Nygaard-Østby Per, Bakke Vibeke, Nesdal Oddny, Nilssen Helene Klerck, Susin Cristiano, Wikesjö Ulf M E
Department of Periodontology, Faculty of Dentistry, University of Oslo, Oslo, Norway.
J Clin Periodontol. 2008 Jan;35(1):37-43. doi: 10.1111/j.1600-051X.2007.01160.x.
The objective of this randomized-controlled clinical trial was to evaluate the adjunctive effect of guided tissue regeneration (GTR) using a bioresorbable polylactic acid (PLA) barrier device when combined with autogenous bone grafting in the treatment of deep intra-bony periodontal defects.
Forty systemically healthy patients (20 females; mean age 53 years; non-smokers) participated in the study. Using a parallel-group study design, one intra-bony defect in each of 20 subjects received GTR using the bioresorbable PLA barrier device (Atrisorb), combined with autogenous bone grafting. One intra-bony defect in each of the remaining 20 subjects received bone grafting solo (control). Treatments were evaluated at 9 months post-surgery.
One patient (GTR) was withdrawn from the study due to circumstances unrelated to the study. Eighty-nine per cent of the PLA barriers became exposed within 3 weeks following surgery. Pre-surgery probing depths for GTR and control intra-bony defects averaged (+/-SE) 7.1+/-0.3 mm. Significant probing depth reduction (2.7+/-0.3 versus 2.4+/-0.4 mm), attachment-level gain (1.7+/-0.3 versus 1.7+/-0.5 mm), and bone fill (1.2+/-0.4 versus 1.2+/-0.5 mm) were observed for the GTR and control sites, respectively (p< or =0.02). However, there were no statistically significant differences between treatment protocols.
The results suggest that GTR using the bioresorbable PLA barrier device does not provide additional value to reconstructive surgery including autogenous bone grafting in intra-bony periodontal defects.
本随机对照临床试验的目的是评估使用可生物吸收的聚乳酸（PLA）屏障装置的引导组织再生（GTR）与自体骨移植联合应用于治疗重度骨内牙周缺损时的辅助效果。
40名全身健康的患者（20名女性；平均年龄53岁；非吸烟者）参与了本研究。采用平行组研究设计，20名受试者每人的一处骨内缺损接受使用可生物吸收的PLA屏障装置（Atrisorb）的GTR治疗，并联合自体骨移植。其余20名受试者每人的一处骨内缺损仅接受骨移植（对照组）。在术后9个月对治疗效果进行评估。
1名患者（GTR组）因与研究无关的情况退出研究。89%的PLA屏障在术后3周内暴露。GTR组和对照组骨内缺损术前的探诊深度平均（±标准误）为7.1±0.3mm。GTR组和对照组位点分别观察到显著的探诊深度降低（2.7±0.3对2.4±0.4mm）、附着水平增加（1.7±0.3对1.7±0.5mm）和骨填充（1.2±0.4对1.2±0.5mm）（p≤0.02）。然而，治疗方案之间没有统计学上的显著差异。
结果表明，使用可生物吸收的PLA屏障装置的GTR对包括自体骨移植的骨内牙周缺损重建手术没有提供额外价值。
