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Topical Cryoanesthesia Versus Benzocaine in Pediatric Dentistry

NCT07351383 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2026-01-20

No results posted yet for this study

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.

Conditions

  • Local Anesthetic Infiltration
  • Topical Anesthesia
  • Pain Perception

Interventions

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 Needle carefully withdrawn following injection completion.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

Sponsors & Collaborators

  • Universidad Autonoma de San Luis Potosí

    lead OTHER

Principal Investigators

  • Amaury Pozos Guillén, Ph.D. · Universidad Autónoma de San Luis Potosi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-15
Primary Completion
2025-10-10
Completion
2025-11-25

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07351383 on ClinicalTrials.gov