NCT01425840

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

August 24, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 30, 2011

Completed
Last Updated

August 30, 2011

Status Verified

August 1, 2011

Enrollment Period

8 months

First QC Date

August 24, 2011

Last Update Submit

August 27, 2011

Conditions

Anesthesia

Keywords

Lidocaine,liposome encapsulation,topical anesthesia,palatal mucosa

Outcome Measures

Primary Outcomes (1)

  • The efficacy of topical anesthetics on the oral mucosa.

    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.

    10 seconds

Study Arms (1)

Liposomal lidocaine, topical anesthesia

EXPERIMENTAL

Efficacy of Liposomal lidocaine in topical anesthesia.

Drug: Lidocaine

Interventions

LidocaineDRUG

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.

Also known as: Topical anesthesia in the palatal mucosa
Liposomal lidocaine, topical anesthesia

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy

You may not qualify if:

  • Volunteers were free from cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal and haematological diseases, psychiatric disorders and allergy to local anesthetics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Piracicaba Dental School

Piracicaba, São Paulo, 13414903, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 21106282RESULT

MeSH Terms

Interventions

LidocaineAnesthesia

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesAnesthesia and Analgesia

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2011

First Posted

August 30, 2011

Study Start

March 1, 2008

Primary Completion

November 1, 2008

Study Completion

March 1, 2009

Last Updated

August 30, 2011

Record last verified: 2011-08

Locations

BR(1)