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AzTrials

HealthyPhase 4NCT07198022

Cryotherapy as a Topical Anesthetic in Healthy Children

A Phase 4 study testing Cryotherapy, topical anesthetic and Topical anesthetic gel in people with Healthy and Topical Anesthesia, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 7 to 10 yearsHealthy volunteers can take part
Conditions the study is for
Healthy, Topical Anesthesia, Pediatric Dentistry
What is being tested?
Cryotherapy, topical anesthetic and Topical anesthetic gel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Sep 2025to 15 Jan 2026
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 10 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Ondokuz Mayıs University, Faculty of Dentistry

    Samsun

Other trials in Turkey (Türkiye)

About this study

Official title: Comparative Evaluation of Application of Topical Anesthetic Gel, Solution and Cryotherapy

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?
Read more

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.
Being tested
Cryotherapy, topical anesthetic, Topical anesthetic gel
Keywords
topical anesthetic, cryotherapy, injection, children

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT07198022
Study groupRoleWhat they receive
Topical Anesthetic SolutionActive comparatorIn 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.
Receives: Drug: topical anesthetic
Topical Anesthetic GelExperimentalIn 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.
Receives: Drug: Topical anesthetic gel
Cryotherapy as Distilled WaterExperimentalAs 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.
Receives: Drug: Cryotherapy
Cryotherapy as Anesthetic SolutionExperimentalThe 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.
Receives: Drug: Cryotherapy; Drug: topical anesthetic

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From the beginning of the topical anesthetic implementation to the injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2025
  2. Study start1 Sep 2025
  3. Primary completion15 Jan 2026
  4. Study completion15 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07198022
Sponsor's protocol ID
2024000316
Status last verified
Jan 2026
First submitted
25 Sep 2025
Last updated
9 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28879311

  • 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.

    PubMed 17908846

  • 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.

    PubMed 33877402

  • 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.

    PubMed 33315183

  • 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.

    PubMed 25526231

  • 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.

    PubMed 16858479

  • 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.

    PubMed 24379869

  • 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.

    PubMed 34934271

  • Aydin Cetin EZ, Ozmen B. Pain, sensory acceptability, and treatment compliance following cryotherapy and topical anesthetics in children: A randomized clinical trial. PLoS One. 2026 Nov 3;21(11):e0362074. doi: 10.1371/journal.pone.0362074. eCollection 2026.

    PubMed 42976146

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Cryotherapy, topical anesthetic and Topical anesthetic gel in people with Healthy and Topical Anesthesia, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Eased Injection Pain (time frame: From the beginning of the topical anesthetic implementation to the injection). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07198022, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.

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