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

NCT07498621 | Completed

• 1 other identifier: 190-11-24
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain Perception of the New Device

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Pain perception survey

  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

  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

Study Arms (2)

Standard needle injection dental syringe

ACTIVE COMPARATOR

Device: Conventional dental syringe injection

Needle free injector

ACTIVE COMPARATOR

Device: needle-free anesthesia jet (Comfort-in™)

Interventions

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

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

Needle free injector

Conventional dental syringe injection DEVICE

Conventional dental syringe injection

Standard needle injection dental syringe

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Abdulaziz University: lead

Study Sites (1)

King Abdulaziz University

Jeddah, Saudi Arabia

Location

Related Publications (20)

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  BACKGROUND

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  BACKGROUND

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  PMID: 35580835 BACKGROUND

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  PMID: 36579904 BACKGROUND

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  PMID: 40750288 BACKGROUND

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  BACKGROUND

• Shareef RA, Chaturvedi S, Suleman G, Elmahdi AE, Elagib MFA. Analysis of tooth extraction causes and patterns. Open Access Macedonian J Med Sci 2020; 8:36-41.

  BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DEVICE FEASIBILITY
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: March 14, 2026
• First Posted: March 27, 2026
• Study Start: January 1, 2025
• Primary Completion: June 30, 2025
• Study Completion: July 30, 2025
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)