- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01307969
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
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
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São Paulo
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Piracicaba, São Paulo, Brazil
- Piracicaba Dental School
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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 |
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Experimental: Anesthetic efficacy
Local anesthetics were injected at the apex of the maxillary right canine.
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1,8 mL of the local anesthetic formulations were injected at the apex of the maxillary right canine.
Other Names:
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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
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100 minutes
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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
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240 minutes
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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.
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
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Adrenergic beta-Agonists
- Sympathomimetics
- Vasoconstrictor Agents
- Mydriatics
- Lidocaine
- Ropivacaine
- Epinephrine
- Racepinephrine
- Epinephryl borate
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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