Comparison of Five Anesthetic Delivery Systems for Palatal Infiltration

NCT07184879 | Completed

• 1 other identifier: IAU-PalatalRCT-2025
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Anxiety; Pain; Dental; Palatal Anesthesia

Keywords

Dental Anesthesia; Palatal Infiltration; Visual Analog Scale (VAS); Computer-Controlled Local Anesthetic Delivery (CCLAD); Needle-Free Jet Injector; Injection Pain; Patient Fear; Dental Fear

Outcome Measures

Primary Outcomes (1)

• Pain during injection (VAS, 0-10 cm)

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

  Immediately after injection

Secondary Outcomes (4)

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

  Baseline (before injection) and immediately after injection

• Pulse rate (bpm)

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

• Oxygen saturation (SpO₂, %)

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

• Adverse events

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

Study Arms (5)

Conventional Dental Syringe (CDS)

EXPERIMENTAL

Palatal infiltration using a conventional dental syringe with 27G needle; manual injection of 0.4 mL articaine with epinephrine over 15-20 seconds, with aspiration. Intervention Name: Device: Conventional Dental Syringe

Device: Conventional Dental Syringe

Manual Pressure Syringe (MCJ)

EXPERIMENTAL

Palatal infiltration using ASPIJECT™ manual pressure syringe with 30G, 16 mm needle; manually controlled injection of 0.4 mL articaine with epinephrine over 15-20 seconds, with aspiration. Intervention Name: Device: Manual Pressure Syringe (ASPIJECT™)

Device: Manual Pressure Syringe (MCJ, ASPIJECT™)

Spring-Activated Syringe (PCJ)

EXPERIMENTAL

Palatal infiltration using PAROJECT™ spring-activated syringe; two calibrated 0.2 mL doses of articaine with epinephrine following aspiration. Intervention Name: Device: Spring-Activated Syringe (PAROJECT™)

Device: Spring-Activated Syringe (PCJ, PAROJECT™)

Needle-Free Jet Injector (NFI)

EXPERIMENTAL

Palatal infiltration using Comfort-in™ needle-free jet injector; 0.4 mL articaine with epinephrine delivered in \<1 second, at 4-5 bar pressure; aspiration not applicable. Intervention Name: Device: Needle-Free Jet Injector (Comfort-in™)

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

Computer-Controlled Local Anesthetic Delivery (CCLAD)

EXPERIMENTAL

Palatal infiltration using CALAJECT™ Program I; 30G, 16 mm needle; AutoFlow delivery (0.006-0.009 mL/s) with automatic aspiration; microprocessor-controlled constant pressure. Intervention Name: Device: Computer-Controlled Local Anesthetic Delivery (CALAJECT™)

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

Interventions

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.

Conventional Dental Syringe (CDS)

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.

Spring-Activated Syringe (PCJ)

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.

Needle-Free Jet Injector (NFI)

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.

Computer-Controlled Local Anesthetic Delivery (CCLAD)

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.

Manual Pressure Syringe (MCJ)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sercan Küçükkurt: lead

Study Sites (1)

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

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Single-blind design: outcome assessors and the statistician were blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assoc. Prof. Dr. Sercan Küçükkurt, Oral and Maxillofacial Surgeon

Model Details: This is a randomized, parallel-arm superiority clinical trial with five intervention groups comparing anesthetic delivery systems for palatal infiltration.

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: September 22, 2025
• Study Start: September 1, 2023
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)