Cryotherapy as a Topical Anesthetic in Healthy Children

Ondokuz Mayıs University

Status and phase: Active, not recruiting; Phase 4

Conditions: Healthy; Cryotherapy; Pediatric Dentistry; Topical Anesthesia

Treatments: Drug: Cryotherapy; Drug: topical anesthetic; Drug: Placebo; Drug: Topical anesthetic gel

Study type: Interventional

Funder types: Other

Identifiers

NCT07198022

2024000316

Details and patient eligibility

About

In this study, we 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. Their mission is to answer the questionnaires correctly and cooperate the treatment. Participanst will be divided into 5 groups containing 25 child per group:

• First group: topical anesthetic solution.
• Second group: topical anesthetic gel
• Third group: Cryotherapy as distilled water
• Fourth group: Cryotherapy as topical anesthetic solution.
• Fifth group: Placebo group All participants will answer questionnaire of pain, anxiety and taste. Their oxygen saturation and pulses will be measured with a pulse-oxymeter device to be recorded.

Enrollment: 125 patients

Sex: All

Ages: 7 to 10 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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125 participants in 5 patient groups, including a placebo group

Topical Anesthetic Solution

Active Comparator group

Description:

In spray group, as a topical anaesthetic solution containing 10% lidocaine will be applied to the injection site with the help of a pressel for 20 seconds after the application area is dried by squeezing a cotton pellet. The taste/odour evaluation of the applied topical anaesthetic material will be measured with the 3 Category Hedonic Scale. After sufficient numbness is achieved, local infiltrative injection will be performed. Anxiety levels will be evaluated by measuring with the same parameters before topical anaesthesia application, during topical anaesthesia application and injection.

Treatment:

Drug: topical anesthetic

Topical Anesthetic Gel

Experimental group

Description:

In topical anesthetic gel group, a gel containing %20 benzocain with strawberry aroma, will be applied to the injection site with the help of a pressel for 20 seconds after the application area is dried by squeezing a cotton pellet. The taste/odour evaluation of the applied topical anaesthetic material will be measured with the 3 Category Hedonic Scale. After sufficient numbness is achieved, local infiltrative injection will be performed. Anxiety levels will be evaluated by measuring with the same parameters before topical anaesthesia application, during topical anaesthesia application and injection.

Treatment:

Drug: Topical anesthetic gel

Cryotherapy as Distilled Water

Experimental group

Description:

As cryotherapy material, distilled water solution will be cooled in the refrigerator at +4 degrees, removed from the refrigerator just before the application and a cotton swab will be wetted with this solution and applied to the area. The taste/odour evaluation of the applied topical anaesthetic material will be measured with 3 Category Hedonic Scale. After sufficient numbness is achieved, local infiltrative injection will be performed. Anxiety levels will be evaluated by measuring with the same parameters before, during and after topical anaesthesia application and injection.

Treatment:

Drug: Cryotherapy

Cryotherapy as Anesthetic Solution

Experimental group

Description:

The topical anaesthetic solution will be stored in the refrigerator at +4 degrees Celsius, removed from the refrigerator just before the application and a cotton swab will be wetted with this solution and applied to the area. The taste/odour evaluation of the applied topical anaesthetic material will be measured with 3 Category Hedonic Scale. After sufficient numbness is achieved, local infiltrative injection will be performed. Anxiety levels will be evaluated by measuring with the same parameters before, during and after topical anaesthesia application and injection.

Treatment:

Drug: topical anesthetic

Drug: Cryotherapy

Placebo

Placebo Comparator group

Description:

The group who chooses the number 5 which implies placebo, will be informed to have the standard topical anesthetic spray. The procedure will be conducted with only dry cotton pellet implementation for 20 seconds, then waiting after waiting for a while, injecting the local anesthetic to the related area. Pulse and oxygen saturation will be recorded identically as the other groups.

Treatment:

Drug: Placebo