- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07348770
Cold Plasma Effects on Dental Implant Stability
Clinical Evaluation of Cold Plasma Surface Activation Using Different Plasma Systems on Early Implant Stability: A Randomized Controlled Within-Patient Trial
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Kahramanmaraş, Turkey (Türkiye)
- Kahramanmaras Sutcu Imam University, Faculty of Dentistry
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control Arm
The implant was inserted without the application of any supplementary surface modification.
|
The dental implant was placed without any plasma application.
|
|
Experimental: Vacuum Plasma Application
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.
|
The dental implant was placed with non-thermal low-pressure cold plasma application
|
|
Experimental: Argon Jet Plasma Application
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.
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The dental implant was placed with argon jet plasma application
|
|
Experimental: Cold Atmospheric Plasma (CAP) Application
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.
|
The dental implant was placed with cold atmospheric plasma application
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
Measurements were performed at four different time points: • Immediately after placement (baseline), • 2 weeks, • 4 weeks, • 8 weeks.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- HRÜ/25.03.28
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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