Liposomal Lidocaine Gel for Oral Topical Anesthesia

Phase 1

Completed

• Conditions: Anesthesia
• Interventions: Drug: Lidocaine

• Registration Number: NCT01425840
• Lead Sponsor: University of Campinas, Brazil

Brief Summary

This blinded cross-over study aimed to evaluate the efficacy of topical liposome-encapsulated lidocaine on oral mucosa.

Detailed Description

This blinded cross-over study aimed to evaluate the efficacy of topical liposome-encapsulated 2,5 and 5% lidocaine gel formulations on the palatal mucosa.

Study Timeline

• Study Start: 2008-03
• Primary Completion: 2008-11
• Study Completion: 2009-03
• Status Verified: 2011-08
• Study First Submitted: 2011-08-24
• Study First Submitted QC: 2011-08-27
• Last Update Submitted: 2011-08-27
• Study First Posted: 2011-08-30
• Last Update Posted: 2011-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Liposomal lidocaine, topical anesthesia	Lidocaine	Efficacy of Liposomal lidocaine in topical anesthesia.

Primary Outcome Measures

Name	Time	Method
The efficacy of topical anesthetics on the oral mucosa.	10 seconds	The topical formulations were kept in the palatal mucosa during 2 min. The efficacy of the topical formulations was assessed after a pinprick and a local anesthetic injection on the application site.

Trial Locations

Locations (1)

Piracicaba Dental School; 🇧🇷 Piracicaba, São Paulo, Brazil