Periodontal regeneration of human intrabony defects with bioresorbable membranes. A controlled clinical trial

Periodontal regeneration of human intrabony defects with bioresorbable membranes. A controlled clinical trial
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DOI:
10.1902/jop.1996.67.3.217
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发表时间:
1996-03-01
影响因子:
4.3
通讯作者:
Tonetti, MS
Tonetti, MS
中科院分区:
医学2区
文献类型:
--
作者:
Cortellini, P;Prato, GP;Tonetti, MS

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本对照临床试验的目的是比较3种治疗方法治疗深邻间骨内缺损的临床疗效。36例患者的36个缺陷通过分组至预后变量随机分配至3个治疗组之一。试验组采用生物可吸收膜治疗,将生物可吸收膜置于邻间骨嵴冠侧;第二组(膜对照)采用传统不可吸收(ePTFE)屏障膜治疗,将传统不可吸收(ePTFE)屏障膜置于牙槽嵴冠侧;第三组(瓣对照)采用入路瓣手术(MWF)治疗。在基线口腔卫生和缺陷特征方面,3组之间没有观察到差异,表明封闭方法是有效的。一个严格的感染控制程序被执行了一年。结果表明:1)在1年时,所有治疗方式均导致临床附着水平(GAL)的临床显著改善和探测深度的减少; 2)具有统计学显著性的治疗效果经方差分析,P < 0.0001,(4.6 +/- 1.2 mm),膜对照(5.2 ± 1.4 mm),皮瓣对照组(2.3 +/- 0.8 mm); 3)测试之间CAL增益方面的差异(生物可吸收)和膜对照(ePTFE)组的差异无统计学意义(P = 0.19,t检验); 4)试验组和膜对照组在1年时获得的CAL均显著高于MWF组(P < 0.0001,t检验)。在两个GTR组中,83.3%的病例中观察到CAL增益大于或等于4 mm,而MWF组中未检测到CAL增益。我们得出的结论是,使用生物可吸收和非可吸收膜的GTR手术可以获得临床显著的CAL增益。然而,使用生物可吸收膜治疗组的患者发病率较低。
THE PURPOSE OF THIS CONTROLLED CLINICAL TRIAL was to compare the clinical efficacy of 3 treatment modalities in the treatment of deep interproximal intrabony defects. Thirty-six (36) defects in 36 patients were randomly assigned to 1 of 3 treatment groups by blocking to prognostic variables. The test group was treated with bioresorbable membranes positioned coronal to the interproximal bone crest; the second group (membrane control) was treated with conventional non-resorbable (ePTFE) barrier membranes applied coronal to the alveolar crest; the third group (flap control) was treated with an access flap procedure (MWF). No differences were observed in terms of baseline oral hygiene and defect characteristics among the 3 groups, indicating that the blocking approach was effective. A stringent infection control program was enforced for 1 year. The results indicated that: 1) at 1 year all treatment modalities resulted in clinically significant improvements in clinical attachment levels (GAL) and reductions in probing depths; 2) a statistically significant treatment effect (P < 0.0001, ANOVA) was observed comparing the test (4.6 +/- 1.2 mm), the membrane control (5.2 +/- 1.4 mm), and the flap control groups (2.3 +/- 0.8 mm) in terms of CAL gains; 3) differences in terms of CAL gain between the test (bioresorbable) and the membrane control (ePTFE) groups were not statistically significant (P = 0.19, t-test); 4) both the test and the membrane control groups gained significantly more CAL at 1 year than the MWF group (P < 0.0001, t-test). CAL gains greater than or equal to 4 mm were observed in 83.3% of cases in both GTR groups, while CAL, gains of this magnitude were not detected in the MWF group. We concluded that clinically significant CAL gains can be obtained with GTR procedures using both bioresorbable and non-resorbable membranes. Patients' morbidity, however, was lower in the group treated with bioresorbable membranes.