Local AnesthesiaPhase 4NCT02440347
Effects of Articaine Computer-controlled and Conventional Delivery for Anterior and Middle Superior Alveolar Nerve Block
A Phase 4 study testing Conventional anesthetic 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 in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Local Anesthesia
- What is being tested?
- Conventional anesthetic delivery by carpule syringe
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSerbia
- Study dates
- Jun 2014to Jun 2015
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ASA I
- full maxillary dental arch
- vital maxillary teeth without caries, restorations, periodontal disease or history of trauma
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 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.
Read the 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.
- Conditions
- Local Anesthesia
- Being tested
- Computer controlled anesthetic delivery by Anaeject, Conventional anesthetic delivery by carpule syringe
- Keywords
- local anesthesia, articaine, AMSA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer controlled anesthetic delivery by AnaejectDevice
Single dose of 0.6ml 4% articaine with epinephrine (1:100.000) delivered by computer controlled local anesthetic delivery system (Anaeject).
Conventional anesthetic delivery by carpule syringeDevice
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 anesthetic delivery by Anaeject | Experimental | 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 Receives: Device: Computer controlled anesthetic delivery by Anaeject |
| Conventional anesthetic delivery by carpule syringe | Active comparator | Patients received single dose of 0.6 ml of 4% articaine with epinephrine (1:100.000) by conventional anesthetic delivery for AMSA nerve block Receives: Device: Conventional anesthetic delivery by carpule syringe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of pulpal anesthesia
Duration of pulpal maxillary anesthesia of all maxillary teeth in anesthetized side of upper jaw assessed by electrical pulp testing at 2-minute intervals.
Measured: up to 64 minutes from baseline
Secondary outcomes (23)
Onset of pulpal anesthesia
Pulpal response to electrical pulp tester measured up to 8 minutes after injection
Measured: Up to 8 minutes
Width of anesthetic field marginal-superior
Width of area of soft tissue numbness measured 5 minutes after injection
Measured: 5 minutes
Width of anesthetic field medial-lateral
Width of area of soft tissue numbness measured 5 minutes after injection
Measured: 5 minutes
Duration of soft tissue anesthesia buccal
Duration of soft tissue numbness followed up to 120 minutes after injection
Measured: Up to 120 min
Duration of soft tissue anesthesia palatal
Duration of soft tissue numbness followed up to 120 minutes after injection
Measured: Up to 120 minutes
Systolic blood pressure at baseline
Systolic blood pressure before injection
Measured: 0 minutes
Systolic blood pressure at 5 minutes
Changes in systolic blood pressure from baseline at the time of injection delivery
Measured: 0, 5 minutes
Systolic blood pressure at 10 minutes
Changes in systolic blood pressure from baseline 5 minutes after injection delivery
Measured: 0, 10 minutes
Systolic blood pressure at 15 minutes
Changes in systolic blood pressure from baseline 10 minutes after injection delivery
Measured: 0, 15 minutes
Systolic blood pressure at 20 minutes
Changes in systolic blood pressure from baseline 15 minutes after injection delivery
Measured: 0, 20 minutes
Systolic blood pressure at 35 minutes
Changes in systolic blood pressure from baseline 30 minutes after injection delivery
Measured: 0, 35 minutes
Diastolic blood pressure at baseline
Diastolic blood pressure before injection
Measured: 0 minutes
Diastolic blood pressure at 5 minutes
Changes in diastolic blood pressure from baseline at the time of injection delivery
Measured: 0, 5 minutes
Diastolic blood pressure at 10 minutes
Changes in diastolic blood pressure from baseline 5 minutes after injection delivery
Measured: 0, 10 minutes
Diastolic blood pressure at 15 minutes
Changes in diastolic blood pressure from baseline 10 minutes after injection delivery
Measured: 0, 15 minutes
Diastolic blood pressure at 20 minutes
Changes in diastolic blood pressure from baseline 15 minutes after injection delivery
Measured: 0, 20 minutes
Diastolic blood pressure at 35 minutes
Changes in diastolic blood pressure from baseline 30 minutes after injection delivery
Measured: 0, 35 minutes
Heart rate at baseline
Heart rate before injection delivery
Measured: 0 minutes
Heart rate at 5 minutes
Changes in heart rate from baseline at the time of injection delivery
Measured: 0, 5 mninutes
Heart rate at 10 minutes
Changes in heart rate from baseline 5 minutes after injection delivery
Measured: 0, 10 minutes
Heart rate at 15 minutes
Changes in heart rate from baseline 10 minutes after injection delivery
Measured: 0, 15 minutes
Heart rate at 20 minutes
Changes in heart rate from baseline 15 minutes after injection delivery
Measured: 0, 20 minutes
Heart rate at 35 minutes
Changes in heart rate from baseline 30 minutes after injection delivery
Measured: 0, 35 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startJun 2014
- Primary completionJun 2015
- Study completionJun 2015
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
- 30 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
- Bozidar M Brkovic, DDS, PhD, Principal investigator, School of Dental Medicine, University of BelgradeDejan Cetkovic, DDS, Principal investigator, School of Dental Medicine, University of BelgradeVladimir M Biocanin, DDS, PhD, Principal investigator, Faculty of Pharmacy and Health, University of Travnik, Bosnia and HerzegovinaMarija S Milic, DDS, Principal investigator, School of Dental Medicine, University of BelgradeIvana Brajic, DDS, Principal investigator, School of Dental Medicine, University of Belgrade
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02440347
- Sponsor's protocol ID
- 36/5-2015
- Other IDs
- 175021
- Status last verified
- Jul 2015
- First submitted
- 23 Apr 2015
- Last updated
- 24 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Pulpal Anesthesia After Anterior and Middle Superior Alveolar (AMSA) Nerve Block Obtained by Articaine Computer-controlled and Conventional Delivery
- ClinicalTrials.gov ID
- NCT02440347
- Acronym / sponsor ID
- 36/5-2015
- Conditions
- Local Anesthesia
- Keywords
- local anesthesia, articaine, AMSA
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of BelgradeUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 12 May 2015 (estimated)
- 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 in healthy volunteers.
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 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 anesthetic delivery by Anaeject | Experimental | Device: Computer controlled anesthetic delivery by AnaejectPatients 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 |
| Conventional anesthetic delivery by carpule syringe | Active comparator | Device: Conventional anesthetic delivery by carpule syringePatients received single dose of 0.6 ml of 4% articaine with epinephrine (1:100.000) by conventional anesthetic delivery for AMSA nerve block |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ASA I
- full maxillary dental arch
- vital maxillary teeth without caries, restorations, periodontal disease or history of trauma
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 anesthetic delivery by AnaejectSingle dose of 0.6ml 4% articaine with epinephrine (1:100.000) delivered by computer controlled local anesthetic delivery system (Anaeject). | Device | Computer controlled anesthetic delivery by Anaeject |
| Conventional anesthetic delivery by carpule syringeSingle dose of 0.6ml 4% articaine with epinephrine (1:100.000) delivered by conventional syringe (carpule syringe). | Device | Conventional anesthetic delivery by carpule syringe |
Primary outcome
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.
23 secondary outcomes
Onset of pulpal anesthesia
Time frame: Up to 8 minutes
Width of anesthetic field marginal-superior
Time frame: 5 minutes
Width of anesthetic field medial-lateral
Time frame: 5 minutes
Duration of soft tissue anesthesia buccal
Time frame: Up to 120 min
Duration of soft tissue anesthesia palatal
Time frame: Up to 120 minutes
Systolic blood pressure at baseline
Time frame: 0 minutes
Systolic blood pressure at 5 minutes
Time frame: 0, 5 minutes
Systolic blood pressure at 10 minutes
Time frame: 0, 10 minutes
Systolic blood pressure at 15 minutes
Time frame: 0, 15 minutes
Systolic blood pressure at 20 minutes
Time frame: 0, 20 minutes
Systolic blood pressure at 35 minutes
Time frame: 0, 35 minutes
Diastolic blood pressure at baseline
Time frame: 0 minutes
Diastolic blood pressure at 5 minutes
Time frame: 0, 5 minutes
Diastolic blood pressure at 10 minutes
Time frame: 0, 10 minutes
Diastolic blood pressure at 15 minutes
Time frame: 0, 15 minutes
Diastolic blood pressure at 20 minutes
Time frame: 0, 20 minutes
Diastolic blood pressure at 35 minutes
Time frame: 0, 35 minutes
Heart rate at baseline
Time frame: 0 minutes
Heart rate at 5 minutes
Time frame: 0, 5 mninutes
Heart rate at 10 minutes
Time frame: 0, 10 minutes
Heart rate at 15 minutes
Time frame: 0, 15 minutes
Heart rate at 20 minutes
Time frame: 0, 20 minutes
Heart rate at 35 minutes
Time frame: 0, 35 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2015.
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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.
Bozidar M Brkovic, DDS, PhD principal investigator
School of Dental Medicine, University of Belgrade
Dejan Cetkovic, DDS principal investigator
School of Dental Medicine, University of Belgrade
Vladimir M Biocanin, DDS, PhD 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 anesthetic 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 3 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: finished, as of the sponsor's last update on 24 Jul 2015. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Duration of pulpal anesthesia (time frame: up to 64 minutes from baseline). 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 24 Jul 2015.