Department of Periodontology, Faculty of Dental Medicine, Anton Sculean Research Center for Periodontal and Peri-Implant Diseases, Victor Babes University of Medicine and Pharmacy, 300041 Timisoara, Romania.
Department of Endodontics, Faculty of Dental Medicine, TADERP Research Center, Victor Babes University of Medicine and Pharmacy, 300041 Timisoara, Romania.
Medicina (Kaunas). 2024 May 17;60(5):829. doi: 10.3390/medicina60050829.
This randomized, double-arm, multicentric clinical trial aims to compare the clinical outcomes following the treatment of suprabony periodontal defects using open flap debridement (OFD) with or without the application of hyaluronic acid (HA). Sixty systemically healthy patients with at least two teeth presenting suprabony periodontal defects were randomly assigned with a 1:1 allocation ratio using computer-generated tables into a test (OFD + HA) or control group (OFD). The main outcome variable was clinical attachment level (CAL). The secondary outcome variables were changes in mean probing pocket depth (PPD), gingival recession (GR), full-mouth plaque score (FMPS), and full-mouth bleeding score (FMBS). All clinical measurements were carried out at baseline and 12 months. Sixty patients, thirty in each group, were available for statistical analysis. The mean CAL gain was statistically significantly different ( < 0.001) in the test group compared with the control group (3.06 ± 1.13 mm vs. 1.44 ± 1.07 mm). PPD reduction of test group measurements (3.28 ± 1.14 mm) versus the control group measurements (2.61 ± 1.22 mm) were statistically significant ( = 0.032). GR changes were statistically significant only in the test group 0.74 ± 1.03 mm ( < 0.001). FMBS and FMPS revealed a statistically significant improvement mostly in the test group. Suprabony periodontal defects could benefit from the additional application of HA in conjunction with OFD in terms of improvement of the clinical parameters compared with OFD alone.
这项随机、双臂、多中心临床试验旨在比较使用开放式翻瓣清创术（OFD）联合或不联合透明质酸（HA）治疗骨上牙周缺损的临床疗效。 60 名系统健康的患者至少有两颗牙齿存在骨上牙周缺损，采用计算机生成的表格按 1:1 的比例随机分为试验组（OFD+HA）和对照组（OFD）。主要观察变量为临床附着水平（CAL）。次要观察变量为平均探诊牙周袋深度（PPD）、牙龈退缩（GR）、全口菌斑指数（FMPS）和全口出血指数（FMBS）的变化。所有临床测量均在基线和 12 个月时进行。60 名患者，每组 30 名，可进行统计学分析。与对照组相比，试验组的平均 CAL 增益有统计学显著差异（<0.001）（3.06±1.13mm 比 1.44±1.07mm）。试验组测量的 PPD 减少（3.28±1.14mm）与对照组测量的 PPD 减少（2.61±1.22mm）有统计学显著差异（=0.032）。GR 变化仅在试验组有统计学意义（0.74±1.03mm）（<0.001）。FMBS 和 FMPS 显示，与单独使用 OFD 相比，联合使用 OFD 和 HA 可显著改善大多数临床参数。 在改善临床参数方面，与单独使用 OFD 相比，骨上牙周缺损可能受益于 HA 的额外应用。
