真空等离子体激活对种植体早期稳定性的影响:单盲裂口随机临床试验。

IF 1 Q3 DENTISTRY, ORAL SURGERY & MEDICINE
eJournal of Oral Maxillofacial Research Pub Date : 2025-06-30 eCollection Date: 2025-04-01 DOI:10.5037/jomr.2025.16205
Claudio Stacchi, Antonio Rapani, Marco Montanari, Rebecca Martini, Teresa Lombardi
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引用次数: 0

摘要

目的:提出等离子体表面活化牙种植体,通过改善钛表面化学来促进骨整合。然而,人类的临床数据仍然有限。本随机对照临床试验旨在评估在人类受试者的早期愈合阶段,在植入钛种植体之前立即进行真空等离子体治疗对其稳定性模式的影响。材料和方法:在这项单盲,裂口随机对照试验中,24例患者需要两个对侧种植体。每位患者接受一个等离子体治疗的种植体和一个未经治疗的对照种植体。在插入之前,使用特定的系统(plasma X®Motion - MegaGen Implant Co., Ltd)立即进行真空等离子体激活。使用共振频率分析(种植体稳定性商[ISQ])评估种植体在放置时和7、14、21、28、42、60和90天的稳定性。结果:所有48个种植体在90天内实现骨整合,无不良事件或并发症。平均插入扭矩组间差异无统计学意义(P = 0.86)。两组均表现出典型的初始稳定性下降,在21天时ISQ值最低。等离子体处理的种植体显示出更有利的恢复模式,在60天和90天的ISQ值显著高于对照组(P = 0.04和P = 0.03)。各组间ISQ值的绝对差异仍然有限。结论:真空等离子体激活钛种植体可能有助于更有利的早期稳定性模式,尽管等离子体处理和未处理的种植体均表现出可预测的骨整合结果。进一步的研究需要更大的队列和更长的随访来评估这些发现的临床意义。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Effect of Vacuum Plasma Activation on Early Implant Stability: a Single-Blind Split-Mouth Randomized Clinical Trial.

Objectives: 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.

Material and methods: 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]).

Results: 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.

Conclusions: 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.

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