Randomized Clinical Trial: Bone Bioactive Liquid Improves Implant Stability and Osseointegration.

IF 5 3区 医学 Q1 ENGINEERING, BIOMEDICAL Journal of Functional Biomaterials Pub Date : 2024-10-01 DOI:10.3390/jfb15100293
Ashraf Al Madhoun, Khaled Meshal, Neus Carrió, Eduard Ferrés-Amat, Elvira Ferrés-Amat, Miguel Barajas, Ana Leticia Jiménez-Escobar, Areej Said Al-Madhoun, Alaa Saber, Yazan Abou Alsamen, Carles Marti, Maher Atari
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Abstract

Implant stability can be compromised by factors such as inadequate bone quality and infection, leading to potential implant failure. Ensuring implant stability and longevity is crucial for patient satisfaction and quality of life. In this multicenter, randomized, double-blind clinical trial, we assessed the impact of a bone bioactive liquid (BBL) on the Galaxy TS implant's performance, stability, and osseointegration. We evaluated the impact stability, osseointegration, and pain levels using initial stability quotient (ISQ) measurements, CBCT scans, and pain assessment post-surgery. Surface analysis was performed using scanning electron microscopy (SEM) and atomic force microscopy (AFM). In vitro studies examined the BBL's effects on dental pulp pluripotent stem cells' (DPPSCs') osteogenesis and inflammation modulation in human macrophages. All implants successfully osseointegrated, as demonstrated by the results of our clinical and histological studies. The BBL-treated implants showed significantly lower pain scores by day 7 (p < 0.00001) and improved stability by day 30 (ISQ > 62.00 ± 0.59, p < 8 × 10-7). By day 60, CBCT scans revealed an increased bone area ratio in BBL-treated implants. AFM images demonstrated the BBL's softening and wettability effect on implant surfaces. Furthermore, the BBL promoted DPPSCs' osteogenesis and modulated inflammatory markers in human primary macrophages. This study presents compelling clinical and biological evidence that BBL treatment improves Galaxy TS implant stability, reduces pain, and enhances bone formation, possibly through surface tension modulation and immunomodulatory effects. This advancement holds promise for enhancing patient outcomes and implant longevity.

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随机临床试验:骨生物活性液能改善种植体的稳定性和骨结合。
骨质不足和感染等因素会影响种植体的稳定性,从而导致种植失败。确保种植体的稳定性和使用寿命对患者的满意度和生活质量至关重要。在这项多中心、随机、双盲临床试验中,我们评估了骨生物活性液体(BBL)对 Galaxy TS 种植体的性能、稳定性和骨结合的影响。我们通过初始稳定商数(ISQ)测量、CBCT 扫描和术后疼痛评估来评估植入物的稳定性、骨结合性和疼痛程度。我们使用扫描电子显微镜(SEM)和原子力显微镜(AFM)进行了表面分析。体外研究检验了 BBL 对牙髓多能干细胞(DPPSCs)成骨和人类巨噬细胞炎症调节的影响。我们的临床和组织学研究结果表明,所有种植体都成功实现了骨结合。经 BBL 处理的种植体在第 7 天时疼痛评分明显降低(p < 0.00001),在第 30 天时稳定性提高(ISQ > 62.00 ± 0.59,p < 8 × 10-7)。到第 60 天,CBCT 扫描显示 BBL 处理过的种植体的骨面积比有所增加。原子力显微镜图像显示了 BBL 对种植体表面的软化和润湿效果。此外,BBL 还促进了 DPPSCs 的成骨过程,并调节了人类原代巨噬细胞中的炎症标志物。这项研究提供了令人信服的临床和生物学证据,证明 BBL 治疗可改善 Galaxy TS 种植体的稳定性、减轻疼痛并促进骨形成,这可能是通过表面张力调节和免疫调节作用实现的。这一进步有望提高患者的治疗效果和种植体的使用寿命。
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来源期刊
Journal of Functional Biomaterials
Journal of Functional Biomaterials Engineering-Biomedical Engineering
CiteScore
4.60
自引率
4.20%
发文量
226
审稿时长
11 weeks
期刊介绍: Journal of Functional Biomaterials (JFB, ISSN 2079-4983) is an international and interdisciplinary scientific journal that publishes regular research papers (articles), reviews and short communications about applications of materials for biomedical use. JFB covers subjects from chemistry, pharmacy, biology, physics over to engineering. The journal focuses on the preparation, performance and use of functional biomaterials in biomedical devices and their behaviour in physiological environments. Our aim is to encourage scientists to publish their results in as much detail as possible. Therefore, there is no restriction on the length of the papers. The full experimental details must be provided so that the results can be reproduced. Several topical special issues will be published. Scope: adhesion, adsorption, biocompatibility, biohybrid materials, bio-inert materials, biomaterials, biomedical devices, biomimetic materials, bone repair, cardiovascular devices, ceramics, composite materials, dental implants, dental materials, drug delivery systems, functional biopolymers, glasses, hyper branched polymers, molecularly imprinted polymers (MIPs), nanomedicine, nanoparticles, nanotechnology, natural materials, self-assembly smart materials, stimuli responsive materials, surface modification, tissue devices, tissue engineering, tissue-derived materials, urological devices.
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