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

NCT ID: NCT02440347

Last Updated: 2015-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2015-06-30

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.

Conditions

Local Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

Computer controlled anesthetic delivery by Anaeject

Intervention Type: DEVICE

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 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

Group Type: ACTIVE_COMPARATOR

Conventional anesthetic delivery by carpule syringe

Intervention Type: DEVICE

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

Interventions

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).

Intervention Type: 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).

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Belgrade

OTHER

Sponsor Role: lead

Responsible Party

Bozidar Brkovic, DDS, MSc, PhD, Professor

DDS PhD Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bozidar M Brkovic, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

School of Dental Medicine, University of Belgrade

Dejan Cetkovic, DDS

Role: PRINCIPAL_INVESTIGATOR

School of Dental Medicine, University of Belgrade

Vladimir M Biocanin, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Pharmacy and Health, University of Travnik, Bosnia and Herzegovina

Marija S Milic, DDS

Role: PRINCIPAL_INVESTIGATOR

School of Dental Medicine, University of Belgrade

Ivana Brajic, DDS

Role: PRINCIPAL_INVESTIGATOR

School of Dental Medicine, University of Belgrade

Locations

School of Dental Medicine, University of Belgrade

Belgrade, , Serbia

Countries

Serbia

Other Identifiers

175021

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

36/5-2015

Identifier Type: -

Identifier Source: org_study_id