Topical Formulations of Liposomal Local Anesthetics
This blinded cross-over study aim to evaluate the efficacy of topical liposome-encapsulated ropivacaine formulations.
Administration, Topical Drug
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Health Services Research
|Official Title:||Local Anesthetic Activity of Liposomal Formulations in Dentistry|
- After topical application of the local anesthetic formulations at the oral mucosa, their influence on pulpal response was assessed by an electrical pulp tester. [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]
- 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). [ Time Frame: 10 seconds after removal of topical formulation ] [ Designated as safety issue: No ]
|Study Start Date:||September 2006|
|Study Completion Date:||April 2007|
|Primary Completion Date:||December 2006 (Final data collection date for primary outcome measure)|
Placebo Comparator: Liposomal ropivacaine, topical
The topical anesthetics were applied at the region of right and left maxillary lateral incisors at the buccal mucosa.
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.
Other Name: Topical anesthesia in the buccal mucosa.
Placebo Comparator: Liposomal ropivacaine, palatal mucosa
Topical formulations were applied at the palatal mucosa at the right canine region and efficacy of topical formulations was accessed through insertion of a 30 gauge needle and injection of anesthetic solution.
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.
Other Name: Topical anesthesia in the palatal mucosa
This blinded cross-over study aim to evaluate the efficacy of topical liposome-encapsulated 1 and 2% ropivacaine gel formulations.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01054547
|Piracicaba Dental School|
|Piracicaba, Sao Paulo, Brazil, 13414903|