Cold Atmospheric PlasmaNCT07288125
Effect of Cold Atmospheric Plasma on Patient Comfort During Dental Anesthesia
A study testing Cold Atmospheric Plasma and No pretreatment in people with Cold Atmospheric Plasma and Dental Anesthesia, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Cold Atmospheric Plasma, Dental Anesthesia
- What is being tested?
- Cold Atmospheric Plasma and No pretreatment
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2025to 3 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kahramanmaras Sutcu Imam University, Faculty of Dentistry
Kahramanmaraş
About this study
Official title: 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.
- Conditions
- Cold Atmospheric Plasma, Dental Anesthesia
- Being tested
- Cold Atmospheric Plasma, No pretreatment
- Keywords
- Cold Atmospheric Plasma, Local Anesthesia, Injection Pain, Dental Anxiety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold Atmospheric PlasmaOther
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 pretreatmentOther
No pretreatment is applied. The control side receives only the standard buccal local infiltration anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| CAP | Experimental | Cold Atmospheric Plasma applied before injection Receives: Other: Cold Atmospheric Plasma |
| Control | Active comparator | No pretreatment, standard injection only Receives: Other: No pretreatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Immediately after injection
Secondary outcomes (1)
Patient satisfaction related to the injection experience
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.
Measured: Immediately after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start1 Sep 2025
- Primary completion27 Oct 2025
- Study completion3 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cold Atmospheric PlasmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Izzet Acikan, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07288125
- Sponsor's protocol ID
- Harran university HRÜ/25.13.39
- Status last verified
- Dec 2025
- First submitted
- 4 Dec 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31338422Ucar 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.
PubMed 34738278
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cold Atmospheric Plasma on Patient Comfort During Dental Infiltration Anesthesia: A Randomized Controlled Split-Mouth Clinical Trial
- ClinicalTrials.gov ID
- NCT07288125
- Acronym / sponsor ID
- Harran university HRÜ/25.13.39
- Conditions
- Cold Atmospheric Plasma, Dental Anesthesia
- Keywords
- Cold Atmospheric Plasma, Local Anesthesia, Injection Pain, Dental Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 27 Oct 2025 (actual)
- Study completion
- 3 Nov 2025 (actual)
- First posted
- 17 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAP | Experimental | Other: Cold Atmospheric PlasmaCold Atmospheric Plasma applied before injection |
| Control | Active comparator | Other: No pretreatmentNo pretreatment, standard injection only |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cold Atmospheric PlasmaCold 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. | Other | CAP |
| No pretreatmentNo pretreatment is applied. The control side receives only the standard buccal local infiltration anesthesia. | Other | Control |
Primary outcome
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
1 secondary outcome
Patient satisfaction related to the injection experience
Time frame: Immediately after injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Results publication: PubMed 31338422Jagtap 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.
- Results publication: PubMed 34738278Ucar 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold Atmospheric Plasma and No pretreatment in people with Cold Atmospheric Plasma and Dental Anesthesia, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity During Local Anesthesia Injection (time frame: Immediately after injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07288125, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.