Effect of Cold Atmospheric Plasma on Patient Comfort During Dental Anesthesia

December 16, 2025 updated by: Izzet Acikan, Kahramanmaras Sutcu Imam University

The Effect of Cold Atmospheric Plasma on Patient Comfort During Dental Infiltration Anesthesia: A Randomized Controlled Split-Mouth Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Kahramanmaraş, Turkey (Türkiye)
        • Kahramanmaras Sutcu Imam University, Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CAP
Cold Atmospheric Plasma applied before injection
Other: 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.
Active Comparator: Control
No pretreatment, standard injection only
Other: No pretreatment
No pretreatment is applied. The control side receives only the standard buccal local infiltration anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Intensity During Local Anesthesia Injection
Time Frame: Immediately after injection
The primary outcome was the intensity of pain experienced during the injection, assessed by the patient using a visual analog scale (VAS). The VAS ranged from 0 to 10, where 0 represented "no pain" and 10 represented "unbearable pain." Immediately after
Immediately after injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction related to the injection experience
Time Frame: Immediately after injection
Patient satisfaction will be assessed using a 15-item Likert-type questionnaire completed after both local anesthesia injections. Each item is scored on a 5-point Likert scale (1 = strongly disagree, 5 = strongly agree). Patients will rate their experiences for the CAP-treated side and the control side separately. The questionnaire includes both negative statements (e.g., insufficient information, fear of the device/procedure, perceived pain, negative emotions, unwillingness to repeat or recommend the procedure) and positive statements (e.g., adequate information, reduced fear, willingness to accept the method even with additional cost, increased motivation to continue treatment, overall satisfaction). Scores will be used to generate satisfaction profiles for each side.
Immediately after injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kahramanmaras Sutcu Imam University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2025

Primary Completion (Actual)

October 27, 2025

Study Completion (Actual)

November 3, 2025

Study Registration Dates

First Submitted

December 4, 2025

First Submitted That Met QC Criteria

December 4, 2025

First Posted (Estimated)

December 17, 2025

Study Record Updates

Last Update Posted (Actual)

December 23, 2025

Last Update Submitted That Met QC Criteria

December 16, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Harran university HRÜ/25.13.39

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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