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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02440347
Enrollment
30
Registered
2015-05-12
Start date
2014-06-30
Completion date
2015-06-30
Last updated
2015-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Local Anesthesia

Keywords

local anesthesia, articaine, AMSA

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 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.

Interventions

DEVICEComputer 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).

DEVICEConventional anesthetic delivery by carpule syringe

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

Sponsors

University of Belgrade
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Duration of pulpal anesthesiaup to 64 minutes from baselineDuration of pulpal maxillary anesthesia of all maxillary teeth in anesthetized side of upper jaw assessed by electrical pulp testing at 2-minute intervals.

Secondary

MeasureTime frameDescription
Width of anesthetic field marginal-superior5 minutesWidth of area of soft tissue numbness measured 5 minutes after injection
Width of anesthetic field medial-lateral5 minutesWidth of area of soft tissue numbness measured 5 minutes after injection
Duration of soft tissue anesthesia buccalUp to 120 minDuration of soft tissue numbness followed up to 120 minutes after injection
Duration of soft tissue anesthesia palatalUp to 120 minutesDuration of soft tissue numbness followed up to 120 minutes after injection
Systolic blood pressure at baseline0 minutesSystolic blood pressure before injection
Systolic blood pressure at 5 minutes0, 5 minutesChanges in systolic blood pressure from baseline at the time of injection delivery
Systolic blood pressure at 10 minutes0, 10 minutesChanges in systolic blood pressure from baseline 5 minutes after injection delivery
Systolic blood pressure at 15 minutes0, 15 minutesChanges in systolic blood pressure from baseline 10 minutes after injection delivery
Systolic blood pressure at 20 minutes0, 20 minutesChanges in systolic blood pressure from baseline 15 minutes after injection delivery
Systolic blood pressure at 35 minutes0, 35 minutesChanges in systolic blood pressure from baseline 30 minutes after injection delivery
Diastolic blood pressure at baseline0 minutesDiastolic blood pressure before injection
Onset of pulpal anesthesiaUp to 8 minutesPulpal response to electrical pulp tester measured up to 8 minutes after injection
Diastolic blood pressure at 10 minutes0, 10 minutesChanges in diastolic blood pressure from baseline 5 minutes after injection delivery
Diastolic blood pressure at 15 minutes0, 15 minutesChanges in diastolic blood pressure from baseline 10 minutes after injection delivery
Diastolic blood pressure at 20 minutes0, 20 minutesChanges in diastolic blood pressure from baseline 15 minutes after injection delivery
Diastolic blood pressure at 35 minutes0, 35 minutesChanges in diastolic blood pressure from baseline 30 minutes after injection delivery
Heart rate at baseline0 minutesHeart rate before injection delivery
Heart rate at 5 minutes0, 5 mninutesChanges in heart rate from baseline at the time of injection delivery
Heart rate at 10 minutes0, 10 minutesChanges in heart rate from baseline 5 minutes after injection delivery
Heart rate at 15 minutes0, 15 minutesChanges in heart rate from baseline 10 minutes after injection delivery
Heart rate at 20 minutes0, 20 minutesChanges in heart rate from baseline 15 minutes after injection delivery
Heart rate at 35 minutes0, 35 minutesChanges in heart rate from baseline 30 minutes after injection delivery
Diastolic blood pressure at 5 minutes0, 5 minutesChanges in diastolic blood pressure from baseline at the time of injection delivery

Countries

Serbia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026