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Completed

NCT Number: NCT02440347

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

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.

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Key information

Conditions

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

School of Dental Medicine, University of Belgrade

Belgrade, 11000, Serbia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Computer controlled anesthetic delivery by Anaeject

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

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Onset of pulpal anesthesia

    Time frame: Up to 8 minutes

    Pulpal response to electrical pulp tester measured up to 8 minutes after injection

  2. Width of anesthetic field marginal-superior

    Time frame: 5 minutes

    Width of area of soft tissue numbness measured 5 minutes after injection

  3. Width of anesthetic field medial-lateral

    Time frame: 5 minutes

    Width of area of soft tissue numbness measured 5 minutes after injection

  4. Duration of soft tissue anesthesia buccal

    Time frame: Up to 120 min

    Duration of soft tissue numbness followed up to 120 minutes after injection

  5. Duration of soft tissue anesthesia palatal

    Time frame: Up to 120 minutes

    Duration of soft tissue numbness followed up to 120 minutes after injection

  6. Systolic blood pressure at baseline

    Time frame: 0 minutes

    Systolic blood pressure before injection

  7. Systolic blood pressure at 5 minutes

    Time frame: 0, 5 minutes

    Changes in systolic blood pressure from baseline at the time of injection delivery

  8. Systolic blood pressure at 10 minutes

    Time frame: 0, 10 minutes

    Changes in systolic blood pressure from baseline 5 minutes after injection delivery

  9. Systolic blood pressure at 15 minutes

    Time frame: 0, 15 minutes

    Changes in systolic blood pressure from baseline 10 minutes after injection delivery

  10. Systolic blood pressure at 20 minutes

    Time frame: 0, 20 minutes

    Changes in systolic blood pressure from baseline 15 minutes after injection delivery

  11. Systolic blood pressure at 35 minutes

    Time frame: 0, 35 minutes

    Changes in systolic blood pressure from baseline 30 minutes after injection delivery

  12. Diastolic blood pressure at baseline

    Time frame: 0 minutes

    Diastolic blood pressure before injection

  13. Diastolic blood pressure at 5 minutes

    Time frame: 0, 5 minutes

    Changes in diastolic blood pressure from baseline at the time of injection delivery

  14. Diastolic blood pressure at 10 minutes

    Time frame: 0, 10 minutes

    Changes in diastolic blood pressure from baseline 5 minutes after injection delivery

  15. Diastolic blood pressure at 15 minutes

    Time frame: 0, 15 minutes

    Changes in diastolic blood pressure from baseline 10 minutes after injection delivery

  16. Diastolic blood pressure at 20 minutes

    Time frame: 0, 20 minutes

    Changes in diastolic blood pressure from baseline 15 minutes after injection delivery

  17. Diastolic blood pressure at 35 minutes

    Time frame: 0, 35 minutes

    Changes in diastolic blood pressure from baseline 30 minutes after injection delivery

  18. Heart rate at baseline

    Time frame: 0 minutes

    Heart rate before injection delivery

  19. Heart rate at 5 minutes

    Time frame: 0, 5 mninutes

    Changes in heart rate from baseline at the time of injection delivery

  20. Heart rate at 10 minutes

    Time frame: 0, 10 minutes

    Changes in heart rate from baseline 5 minutes after injection delivery

  21. Heart rate at 15 minutes

    Time frame: 0, 15 minutes

    Changes in heart rate from baseline 10 minutes after injection delivery

  22. Heart rate at 20 minutes

    Time frame: 0, 20 minutes

    Changes in heart rate from baseline 15 minutes after injection delivery

  23. Heart rate at 35 minutes

    Time frame: 0, 35 minutes

    Changes in heart rate from baseline 30 minutes after injection delivery

Sponsors and collaborators

Lead sponsor

University of Belgrade

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 12, 2015
Registry last updated
Jul 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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