Skip to main content
OpenTrials
Completed

NCT Number: NCT07184879

Comparison of Five Anesthetic Delivery Systems for Palatal Infiltration

This study is a randomized clinical trial evaluating five different anesthetic delivery systems for palatal infiltration in adults undergoing maxillary molar extraction. A total of 200 healthy volunteers were enrolled and randomly assigned to receive anesthesia using one of the following devices: conventional dental syringe, manual pressure syringe, spring-activated syringe, needle-free jet injector, or computer-controlled local anesthetic delivery system.

The purpose of the study is to compare patient-reported pain, dental fear, and physiological responses (pulse rate and oxygen saturation) associated with each system. The results are expected to provide evidence on which devices may improve patient comfort and cooperation during palatal infiltration procedures.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dental Anxiety Dental Neurologic Manifestations Pain Palatal Anesthesia Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Aydın University Faculty of Dentistry, Department of Oral and Maxillofacial Surgery

Istanbul, Turkey (Türkiye)

About this study

This randomized, parallel-arm superiority trial was conducted at Istanbul Aydın University, Faculty of Dentistry, between September 2023 and March 2025. Two hundred healthy adults (≥18 years) requiring maxillary molar extraction under palatal infiltration anesthesia were equally randomized into five groups (n=40).

All participants received 0.4 mL of 4% articaine with 1:100,000 epinephrine, delivered with one of the five systems. The primary outcome was pain perception measured immediately after injection using a visual analog scale (VAS). Secondary outcomes included changes in dental fear, pulse rate, oxygen saturation, and any adverse events.

The study was approved by the Istanbul Aydın University Ethics Committee. Written informed consent was obtained from all participants.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age ≥ 18 years
  • ASA physical status I or II
  • No systemic conditions affecting anesthetic metabolism
  • No known allergy to local anesthetics or vasoconstrictors
  • No psychiatric disorders or anxiolytic medication
  • Ability to provide written informed consent

Exclusion criteria

  • Pregnancy or lactation
  • Active infection at the injection site
  • Diagnosed needle phobia
  • Prior exposure to any of the tested injection systems
  • Use of premedication, sedatives, or topical anesthetics on the day of the procedure

Treatment and study plan

Conventional Dental Syringe

Device

Palatal infiltration anesthesia using a conventional dental syringe with a 27G needle. A total of 0.4 mL of articaine 4% with epinephrine 1:100,000 was administered manually over 15-20 seconds following aspiration.

Spring-Activated Syringe (PCJ, PAROJECT™)

Device

Palatal infiltration using a spring-activated push-button syringe (PAROJECT™). Two calibrated 0.2 mL doses of articaine 4% with epinephrine 1:100,000 were administered following aspiration.

Needle-Free Jet Injector (NFI, Comfort-in™)

Device

Palatal infiltration using a needle-free jet injector (Comfort-in™). A total of 0.4 mL of articaine 4% with epinephrine 1:100,000 was delivered in less than one second at 4-5 bar pressure. Aspiration not applicable.

Computer-Controlled Local Anesthetic Delivery (CCLAD, CALAJECT™)

Device

Palatal infiltration using a computer-controlled local anesthetic delivery system (CALAJECT™, Program I) with a 30G, 16 mm needle. AutoFlow rate 0.006-0.009 mL/s, with automatic aspiration after 5 seconds and constant microprocessor-controlled pressure. A total of 0.4 mL of articaine 4% with epinephrine 1:100,000 was administered.

Manual Pressure Syringe (MCJ, ASPIJECT™)

Device

Palatal infiltration using a manual pressure-controlled syringe (ASPIJECT™) with a 30G, 16 mm needle. A total of 0.4 mL of articaine 4% with epinephrine 1:100,000 was administered manually over 15-20 seconds with aspiration.

Primary outcomes

  1. Pain during injection (VAS, 0-10 cm)

    Time frame: Immediately after injection

    Pain perception recorded immediately after palatal infiltration using a 10-cm visual analog scale (VAS; 0 = no pain, 10 = worst imaginable pain).

Secondary outcomes

  1. Change in dental fear (VAS, 0-10 cm)

    Time frame: Baseline (before injection) and immediately after injection

    Fear measured on a 10-cm VAS before and after injection; difference (ΔVAS) represents fear reduction.

  2. Pulse rate (bpm)

    Time frame: Baseline (before injection), peri-procedural (during injection), and 3 minutes post-injection

    Pulse rate measured with fingertip oximeter at three time points: baseline (before injection), peri-procedural (during injection), and 3 minutes after injection.

  3. Oxygen saturation (SpO₂, %)

    Time frame: Baseline (before injection), peri-procedural (during injection), and 3 minutes post-injection

    Oxygen saturation measured with fingertip oximeter at three time points: baseline (before injection), peri-procedural (during injection), and 3 minutes after injection.

  4. Adverse events

    Time frame: From the time of injection through study completion (average of 1 week follow-up)

    Recording of any immediate or delayed adverse events associated with anesthetic delivery (pain, swelling, bleeding, syncope, allergic reactions).

Sponsors and collaborators

Lead sponsor

Sercan Küçükkurt

Other

Registry information

Official study title

Comparison of Five Anesthetic Delivery Systems for Palatal Infiltration: A Randomized Clinical Trial

Acronym: PAL-INJECT

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 22, 2025
Registry last updated
Sep 22, 2025

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.