Clinical Evaluation of Cold Plasma Surface Activation Using Different Plasma Systems on Early Implant Stability: A Randomized Controlled Within-Patient Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Evaluation of Implant Stability
研究概览
简要总结
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 within-patient trial, 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Dental implant placement and cold atmospheric plasma application (Procedure)
Control Arm
The implant was inserted without the application of any supplementary surface modification.
干预措施: Dental implant placement (Procedure)
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.
干预措施: Dental implant placement and argon jet plasma application (Procedure)
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.
干预措施: Dental implant placement and vacuum plasma application (Procedure)
结局指标
主要结局
Evaluation of Implant Stability
时间窗: 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.
次要结局
未报告次要终点
研究者
Izzet Acikan
Assistant Professor
Kahramanmaras Sutcu Imam University