Topical Formulations of Liposomal Local Anesthetics
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01054547
|Piracicaba Dental School|
|Piracicaba, Sao Paulo, Brazil, 13414903|