Cryotherapy as a Topical Anesthetic in Healthy Children

NCT07198022 | Completed Phase 4

• 1 other identifier: 2024000316
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

topical anesthetic; cryotherapy; injection; children

Outcome Measures

Primary Outcomes (1)

• 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.

  From the beginning of the topical anesthetic implementation to the injection

Study Arms (4)

Topical Anesthetic Solution

ACTIVE COMPARATOR

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.

Drug: topical anesthetic

Topical Anesthetic Gel

EXPERIMENTAL

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.

Drug: Topical anesthetic gel

Cryotherapy as Distilled Water

EXPERIMENTAL

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.

Drug: Cryotherapy

Cryotherapy as Anesthetic Solution

EXPERIMENTAL

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.

Drug: Cryotherapy; Drug: topical anesthetic

Interventions

Cryotherapy DRUG

Using crytotherapy as topical anesthetic

Cryotherapy as Anesthetic Solution; Cryotherapy as Distilled Water

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.

Cryotherapy as Anesthetic Solution; Topical Anesthetic Solution

Topical anesthetic gel DRUG

Tolerable taste, containing benzocaine at gel formula.

Topical Anesthetic Gel

Eligibility Criteria

• Age: 7 Years - 10 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Ondokuz Mayıs University, Faculty of Dentistry

Samsun, Turkey (Türkiye)

Location

Related Publications (8)

• Lee HS. Recent advances in topical anesthesia. J Dent Anesth Pain Med. 2016 Dec;16(4):237-244. doi: 10.17245/jdapm.2016.16.4.237. Epub 2016 Dec 31.

  PMID: 28879311 BACKGROUND

• Kravitz ND. The use of compound topical anesthetics: a review. J Am Dent Assoc. 2007 Oct;138(10):1333-9; quiz 1382. doi: 10.14219/jada.archive.2007.0048.

  PMID: 17908846 BACKGROUND

• Kwiecien SY, McHugh MP. The cold truth: the role of cryotherapy in the treatment of injury and recovery from exercise. Eur J Appl Physiol. 2021 Aug;121(8):2125-2142. doi: 10.1007/s00421-021-04683-8. Epub 2021 Apr 20.

  PMID: 33877402 BACKGROUND

• Garcia C, Karri J, Zacharias NA, Abd-Elsayed A. Use of Cryotherapy for Managing Chronic Pain: An Evidence-Based Narrative. Pain Ther. 2021 Jun;10(1):81-100. doi: 10.1007/s40122-020-00225-w. Epub 2020 Dec 14.

  PMID: 33315183 BACKGROUND

• Malanga GA, Yan N, Stark J. Mechanisms and efficacy of heat and cold therapies for musculoskeletal injury. Postgrad Med. 2015 Jan;127(1):57-65. doi: 10.1080/00325481.2015.992719. Epub 2014 Dec 15.

  PMID: 25526231 BACKGROUND

• Nadler SF, Weingand K, Kruse RJ. The physiologic basis and clinical applications of cryotherapy and thermotherapy for the pain practitioner. Pain Physician. 2004 Jul;7(3):395-9.

  PMID: 16858479 BACKGROUND

• Ghaderi F, Banakar S, Rostami S. Effect of pre-cooling injection site on pain perception in pediatric dentistry: "A randomized clinical trial". Dent Res J (Isfahan). 2013 Nov;10(6):790-4.

  PMID: 24379869 BACKGROUND

• Lakshmanan L, Ravindran V. Efficacy of Cryotherapy Application on the Pain Perception during Intraoral Injection: A Randomized Controlled Trial. Int J Clin Pediatr Dent. 2021 Sep-Oct;14(5):616-620. doi: 10.5005/jp-journals-10005-2032.

  PMID: 34934271 BACKGROUND

Related Links

• During the planning period of our study, the investigators searched the literature. For the study method, the investigators were inspired and innovated from literature, the link aforehead belongs to the inspirational source.

MeSH Terms

Interventions

Cryotherapy; Anesthetics, Local

Intervention Hierarchy (Ancestors)

Therapeutics; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc.Prof.Bilal OZMEN

Study Record Dates

• First Submitted: September 25, 2025
• First Posted: September 30, 2025
• Study Start: September 1, 2025
• Primary Completion: January 15, 2026
• Study Completion: January 15, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)