Topical Cryoanesthesia Versus Benzocaine in Pediatric Dentistry

NCT07351383 | Completed Phase 3

• 2 other identifiers: U.A.S.L.P.No funding
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Topical dental anesthesia; Children; Anesthesia punction; Pain perception; Cryoanesthesia; Benzocaine

Outcome Measures

Primary Outcomes (1)

• Pain perception

  Pain intensity was assessed using a validated instrument: Wong-Baker FACES® Pain Rating Scale (Visual Analog Scale): Immediately following completion of infiltration anesthesia injection, the participant was asked to indicate the level of pain experienced using the face scale (0 = no hurt to 10 = hurts worst).

  Baseline: At the time of the anesthetic injection (or needle puncture) at the oral mucosa.

Secondary Outcomes (3)

• Heart Rate

  Periprocedural: During the injection anesthetic procedure, from the anesthetic solution injection to the removal of the needle (approximately 45 seconds)

• Oxygen saturation

  Periprocedural: During the injection anesthetic procedure, from the needle puncture to the removal of the needle (approximately 45 seconds).

• Patient's behavioral response

  Periprocedural: 45 seconds, from the anesthetic injection to the removal of the needle.

Study Arms (2)

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

EXPERIMENTAL

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.

Procedure: Local Anesthesia (lidocaine hydrochloride)

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

ACTIVE COMPARATOR

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

Procedure: Local Anesthesia (lidocaine hydrochloride)

Interventions

Local Anesthesia (lidocaine hydrochloride) PROCEDURE

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.

Benzocaine group: Topical anesthesia using 20% benzocaine, before anesthetic punction.; Cryanesthesia. Topical anesthesia using application of ice cones, before anesthesic punction.

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Autonoma de San Luis Potosí: lead

Study Sites (1)

Pediatric Dentistry Postgraduate Program, Faculty of Denttistry

San Luis Potosí City, S.l.p., 78990, Mexico

Location

Related Publications (3)

• Ninawe N, Anija CK. Comparative Evaluation of Effectiveness of Benzocaine Gel and Ice for Pain Management in Children during Local Anesthetic Administration by CCLAD: A Randomized Controlled Trial. Int J Clin Pediatr Dent. 2025 Jan;18(1):19-23. doi: 10.5005/jp-journals-10005-3045. Epub 2025 Feb 14.

  PMID: 40110448 BACKGROUND

• Tirupathi SP, Rajasekhar S. Effect of precooling on pain during local anesthesia administration in children: a systematic review. J Dent Anesth Pain Med. 2020 Jun;20(3):119-127. doi: 10.17245/jdapm.2020.20.3.119. Epub 2020 Jun 24.

  PMID: 32617406 BACKGROUND

• Lathwal G, Pandit IK, Gugnani N, Gupta M. Efficacy of Different Precooling Agents and Topical Anesthetics on the Pain Perception during Intraoral Injection: A Comparative Clinical Study. Int J Clin Pediatr Dent. 2015 May-Aug;8(2):119-22. doi: 10.5005/jp-journals-10005-1296. Epub 2015 Aug 11.

  PMID: 26379379 BACKGROUND

Related Links

• Step-by-step instructions for performing oral cryotherapy

MeSH Terms

Interventions

Anesthesia, Local; Lidocaine

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Amaury Pozos Guillén, Ph.D.

  Universidad Autónoma de San Luis Potosi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: 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).

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: January 20, 2026
• Study Start: June 15, 2025
• Primary Completion: October 10, 2025
• Study Completion: November 25, 2025
• Last Updated: January 20, 2026

Record last verified: 2025-12

Locations

ME (1)