NCT02054767

Brief Summary

The purpose of this study was to compare the anesthetic efficacy of articaine, lidocaine and mepivacaine in patients with irreversible pulpitis of mandibular molar.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2010

Typical duration for phase_4

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

August 1, 2010

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 3, 2013

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 4, 2014

Completed
Last Updated

February 4, 2014

Status Verified

September 1, 2013

Enrollment Period

2.3 years

First QC Date

September 3, 2013

Last Update Submit

January 31, 2014

Conditions

Anesthesia

Keywords

articainelidocainemepivacaineinferior alveolar nerve blockirreversible pulpitis

Outcome Measures

Primary Outcomes (1)

  • pulpal anesthesia

    pulpal anesthesia was tested with an electric pulp stimulator

    Ten minutes after the inferior alveolar nerve block

Secondary Outcomes (1)

  • analgesia

    the patients were instructed to report any painful sensation at three phases: 1) dentin 2) pulp chamber 3) root canal

Other Outcomes (1)

  • lip anesthesia

    ten minutes after the inferior alveolar nerve block

Study Arms (3)

lidocaine

EXPERIMENTAL

injections of 3.6 mL of 2% lidocaine with 1:100,000 epinephrine Intervention: inferior alveolar nerve block injection

Drug: Intervention: inferior alveolar nerve block injection

mepivacaine

EXPERIMENTAL

injections of 3.6 mL of 2% mepivacaine with 1:100,000 epinephrine Intervention: inferior alveolar nerve block injection

Drug: Intervention: inferior alveolar nerve block injection

articaine

EXPERIMENTAL

injections of 3.6 mL of 4% articaine with 1:100,000 epinephrine Intervention: inferior alveolar nerve block injection

Drug: Intervention: inferior alveolar nerve block injection

Interventions

Intervention: inferior alveolar nerve block injectionDRUG

-22 patients received inferior alveolar nerve block injections of 3.6 mL (equivalent to 2 cartridges)

articainelidocainemepivacaine

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • clinical diagnosis of irreversible pulpitis
  • good health
  • had at least 1 adjacent tooth plus a healthy canine

You may not qualify if:

  • took medication could be interacting with any of the anesthetics used

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emergency Center of the School of Dentistry at the University of São Paulo

São Paulo, São Paulo, 05508-900, Brazil

Location

Study Officials

  • Isabel P Tortamano, PhD

    USão Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

September 3, 2013

First Posted

February 4, 2014

Study Start

August 1, 2010

Primary Completion

November 1, 2012

Study Completion

July 1, 2013

Last Updated

February 4, 2014

Record last verified: 2013-09

Locations

BR(1)