Cryotherapy as a Topical Anesthetic in Healthy Children
NCT07198022 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2026-02-09
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
- Cryotherapy
- Pediatric Dentistry
- Healthy
- Topical Anesthesia
Interventions
- 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.
Sponsors & Collaborators
-
Ondokuz Mayıs University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 7 Years
- Max Age
- 10 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-09-01
- Primary Completion
- 2026-01-15
- Completion
- 2026-01-15
Countries
- Turkey (Türkiye)
Study Locations
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