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

IF 3.1 2区医学 Q1 DENTISTRY, ORAL SURGERY & MEDICINE

Clinical Oral Investigations Pub Date : 2025-04-07 DOI:10.1007/s00784-025-06303-7

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

{"title":"Safety and preliminary efficacy of an electrically stimulated implant for mandibular bone regeneration: a pilot study in a large animal model.","authors":"Peer W Kämmerer, Nadja Engel, Rainer Bader, Vivien Engel, Bernhard Frerich, Diana Heimes, Justin Kröger, Laura Lembcke, Franz Plocksties, Hendrikje Raben, Ursula van Rienen, Armin Springer, Dirk Timmermann, Julius Zimmermann, Michael Dau","doi":"10.1007/s00784-025-06303-7","DOIUrl":null,"url":null,"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.","PeriodicalId":10461,"journal":{"name":"Clinical Oral Investigations","volume":"29 5","pages":"226"},"PeriodicalIF":3.1000,"publicationDate":"2025-04-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical Oral Investigations","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s00784-025-06303-7","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"DENTISTRY, ORAL SURGERY & MEDICINE","Score":null,"Total":0}

引用次数: 0

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.

查看原文本刊更多论文

求助全文

约1分钟内获得全文求助全文

来源期刊

Clinical Oral Investigations 医学-牙科与口腔外科

CiteScore

6.30

自引率

5.90%

发文量

484

审稿时长

3 months

期刊介绍： The journal Clinical Oral Investigations is a multidisciplinary, international forum for publication of research from all fields of oral medicine. The journal publishes original scientific articles and invited reviews which provide up-to-date results of basic and clinical studies in oral and maxillofacial science and medicine. The aim is to clarify the relevance of new results to modern practice, for an international readership. Coverage includes maxillofacial and oral surgery, prosthetics and restorative dentistry, operative dentistry, endodontics, periodontology, orthodontics, dental materials science, clinical trials, epidemiology, pedodontics, oral implant, preventive dentistiry, oral pathology, oral basic sciences and more.