Cortellini P, Carnevale G, Sanz M, Tonetti M S
Department of Periodontology and Fixed Prosthodontics, School of Dental Medicine, University of Bern, Switzerland.
J Clin Periodontol. 1998 Dec;25(12):981-7. doi: 10.1111/j.1600-051x.1998.tb02402.x.
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 1 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 < or =3 mm) treated with the access flap alone, CAL gains were 1+/-1.5 mm, while in deep ones (INFRA > or =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 CAL. 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.
这项前瞻性多中心个体内随机对照临床试验旨在比较可生物吸收屏障膜引导组织再生术（GTR）与翻瓣手术治疗骨内缺损的疗效。在23例患者中，为每例患者选择2个相似的缺损，并随机分配至两种治疗方法之一。手术过程除在翻瓣对照部位不使用屏障膜外，其余步骤相同。1年后，GTR治疗部位的探诊深度减少4.3±2.3mm，翻瓣对照部位减少3.0±1.5mm（配对t检验，p=0.02）。GTR部位的临床附着水平（CAL）增加3.0±1.7mm，对照部位增加1.6±1.8mm（配对t检验，p=0.009）。根据缺损骨内部分的初始深度（INFRA）进行的亚组分析表明，仅行翻瓣手术治疗的浅缺损（INFRA≤3mm）部位，CAL增加1±1.5mm，而深缺损（INFRA≥4mm）部位的增加量持续更大（1.9±1.9mm）。然而，以基线骨内部分深度的百分比计算的CAL增加百分比，在这两个亚组中几乎相同（浅缺损为45.8±64.7%，深缺损为43.8±37.6%）。同样，在GTR部位，深缺损的线性CAL增加量（3.7±1.7mm）大于浅缺损（2.2±1.3mm），但在CAL增加百分比方面未观察到差异（分别为76.7±27.7%和75.8±45%）。以基线INFRA的百分比表示的CAL变化频率分布表明，大多数接受GTR治疗的部位（浅缺损中为73%，深缺损中为92%）CAL增加50%或更多。此外，许多缺损（浅缺损的64%和深缺损的33%）达到了100%的CAL增加。本研究表明：（i）与单纯翻瓣手术相比，使用可生物吸收屏障膜的GTR有显著的额外益处；（ii）深缺损的线性CAL增加量大于浅缺损；（iii）以骨内部分基线深度的百分比表示的CAL增加量，在浅缺损和深缺损中相似；（iii）本研究中测试的再生程序在一些但并非大多数情况下导致CAL增加量等于缺损骨内部分的深度。
