NCT07288125

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 27, 2025

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 3, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 4, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 17, 2025

Completed
Last Updated

December 23, 2025

Status Verified

December 1, 2025

Enrollment Period

2 months

First QC Date

December 4, 2025

Last Update Submit

December 16, 2025

Conditions

Keywords

Cold Atmospheric PlasmaLocal AnesthesiaInjection PainDental Anxiety

Outcome Measures

Primary Outcomes (1)

  • Pain Intensity During Local Anesthesia 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 Outcomes (1)

  • Patient satisfaction related to the injection experience

    Immediately after injection

Study Arms (2)

CAP

EXPERIMENTAL

Cold Atmospheric Plasma applied before injection

Other: Cold Atmospheric Plasma

Control

ACTIVE COMPARATOR

No pretreatment, standard injection only

Other: No pretreatment

Interventions

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

Control

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.

CAP

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kahramanmaras Sutcu Imam University, Faculty of Dentistry

Kahramanmaraş, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Interventions

Plasma Gases

Intervention Hierarchy (Ancestors)

GasesInorganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 4, 2025

First Posted

December 17, 2025

Study Start

September 1, 2025

Primary Completion

October 27, 2025

Study Completion

November 3, 2025

Last Updated

December 23, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations