A Randomized Clinical Trial Evaluating rh-FGF-2/-TCP in Periodontal Defects
A Randomized Clinical Trial Evaluating rh-FGF-2/-TCP in Periodontal Defects
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DOI：
10.1177/0022034516632497
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发表时间：
2016-05-01
影响因子：
7.6
通讯作者：
Takemura, A.
中科院分区：
文献类型：
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作者：
Cochran, D. L.;Oh, T. -J.;Takemura, A.
生物介体已被用于促进牙周再生。本前瞻性随机对照研究的目的是评价3种剂量的成纤维细胞生长因子-2(成纤维细胞生长因子-2)联合α-磷酸三钙支架载体在成人垂直向骨下牙周缺损修复中的安全性和有效性。在这项双盲、剂量验证、外部监测的临床研究中，88名需要手术干预以治疗符合条件的骨下牙周缺损的患者被随机分为4组：单独使用磷酸三钙(对照组)和0.1%重组人成纤维细胞生长因子-2(rh-FGF-2)、0.3%重组人成纤维细胞生长因子-2和0.4%重组人成纤维细胞生长因子-2加-TCP，在手术预约前对牙齿进行洁治和根面平整。在装置植入前，在根部进行EDTA处理的皮瓣手术。在4个治疗组之间，患者的人口统计学特征和基线特征没有统计学意义上的差异。当临床附着增加的综合结果为1.5 mm，线性骨生长为2.5 mm时，0.3%和0.4%rh-FGF-2/-tcp组的剂量反应模式检测到平台，显著改善了对照组和0.1%rh-fgf-2/-tcp组。在6个月时，两个高浓度组的成功率为71%，而对照组和低浓度组为45%。两个高浓度组的骨填充百分率分别为75%和71%，而对照组和最低浓度组分别为63%和61%。未检测到重组人成纤维细胞生长因子-2的特异性抗体增加，也没有与该产品相关的严重不良反应的报道。这项多中心试验的结果表明，添加rh-FGF-2/-TCP(ClinicalTrials.gov NCT01728844)可以增强骨下垂直牙周缺陷的治疗。
Biological mediators have been used to enhance periodontal regeneration. The aim of this prospective randomized controlled study was to evaluate the safety and effectiveness of 3 doses of fibroblast growth factor 2 (FGF-2) when combined with a -tricalcium phosphate (-TCP) scaffold carrier placed in vertical infrabony periodontal defects in adult patients. In this double-blinded, dose-verification, externally monitored clinical study, 88 patients who required surgical intervention to treat a qualifying infrabony periodontal defect were randomized to 1 of 4 treatment groups-TCP alone (control) and 0.1% recombinant human FGF-2 (rh-FGF-2), 0.3% rh-FGF-2, and 0.4% rh-FGF-2 with -TCPfollowing scaling and root planing of the tooth prior to a surgical appointment. Flap surgery was performed with EDTA conditioning of the root prior to device implantation. There were no statistically significant differences in patient demographics and baseline characteristics among the 4 treatment groups. When a composite outcome of gain in clinical attachment of 1.5 mm was used with a linear bone growth of 2.5 mm, a dose response pattern detected a plateau in the 0.3% and 0.4% rh-FGF-2/-TCP groups with significant improvements over control and 0.1% rh-FGF-2/-TCP groups. The success rate at 6 mo was 71% in the 2 higher-concentration groups, as compared with 45% in the control and lowest treatment groups. Percentage bone fill in the 2 higher-concentration groups was 75% and 71%, compared with 63% and 61% in the control and lowest treatment group. No increases in specific antibody to rh-FGF-2 were detected, and no serious adverse events related to the products were reported. The results from this multicenter trial demonstrated that the treatment of infrabony vertical periodontal defects can be enhanced with the addition of rh-FGF-2/-TCP (ClinicalTrials.gov NCT01728844).