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

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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07498621

Enrollment

Registered

2026-03-27

Start date

2025-01-01

Completion date

2025-07-30

Last updated

2026-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain Perception of the New Device

Keywords

Dental Syringe, Needle-free jet, Tooth Extraction, Anesthesia

Brief summary

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.

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.

Interventions

DEVICEneedle-free anesthesia jet (Comfort-in™)

Dental needle-free anesthesia jet (Comfort-in™)

DEVICEConventional dental syringe injection

Conventional dental syringe injection

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

DEVICE_FEASIBILITY

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Pain perception survey	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)

Countries

Saudi Arabia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026