Effects of Articaine Computer-controlled and Conventional Delivery for Anterior and Middle Superior Alveolar Nerve Block for Tooth Extraction

March 21, 2018 updated by: Bozidar Brkovic, DDS, MSc, PhD, Professor, University of Belgrade

Efficacy of Anterior and Middle Superior Alveolar (AMSA) Nerve Block Anesthesia Obtained by Articaine Computer-controlled and Conventional Delivery

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Serbia
      • Belgrade, Serbia, 11000
        • School of dental medicine, University of Belgrade

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Computer controlled 4% articaine delivery by Anaeject
Drug: Computer controlled 4% articaine delivery by Anaeject
Single dose of 0.6ml 4% articaine with epinephrine (1:100.000) delivered by computer controlled local anesthetic delivery system (Anaeject)
Active Comparator: Conventional 4% articaine delivery by carpule syringe
Drug: Conventional 4% articaine delivery by carpule syringe
Single dose of 0.6ml 4% articaine with epinephrine (1:100.000) delivered by conventional syringe (carpule syringe).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Success of Pulpal Anesthesia for Central Incisive
Time Frame: after 1 hour
Measured by pulp sensitivity to electrical pulp tester
after 1 hour
Success of Pulpal Anesthesia for Lateral Incisive
Time Frame: after 1 hour
Measured by pulp sensitivity to electrical pulp tester
after 1 hour
Success of Pulpal Anesthesia for Canine
Time Frame: after 1 hour
Measured by pulp sensitivity to electrical pulp tester
after 1 hour
Success of Pulpal Anesthesia for First Premolar
Time Frame: after 1 hour
Measured by pulp sensitivity to electrical pulp tester
after 1 hour
Success of Pulpal Anesthesia for Second Premolar
Time Frame: after 1 hour
Measured by pulp sensitivity to electrical pulp tester
after 1 hour

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Onset Central Incisive
Time Frame: up to 8 minutes
Measured by pulp sensitivity to electrical pulp tester
up to 8 minutes
Onset Lateral Incisive
Time Frame: up to 8 minutes
Measured by pulp sensitivity to electrical pulp tester
up to 8 minutes
Onset Canine
Time Frame: up to 8 minutes
Measured by pulp sensitivity to electrical pulp tester
up to 8 minutes
Onset First Premolar
Time Frame: up to 8 minutes
Measured by pulp sensitivity to electrical pulp tester
up to 8 minutes
Onset Second Premolar
Time Frame: up to 8 minutes
Measured by pulp sensitivity to electrical pulp tester
up to 8 minutes
Duration Central Incisive
Time Frame: up to 60 minutes
Measured by pulp sensitivity to electrical pulp tester
up to 60 minutes
Duration Lateral Incisive
Time Frame: up to 60 minutes
Measured by pulp sensitivity to electrical pulp tester
up to 60 minutes
Duration Canine
Time Frame: up to 60 minutes
Measured by pulp sensitivity to electrical pulp tester
up to 60 minutes
Duration First Premolar
Time Frame: up to 60 minutes
Measured by pulp sensitivity to electrical pulp tester
up to 60 minutes
Duration Second Premolar
Time Frame: up to 60 minutes
Measured by pulp sensitivity to electrical pulp tester
up to 60 minutes
Systolic blood pressure
Time Frame: baseline
Measured noninvasively in mm Hg
baseline
Systolic blood pressure at 5th minute
Time Frame: 5th minute
Measured noninvasively in mm Hg
5th minute
Systolic blood pressure at 10th minute
Time Frame: 10th minute
Measured noninvasively in mm Hg
10th minute
Systolic blood pressure at 15th minute
Time Frame: 15th minute
Measured noninvasively in mm Hg
15th minute
Systolic blood pressure at 30th minute
Time Frame: 30th minute
Measured noninvasively in mm Hg
30th minute
Diastolic blood pressure
Time Frame: baseline
Measured noninvasively in mm Hg
baseline
Diastolic blood pressure at 5th minute
Time Frame: 5th minute
Measured noninvasively in mm Hg
5th minute
Diastolic blood pressure at 10th minute
Time Frame: 10th minute
Measured noninvasively in mm Hg
10th minute
Diastolic blood pressure at 15th minute
Time Frame: 15th minute
Measured noninvasively in mm Hg
15th minute
Diastolic blood pressure at 30th minute
Time Frame: 30th minute
Measured noninvasively in mm Hg
30th minute
Heart rate
Time Frame: baseline
Measured noninvasively in beats per minute
baseline
Heart rate at 5th minute
Time Frame: 5th minute
Measured noninvasively in beats per minute
5th minute
Heart rate at 10th minute
Time Frame: 10th minute
Measured noninvasively in beats per minute
10th minute
Heart rate at 15th minute
Time Frame: 15th minute
Measured noninvasively in beats per minute
15th minute
Heart rate at 30th minute
Time Frame: 30th minute
Measured noninvasively in beats per minute
30th minute

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Belgrade

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 17, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 21, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 22, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UBelgrade 784/2

Drug and device information, study documents

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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