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

King Abdulaziz University

Status: Completed

Conditions: Pain Perception of the New Device

Treatments: Device: needle-free anesthesia jet (Comfort-in™); Device: Conventional dental syringe injection

Study type: Interventional

Funder types: Other

Identifiers

NCT07498621

190-11-24

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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10 participants in 2 patient groups

Standard needle injection dental syringe

Active Comparator group

Treatment:

Device: Conventional dental syringe injection

Needle free injector

Active Comparator group

Treatment:

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