Cold Plasma and Early Microbial Colonization of Healing Abutments

NCT07548931 | Completed

• 1 other identifier: HRÜ/25.03.27
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Tooth Loss

Keywords

dental implant; healing abutment; cold atmospheric plasma; argon jet plasma; microbial colonization; split-mouth; linear mixed-effects model

Outcome Measures

Primary Outcomes (1)

• 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.

  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])

  Two week after implant placement (postoperative week 2)

Study Arms (4)

Control Arm

ACTIVE COMPARATOR

After implant placement, a healing abutment without any prior treatment was placed.

Other: Control

vacuum plasma

EXPERIMENTAL

After implant placement, a vacuum plasma-treated healing abutment was placed.

Other: Vacuum plasma

Argon jet plasma

EXPERIMENTAL

After implant placement, an argon jet plasma-treated healing abutment was placed.

Other: Argon jet plasma

Cold atmospheric plasma

EXPERIMENTAL

After implant placement, a cold atmospheric plasma-treated healing abutment was placed.

Other: Cold atmospheric plasma

Interventions

Control OTHER

After implant placement, an untreated healing abutment was placed.

Control Arm

Vacuum plasma OTHER

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.

vacuum plasma

Argon jet plasma OTHER

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.

Argon jet plasma

Cold atmospheric plasma OTHER

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.

Cold atmospheric plasma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kahramanmaras Sutcu Imam University: lead

Study Sites (1)

Kahramanmaras Sutcu Imam University, Faculty of Dentistry

Kahramanmaraş, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 36650477 BACKGROUND

• Yang 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.

  PMID: 31940064 BACKGROUND

• Ardakani 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.

  PMID: 31389766 BACKGROUND

MeSH Terms

Conditions

Tooth Loss; Communicable Diseases

Interventions

Plasma Gases

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Gases; Inorganic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 10, 2026
• First Posted: April 23, 2026
• Study Start: April 21, 2025
• Primary Completion: September 24, 2025
• Study Completion: October 8, 2025
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)