This Study Evaluate the Patient Response to Jet Injection, Pain and Satisfaction Compared to Conventional Method of Local Anasthesia Especially in Maxillary Teeth

NCT07581249 | Completed FDA Device

• 1 other identifier: 1040125
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Pain during administration of local anesthesia remains one of the major concerns in dental practice, often leading to anxiety and treatment avoidance. Conventional syringe infiltration, while effective, is associated with discomfort during needle insertion and injection. This study aimed to evaluate the effectiveness, patient comfort, and clinical applicability of jet injection as a needle-free alternative for maxillary tooth extractions. A total of 80 adult patients were enrolled from the College of Dentistry, University of Baghdad, and Al-Amiriya Specialized Center for Dentistry between December 2024 and March 2025. Jet injection with 2% lidocaine and 1:100,000 epinephrine was delivered buccally and palatally using the Comfort-In system, and patient responses were assessed through a visual analog scale and Likert-based subjective feedback.

Conditions

Jet Injection; Local Anasthesia

Outcome Measures

Primary Outcomes (1)

• Visual Analogue pain Scale

  use of Visual Analogue pain Scale from 1-10 to assess the pain of injection

  "Perioperative/Periprocedural

Study Arms (2)

Observasional group

ACTIVE COMPARATOR

Device: Non aspirating dental syringe

Study group

EXPERIMENTAL

Use of jet injection

Device: The use of jet injection

Interventions

The use of jet injection DEVICE

The use of jet injectors to deliver anesthesia to upper jaw

Study group

Non aspirating dental syringe DEVICE

The use of non aspirating dental syringe for delivery anesthesia to upper jaw

Observasional group

Eligibility Criteria

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

You may qualify if:

• above 18 years of either gender
• had received dental anesthesia in the past with conventional syringe and needle
• required extraction on their maxillary teeth
• indicating their agreement to involving our study

You may not qualify if:

• adult with uncontrolled systemic conditions
• allergies to material used in this study
• patient who need surgical extraction
• intra-oral or facial swelling or presence of fistula or sinus tract
• patients who needed extraction to thier mandibular teeth patents refused to involve our study

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

University of Baghdad College of Dentistry

Baghdad, Iraq

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: August 31, 2025
• First Posted: May 12, 2026
• Study Start: December 15, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 15, 2025
• Last Updated: May 12, 2026

Record last verified: 2026-05

Locations

IR (1)