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NCT Number: NCT07198022

Cryotherapy as a Topical Anesthetic in Healthy Children

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.

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Key information

Conditions

Healthy Cryotherapy Pediatric Dentistry Topical Anesthesia

Age range

7 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ondokuz Mayıs University, Faculty of Dentistry

Samsun, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 7 to 10 years old,
  • Literate,
  • ASA score 1 and 2,
  • FRANKL score 3 and 4
  • Modified Dental Anxiety score less than 19,
  • Not allergic to the active ingredient of the topical anaesthetics used
  • Indication for treatment of primary teeth,
  • Children who have never had dental treatment under local anaesthesia,
  • Patients who agree to participate in the study will be included in the study

Exclusion criteria

  • Not between the ages of 7 and 10,
  • Illiterate,
  • ASA score greater than 2,
  • FRANKL score 1 and 2
  • Modified Dental Anxiety score greater than 19,
  • Known allergy to the active ingredient of the topical anaesthetics used
  • Children with previous dental experience will not be included in the study

Treatment and study plan

CRYOTHERAPY

Drug

Using crytotherapy as topical anesthetic

Topical anesthetic

Drug

Comparing the two versions (the room temperature and + 4°C) of the gold standard of local anesthetics, the solution, which contains lidocaine.

Topical anesthetic gel

Drug

Tolerable taste, containing benzocaine at gel formula.

Primary outcomes

  1. Number of Participants with Eased Injection Pain

    Time frame: From the beginning of the topical anesthetic implementation to the injection

    During the procedure, all of the data of the participants containing oxygen saturation, pulse and questionnaire about their experience will be collected to assess the statistical differences between groups.

Sponsors and collaborators

Lead sponsor

Ondokuz Mayıs University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 30, 2025
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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