NANOTEX骨移植联合腓骨瓣重建下颌骨节段性缺损:初步临床试验方案。

IF 1.1 Q3 SURGERY
Anna Serene Babu, R Rashmi, V Manju, Pramod Subash, Arjun Krishnadas, Manitha Nair, Subramania Iyer
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引用次数: 0

摘要

前言与目的:带血管腓骨皮瓣重建下颌骨是肿瘤或创伤下颌骨切除术的标准治疗方法。但是腓骨移植物的高度不足以用于牙种植体的植入和假体康复来替代缺失的牙齿,这反过来又会损害患者的功能效率和美观。虽然骨高度可以通过髂骨移植来增加,但它有局限性,如供体部位发病率和快速可吸收性。这表明需要一种人工合成的生物材料用于种植牙科的垂直骨增强。我们开发了一种仿生的、多孔的、机械稳定的、可生物降解的纳米复合材料,命名为“NANOTEX骨移植”,并在临床前动物模型中评估了其骨再生潜力。在这项临床试验中,将研究NANOTEX在腓骨上增加新骨的安全性和有效性,并进一步研究其与种植体结合的能力。这项研究已经得到了印度Amrita医学科学研究所和中央药物标准控制组织(CDSCO)伦理委员会的批准。方法:我们设计了一项前瞻性、单中心、非随机的先导临床研究。有良性肿瘤或创伤的患者需要进行下颌骨重建并进行种植体康复。符合条件的患者将在获得知情同意后入组。该研究将按照规定的时间表启动和跟进。重点:切除良性下颌骨肿瘤需要手术切除颌骨和邻近受影响的区域。节段性下颌骨切除术会给患者留下功能障碍和审美缺陷,进而影响患者的生活质量。带血管腓骨瓣重建的标准治疗在获得足够的垂直骨高度以进行种植体植入和假体康复方面存在挑战。替代手术技术导致供体部位发病率和手术并发症。需要一种人工合成的生物材料在腓骨上进行垂直骨增强。NANOTEX骨移植,一种纳米纤维复合支架,模拟天然骨,促进细胞浸润,新血管生成和新骨形成。在动物模型上的临床前研究表明,NANOTEX可以再生骨组织,在临界尺寸的缺陷中具有更好的生物降解能力,并与种植体有效结合。本临床研究旨在评价NANOTEX骨移植在腓骨骨再生和钛牙种植体整合中的安全性和有效性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
NANOTEX BONE Graft along with Fibula Flap in the Reconstruction of Segmental Mandibular Defect: Protocol for Pilot Clinical Trial.

Introduction and objectives: Mandible reconstruction with vascularized fibula flap is the standard treatment for segmental mandibulectomy in patients with tumor or trauma. But the height of the fibula graft is insufficient for dental implant placement and prosthetic rehabilitation to replace the missing teeth, which in turn will compromise the functional efficiency and aesthetics of the patient. Although the bone height can be augmented through onlay grafting with iliac crest, it is associated with limitations like donor site morbidity and fast resorbability. This suggests the need for a synthetic biomaterial for vertical bone augmentation in implant dentistry.We have developed a biomimetic, porous, mechanically stable, and biodegradable nanocomposite named "NANOTEX BONE Graft" and its bone regeneration potential was evaluated in pre-clinical animal models. In this clinical trial, the safety as well as the efficacy of NANOTEX to augment new bone over fibula and further its ability to integrate with dental implants will be studied. The study has received the approval of the Ethics Committee of Amrita Institute of Medical Sciences and Central Drugs Standard Control Organization (CDSCO), India.

Methods: We have designed a prospective, single-center, non-randomized pilot clinical study. Patients with benign tumor or trauma indicated for mandibular reconstruction followed by implant rehabilitation will be included in the study. Eligible patients will be enrolled after obtaining informed consent. The study will be initiated and followed up as per defined timelines.

Highlights: Resection of benign mandibular tumours necessitates surgical removal of jaw bone and adjacent affected areas.The segmental mandibulectomy leaves the patient with functional impairments and aesthetic defects which in turn affect the quality of life.The standard treatment of reconstruction with vascularized fibula flap has challenge in achieving sufficient vertical bone height for implant placement and prosthetic rehabilitation.Alternate surgical techniques cause donor site morbidity and surgical complications.There is need for a synthetic biomaterial to be grafted over fibula for vertical bone augmentation.NANOTEX BONE Graft, a nanofibrous composite scaffold that mimics native bone, promote cell infiltration, neo-angiogenesis and new bone formation.Preclinical studies of NANOTEX in animal models showed bone tissue regeneration, better biodegradation in critical sized defects and efficient integration with dental implants.This clinical study propose to evaluate the safety and efficacy of NANOTEX bone graft augmented over fibula in bone regeneration and Titanium dental implant integration.

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期刊介绍: IJS Protocols is the first peer-reviewed, international, open access journal seeking to publish research protocols across across the full breadth of the surgical field. We are aim to provide rapid submission to decision times whilst maintaining a high quality peer-review process.
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