Stacchi Claudio, Rapani Antonio, Montanari Marco, Martini Rebecca, Lombardi Teresa
Department of Medical, Surgical and Health Sciences, University of Trieste, 34100 TriesteItaly.
Department of Medical Sciences, University of Ferrara, 44121 FerraraItaly.
J Oral Maxillofac Res. 2025 Jun 30;16(2):e4. doi: 10.5037/jomr.2025.16205. eCollection 2025 Apr-Jun.
Plasma surface activation of dental implants has been proposed to enhance osseointegration by improving titanium surface chemistry. However, clinical data in humans remain limited. This randomized controlled clinical trial aimed to evaluate the effect of vacuum plasma treatment applied to titanium implants immediately prior to insertion on their stability pattern during the early phases of healing in human subjects.
In this single-blind, split-mouth randomized controlled trial, 24 patients requiring two contralateral implants were enrolled. Each patient received one plasma-treated implant and one untreated control implant. Vacuum plasma activation was performed immediately before insertion using a specific system (Plasma X Motion - MegaGen Implant Co., Ltd.). Implant stability was assessed at placement and at 7, 14, 21, 28, 42, 60, and 90 days using resonance frequency analysis (implant stability quotient [ISQ]).
All 48 implants achieved osseointegration at 90 days, with no adverse events or complications. Mean insertion torque did not differ significantly between groups (P = 0.86). Both groups exhibited a typical initial reduction in stability, with the lowest ISQ values at 21 days. Plasma-treated implants showed a more favourable recovery pattern, with significantly higher ISQ values than controls at 60 and 90 days (P = 0.04 and P = 0.03, respectively). The absolute difference in ISQ values between groups remained limited.
Vacuum plasma activation of titanium implants may contribute to a more favourable early stability pattern, although both plasma-treated and untreated implants demonstrated predictable osseointegration outcomes. Further research with larger cohorts and longer follow-up is needed to assess the clinical significance of these findings.
有人提出对牙种植体进行等离子体表面活化，以通过改善钛表面化学性质来增强骨整合。然而，人类的临床数据仍然有限。这项随机对照临床试验旨在评估在植入前立即对钛种植体进行真空等离子体处理对人类受试者愈合早期其稳定性模式的影响。
在这项单盲、分口随机对照试验中，招募了24名需要植入两颗对侧种植体的患者。每位患者接受一枚经等离子体处理的种植体和一枚未处理的对照种植体。使用特定系统（Plasma X Motion - 美格真种植有限公司）在植入前立即进行真空等离子体活化。使用共振频率分析（种植体稳定性商数[ISQ]）在植入时以及第7、14、21、28、42、60和90天评估种植体稳定性。
所有48枚种植体在90天时均实现骨整合，无不良事件或并发症。两组之间的平均植入扭矩无显著差异（P = 0.86）。两组均表现出典型的初期稳定性下降，在第21天时ISQ值最低。经等离子体处理的种植体显示出更有利的恢复模式，在第60天和第90天时ISQ值显著高于对照组（分别为P = 0.04和P = 0.03）。两组之间ISQ值的绝对差异仍然有限。
钛种植体的真空等离子体活化可能有助于形成更有利的早期稳定性模式，尽管经等离子体处理和未处理的种植体均显示出可预测的骨整合结果。需要进行更大样本量和更长随访时间的进一步研究，以评估这些发现的临床意义。
