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一种用于下颌骨再生的电刺激植入物的安全性和初步疗效:大型动物模型的初步研究

Safety and preliminary efficacy of an electrically stimulated implant for mandibular bone regeneration: a pilot study in a large animal model.

作者信息

Kämmerer Peer W, Engel Nadja, Bader Rainer, Engel Vivien, Frerich Bernhard, Heimes Diana, Kröger Justin, Lembcke Laura, Plocksties Franz, Raben Hendrikje, van Rienen Ursula, Springer Armin, Timmermann Dirk, Zimmermann Julius, Dau Michael

机构信息

Department of Oral and Maxillofacial Surgery, Facial Plastic Surgery, University Medical Center, Johannes Gutenberg University Mainz, Augustusplatz 2, 55131, Mainz, Germany.

Department of Oral and Maxillofacial Surgery, Facial Plastic Surgery, Rostock University Medical Center, Schillingallee 35, 18057, Rostock, Germany.

出版信息

Clin Oral Investig. 2025 Apr 7;29(5):226. doi: 10.1007/s00784-025-06303-7.

DOI:10.1007/s00784-025-06303-7
PMID:40192829
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11976354/
Abstract

OBJECTIVES

Large mandibular defects present challenges for bone regeneration. This pilot study evaluates the safety and preliminary efficacy of direct electrical stimulation (ES) on tissue healing in a preclinical model, testing whether ES can enhance bone formation in critical-size mandibular defects.

MATERIALS AND METHODS

Six adult mini pigs with critical-size mandibular defects were used in a split-mouth design. The test group (n = 6) received 0.5 V AC/20 Hz ES for 3 × 45 min daily over three weeks, while the control group (n = 6) had no stimulation. Safety, early bone growth, and soft tissue effects were assessed at three locations: S1 (cancellous bone interface), S2 (middle of the defect), and S3 (pristine dense bone).

RESULTS

The ES group showed no adverse effects, confirming implant safety. The ES group exhibited significantly higher bone formation, particularly in S2 and S3. Enhanced vascularization and immune response, in terms of increased mast cells, were also observed in S2.

CONCLUSIONS

The implant device with ES is safe and promotes bone formation and vascularization in select sub-regions (S2 and S3). However, ES alone may not suffice for complete bone regeneration in critical-sized defects, and further optimization is needed.

CLINICAL RELEVANCE

This study demonstrates the potential of ES to improve bone healing in large mandibular defects, offering insights for clinical use in maxillofacial reconstruction.

摘要

目的

大型下颌骨缺损给骨再生带来挑战。本前瞻性研究在临床前模型中评估直接电刺激(ES)对组织愈合的安全性和初步疗效,测试ES是否能促进临界大小下颌骨缺损的骨形成。

材料与方法

采用六只患有临界大小下颌骨缺损的成年小型猪进行双侧对照设计。试验组(n = 6)每天接受0.5V交流电/20Hz的电刺激,每次45分钟,共持续三周,而对照组(n = 6)不接受刺激。在三个位置评估安全性、早期骨生长和软组织效应:S1(松质骨界面)、S2(缺损中部)和S3(原始致密骨)。

结果

电刺激组未显示出不良反应,证实了植入物的安全性。电刺激组的骨形成明显更高,特别是在S2和S3区域。在S2区域还观察到血管生成增加和肥大细胞增多,免疫反应增强。

结论

带有电刺激的植入装置是安全的,并能促进选定子区域(S2和S3)的骨形成和血管生成。然而,单独的电刺激可能不足以实现临界大小缺损的完全骨再生,需要进一步优化。

临床意义

本研究证明了电刺激在改善大型下颌骨缺损骨愈合方面的潜力,为颌面重建的临床应用提供了见解。

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本文引用的文献

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IEEE Trans Biomed Eng. 2024 Oct;71(10):3055-3068. doi: 10.1109/TBME.2024.3408076. Epub 2024 Sep 19.
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MORPHOLOGICAL CHARACTERISTICS OF REPARATIVE OSTEOGENESIS IN THE RATS LOWER JAW UNDER THE CONDITIONS OF USING ELECTRICAL STIMULATION.电刺激条件下大鼠下颌修复性骨生成的形态学特征。
Pol Merkur Lekarski. 2023;51(6):592-597. doi: 10.36740/Merkur202306102.
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Invasive electrical stimulation in the treatment of avascular osteonecrosis of the femoral head - mid-term results.
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Acta Orthop Belg. 2023 Dec;89(4):587-593. doi: 10.52628/89.4.9082.
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Rehabilitation exercise-driven symbiotic electrical stimulation system accelerating bone regeneration.康复运动驱动的共生电刺激系统加速骨再生。
Sci Adv. 2024 Jan 5;10(1):eadi6799. doi: 10.1126/sciadv.adi6799.
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Nonvascularized bone grafts: how successful are they in reconstruction of segmental mandibular defects?非血管化骨移植:在重建下颌骨节段性缺损方面的成功率如何?
Oral Surg Oral Med Oral Pathol Oral Radiol. 2024 May;137(5):e63-e72. doi: 10.1016/j.oooo.2023.10.010. Epub 2023 Oct 29.
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Pol Merkur Lekarski. 2023;51(4):358-366. doi: 10.36740/Merkur202304110.
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Bone reconstruction of extensive maxillomandibular defects in adults.成人广泛的上下颌骨缺损的骨重建。
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