Assessment of Maxillary Local Anesthesia Infiltration Using Needle-free Jet vs Conventional Syringe in Tooth Extraction

March 23, 2026 updated by: Ghassan Darwish, King Abdulaziz University

Assessment of Maxillary Local Anesthesia Infiltration Efficiency and Adult Patient Satisfaction: Needle-free Jet vs Conventional Syringe in Simple Tooth Extraction in a Single-blinded, Randomized Controlled Trial

Managing pain and anxiety during dental anesthesia remains a key concern, particularly in procedures involving needle-sensitive adult patients. Needle-free jet injection systems, such as Comfort- InTM, offer a potential alternative to conventional syringes by minimizing invasiveness and enhancing patient comfort during simple tooth extractions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

the study aimed to compare the efficacy, patient comfort, and pain perception between the conventional syringe injection technique and the needle-free jet injection system (Comfort-In) in dental anesthesia for simple tooth extractions.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
      • Jeddah, Saudi Arabia
        • King Abdulaziz University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • KAUDH patients aged 18 to 65 years.
  • Bilateral posterior dentition suitable for the split-mouth technique.
  • Classified as American Society of Anesthesiologists (ASA) I or ASA II.

Exclusion Criteria:

  • Pediatric patients (<18 years).
  • Medically compromised individuals.
  • Patients with unilateral teeth indicated for extraction,
  • Patient with upper anterior teeth requiring a nasopalatine nerve block.
  • Patient with lower teeth requiring a nerve block.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard needle injection dental syringe
Device: Conventional dental syringe injection
Conventional dental syringe injection
Active Comparator: Needle free injector
Device: needle-free anesthesia jet (Comfort-in™)
Dental needle-free anesthesia jet (Comfort-in™)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain perception survey
Time Frame: From enrollment to the end of assessment of treatment at 24 weeks
Pain levels were recorded using the Visual Analog Scale (VAS) in a survey after the extraction procedures. VAS scores were measured by asking patients to mark their pain level on a 1-10 line, and these pain scores were summarized using means and standard deviations (SD), and medians with interquartile ranges (IQR). ( 1 low pain, 10 worst pain)
From enrollment to the end of assessment of treatment at 24 weeks
Pain perception survey
Time Frame: From enrollment to the end of assessment of treatment at 24 weeks
Pain levels were recorded using the Numerical Rating Scale (NRS) in a survey after the extraction procedures. NRS scores were recorded verbally by the patient on a scale from 0 to 10, and these pain scores were summarized using means and standard deviations (SD), and medians with interquartile ranges (IQR). ( 0 is low pain, 10 worst pain)
From enrollment to the end of assessment of treatment at 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Abdulaziz University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2025

Primary Completion (Actual)

June 30, 2025

Study Completion (Actual)

July 30, 2025

Study Registration Dates

First Submitted

March 14, 2026

First Submitted That Met QC Criteria

March 23, 2026

First Posted (Actual)

March 27, 2026

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 190-11-24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The study completed by one center and no data of individual patient data required to be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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