Cryotherapy as a Topical Anesthetic in Healthy Children
NCT ID: NCT07198022
Last Updated: 2025-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
125 participants
INTERVENTIONAL
2025-09-01
2026-02-01
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Topical Anesthetic Solution
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.
topical anesthetic
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
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.
Topical anesthetic gel
Tolerable taste, containing benzocaine at gel formula.
Cryotherapy as Distilled Water
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.
Cryotherapy
Using crytotherapy as topical anesthetic
Cryotherapy as Anesthetic Solution
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.
Cryotherapy
Using crytotherapy as topical anesthetic
topical anesthetic
Comparing the two versions (the room temperature and + 4°C) of the gold standard of local anesthetics, the solution, which contains lidocaine.
Placebo
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.
Placebo
The placebo participants will be informed to have the standard topical anesthetic spray.
Interventions
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Cryotherapy
Using crytotherapy as topical anesthetic
topical anesthetic
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
Tolerable taste, containing benzocaine at gel formula.
Placebo
The placebo participants will be informed to have the standard topical anesthetic spray.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
7 Years
10 Years
ALL
Yes
Sponsors
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Ondokuz Mayıs University
OTHER
Responsible Party
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Bilal OZMEN
Assoc.Prof.Bilal OZMEN
Locations
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Ondokuz Mayıs University, Faculty of Dentistry
Samsun, , Turkey (Türkiye)
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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2024000316
Identifier Type: -
Identifier Source: org_study_id
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