Cryotherapy as a Topical Anesthetic in Healthy Children

Phase 4CompletedNCT07198022

Ondokuz Mayıs University100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

100

Conditions

Healthy Topical Anesthesia Pediatric Dentistry

Interventions

CryotherapyDRUG

Using crytotherapy as topical anesthetic

topical anestheticDRUG

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

Topical anesthetic gelDRUG

Tolerable taste, containing benzocaine at gel formula.

Eligibility

Sex: ALLMin age: 7 YearsMax age: 10 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of Participants with Eased Injection Pain

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.

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