Topical Formulations of Liposomal Local Anesthetics

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

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

Official Title
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Local Anesthetic Activity of Liposomal Formulations in Dentistry

Conditions
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Administration, Topical Drug, Administration, Topical, Anesthetic Drugs

Intervention / Treatment
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* Drug: Ropivacaine
* Drug: Ropivacaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 43 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Liposomal ropivacaine, topical<br>The topical anesthetics were applied at the region of right and left maxillary lateral incisors at the buccal mucosa. | Drug: Ropivacaine<br>* 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.<br>* Other names: Topical anesthesia in the buccal mucosa.;|
| Placebo Comparator: Liposomal ropivacaine, palatal mucosa<br>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. | Drug: Ropivacaine<br>* 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.<br>* Other names: Topical anesthesia in the palatal mucosa;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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topical anesthetic, liposomal ropivacaine, dentistry