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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02440347
Other study ID # 36/5-2015
Secondary ID 175021
Status Completed
Phase Phase 4
First received April 23, 2015
Last updated July 23, 2015
Start date June 2014
Est. completion date June 2015

Study information

Verified date July 2015
Source University of Belgrade
Contact n/a
Is FDA regulated No
Health authority Serbia: Ethics Committee
Study type Interventional

Clinical 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.


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 proceĀ¬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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date June 2015
Est. primary completion date June 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 30 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Serbia School of Dental Medicine, University of Belgrade Belgrade

Sponsors (1)

Lead Sponsor Collaborator
University of Belgrade

Country where clinical trial is conducted

Serbia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. up to 64 minutes from baseline No
Secondary Onset of pulpal anesthesia Pulpal response to electrical pulp tester measured up to 8 minutes after injection Up to 8 minutes No
Secondary Width of anesthetic field marginal-superior Width of area of soft tissue numbness measured 5 minutes after injection 5 minutes No
Secondary Width of anesthetic field medial-lateral Width of area of soft tissue numbness measured 5 minutes after injection 5 minutes No
Secondary Duration of soft tissue anesthesia buccal Duration of soft tissue numbness followed up to 120 minutes after injection Up to 120 min No
Secondary Duration of soft tissue anesthesia palatal Duration of soft tissue numbness followed up to 120 minutes after injection Up to 120 minutes No
Secondary Systolic blood pressure at baseline Systolic blood pressure before injection 0 minutes Yes
Secondary Systolic blood pressure at 5 minutes Changes in systolic blood pressure from baseline at the time of injection delivery 0, 5 minutes Yes
Secondary Systolic blood pressure at 10 minutes Changes in systolic blood pressure from baseline 5 minutes after injection delivery 0, 10 minutes Yes
Secondary Systolic blood pressure at 15 minutes Changes in systolic blood pressure from baseline 10 minutes after injection delivery 0, 15 minutes Yes
Secondary Systolic blood pressure at 20 minutes Changes in systolic blood pressure from baseline 15 minutes after injection delivery 0, 20 minutes Yes
Secondary Systolic blood pressure at 35 minutes Changes in systolic blood pressure from baseline 30 minutes after injection delivery 0, 35 minutes Yes
Secondary Diastolic blood pressure at baseline Diastolic blood pressure before injection 0 minutes Yes
Secondary Diastolic blood pressure at 5 minutes Changes in diastolic blood pressure from baseline at the time of injection delivery 0, 5 minutes Yes
Secondary Diastolic blood pressure at 10 minutes Changes in diastolic blood pressure from baseline 5 minutes after injection delivery 0, 10 minutes Yes
Secondary Diastolic blood pressure at 15 minutes Changes in diastolic blood pressure from baseline 10 minutes after injection delivery 0, 15 minutes Yes
Secondary Diastolic blood pressure at 20 minutes Changes in diastolic blood pressure from baseline 15 minutes after injection delivery 0, 20 minutes Yes
Secondary Diastolic blood pressure at 35 minutes Changes in diastolic blood pressure from baseline 30 minutes after injection delivery 0, 35 minutes Yes
Secondary Heart rate at baseline Heart rate before injection delivery 0 minutes Yes
Secondary Heart rate at 5 minutes Changes in heart rate from baseline at the time of injection delivery 0, 5 mninutes Yes
Secondary Heart rate at 10 minutes Changes in heart rate from baseline 5 minutes after injection delivery 0, 10 minutes Yes
Secondary Heart rate at 15 minutes Changes in heart rate from baseline 10 minutes after injection delivery 0, 15 minutes Yes
Secondary Heart rate at 20 minutes Changes in heart rate from baseline 15 minutes after injection delivery 0, 20 minutes Yes
Secondary Heart rate at 35 minutes Changes in heart rate from baseline 30 minutes after injection delivery 0, 35 minutes Yes
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