Cold Plasma and Early Microbial Colonization of Healing Abutments

April 21, 2026 updated by: Izzet Acikan, Kahramanmaras Sutcu Imam University

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.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Kahramanmaraş, Turkey (Türkiye)
        • Kahramanmaras Sutcu Imam University, Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Arm
After implant placement, a healing abutment without any prior treatment was placed.
Other: Control
After implant placement, an untreated healing abutment was placed.
Experimental: vacuum plasma
After implant placement, a vacuum plasma-treated healing abutment was placed.
Other: Vacuum plasma
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.
Experimental: Argon jet plasma
After implant placement, an argon jet plasma-treated healing abutment was placed.
Other: Argon jet plasma
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.
Experimental: Cold atmospheric plasma
After implant placement, a cold atmospheric plasma-treated healing abutment was placed.
Other: Cold atmospheric plasma
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Two week after implant placement (postoperative week 2)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aerobic and anaerobic microbials load recovered from implant healing abutments (log10[CFU/mL + 1])
Time Frame: Two week after implant placement (postoperative week 2)
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.
Two week after implant placement (postoperative week 2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kahramanmaras Sutcu Imam University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 21, 2025

Primary Completion (Actual)

September 24, 2025

Study Completion (Actual)

October 8, 2025

Study Registration Dates

First Submitted

April 10, 2026

First Submitted That Met QC Criteria

April 21, 2026

First Posted (Actual)

April 23, 2026

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HRÜ/25.03.27

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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