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OpenTrials
Completed

NCT Number: NCT07498621

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

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.

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Key information

Conditions

Pain Perception of the New Device

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King Abdulaziz University

Jeddah, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

needle-free anesthesia jet (Comfort-in™)

Device

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

Conventional dental syringe injection

Device

Conventional dental syringe injection

Primary outcomes

  1. 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)

  2. 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)

Sponsors and collaborators

Lead sponsor

King Abdulaziz University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 27, 2026
Registry last updated
Mar 27, 2026

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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