinas, Brazil Identifier:
First received: August 24, 2011
Last updated: August 27, 2011
Last verified: August 2011
This blinded cross-over study aimed to evaluate the efficacy of topical liposome-encapsulated lidocaine on oral mucosa.

Condition Intervention Phase
Drug: Lidocaine
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: Efficacy of Liposome Lidocaine Gel for Topical Anesthesia in the Palatal Mucosa

Resource links provided by NLM:

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

Primary Outcome Measures:
  • The efficacy of topical anesthetics on the oral mucosa. [ Time Frame: 10 seconds ] [ Designated as safety issue: No ]
    The topical formulations were kept in the palatal mucosa during 2 min. The efficacy of the topical formulations was assessed after a pinprick and a local anesthetic injection on the application site.

Enrollment: 40
Study Start Date: March 2008
Study Completion Date: March 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Liposomal lidocaine, topical anesthesia
Efficacy of Liposomal lidocaine in topical anesthesia.
Drug: Lidocaine
100 mg of the following formulations: Liposome-encapsulated 2,5% and 5% lidocaine 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 aimed to evaluate the efficacy of topical liposome-encapsulated 2,5 and 5% lidocaine gel formulations on the palatal mucosa.

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
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: NCT01425840

Piracicaba Dental School
Piracicaba, São Paulo, Brazil, 13414903
Sponsors and Collaborators
University of Campinas, Brazil
Fundação de Amparo à Pesquisa do Estado de São Paulo
  More Information

Responsible Party: University of Campinas, Brazil Identifier: NCT01425840     History of Changes
Other Study ID Numbers: 112/2007 
Study First Received: August 24, 2011
Last Updated: August 27, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Campinas, Brazil:
liposome encapsulation,
topical anesthesia,
palatal mucosa

Additional relevant MeSH terms:
Anesthetics, Local
Anti-Arrhythmia Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents
Sodium Channel Blockers
Voltage-Gated Sodium Channel Blockers processed this record on May 26, 2016