Topical Cryoanesthesia Versus Benzocaine in Pediatric Dentistry (No acronym)

Universidad Autonoma de San Luis Potosí

Status and phase: Completed; Phase 3

Conditions: Local Anesthetic Infiltration; Pain Perception; Topical Anesthesia

Treatments: Procedure: Local Anesthesia (lidocaine hydrochloride)

Study type: Interventional

Funder types: Other

Identifiers

NCT07351383

No funding

U.A.S.L.P.

Details and patient eligibility

About

This clinical study tested and compared two ways (cold-base technique or "cryoanesthesia" and conventional benzocaine gel) to reduce pain from dental injections in children.

Researchers worked with 28 children between 6 and 12 years old who needed injections on both sides of the lower jaw for dental treatment. Each child received cryoanesthesia on one side and 20% benzocaine gel on the other side, in different appointments, and the team measured pain, behavior, heart rate, and blood oxygen levels.

Full description

Objective: To evaluate and compare pain perception during inferior alveolar nerve block puncture in pediatric patients using cryoanesthesia versus conventional topical benzocaine anesthesia.

Methods: A split-mouth randomized controlled clinical trial was conducted with 28 patients aged 6 to 12 years requiring bilateral inferior alveolar nerve blocks for bilateral lower arch dental treatment. Each participant received both anesthetic techniques in a randomized order on separate appointments, with treatment allocated to contralateral mandibular hemiarches. Primary and secondary outcome measures included pain intensity (Visual Analog Scale), heart rate, oxygen saturation, and behavioral response (FLACC scale).

Enrollment: 28 patients

Sex: All

Ages: 6 to 12 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Systemic health: No significant medical history or uncontrolled systemic disease.
• Bilateral dental pathology requiring treatment: At least two teeth (one per mandibular hemiarch) requiring bilateral inferior alveolar nerve blocks for restorative or endodontic treatment.
• Cooperation level: Frankl behavioral rating scale classification III or IV (positive or very positive).
• Informed consent/Child assent: Signed informed consent from parent or legal guardian; signed assent from participant (age-appropriate).

Exclusion criteria

• Acute dental emergency requiring immediate treatment.
• Known hypersensitivity or allergy to benzocaine or other local anesthetics.
• Known hypersensitivity to cold (cryophobia or cold urticaria).
• Significant dental anxiety or phobia precluding study participation.
• Developmental delay or behavioral disorders limiting communication or cooperation.
• Current use of medications affecting pain perception or hemodynamic parameters.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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28 participants in 2 patient groups

Cryanesthesia. Topical anesthesia using application of ice cones, before anesthesic punction.

Experimental group

Description:

Ice cones were prepared using sterile, individual-sized latex gloves filled with purified, sterile water. The open end of each glove was sealed and the glove was placed in a freezer (temperature: -18°C to -20°C) for minimum 24 hours prior to use. This produced a textured ice cone of approximately 5 cm × 3 cm suitable for direct application to the infiltration site. 1. The application site (infiltration area on mucous membrane) was gently dried with sterile gauze. 2. The ice cone was applied directly to the area using gentle circular rubbing motions. 3. Duration of application: 60 seconds. 4. Assessment: Observation for tissue blanching (white appearance) indicating adequate cooling.

Treatment:

Procedure: Local Anesthesia (lidocaine hydrochloride)

Procedure: Local Anesthesia (lidocaine hydrochloride)

Benzocaine group: Topical anesthesia using 20% benzocaine, before anesthetic punction.

Active Comparator group

Description:

Benzocaine 20% Topical Anesthesia Technique: 1. The application site was gently dried with sterile gauze 2. Benzocaine 20% topical solution was applied using a sterile cotton applicator via gentle rubbing of the infiltration site 3. Duration of application: 60 seconds 4. No mechanical removal was performed; anesthetic was allowed to remain on tissue

Treatment:

Procedure: Local Anesthesia (lidocaine hydrochloride)

Procedure: Local Anesthesia (lidocaine hydrochloride)