Formulations of Liposomal Local Anesthetics

March 2, 2011 updated by: University of Campinas, Brazil

Formulations of Liposomal Local Anesthetics for Dental Anesthesia

This blinded cross-over study aim to evaluate the efficacy of liposome-encapsulated ropivacaine formulation for dental anesthesia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This blinded cross-over study aim to evaluate the efficacy of liposome-encapsulated 0, 5% ropivacaine for dental anesthesia after maxillary infiltration.

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
        • 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 44 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: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
After anesthetic injection the pulpal response was assessed by an electrical pulp tester.
Time Frame: 100 minutes
100 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of soft tissue anesthesia was measured as the time from beginning to end of lip and gingival numbness.
Time Frame: 240 minutes
240 minutes

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

Investigators

  • Principal Investigator: Michelle Franz-Montan, PhD, Researcher at Unicamp

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

February 1, 2007

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

February 16, 2011

First Submitted That Met QC Criteria

March 2, 2011

First Posted (Estimate)

March 3, 2011

Study Record Updates

Last Update Posted (Estimate)

March 3, 2011

Last Update Submitted That Met QC Criteria

March 2, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 164/2006

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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