Assessment of Pain and Anxiety During Infiltration Anesthesia Using Dental Anesthesia Injector Versus Conventional Syringe in Pediatric Patients

Ain Shams University

Status: Enrolling

Conditions: Dental Caries; Reversible Pulpitis

Treatments: Device: Dental Anesthesia Injector; Other: conventional syringe

Study type: Interventional

Funder types: Other

Identifiers

NCT07101068

FDSU-Rec IMO12441

Details and patient eligibility

About

This randomized controlled trial is conducted on pediatric dental patients to compare the effectiveness of local anesthesia administered using a dental anesthesia injector device versus the traditional syringe method. The study aims to assess and compare pain and anxiety levels associated with both methods, using both subjective (self-reported) and objective measures. The goal is to identify an alternative technique that minimizes pain and anxiety in pediatric dental patients.

Full description

This randomized controlled split-mouth clinical trial aims to assess pain and anxiety in pediatric dental patients during and immediately after the administration of local anesthesia using a dental anesthesia injector device compared to a conventional syringe.

The study will include healthy, cooperative children aged 6 to 8 years, each having at least one vital deeply carious maxillary primary molar with signs and symptoms of reversible pulpitis on each side of the maxilla requiring buccal infiltration anesthesia prior to pulpotomy.

Each child will receive both injection techniques on separate occasions, with random assignment of the injection method to either the right or left side (split-mouth design).

To evaluate pain and anxiety, the following tools will be used:

Pain: Visual Analogue Scale (VAS) Anxiety: Corah Dental Anxiety Scale Physiological measures: Heart rate and oxygen saturation levels, recorded using a pulse oximeter Data will be collected during and immediately after the injection. The aim is to determine whether the dental anesthesia injector provides a less painful and less anxiety-inducing experience compared to the traditional syringe method.

Enrollment: 40 estimated patients

Sex: All

Ages: 6 to 8 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• normal healthy patients (ASA I)
• Undergoing the first dental local anesthesia experience
• Presence of one at least vital deeply carious maxillary primary molar indicated for pulpotomy on each side of maxilla
• Score 3 or 4 of Frankl scale of child behavior

Exclusion criteria

• Presence of gingivitis, dental abscess, facial trauma/ injury
• Administration of analgesic 48 h before randomization
• Presence of allergy from local anesthesia

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

Dental Anesthesia Injector

Experimental group

Description:

Topical anesthesia lidocain for 1 minute will be applied on previously dried mucosa. Local anesthesia administration( artican 4% +1/100,000 With extra short needles 30G-10mm ) using Dental Anesthesia injector .

Treatment:

Device: Dental Anesthesia Injector

Conventional syringe

Active Comparator group

Description:

Topical anesthesia lidocain for 1 minute will be applied on previously dried mucosa. Local anesthesia administration( artican 4% +1/100,000 With extra short needles 30G-10mm ) using conventional syringe

Treatment:

Other: conventional syringe