Formulations of Liposomal Local Anesthetics
1 other identifier
interventional
40
1 country
1
Brief Summary
This blinded cross-over study aim to evaluate the efficacy of liposome-encapsulated ropivacaine formulation for dental anesthesia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Feb 2007
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 16, 2011
CompletedFirst Posted
Study publicly available on registry
March 3, 2011
CompletedMarch 3, 2011
February 1, 2011
3 months
February 16, 2011
March 2, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
After anesthetic injection the pulpal response was assessed by an electrical pulp tester.
100 minutes
Secondary Outcomes (1)
Duration of soft tissue anesthesia was measured as the time from beginning to end of lip and gingival numbness.
240 minutes
Study Arms (1)
Anesthetic efficacy
EXPERIMENTALLocal anesthetics were injected at the apex of the maxillary right canine.
Interventions
1,8 mL of the local anesthetic formulations were injected at the apex of the maxillary right canine.
Eligibility Criteria
You may qualify if:
- Healthy
You may not qualify if:
- Volunteers were free from cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal and haematological diseases, psychiatric disorders and allergy to local anesthetics
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Piracicaba Dental School
Piracicaba, São Paulo, Brazil
Related Publications (1)
Franz-Montan M, de Paula E, Groppo FC, Ranali J, Volpato MC. Efficacy of liposome-encapsulated 0.5% ropivacaine in maxillary dental anaesthesia. Br J Oral Maxillofac Surg. 2012 Jul;50(5):454-8. doi: 10.1016/j.bjoms.2011.07.010. Epub 2011 Aug 9.
PMID: 21831487DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michelle Franz-Montan, PhD
Researcher at Unicamp
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 16, 2011
First Posted
March 3, 2011
Study Start
February 1, 2007
Primary Completion
May 1, 2007
Study Completion
June 1, 2007
Last Updated
March 3, 2011
Record last verified: 2011-02