NCT07351383

Topical Cryoanesthesia Versus Benzocaine in Pediatric Dentistry

Comparison of Topical Cryoanethesia and Benzocaine in Pain Perception During Mandibular Nerve Block in Pediatric Patients: A Randomized Controlled Clinical Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Universidad Autonoma de San Luis Potosí · Academic / Other
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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).

Conditions

• Local Anesthetic Infiltration
• Topical Anesthesia
• Pain Perception

Interventions

Type	Name	Description
PROCEDURE	Local Anesthesia (lidocaine hydrochloride)	After topical anesthesia (either technique), the clinician proceeded with conventional inferior alveolar nerve block using standardized technique: 1. Patient positioned recumbent in dental chair with mouth held open. 2. Palpation of ipsilateral mandibular condyle by clinician's non-dominant hand. 3. Cheek retracted with non-dominant hand to improve visualization. 4. Long needle (27-gauge, 32 mm) inserted at horizontal level of contralateral mandibular canine, directed toward insertion of lateral pterygoid muscle below maxillary tuberosity. 5. Needle advanced to contact medial mandibular wall (lingual surface). 6. Aspiration performed to rule out intravascular needle placement. 7. Injection of local anesthetic solution (1.8 mL of 2% lidocaine with 1:100,000 epinephrine). 8. Needle carefully withdrawn following injection completion.
PROCEDURE	Local Anesthesia (lidocaine hydrochloride)	After topical anesthesia (either technique), the clinician proceeded with conventional inferior alveolar nerve block using standardized technique: 1. Patient positioned recumbent in dental chair with mouth held open 2. Palpation of ipsilateral mandibular condyle by clinician's non-dominant hand 3. Cheek retracted with non-dominant hand to improve visualization 4. Long needle (27-gauge, 32 mm) inserted at horizontal level of contralateral mandibular canine, directed toward insertion of lateral pterygoid muscle below maxillary tuberosity 5. Needle advanced to contact medial mandibular wall (lingual surface) 6. Aspiration performed to rule out intravascular needle placement 7. Injection of local anesthetic solution (1.8 mL of 2% lidocaine with 1:100,000 epinephrine) 8. Needle carefully withdrawn following injection completion

Timeline

• Start date: 2025-06-15
• Primary completion: 2025-10-10
• Completion: 2025-11-25
• First posted: 2026-01-20
• Last updated: 2026-01-20

Locations

1 site across 1 country: Mexico