Tooth LossNCT07548931
Cold Plasma and Early Microbial Colonization of Healing Abutments
A study testing Vacuum plasma, Argon jet plasma and Cold atmospheric plasma in people with Tooth Loss, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial summary
This prospective split-mouth clinical study will evaluate the effects of different plasma systems on the early microbiological colonization of implant healing abutments after implant surgery. Written informed consent will be obtained from all volunteers prior to participation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tooth Loss
- What is being tested?
- Vacuum plasma, Argon jet plasma and Cold atmospheric plasma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Apr 2025to 8 Oct 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients presenting to the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Kahramanmaraş Sütçü İmam University, for implant treatment, with edentulous areas requiring at least four implants to support a fixed prosthesis.
- Willingness to participate in the study.
- Age over 18 years.
- No allergy to any of the products used in the study.
- Non-smokers or light smokers (<10 cigarettes/day).
- Good patient compliance, adequate understanding of the study information, and provision of signed informed consent.
- Good or moderate oral hygiene.
Who cannot join
- Refusal to participate in the study.
- Need for alveolar ridge augmentation.
- Poor general health status (including immune system disorders, uncontrolled diabetes, ongoing chemotherapy or radiotherapy, history of radiotherapy to the head and neck region, alcohol dependence, drug dependence, or psychiatric illness).
- Presence of untreated periodontal disease.
- Heavy smoking (>10 cigarettes/day).
- Age under 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: The Effect of Different Cold Plasma Systems on Early Microbial Colonization of Implant Healing Abutments
This prospective split-mouth clinical study will evaluate the effects of different plasma systems on the early microbiological colonization of implant healing abutments after implant surgery. Written informed consent will be obtained from all volunteers prior to participation.
Before implant placement, all patients will be instructed to rinse with 0.2% chlorhexidine for 1 minute. Surgery will be performed under local anesthesia using articaine containing 1:100,000 epinephrine. Full-thickness flaps will be elevated, and implant-site osteotomies will be prepared under saline irrigation in accordance with the manufacturer's protocols. In all patients, four implants will be placed during the same surgical session. After completion of the osteotomies for all four implants, each implant site will be assigned, using the sealed-envelope method, to one of the following conditions: control, vacuum plasma, argon jet plasma, or cold atmospheric plasma. The corresponding healing abutment will then be placed, and the wound margins will be primarily sutured.
Read more
The intervention arms will be defined as control, vacuum plasma, argon jet plasma, and cold atmospheric plasma, and these operational group labels will be used in all statistical analyses. In all groups, titanium Medentika healing abutments measuring 4.5 mm in diameter and 6 mm in length will be used; no pretreatment will be applied in the control group. In the cold atmospheric plasma group, plasma will be applied for 60 seconds using the piezobrush® PZ3 device manufactured by relyon plasma GmbH (Germany), with ambient air as the working gas (electrical connection: 110-240 V/50-60 Hz; maximum power consumption: 18 W). The nozzle-to-surface distance will be standardized at 5 mm, and the application angle will be kept perpendicular. In the argon jet plasma group, the same piezobrush® PZ3 device will be used with the Multigas Module and argon gas; a flow rate of 11 L/min will be provided via the regulator, and the application time, distance, and angle will be kept identical to those in the cold atmospheric plasma group. In the vacuum plasma group, a 60-second treatment will be applied using the Plasma Active device. The nominal technical specifications of the device are as follows: dimensions, 150 × 354 × 267 mm; capacitive touchscreen IPS LCD display; 2 treatment slots; chamber dimensions, 65 × 28 mm; treatment duration, 60-120 seconds; power supply, 220 V/50-60 Hz; and power consumption, ≤200 W.
During the postoperative period, a standard care protocol will be applied to all patients; amoxicillin/clavulanate (or clindamycin in cases of penicillin allergy) will be prescribed for 7 days, ibuprofen for 3 days, and 0.2% chlorhexidine mouthwash twice daily. Sutures will be removed at postoperative week 1. At the same visit, the healing abutments will also be removed and sent for microbiological analysis, and new abutments will be placed in their position.
- Conditions
- Tooth Loss
- Being tested
- Control, Vacuum plasma, Argon jet plasma, Cold atmospheric plasma
- Keywords
- dental implant, healing abutment, cold atmospheric plasma, argon jet plasma, microbial colonization, split-mouth, linear mixed-effects model
- Medical subject headings
- Tooth Loss, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
After implant placement, an untreated healing abutment was placed.
Vacuum plasmaOther
In the vacuum plasma group, the healing abutment was treated for 60 seconds using the Plasma Active device. The nominal technical specifications of the device were as follows: dimensions, 150 × 354 × 267 mm; capacitive touchscreen IPS LCD display; 2 treatment slots; chamber dimensions, 65 × 28 mm; treatment duration, 60-120 seconds; power supply, 220 V/50-60 Hz; and power consumption, ≤200 W. After implant placement, the vacuum plasma-treated healing abutment was placed.
Argon jet plasmaOther
In the argon jet plasma group, the healing abutment was treated with argon jet plasma for 60 seconds using the piezobrush® PZ3 device manufactured by relyon plasma GmbH (Germany) equipped with the Multigas Module. Argon gas was used as the working gas, and a flow rate of 11 L/min was delivered via the regulator. The nozzle-to-surface distance was standardized at 5 mm, and the application angle was kept perpendicular. After implant placement, the argon jet plasma-treated healing abutment was placed.
Cold atmospheric plasmaOther
In the cold atmospheric plasma group, the healing abutment was treated with cold atmospheric plasma for 60 seconds using the piezobrush® PZ3 device manufactured by relyon plasma GmbH (Germany), with ambient air as the working gas (electrical connection: 110-240 V/50-60 Hz; maximum power consumption: 18 W). The nozzle-to-surface distance was standardized at 5 mm, and the application angle was kept perpendicular. After implant placement, the cold atmospheric plasma-treated healing abutment was placed.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Active comparator | After implant placement, a healing abutment without any prior treatment was placed. Receives: Other: Control |
| vacuum plasma | Experimental | After implant placement, a vacuum plasma-treated healing abutment was placed. Receives: Other: Vacuum plasma |
| Argon jet plasma | Experimental | After implant placement, an argon jet plasma-treated healing abutment was placed. Receives: Other: Argon jet plasma |
| Cold atmospheric plasma | Experimental | After implant placement, a cold atmospheric plasma-treated healing abutment was placed. Receives: Other: Cold atmospheric plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total microbial load recovered from implant healing abutments (log10[CFU/mL + 1])
Culture-based total microbial load measured from removed implant healing abutments. Total CFU/mL is defined as aerobic CFU/mL plus anaerobic CFU/mL.
Measured: Two week after implant placement (postoperative week 2)
Secondary outcomes (1)
Aerobic and anaerobic microbials load recovered from implant healing abutments (log10[CFU/mL + 1])
Culture-based aerobic microbial load measured from removed implant healing abutments. Culture-based anaerobic microbial load measured from removed implant healing abutments. Presence of anaerobic growth, defined as anaerobic CFU/mL greater than 0.
Measured: Two week after implant placement (postoperative week 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start21 Apr 2025
- Primary completion24 Sep 2025
- Study completion8 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Tooth LossStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 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
- NCT07548931
- Sponsor's protocol ID
- HRÜ/25.03.27
- Status last verified
- Apr 2026
- First submitted
- 10 Apr 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Canullo L, Rakic M, Corvino E, Burton M, Krumbeck JA, Chittoor Prem A, Ravida A, Ignjatovic N, Sculean A, Menini M, Pesce P. Effect of argon plasma pre-treatment of healing abutments on peri-implant microbiome and soft tissue integration: a proof-of-concept randomized study. BMC Oral Health. 2023 Jan 17;23(1):27. doi: 10.1186/s12903-023-02729-1.
PubMed 36650477Yang Y, Zheng M, Yang Y, Li J, Su YF, Li HP, Tan JG. Inhibition of bacterial growth on zirconia abutment with a helium cold atmospheric plasma jet treatment. Clin Oral Investig. 2020 Apr;24(4):1465-1477. doi: 10.1007/s00784-019-03179-2. Epub 2020 Jan 15.
PubMed 31940064Ardakani MRT, Meimandi M, Amid R, Pourahmadie AD, Shidfar S. In Vitro Comparison of Microbial Leakage of the Implant-Healing Abutment Interface in Four Connection Systems. J Oral Implantol. 2019 Oct;45(5):350-355. doi: 10.1563/aaid-joi-D-18-00311. Epub 2019 Aug 7.
PubMed 31389766
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Cold Plasma Systems on Early Microbial Colonization of Implant Healing Abutments
- ClinicalTrials.gov ID
- NCT07548931
- Acronym / sponsor ID
- HRÜ/25.03.27
- Conditions
- Tooth Loss
- Keywords
- dental implant, healing abutment, cold atmospheric plasma, argon jet plasma, microbial colonization, split-mouth, linear mixed-effects model
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 21 Apr 2025 (actual)
- Primary completion
- 24 Sep 2025 (actual)
- Study completion
- 8 Oct 2025 (actual)
- First posted
- 23 Apr 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.
This prospective split-mouth clinical study will evaluate the effects of different plasma systems on the early microbiological colonization of implant healing abutments after implant surgery. Written informed consent will be obtained from all volunteers prior to participation.
Before implant placement, all patients will be instructed to rinse with 0.2% chlorhexidine for 1 minute. Surgery will be performed under local anesthesia using articaine containing 1:100,000 epinephrine. Full-thickness flaps will be elevated, and implant-site osteotomies will be prepared under saline irrigation in accordance with the manufacturer's protocols. In all patients, four implants will be placed during the same surgical session. After completion of the osteotomies for all four implants, each implant site will be assigned, using the sealed-envelope method, to one of the following conditions: control, vacuum plasma, argon jet plasma, or cold atmospheric plasma. The corresponding healing abutment will then be placed, and the wound margins will be primarily sutured.
The intervention arms will be defined as control, vacuum plasma, argon jet plasma, and cold atmospheric plasma, and these operational group labels will be used in all statistical analyses. In all groups, titanium Medentika healing abutments measuring 4.5 mm in diameter and 6 mm in length will be used; no pretreatment will be applied in the control group. In the cold atmospheric plasma group, plasma will be applied for 60 seconds using the piezobrush® PZ3 device manufactured by relyon plasma GmbH (Germany), with ambient air as the working gas (electrical connection: 110-240 V/50-60 Hz; maximum power consumption: 18 W). The nozzle-to-surface distance will be standardized at 5 mm, and the application angle will be kept perpendicular. In the argon jet plasma group, the same piezobrush® PZ3 device will be used with the Multigas Module and argon gas; a flow rate of 11 L/min will be provided via the regulator, and the application time, distance, and angle will be kept identical to those in the cold atmospheric plasma group. In the vacuum plasma group, a 60-second treatment will be applied using the Plasma Active device. The nominal technical specifications of the device are as follows: dimensions, 150 × 354 × 267 mm; capacitive touchscreen IPS LCD display; 2 treatment slots; chamber dimensions, 65 × 28 mm; treatment duration, 60-120 seconds; power supply, 220 V/50-60 Hz; and power consumption, ≤200 W.
During the postoperative period, a standard care protocol will be applied to all patients; amoxicillin/clavulanate (or clindamycin in cases of penicillin allergy) will be prescribed for 7 days, ibuprofen for 3 days, and 0.2% chlorhexidine mouthwash twice daily. Sutures will be removed at postoperative week 1. At the same visit, the healing abutments will also be removed and sent for microbiological analysis, and new abutments will be placed in their position.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control Arm | Active comparator | Other: ControlAfter implant placement, a healing abutment without any prior treatment was placed. |
| vacuum plasma | Experimental | Other: Vacuum plasmaAfter implant placement, a vacuum plasma-treated healing abutment was placed. |
| Argon jet plasma | Experimental | Other: Argon jet plasmaAfter implant placement, an argon jet plasma-treated healing abutment was placed. |
| Cold atmospheric plasma | Experimental | Other: Cold atmospheric plasmaAfter implant placement, a cold atmospheric plasma-treated healing abutment was placed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients presenting to the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Kahramanmaraş Sütçü İmam University, for implant treatment, with edentulous areas requiring at least four implants to support a fixed prosthesis.
- Willingness to participate in the study.
- Age over 18 years.
- No allergy to any of the products used in the study.
- Non-smokers or light smokers (<10 cigarettes/day).
Key exclusion criteria (6 listed)
- Refusal to participate in the study.
- Need for alveolar ridge augmentation.
- Poor general health status (including immune system disorders, uncontrolled diabetes, ongoing chemotherapy or radiotherapy, history of radiotherapy to the head and neck region, alcohol dependence, drug dependence, or psychiatric illness).
- Presence of 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 |
|---|---|---|
| ControlAfter implant placement, an untreated healing abutment was placed. | Other | Control Arm |
| Vacuum plasmaIn the vacuum plasma group, the healing abutment was treated for 60 seconds using the Plasma Active device. The nominal technical specifications of the device were as follows: dimensions, 150 × 354 × 267 mm; capacitive touchscreen IPS LCD display; 2 treatment slots; chamber dimensions, 65 × 28 mm; treatment duration, 60-120 seconds; power supply, 220 V/50-60 Hz; and power consumption, ≤200 W. After implant placement, the vacuum plasma-treated healing abutment was placed. | Other | vacuum plasma |
| Argon jet plasmaIn the argon jet plasma group, the healing abutment was treated with argon jet plasma for 60 seconds using the piezobrush® PZ3 device manufactured by relyon plasma GmbH (Germany) equipped with the Multigas Module. Argon gas was used as the working gas, and a flow rate of 11 L/min was delivered via the regulator. The nozzle-to-surface distance was standardized at 5 mm, and the application angle was kept perpendicular. After implant placement, the argon jet plasma-treated healing abutment was placed. | Other | Argon jet plasma |
| Cold atmospheric plasmaIn the cold atmospheric plasma group, the healing abutment was treated with cold atmospheric plasma for 60 seconds using the piezobrush® PZ3 device manufactured by relyon plasma GmbH (Germany), with ambient air as the working gas (electrical connection: 110-240 V/50-60 Hz; maximum power consumption: 18 W). The nozzle-to-surface distance was standardized at 5 mm, and the application angle was kept perpendicular. After implant placement, the cold atmospheric plasma-treated healing abutment was placed. | Other | Cold atmospheric plasma |
Primary outcome
Total microbial load recovered from implant healing abutments (log10[CFU/mL + 1])
Time frame: Two week after implant placement (postoperative week 2)
Culture-based total microbial load measured from removed implant healing abutments. Total CFU/mL is defined as aerobic CFU/mL plus anaerobic CFU/mL.
1 secondary outcome
Aerobic and anaerobic microbials load recovered from implant healing abutments (log10[CFU/mL + 1])
Time frame: Two week after implant placement (postoperative week 2)
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 Apr 2026.
- Background: PubMed 36650477Canullo L, Rakic M, Corvino E, Burton M, Krumbeck JA, Chittoor Prem A, Ravida A, Ignjatovic N, Sculean A, Menini M, Pesce P. Effect of argon plasma pre-treatment of healing abutments on peri-implant microbiome and soft tissue integration: a proof-of-concept randomized study. BMC Oral Health. 2023 Jan 17;23(1):27. doi: 10.1186/s12903-023-02729-1.
- Background: PubMed 31940064Yang Y, Zheng M, Yang Y, Li J, Su YF, Li HP, Tan JG. Inhibition of bacterial growth on zirconia abutment with a helium cold atmospheric plasma jet treatment. Clin Oral Investig. 2020 Apr;24(4):1465-1477. doi: 10.1007/s00784-019-03179-2. Epub 2020 Jan 15.
- Background: PubMed 31389766Ardakani MRT, Meimandi M, Amid R, Pourahmadie AD, Shidfar S. In Vitro Comparison of Microbial Leakage of the Implant-Healing Abutment Interface in Four Connection Systems. J Oral Implantol. 2019 Oct;45(5):350-355. doi: 10.1563/aaid-joi-D-18-00311. Epub 2019 Aug 7.
- 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 Vacuum plasma, Argon jet plasma and Cold atmospheric plasma in people with Tooth Loss, 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 7 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 23 Apr 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?
Total microbial load recovered from implant healing abutments (log10[CFU/mL + 1]) (time frame: Two week after implant placement (postoperative week 2)). 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 NCT07548931, which also lists 3 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 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.