Cold Plasma Effects on Dental Implant Stability

NCT07348770 | Completed

• 1 other identifier: HRÜ/25.03.28
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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. In this prospective randomized controlled split-mouth study, 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

Keywords

Osseointegration; Surface modification; Cold atmospheric plasma

Outcome Measures

Primary Outcomes (1)

• 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.

  Measurements were performed at four different time points: • Immediately after placement (baseline), • 2 weeks, • 4 weeks, • 8 weeks.

Study Arms (4)

Control Arm

ACTIVE COMPARATOR

The implant was inserted without the application of any supplementary surface modification.

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.

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.

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.

Procedure: Dental implant placement and cold atmospheric plasma application

Interventions

Dental implant placement PROCEDURE

The dental implant was placed without any plasma application.

Control Arm

Dental implant placement and vacuum plasma application PROCEDURE

The dental implant was placed with non-thermal low-pressure cold plasma application

Vacuum Plasma Application

Dental implant placement and argon jet plasma application PROCEDURE

The dental implant was placed with argon jet plasma application

Argon Jet Plasma Application

Dental implant placement and cold atmospheric plasma application PROCEDURE

The dental implant was placed with cold atmospheric plasma application

Cold Atmospheric Plasma (CAP) Application

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kahramanmaras Sutcu Imam University: lead

Study Sites (1)

Kahramanmaras Sutcu Imam University, Faculty of Dentistry

Kahramanmaraş, Turkey (Türkiye)

Location

Study Design

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

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: January 16, 2026
• Study Start: February 24, 2025
• Primary Completion: July 8, 2025
• Study Completion: September 9, 2025
• Last Updated: April 30, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)