Local AnesthesiaPhase 4NCT03225326
Effects of Articaine Computer-controlled and Conventional Delivery for Anterior and Middle Superior Alveolar Nerve Block for Tooth Extraction
A Phase 4 study testing Conventional 4% articaine delivery by carpule syringe in people with Local Anesthesia, run by University of Belgrade at 1 site in Serbia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Local Anesthesia
- What is being tested?
- Conventional 4% articaine delivery by carpule syringe
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSerbia
- Study dates
- Dec 2016to Jul 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA 1
- maxillary incisors canines or premolars indicated for extraction due to periapical pathology, root fracture or orthodontic treatment
Who cannot join
- allergies to local anesthetic solution ingredients, food and drugs
- alcohol and drugs abuse
- heavy tobacco smoking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Local Anesthesia
- Being tested
- Computer controlled 4% articaine delivery by Anaeject, Conventional 4% articaine delivery by carpule syringe
- Keywords
- articaine, local anesthesia, AMSA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
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).
| Study group | Role | What they receive |
|---|---|---|
| Computer controlled 4% articaine delivery by Anaeject | Experimental | Not described Receives: Drug: Computer controlled 4% articaine delivery by Anaeject |
| Conventional 4% articaine delivery by carpule syringe | Active comparator | Not described Receives: Drug: Conventional 4% articaine delivery by carpule syringe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of Pulpal Anesthesia for Central Incisive
Measured by pulp sensitivity to electrical pulp tester
Measured: after 1 hour
Success of Pulpal Anesthesia for Lateral Incisive
Measured by pulp sensitivity to electrical pulp tester
Measured: after 1 hour
Success of Pulpal Anesthesia for Canine
Measured by pulp sensitivity to electrical pulp tester
Measured: after 1 hour
Success of Pulpal Anesthesia for First Premolar
Measured by pulp sensitivity to electrical pulp tester
Measured: after 1 hour
Success of Pulpal Anesthesia for Second Premolar
Measured by pulp sensitivity to electrical pulp tester
Measured: after 1 hour
Secondary outcomes (25)
Onset Central Incisive
Measured by pulp sensitivity to electrical pulp tester
Measured: up to 8 minutes
Onset Lateral Incisive
Measured by pulp sensitivity to electrical pulp tester
Measured: up to 8 minutes
Onset Canine
Measured by pulp sensitivity to electrical pulp tester
Measured: up to 8 minutes
Onset First Premolar
Measured by pulp sensitivity to electrical pulp tester
Measured: up to 8 minutes
Onset Second Premolar
Measured by pulp sensitivity to electrical pulp tester
Measured: up to 8 minutes
Duration Central Incisive
Measured by pulp sensitivity to electrical pulp tester
Measured: up to 60 minutes
Duration Lateral Incisive
Measured by pulp sensitivity to electrical pulp tester
Measured: up to 60 minutes
Duration Canine
Measured by pulp sensitivity to electrical pulp tester
Measured: up to 60 minutes
Duration First Premolar
Measured by pulp sensitivity to electrical pulp tester
Measured: up to 60 minutes
Duration Second Premolar
Measured by pulp sensitivity to electrical pulp tester
Measured: up to 60 minutes
Systolic blood pressure
Measured noninvasively in mm Hg
Measured: baseline
Systolic blood pressure at 5th minute
Measured noninvasively in mm Hg
Measured: 5th minute
Systolic blood pressure at 10th minute
Measured noninvasively in mm Hg
Measured: 10th minute
Systolic blood pressure at 15th minute
Measured noninvasively in mm Hg
Measured: 15th minute
Systolic blood pressure at 30th minute
Measured noninvasively in mm Hg
Measured: 30th minute
Diastolic blood pressure
Measured noninvasively in mm Hg
Measured: baseline
Diastolic blood pressure at 5th minute
Measured noninvasively in mm Hg
Measured: 5th minute
Diastolic blood pressure at 10th minute
Measured noninvasively in mm Hg
Measured: 10th minute
Diastolic blood pressure at 15th minute
Measured noninvasively in mm Hg
Measured: 15th minute
Diastolic blood pressure at 30th minute
Measured noninvasively in mm Hg
Measured: 30th minute
Heart rate
Measured noninvasively in beats per minute
Measured: baseline
Heart rate at 5th minute
Measured noninvasively in beats per minute
Measured: 5th minute
Heart rate at 10th minute
Measured noninvasively in beats per minute
Measured: 10th minute
Heart rate at 15th minute
Measured noninvasively in beats per minute
Measured: 15th minute
Heart rate at 30th minute
Measured noninvasively in beats per minute
Measured: 30th minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study startDec 2016
- Primary completionJun 2017
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Local AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Belgrade
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bozidar Brkovic, DDS, MSc, PhD, Professor, University of Belgrade
- Investigators
- Marija Milić, Research Associate, Principal investigator, School of Dental Medicine, University of BelgradeVladimir Biočanin, Assistant Professor, Principal investigator, Faculty of Pharmacy and Health, University of Travnik, Bosnia and Herzegovina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03225326
- Sponsor's protocol ID
- UBelgrade 784/2
- Status last verified
- Mar 2018
- First submitted
- 17 Jul 2017
- Last updated
- 22 Mar 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Anterior and Middle Superior Alveolar (AMSA) Nerve Block Anesthesia Obtained by Articaine Computer-controlled and Conventional Delivery
- ClinicalTrials.gov ID
- NCT03225326
- Acronym / sponsor ID
- UBelgrade 784/2
- Conditions
- Local Anesthesia
- Keywords
- articaine, local anesthesia, AMSA
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of BelgradeUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jul 2017 (estimated)
- First posted
- 21 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA 1
- maxillary incisors canines or premolars indicated for extraction due to periapical pathology, root fracture or orthodontic treatment
Key exclusion criteria (3 listed)
- allergies to local anesthetic solution ingredients, food and drugs
- alcohol and drugs abuse
- heavy tobacco smoking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computer controlled 4% articaine delivery by AnaejectSingle dose of 0.6ml 4% articaine with epinephrine (1:100.000) delivered by computer controlled local anesthetic delivery system (Anaeject) | Drug | Computer controlled 4% articaine delivery by Anaeject |
| Conventional 4% articaine delivery by carpule syringeSingle dose of 0.6ml 4% articaine with epinephrine (1:100.000) delivered by conventional syringe (carpule syringe). | Drug | Conventional 4% articaine delivery by carpule syringe |
Primary outcome
Success of Pulpal Anesthesia for Central Incisive
Time frame: after 1 hour
Measured by pulp sensitivity to electrical pulp tester
Success of Pulpal Anesthesia for Lateral Incisive
Time frame: after 1 hour
Measured by pulp sensitivity to electrical pulp tester
Success of Pulpal Anesthesia for Canine
Time frame: after 1 hour
Measured by pulp sensitivity to electrical pulp tester
Success of Pulpal Anesthesia for First Premolar
Time frame: after 1 hour
Measured by pulp sensitivity to electrical pulp tester
Success of Pulpal Anesthesia for Second Premolar
Time frame: after 1 hour
Measured by pulp sensitivity to electrical pulp tester
25 secondary outcomes
Onset Central Incisive
Time frame: up to 8 minutes
Onset Lateral Incisive
Time frame: up to 8 minutes
Onset Canine
Time frame: up to 8 minutes
Onset First Premolar
Time frame: up to 8 minutes
Onset Second Premolar
Time frame: up to 8 minutes
Duration Central Incisive
Time frame: up to 60 minutes
Duration Lateral Incisive
Time frame: up to 60 minutes
Duration Canine
Time frame: up to 60 minutes
Duration First Premolar
Time frame: up to 60 minutes
Duration Second Premolar
Time frame: up to 60 minutes
Systolic blood pressure
Time frame: baseline
Systolic blood pressure at 5th minute
Time frame: 5th minute
Systolic blood pressure at 10th minute
Time frame: 10th minute
Systolic blood pressure at 15th minute
Time frame: 15th minute
Systolic blood pressure at 30th minute
Time frame: 30th minute
Diastolic blood pressure
Time frame: baseline
Diastolic blood pressure at 5th minute
Time frame: 5th minute
Diastolic blood pressure at 10th minute
Time frame: 10th minute
Diastolic blood pressure at 15th minute
Time frame: 15th minute
Diastolic blood pressure at 30th minute
Time frame: 30th minute
Heart rate
Time frame: baseline
Heart rate at 5th minute
Time frame: 5th minute
Heart rate at 10th minute
Time frame: 10th minute
Heart rate at 15th minute
Time frame: 15th minute
Heart rate at 30th minute
Time frame: 30th minute
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marija Milić, Research Associate principal investigator
School of Dental Medicine, University of Belgrade
Vladimir Biočanin, Assistant Professor principal investigator
Faculty of Pharmacy and Health, University of Travnik, Bosnia and Herzegovina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Conventional 4% articaine delivery by carpule syringe in people with Local Anesthesia, run by University of Belgrade at 1 site in Serbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success of Pulpal Anesthesia for Central Incisive (time frame: after 1 hour). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2018.