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

July 23, 2015 updated by: Bozidar Brkovic, DDS, MSc, PhD, Professor, University of Belgrade

Efficacy and Safety of Pulpal Anesthesia After Anterior and Middle Superior Alveolar (AMSA) Nerve Block 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 in healthy volunteers.

Study Overview

Status

Status

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

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.

Detailed Description

Traditionally, pulpal anesthesia is obtained by infiltration or mandibular nerve block. However, it is not always possible to achieve complete pulpal anesthesia with previously mentioned anesthetic techniques.

It is well documented that administration of 0,6-0,9 ml of anesthetic solution with palatal approach with anterior middle superior injection (AMSA) provided successful pulpal anesthesia from central incisor to second premolar. In addition, palatal soft tissues from midpalate to free gingiva and from central incisor to first molar are fully anesthetized with AMSA. The injection site is located at a point that bisects the maxillary first and second premolars, and midway between the crest of the free gingival margin and mid-palatine suture. The needle is orientated at a 45-degree angle with the bevel facing the palatal tissue. AMSA presents intraosseous anesthetic technique.

Traditionally, palatal injection administered with conventional syringe was described as very painful. On the other hand, computer controlled local anesthetic delivery system (CCLADS) has been recommended for AMSA as a system which allows slow administration of anesthetic solution, with constant pressure. It was shown that AMSA do not provide undesired buccal and upper lip anesthesia.

The AMSA technique has been recommended for proce¬dures ranging from operative restorations, crown preparation to scaling and root planning.

The aim of this study is to evaluate and compare parameters of pulpal anesthesia and cardiovascular function after AMSA injection of 4% articaine with epinephrine (1:100.000), delivered by conventional syringe or CCLADS. Study sample will comprise 30 healthy (ASA1) volunteers who will receive 0.6 ml 4% articaine with epinephrine (1:100.000) by conventional syringe, and after two-week washout period the same amount of local anesthetic by CCLADS. Parameters of pulpal and soft tissue anesthesia (onset and duration) for all maxillary teeth on the anesthetized side, as well as parameters of cardiovascular function (systolic blood pressure, diastolic blood pressure, heart rate) will be monitored and compared.

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

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

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 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA I
  • full maxillary dental arch
  • vital maxillary teeth without caries, restorations, periodontal disease or history of trauma

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 anesthetic delivery by Anaeject
Patients received single dose of 0.6 ml of 4% articaine with epinephrine (1:100.000) by computer controlled anesthetic delivery system (C-CLADS) for AMSA nerve block
Device: Computer controlled anesthetic 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 anesthetic delivery by carpule syringe
Patients received single dose of 0.6 ml of 4% articaine with epinephrine (1:100.000) by conventional anesthetic delivery for AMSA nerve block
Device: Conventional anesthetic 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
Duration of pulpal anesthesia
Time Frame: up to 64 minutes from baseline
Duration of pulpal maxillary anesthesia of all maxillary teeth in anesthetized side of upper jaw assessed by electrical pulp testing at 2-minute intervals.
up to 64 minutes from baseline

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 of pulpal anesthesia
Time Frame: Up to 8 minutes
Pulpal response to electrical pulp tester measured up to 8 minutes after injection
Up to 8 minutes
Width of anesthetic field marginal-superior
Time Frame: 5 minutes
Width of area of soft tissue numbness measured 5 minutes after injection
5 minutes
Width of anesthetic field medial-lateral
Time Frame: 5 minutes
Width of area of soft tissue numbness measured 5 minutes after injection
5 minutes
Duration of soft tissue anesthesia buccal
Time Frame: Up to 120 min
Duration of soft tissue numbness followed up to 120 minutes after injection
Up to 120 min
Duration of soft tissue anesthesia palatal
Time Frame: Up to 120 minutes
Duration of soft tissue numbness followed up to 120 minutes after injection
Up to 120 minutes
Systolic blood pressure at baseline
Time Frame: 0 minutes
Systolic blood pressure before injection
0 minutes
Systolic blood pressure at 5 minutes
Time Frame: 0, 5 minutes
Changes in systolic blood pressure from baseline at the time of injection delivery
0, 5 minutes
Systolic blood pressure at 10 minutes
Time Frame: 0, 10 minutes
Changes in systolic blood pressure from baseline 5 minutes after injection delivery
0, 10 minutes
Systolic blood pressure at 15 minutes
Time Frame: 0, 15 minutes
Changes in systolic blood pressure from baseline 10 minutes after injection delivery
0, 15 minutes
Systolic blood pressure at 20 minutes
Time Frame: 0, 20 minutes
Changes in systolic blood pressure from baseline 15 minutes after injection delivery
0, 20 minutes
Systolic blood pressure at 35 minutes
Time Frame: 0, 35 minutes
Changes in systolic blood pressure from baseline 30 minutes after injection delivery
0, 35 minutes
Diastolic blood pressure at baseline
Time Frame: 0 minutes
Diastolic blood pressure before injection
0 minutes
Diastolic blood pressure at 5 minutes
Time Frame: 0, 5 minutes
Changes in diastolic blood pressure from baseline at the time of injection delivery
0, 5 minutes
Diastolic blood pressure at 10 minutes
Time Frame: 0, 10 minutes
Changes in diastolic blood pressure from baseline 5 minutes after injection delivery
0, 10 minutes
Diastolic blood pressure at 15 minutes
Time Frame: 0, 15 minutes
Changes in diastolic blood pressure from baseline 10 minutes after injection delivery
0, 15 minutes
Diastolic blood pressure at 20 minutes
Time Frame: 0, 20 minutes
Changes in diastolic blood pressure from baseline 15 minutes after injection delivery
0, 20 minutes
Diastolic blood pressure at 35 minutes
Time Frame: 0, 35 minutes
Changes in diastolic blood pressure from baseline 30 minutes after injection delivery
0, 35 minutes
Heart rate at baseline
Time Frame: 0 minutes
Heart rate before injection delivery
0 minutes
Heart rate at 5 minutes
Time Frame: 0, 5 mninutes
Changes in heart rate from baseline at the time of injection delivery
0, 5 mninutes
Heart rate at 10 minutes
Time Frame: 0, 10 minutes
Changes in heart rate from baseline 5 minutes after injection delivery
0, 10 minutes
Heart rate at 15 minutes
Time Frame: 0, 15 minutes
Changes in heart rate from baseline 10 minutes after injection delivery
0, 15 minutes
Heart rate at 20 minutes
Time Frame: 0, 20 minutes
Changes in heart rate from baseline 15 minutes after injection delivery
0, 20 minutes
Heart rate at 35 minutes
Time Frame: 0, 35 minutes
Changes in heart rate from baseline 30 minutes after injection delivery
0, 35 minutes

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: Bozidar M Brkovic, DDS, PhD, School of dental medicine, University of Belgrade
  • Principal Investigator: Marija S Milic, DDS, School of dental medicine, University of Belgrade
  • Principal Investigator: Dejan Cetkovic, DDS, School of dental medicine, University of Belgrade
  • Principal Investigator: Vladimir M Biocanin, DDS, PhD, Faculty of Pharmacy and Health, University of Travnik, Bosnia and Herzegovina
  • Principal Investigator: Ivana Brajic, DDS, School of dental medicine, University of Belgrade

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

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.
June 1, 2014

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, 2015

Study Completion (Actual)

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.
June 1, 2015

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).
April 23, 2015

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.
May 6, 2015

First Posted (Estimate)

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.
May 12, 2015

Study Record Updates

Last Update Posted (Estimate)

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.
July 24, 2015

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.
July 23, 2015

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.
July 1, 2015

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.
  • 36/5-2015
  • 175021 (Other Grant/Funding Number: Ministry of Education, Science and Technological Development)

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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