Effect of Cold Atmospheric Plasma on Patient Comfort During Dental Anesthesia
The Effect of Cold Atmospheric Plasma on Patient Comfort During Dental Infiltration Anesthesia: A Randomized Controlled Split-Mouth Clinical Trial
1 other identifier
interventional
30
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 27, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 3, 2025
CompletedFirst Submitted
Initial submission to the registry
December 4, 2025
CompletedFirst Posted
Study publicly available on registry
December 17, 2025
CompletedDecember 23, 2025
December 1, 2025
2 months
December 4, 2025
December 16, 2025
Conditions
Keywords
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
EXPERIMENTALCold Atmospheric Plasma applied before injection
Control
ACTIVE COMPARATORNo pretreatment, standard injection only
Interventions
No pretreatment is applied. The control side receives only the standard buccal local infiltration anesthesia.
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.
Eligibility Criteria
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)
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.
PMID: 31338422RESULTUcar 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.
PMID: 34738278RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
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