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Completed

NCT Number: NCT07288125

Effect of Cold Atmospheric Plasma on Patient Comfort During Dental Anesthesia

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.

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Key information

Conditions

Cold Atmospheric Plasma Dental Anesthesia

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kahramanmaras Sutcu Imam University, Faculty of Dentistry

Kahramanmaraş, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cold Atmospheric Plasma

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.

No pretreatment

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Kahramanmaras Sutcu Imam University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 17, 2025
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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