Effect of Cold Atmospheric Plasma on Patient Comfort During Dental Anesthesia

NCT ID: NCT07288125

Last Updated: 2025-12-23

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-01

Study Completion Date

2025-11-03

Brief Summary

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This study aims to investigate the effectiveness of cold atmospheric plasma, a laser-like biophysical method, in reducing injection pain experienced during local infiltration anesthesia in dental treatments. The purpose is to determine whether applying cold atmospheric plasma before the injection can decrease the level of pain at the injection site and improve patient comfort.

In this study, to help reduce the pain felt during the dental injection, some patients will receive a cold plasma application before the needle is administered. The device is held close to the gum area where the injection will be given-without touching the tissue-for about one minute to help the area relax. Afterwards, the standard local anesthetic injection is performed. On the opposite side of the mouth, only the normal injection will be given. Pain levels on both sides and patient satisfaction will be recorded through questions asked after the procedure.

If you choose to participate in this research, your dental treatments will still be completed, and the pain felt during the injection may be reduced. Additionally, by participating, you will contribute to scientific knowledge and to the development of a potential future treatment option.

Detailed Description

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Conditions

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Cold Atmospheric Plasma Dental Anesthesia

Keywords

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Cold Atmospheric Plasma Local Anesthesia Injection Pain Dental Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Control

No pretreatment, standard injection only

Group Type ACTIVE_COMPARATOR

No pretreatment

Intervention Type OTHER

No pretreatment is applied. The control side receives only the standard buccal local infiltration anesthesia.

CAP

Cold Atmospheric Plasma applied before injection

Group Type EXPERIMENTAL

Cold Atmospheric Plasma

Intervention Type OTHER

Cold atmospheric plasma is applied to the oral mucosa at the planned injection site for 30 seconds using a non-contact atmospheric plasma device before local infiltration anesthesia.

Interventions

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Cold Atmospheric Plasma

Cold atmospheric plasma is applied to the oral mucosa at the planned injection site for 30 seconds using a non-contact atmospheric plasma device before local infiltration anesthesia.

Intervention Type OTHER

No pretreatment

No pretreatment is applied. The control side receives only the standard buccal local infiltration anesthesia.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Being between 18 and 40 years of age;
* American Society of Anesthesiologists (ASA) physical status classification I (systemically healthy);
* No known allergy or intolerance to local anesthetic agents or cold atmospheric plasma (CAP);
* Presence of similar bilateral dental treatment indications in the maxilla or mandible.

Exclusion Criteria

* Pregnancy or breastfeeding;
* Presence of active lesions, ulceration, or signs of infection in the mucosa at the injection site;
* Immunodeficiency or systemic immunosuppressive therapy;
* Use of anticoagulant medications;
* Previous exposure to CAP therapy for any purpose;
* History of allergy to local anesthetic agents;
* Presence of neurological or psychiatric disorders that may affect pain perception.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kahramanmaras Sutcu Imam University

OTHER

Sponsor Role lead

Responsible Party

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Izzet Acikan

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kahramanmaras Sutcu Imam University, Faculty of Dentistry

Kahramanmaraş, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Jagtap B, Bhate K, Magoo S, S N S, Gajendragadkar KS, Joshi S. Painless injections-a possibility with low level laser therapy. J Dent Anesth Pain Med. 2019 Jun;19(3):159-165. doi: 10.17245/jdapm.2019.19.3.159. Epub 2019 Jun 30.

Reference Type RESULT
PMID: 31338422 (View on PubMed)

Ucar G, Sermet Elbay U, Elbay M. Effects of low level laser therapy on injection pain and anesthesia efficacy during local anesthesia in children: A randomized clinical trial. Int J Paediatr Dent. 2022 Jul;32(4):576-584. doi: 10.1111/ipd.12936. Epub 2022 Feb 8.

Reference Type RESULT
PMID: 34738278 (View on PubMed)

Other Identifiers

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Harran university HRÜ/25.13.39

Identifier Type: -

Identifier Source: org_study_id