Topical Formulations of Liposomal Local Anesthetics
|ClinicalTrials.gov Identifier: NCT01054547|
Recruitment Status : Completed
First Posted : January 22, 2010
Last Update Posted : January 22, 2010
|Condition or disease||Intervention/treatment||Phase|
|Administration, Topical Drug Administration, Topical Anesthetic Drugs||Drug: Ropivacaine||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Primary Purpose:||Health Services Research|
|Official Title:||Local Anesthetic Activity of Liposomal Formulations in Dentistry|
|Study Start Date :||September 2006|
|Actual Primary Completion Date :||December 2006|
|Actual Study Completion Date :||April 2007|
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
- 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 ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01054547
|Piracicaba Dental School|
|Piracicaba, Sao Paulo, Brazil, 13414903|