Topical Formulations of Liposomal Local Anesthetics

Administration, Topical Clinical Trial

Official title:

Local Anesthetic Activity of Liposomal Formulations in Dentistry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01054547
• Other study ID #: 093/2006
• Status: Completed
• Phase: Phase 1
• First received: January 20, 2010
• Last updated: January 21, 2010
• Start date: September 2006
• Est. completion date: April 2007

Study information

• Verified date: May 2006
• Source: University of Campinas, Brazil
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

This blinded cross-over study aim to evaluate the efficacy of topical liposome-encapsulated ropivacaine formulations.

Description:

This blinded cross-over study aim to evaluate the efficacy of topical liposome-encapsulated 1 and 2% ropivacaine gel formulations.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 2007
• Est. primary completion date: December 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 43 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Administration, Topical
• Administration, Topical Drug
• Anesthetic Drugs

Intervention

Drug:
• Ropivacaine
100 mg of the following formulations: Liposome-encapsulated 1 and 2% ropivacaine gel, liposome placebo gel and 2.5% lidocaine and 2.5% prilocaine cream were applied once during 5 minutes.
• Ropivacaine
100 mg of the following formulations: Liposome-encapsulated 1 and 2% ropivacaine gel, liposome placebo gel and 20% benzocaine gel were applied once during 30 minutes.

Locations

Country	Name	City	State
Brazil	Piracicaba Dental School	Piracicaba	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Campinas, Brazil	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	After topical application of the local anesthetic formulations at the oral mucosa, their influence on pulpal response was assessed by an electrical pulp tester.		10 minutes	No
Secondary	The efficacy of the topical anesthetics was measured after a simulation of a local anesthesia in the application site (insertion of a 30 gauge needle until periosteum contact).		10 seconds after removal of topical formulation	No