NCT07198022

Cryotherapy as a Topical Anesthetic in Healthy Children

Comparative Evaluation of Application of Topical Anesthetic Gel, Solution and Cryotherapy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Ondokuz Mayıs University · Academic / Other
• Sex: All
• Age: 7 Years – 10 Years
• Healthy volunteers: Accepted

Summary

In this study, the investigators aimed to compare the effects of topical anesthetic materials and cold application on pain perception. The main questions it aims to answer are: * Is cold application is effective as a topical anesthetic replacement? * Is there a difference on pain perception between cold and room temperature topical anesthetic? The treatment contains of participants selected from a group of patients who requires dental treatment. The mission of the participants is to answer the questionnaires correctly and cooperate the treatment. Participants will be divided into 4 groups containing 25 child per group: * First group: topical anesthetic spray solution. * Second group: topical anesthetic gel * Third group: Cryotherapy as distilled water * Fourth group: Cryotherapy as topical anesthetic spray solution. All participants will answer questionnaire of pain, anxiety and taste. The oxygen saturation and pulses will be measured with a pulse-oxymeter device to be recorded.

Conditions

• Healthy
• Topical Anesthesia
• Pediatric Dentistry
• Cryotherapy

Interventions

Type	Name	Description
DRUG	Cryotherapy	Using crytotherapy as topical anesthetic
DRUG	topical anesthetic	Comparing the two versions (the room temperature and + 4°C) of the gold standard of local anesthetics, the solution, which contains lidocaine.
DRUG	Topical anesthetic gel	Tolerable taste, containing benzocaine at gel formula.

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-01-15
• Completion: 2026-01-15
• First posted: 2025-09-30
• Last updated: 2026-02-09

Locations

1 site across 1 country: Turkey (Türkiye)