NCT03225326

Brief Summary

The purpose of this study was to investigate and compare pulpal anesthesia and cardiovascular parameters obtained with 0.6 ml of 4% articaine with epinephrine (1:100.000) for anterior and middle superior alveolar nerve (AMSA) block performed by standard and computer-controlled delivery for maxillary teeth extraction.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

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

December 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

July 17, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 21, 2017

Completed
Last Updated

March 22, 2018

Status Verified

March 1, 2018

Enrollment Period

6 months

First QC Date

July 17, 2017

Last Update Submit

March 21, 2018

Conditions

Local Anesthesia

Keywords

articainelocal anesthesiaAMSA

Outcome Measures

Primary Outcomes (5)

  • Success of Pulpal Anesthesia for Central Incisive

    Measured by pulp sensitivity to electrical pulp tester

    after 1 hour

  • Success of Pulpal Anesthesia for Lateral Incisive

    Measured by pulp sensitivity to electrical pulp tester

    after 1 hour

  • Success of Pulpal Anesthesia for Canine

    Measured by pulp sensitivity to electrical pulp tester

    after 1 hour

  • Success of Pulpal Anesthesia for First Premolar

    Measured by pulp sensitivity to electrical pulp tester

    after 1 hour

  • Success of Pulpal Anesthesia for Second Premolar

    Measured by pulp sensitivity to electrical pulp tester

    after 1 hour

Secondary Outcomes (25)

  • Onset Central Incisive

    up to 8 minutes

  • Onset Lateral Incisive

    up to 8 minutes

  • Onset Canine

    up to 8 minutes

  • Onset First Premolar

    up to 8 minutes

  • Onset Second Premolar

    up to 8 minutes

  • +20 more secondary outcomes

Study Arms (2)

Computer controlled 4% articaine delivery by Anaeject

EXPERIMENTAL
Drug: Computer controlled 4% articaine delivery by Anaeject

Conventional 4% articaine delivery by carpule syringe

ACTIVE COMPARATOR
Drug: Conventional 4% articaine delivery by carpule syringe

Interventions

Computer controlled 4% articaine delivery by AnaejectDRUG

Single dose of 0.6ml 4% articaine with epinephrine (1:100.000) delivered by computer controlled local anesthetic delivery system (Anaeject)

Computer controlled 4% articaine delivery by Anaeject
Conventional 4% articaine delivery by carpule syringeDRUG

Single dose of 0.6ml 4% articaine with epinephrine (1:100.000) delivered by conventional syringe (carpule syringe).

Conventional 4% articaine delivery by carpule syringe

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA 1
  • maxillary incisors canines or premolars indicated for extraction due to periapical pathology, root fracture or orthodontic treatment

You may not qualify if:

  • allergies to local anesthetic solution ingredients, food and drugs
  • alcohol and drugs abuse
  • heavy tobacco smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Dental Medicine, University of Belgrade

Belgrade, 11000, Serbia

Location

MeSH Terms

Interventions

Congresses as Topic

Intervention Hierarchy (Ancestors)

OrganizationsHealth Care Economics and Organizations

Study Officials

  • Marija Milić, Research Associate

    School of Dental Medicine, University of Belgrade

    PRINCIPAL INVESTIGATOR

  • Vladimir Biočanin, Assistant Professor

    Faculty of Pharmacy and Health, University of Travnik, Bosnia and Herzegovina

    PRINCIPAL INVESTIGATOR
0

Study Design

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

Study Record Dates

First Submitted

July 17, 2017

First Posted

July 21, 2017

Study Start

December 1, 2016

Primary Completion

June 1, 2017

Study Completion

July 1, 2017

Last Updated

March 22, 2018

Record last verified: 2018-03

Locations

SE(1)