Liposomal Lidocaine Gel for Oral Topical Anesthesia

August 27, 2011 updated by: University of Campinas, Brazil

Efficacy of Liposome Lidocaine Gel for Topical Anesthesia in the Palatal Mucosa

This blinded cross-over study aimed to evaluate the efficacy of topical liposome-encapsulated lidocaine on oral mucosa.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • Piracicaba, São Paulo, Brazil, 13414903
        • Piracicaba Dental School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Topical anesthesia in the palatal mucosa

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The efficacy of topical anesthetics on the oral mucosa.
Time Frame: 10 seconds
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.
10 seconds

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Campinas, Brazil

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

August 24, 2011

First Submitted That Met QC Criteria

August 27, 2011

First Posted (Estimate)

August 30, 2011

Study Record Updates

Last Update Posted (Estimate)

August 30, 2011

Last Update Submitted That Met QC Criteria

August 27, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 112/2007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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