Department of Clinico-Surgical, Diagnostic and Pediatric Sciences, Dental Clinic, University of Pavia, P.le Golgi 2, 27100 Pavia, Italy.
Nobil Bio Ricerche srl, V. Valcastellana 26, 14037 Portacomaro, Italy.
Int J Mol Sci. 2019 Feb 11;20(3):763. doi: 10.3390/ijms20030763.
Biochemical modification of titanium surfaces (BMTiS) entails immobilization of biomolecules to implant surfaces in order to induce specific host responses. This crossover randomized clinical trial assesses clinical success and marginal bone resorption of dental implants bearing a surface molecular layer of covalently-linked hyaluronan in comparison with control implants up to 36 months after loading. Patients requiring bilateral implant rehabilitation received hyaluronan covered implants in one side of the mouth and traditional implants in the other side. Two months after the first surgery, a second surgery was undergone to uncover the screw and to place a healing abutment. After two weeks, the operator proceeded with prosthetic procedures. Implants were evaluated by periapical radiographs and the crestal bone level was recorded at mesial and distal sites-at baseline and up to 36 months. One hundred and six implants were positioned, 52 HY-coated, and 48 controls were followed up. No differences were observed in terms of insertion and stability, wound healing, implant success, and crestal bone resorption at any time considered. All interventions had an optimal healing, and no adverse events were recorded. This trial shows, for the first time, a successful use in humans of biochemical-modified implants in routine clinical practice and in healthy patients and tissues with satisfactory outcomes.
钛表面的生物化学修饰(BMTiS)涉及将生物分子固定在植入物表面,以诱导特定的宿主反应。这项交叉随机临床试验评估了在负荷后长达 36 个月的时间内,具有共价连接透明质酸表面分子层的牙科种植体的临床成功率和边缘骨吸收与对照种植体相比的情况。需要双侧种植体修复的患者在一侧口腔中接受透明质酸覆盖的种植体,另一侧接受传统种植体。第一次手术后两个月,进行了第二次手术以露出螺丝并放置愈合基台。两周后,操作人员进行了修复程序。通过根尖射线照相评估种植体,并在近中和远中部位记录基线和长达 36 个月时的牙槽骨水平。共定位了 106 个种植体,52 个 HY 涂层,48 个对照。在任何考虑的时间点,在插入和稳定性、伤口愈合、种植体成功率和边缘骨吸收方面均未观察到差异。所有干预措施均具有最佳的愈合效果,且未记录到不良事件。这项试验首次在常规临床实践和健康患者和组织中成功地应用了生物化学修饰的种植体,结果令人满意。