Anesthetic Efficacy of Liposomal Prilocaine in Maxillary Infiltration Anesthesia

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

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2009-11-30

Brief Summary

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This blinded randomized, crossover, three period study aim to evaluate the anesthetic efficacy of liposome-encapsulated 3% prilocaine compared to 3% plain prilocaine and 3% prilocaine with 0,03IU/mL felypressin, after 1.8mL infiltration in the buccal sulcus of the maxillary right canine, in 32 volunteers.

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Detailed Description

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Conditions

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Dental Anesthesia Efficacy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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liposome-encapsulated 3% prilocaine

Group Type ACTIVE_COMPARATOR

Prilocaine

Intervention Type DRUG

1.8mL infiltration of liposome-encapsulated 3% prilocaine, 3% plain prilocaine or 3% prilocaine with 0,03IU/mL felypressin in the buccal sulcus of the maxillary right canine

3% plain prilocaine

Group Type ACTIVE_COMPARATOR

Prilocaine

Intervention Type DRUG

1.8mL infiltration of liposome-encapsulated 3% prilocaine, 3% plain prilocaine or 3% prilocaine with 0,03IU/mL felypressin in the buccal sulcus of the maxillary right canine

3% prilocaine with 0,03IU/mL felypressin

Group Type ACTIVE_COMPARATOR

Prilocaine

Intervention Type DRUG

1.8mL infiltration of liposome-encapsulated 3% prilocaine, 3% plain prilocaine or 3% prilocaine with 0,03IU/mL felypressin in the buccal sulcus of the maxillary right canine

Interventions

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Prilocaine

1.8mL infiltration of liposome-encapsulated 3% prilocaine, 3% plain prilocaine or 3% prilocaine with 0,03IU/mL felypressin in the buccal sulcus of the maxillary right canine

Intervention Type DRUG

Other Intervention Names

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Citocaína®

Eligibility Criteria

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Inclusion Criteria

* good health
* no history of allergy to the components of the local anesthetic formulations tested
* maxillary canine, lateral incisor, and first premolar responsible to electric stimulation

Exclusion Criteria

* intake of any medication that would alter pain perception
* history of trauma or sensitivity, caries, restorations, periodontal disease and endodontic treatment in the maxillary canine, lateral incisor, and first premolar
* systemic disease

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes