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Liposomal Lidocaine Gel for Oral Topical Anesthesia

NCT ID: NCT01425840

Last Updated: 2011-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2009-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Anesthesia

Keywords

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Lidocaine, liposome encapsulation, topical anesthesia, palatal mucosa

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Liposomal lidocaine, topical anesthesia

Efficacy of Liposomal lidocaine in topical anesthesia.

Group Type EXPERIMENTAL

Lidocaine

Intervention Type DRUG

100 mg of the following formulations: Liposome-encapsulated 2,5% and 5% lidocaine gel, liposome placebo gel and 2.5% lidocaine and 2.5% prilocaine cream were applied once during 5 minutes.

Interventions

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Lidocaine

100 mg of the following formulations: Liposome-encapsulated 2,5% and 5% lidocaine gel, liposome placebo gel and 2.5% lidocaine and 2.5% prilocaine cream were applied once during 5 minutes.

Intervention Type DRUG

Other Intervention Names

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Topical anesthesia in the palatal mucosa

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

University of Campinas, Brazil

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Piracicaba Dental School

Piracicaba, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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Franz-Montan M, de Paula E, Groppo FC, Silva AL, Ranali J, Volpato MC. Liposomal delivery system for topical anaesthesia of the palatal mucosa. Br J Oral Maxillofac Surg. 2012 Jan;50(1):60-4. doi: 10.1016/j.bjoms.2010.10.018. Epub 2010 Nov 23.

Reference Type RESULT
PMID: 21106282 (View on PubMed)

Other Identifiers

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112/2007

Identifier Type: -

Identifier Source: org_study_id