Cold Atmospheric PlasmaNCT07348770
Cold Plasma Effects on Dental Implant Stability
A study testing Dental implant placement, Dental implant placement and vacuum plasma application and Dental implant placement and argon jet plasma application in people with Cold Atmospheric Plasma and Dental Implants, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial summary
Cold plasma-mediated implant surface activation may reverse the biological aging of titanium by enhancing hydrophilicity and cellular response. The aim of this study was to clinically compare the effects of three different cold plasma systems on the stability of dental implants. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cold Atmospheric Plasma, Dental Implants
- What is being tested?
- Dental implant placement, Dental implant placement and vacuum plasma application and Dental implant placement and argon jet plasma application
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Feb 2025to 9 Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Presence of edentulous areas requiring ≥4 implants for fixed prosthetic rehabilitation.
- Good or moderate oral hygiene.
- Adequate patient compliance to attend all follow-up appointments.
- Willingness to voluntarily participate in the study.
Who cannot join
- Refusal to participate.
- Need for alveolar ridge augmentation.
- Systemic conditions that may impair healing (e.g., uncontrolled diabetes, immunodeficiency, ongoing chemotherapy or radiotherapy, history of head-and-neck radiotherapy, substance or alcohol abuse).
- Untreated periodontal disease.
- Heavy smoking (>10 cigarettes/day).
- Age < 18 years.
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: Clinical Evaluation of Cold Plasma Surface Activation Using Different Plasma Systems on Early Implant Stability: A Randomized Controlled Within-Patient Trial
Cold plasma-mediated implant surface activation may reverse the biological aging of titanium by enhancing hydrophilicity and cellular response. The aim of this study was to clinically compare the effects of three different cold plasma systems on the stability of dental implants. In this prospective randomized controlled within-patient trial, a total of 44 implants were placed in 11 patients. In each patient, four implants were randomly allocated to one of the following groups: control, vacuum plasma, argon jet plasma, and cold atmospheric plasma. All implants were placed using a single-stage protocol with a minimum insertion torque of 45 Ncm. Implant stability was assessed using resonance frequency analysis (ISQ values) immediately after placement and at 2, 4, and 8 weeks.
- Conditions
- Cold Atmospheric Plasma, Dental Implants
- Being tested
- Dental implant placement, Dental implant placement and vacuum plasma application, Dental implant placement and argon jet plasma application, Dental implant placement and cold atmospheric plasma application
- Keywords
- Osseointegration, Surface modification, Cold atmospheric plasma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental implant placementProcedure or surgery
The dental implant was placed without any plasma application.
Dental implant placement and vacuum plasma applicationProcedure or surgery
The dental implant was placed with non-thermal low-pressure cold plasma application
Dental implant placement and argon jet plasma applicationProcedure or surgery
The dental implant was placed with argon jet plasma application
Dental implant placement and cold atmospheric plasma applicationProcedure or surgery
The dental implant was placed with cold atmospheric plasma application
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Active comparator | The implant was inserted without the application of any supplementary surface modification. Receives: Procedure: Dental implant placement |
| Vacuum Plasma Application | Experimental | The implant was placed into a sterile low-pressure plasma chamber (5-10 Torr) and exposed to non-thermal low-pressure cold plasma for 60 seconds prior to placement. Receives: Procedure: Dental implant placement and vacuum plasma application |
| Argon Jet Plasma Application | Experimental | A portable atmospheric argon plasma jet was applied circumferentially to the implant surface for 60 seconds while the implant was rotated in a sterile holder. Receives: Procedure: Dental implant placement and argon jet plasma application |
| Cold Atmospheric Plasma (CAP) Application | Experimental | Cold plasma generated at atmospheric pressure using ambient air was applied circumferentially to the implant surface for 60 seconds while the implant was rotated in a sterile holder. Receives: Procedure: Dental implant placement and cold atmospheric plasma application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Implant Stability
The primary outcome measure was implant stability, quantified using Implant Stability Quotient (ISQ) values obtained by resonance frequency analysis (RFA). Changes in mean ISQ values were assessed at four predefined time points across four different implant surface treatment groups.
The secondary outcome measure was the early stability pattern, evaluated based on serial ISQ measurements recorded during the first 8 weeks following implant placement.
Measured: Measurements were performed at four different time points: • Immediately after placement (baseline), • 2 weeks, • 4 weeks, • 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start24 Feb 2025
- Primary completion8 Jul 2025
- Study completion9 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 11 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
- NCT07348770
- Sponsor's protocol ID
- HRÜ/25.03.28
- Status last verified
- Dec 2025
- First submitted
- 11 Dec 2025
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Balkanlioglu AC, Acikan I. Clinical evaluation of cold plasma surface activation using different plasma systems on early implant stability: a randomized controlled within-patient trial. BMC Oral Health. 2026 May 30. doi: 10.1186/s12903-026-08679-8. Online ahead of print.
PubMed 42226275
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Cold Plasma Surface Activation Using Different Plasma Systems on Early Implant Stability: A Randomized Controlled Within-Patient Trial
- ClinicalTrials.gov ID
- NCT07348770
- Acronym / sponsor ID
- HRÜ/25.03.28
- Conditions
- Cold Atmospheric Plasma, Dental Implants
- Keywords
- Osseointegration, Surface modification, Cold atmospheric plasma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 24 Feb 2025 (actual)
- Primary completion
- 8 Jul 2025 (actual)
- Study completion
- 9 Sep 2025 (actual)
- First posted
- 16 Jan 2026 (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.
Cold plasma-mediated implant surface activation may reverse the biological aging of titanium by enhancing hydrophilicity and cellular response. The aim of this study was to clinically compare the effects of three different cold plasma systems on the stability of dental implants. In this prospective randomized controlled within-patient trial, a total of 44 implants were placed in 11 patients. In each patient, four implants were randomly allocated to one of the following groups: control, vacuum plasma, argon jet plasma, and cold atmospheric plasma. All implants were placed using a single-stage protocol with a minimum insertion torque of 45 Ncm. Implant stability was assessed using resonance frequency analysis (ISQ values) immediately after placement and at 2, 4, and 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control Arm | Active comparator | Procedure: Dental implant placementThe implant was inserted without the application of any supplementary surface modification. |
| Vacuum Plasma Application | Experimental | Procedure: Dental implant placement and vacuum plasma applicationThe implant was placed into a sterile low-pressure plasma chamber (5-10 Torr) and exposed to non-thermal low-pressure cold plasma for 60 seconds prior to placement. |
| Argon Jet Plasma Application | Experimental | Procedure: Dental implant placement and argon jet plasma applicationA portable atmospheric argon plasma jet was applied circumferentially to the implant surface for 60 seconds while the implant was rotated in a sterile holder. |
| Cold Atmospheric Plasma (CAP) Application | Experimental | Procedure: Dental implant placement and cold atmospheric plasma applicationCold plasma generated at atmospheric pressure using ambient air was applied circumferentially to the implant surface for 60 seconds while the implant was rotated in a sterile holder. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years.
- Presence of edentulous areas requiring ≥4 implants for fixed prosthetic rehabilitation.
- Good or moderate oral hygiene.
- Adequate patient compliance to attend all follow-up appointments.
- Willingness to voluntarily participate in the study.
Key exclusion criteria (6 listed)
- Refusal to participate.
- Need for alveolar ridge augmentation.
- Systemic conditions that may impair healing (e.g., uncontrolled diabetes, immunodeficiency, ongoing chemotherapy or radiotherapy, history of head-and-neck radiotherapy, substance or alcohol abuse).
- Untreated periodontal disease.
- Heavy smoking (>10 cigarettes/day).
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 |
|---|---|---|
| Dental implant placementThe dental implant was placed without any plasma application. | Procedure or surgery | Control Arm |
| Dental implant placement and vacuum plasma applicationThe dental implant was placed with non-thermal low-pressure cold plasma application | Procedure or surgery | Vacuum Plasma Application |
| Dental implant placement and argon jet plasma applicationThe dental implant was placed with argon jet plasma application | Procedure or surgery | Argon Jet Plasma Application |
| Dental implant placement and cold atmospheric plasma applicationThe dental implant was placed with cold atmospheric plasma application | Procedure or surgery | Cold Atmospheric Plasma (CAP) Application |
Primary outcome
Evaluation of Implant Stability
Time frame: Measurements were performed at four different time points: • Immediately after placement (baseline), • 2 weeks, • 4 weeks, • 8 weeks.
The primary outcome measure was implant stability, quantified using Implant Stability Quotient (ISQ) values obtained by resonance frequency analysis (RFA). Changes in mean ISQ values were assessed at four predefined time points across four different implant surface treatment groups. The secondary outcome measure was the early stability pattern, evaluated based on serial ISQ measurements recorded during the first 8 weeks following implant placement.
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 11 May 2026.
- Derived from this study: PubMed 42226275Balkanlioglu AC, Acikan I. Clinical evaluation of cold plasma surface activation using different plasma systems on early implant stability: a randomized controlled within-patient trial. BMC Oral Health. 2026 May 30. doi: 10.1186/s12903-026-08679-8. Online ahead of print.
- 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 Dental implant placement, Dental implant placement and vacuum plasma application and Dental implant placement and argon jet plasma application in people with Cold Atmospheric Plasma and Dental Implants, 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 5 inclusion and 6 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 11 May 2026. 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?
Evaluation of Implant Stability (time frame: Measurements were performed at four different time points: • Immediately after placement (baseline), • 2 weeks, • 4 weeks, • 8 weeks.). 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 NCT07348770, which also lists 1 linked publication.
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 11 May 2026.