Treatment of deep and shallow intrabony defects - A multicenter randomized controlled clinical trial
Treatment of deep and shallow intrabony defects - A multicenter randomized controlled clinical trial
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DOI：
10.1111/j.1600-051x.1998.tb02402.x
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发表时间：
1998-12-01
影响因子：
6.7
通讯作者：
Tonetti, MS
中科院分区：
文献类型：
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作者：
Cortellini, P;Carnevale, G;Tonetti, MS
这项前瞻性多中心个体内随机对照临床试验旨在比较引导组织再生（GTR）与生物可吸收屏障膜与入路皮瓣手术在骨内缺损中的有效性。在23名患者中选择了2个类似的缺陷，并随机分配到2种治疗中的1种。手术包括一个相同的程序，除了省略的屏障膜在皮瓣控制网站。在1年时，GTR治疗部位的探查囊袋深度减少为4.3+/-2.3 mm，皮瓣对照部位为3.0+/-1.5 mm（p=0.02，配对t检验）。GTR部位的临床附着水平（CAL）增量为3.0+/-1.7 mm，对照部位为1.6+/-1.8 mm（p=0.009，配对t检验）。根据缺损骨内部分的初始深度（INFRA）进行的子集分析表明，在仅使用入路皮瓣治疗的浅缺损（INFRA小于或等于3 mm）中，CAL增益为1+/-1.5 mm，而在深缺损（INFRA大于或等于4 mm）中，CAL增益始终更大（1.9+/-1.9 mm）。然而，计算为基线骨内组件深度%的% CAL增益在2个亚群中几乎相同（浅缺损为45.8+/-64.7%，深缺损为43.8+/-37.6%）。同样，在GTR部位，深层缺损（3.7+/-1.7 mm）的线性CAL增益大于浅层缺损（2.2+/-1.3 mm），但在% CAL增益方面没有观察到差异（分别为76.7+/-27.7%和75.8+/-45%）。CAL变化的频率分布（表示为基线INFRA的%s）表明，大多数接受GTR治疗的部位（73%的浅缺损和92%的深缺损）的GAL增加了50%或更多。此外，许多缺陷（64%的浅缺陷和33%的深缺陷）达到100%的CAL增益。目前的研究表明：（i）与单独的入路皮瓣相比，使用生物可吸收屏障膜的GTR产生了显著的额外受益;（ii）深层缺损中CAL增益的线性量大于浅层缺损;（iii）CAL增益表示为骨内组件基线深度的%s，在浅层和深层缺损中相似;（iii）在本研究中测试的再生程序在某些情况下导致CAL增益等于缺损的骨内成分的深度，但在大多数情况下并非如此。
This prospective multicenter intra-individual randomized controlled clinical trial was designed to compare the efficacy of guided tissue regeneration (GTR) with bioresorbable barrier membranes versus access flap surgery, in intrabony defects. 2 similar defects were selected in each of 23 patients and randomly assigned to I of the 2 treatments. Surgery consisted of an identical procedure except for the omission of the barrier membrane in the flap control sites. At 1-year, probing pocket depth reductions were 4.3+/-2.3 mm in GTR treated sites and 3.0+/-1.5 mm in the flap control sites (p=0.02, paired t-test). Clinical attachment level (CAL) gains were 3.0+/-1.7 mm in the GTR sites and 1.6+/-1.8 mm in the control sites (p=0.009, paired t-test). A subset analysis, performed according to the initial depth of the intrabony component of the defects (INFRA), indicated that in shallow defects (INFRA less than or equal to 3 mm) treated with the access flap alone, CAL gains were 1+/-1.5 mm, while in deep ones (INFRA greater than or equal to 4 mm) they were consistently greater (1.9+/-1.9 mm). The % CAL gains, calculated as the % of the baseline intrabony component depth, however, were almost identical in the 2 subpopulations (45.8+/-64.7% in shallow and 43.8+/-37.6% in deep defects). Similarly, in the GTR sites, linear CAL gains were greater in deep (3.7+/-1.7 mm) than in shallow defects (2.2+/-1.3 mm), but no differences were observed in terms of % CAL gains (76.7+/-27.7% and 75.8+/-45%, respectively). The frequency distribution of CAL changes expressed as %s of the baseline INFRA indicates that most of the sites treated with GTR (73% in shallow and 92% in deep defects) gained 50% or more GAL. Furthermore, many defects (64% of shallow and 33% of deep defects) reached 100% of CAL gain. The present study demonstrated that: (i) GTR with bioresorbable barrier membranes resulted in a significant added benefit in comparison with access flap alone; (ii) the linear amounts of CAL gains were greater in deep than in shallow defects; (iii) CAL gains expressed as %s of the baseline depths of the intrabony component, were similar in shallow and deep defects; (iii) the regenerative procedure tested in the present study resulted in CAL gains equal to the depth of the intrabony component of the defect in some, but not in most of the instances.