NCT01073371

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 23, 2010

Completed
Last Updated

February 23, 2010

Status Verified

June 1, 2008

Enrollment Period

1.1 years

First QC Date

February 19, 2010

Last Update Submit

February 22, 2010

Conditions

Dental Anesthesia Efficacy

Keywords

LiposomePrilocaineDental anesthesia

Outcome Measures

Primary Outcomes (1)

  • Anesthesia success, onset and duration of pulpal and gingival anesthesia.

    10 minutes

Secondary Outcomes (1)

  • Injection pain - Visual Analogue Scale

    1 minute after the injections

Study Arms (3)

liposome-encapsulated 3% prilocaine

ACTIVE COMPARATOR
Drug: Prilocaine

3% plain prilocaine

ACTIVE COMPARATOR
Drug: Prilocaine

3% prilocaine with 0,03IU/mL felypressin

ACTIVE COMPARATOR
Drug: Prilocaine

Interventions

PrilocaineDRUG

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

Also known as: Citocaína®
3% plain prilocaine3% prilocaine with 0,03IU/mL felypressinliposome-encapsulated 3% prilocaine

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Piracicaba Dental School

Piracicaba, São Paulo, 13414903, Brazil

Location

MeSH Terms

Interventions

Prilocaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Eneida de Paula, PhD

    University of Campinas, Brazil

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 19, 2010

First Posted

February 23, 2010

Study Start

July 1, 2008

Primary Completion

August 1, 2009

Study Completion

November 1, 2009

Last Updated

February 23, 2010

Record last verified: 2008-06

Locations

BR(1)