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Abstract：
OBJECTIVE: To assess the effect of hyaluronic acid (HyA) application as adjunct to re-instrumentation of residual pockets in patients undergoing regular supportive periodontal care (SPC).
METHODS: Chronic periodontitis patients (stage III and IV, grade B and C) with 4 interproximal residual pockets were randomly assigned to the test (HyA gel) or control (saline) group. After subgingival instrumentation, test or control substance was applied subgingivally, then daily supragingivally for 3 months, and if required a second time after subgingival re-instrumentation after 3 months. Clinical and patient reported outcome parameters were recorded every 3 months for 12 months. Pocket closure [probing pocket depth (PPD) ≤ 4mm with absence of bleeding on probing (BoP) at PPD = 4mm] was the main outcome parameter.
RESULTS: Fifty-six patients (221 experimental sites) were analysed. Pocket closure was achieved in 56.8 and 46.6% of the experimental sites in the test and control group, respectively (p > 0.05), while median PPD and PPD distribution (< 5mm/5mm/ > 5mm) differed significantly between groups in favour of the test group, at 12 months. Further, significantly fewer sites in the HyA group required re-instrumentation at 3 months, and sites in the HyA group showed a tendency for lower odds to remain diseased compared to the control group (OR 0.48, 95%CI 0.22-1.06). The odds for a site to remain diseased after 12 months increased significantly in the presence of plaque (OR 7.94, 95%CI 4.12-15.28), but in general, decreased significantly over time (OR 0.48, 95%CI 0.28-0.81).
CONCLUSIONS: Re-instrumentation of residual pockets in SPC patients, per se, leads to a significant increase in pocket closure over time; this was impeded by poor plaque control. Repeated local application of HyA results in fewer sites requiring re-instrumentation and might slightly improve the rate of pocket closure. (clinicaltrials.gov registration nr. NCT04792541).
CONCLUSIONS: HyA gel is easy to apply, well accepted by patients, and may have some positive effect in terms of fewer sites requiring re-instrumentation at 3 months and higher pocket closure rate at 12 months.
METHODS: Chronic periodontitis patients (stage III and IV, grade B and C) with 4 interproximal residual pockets were randomly assigned to the test (HyA gel) or control (saline) group. After subgingival instrumentation, test or control substance was applied subgingivally, then daily supragingivally for 3 months, and if required a second time after subgingival re-instrumentation after 3 months. Clinical and patient reported outcome parameters were recorded every 3 months for 12 months. Pocket closure [probing pocket depth (PPD) ≤ 4mm with absence of bleeding on probing (BoP) at PPD = 4mm] was the main outcome parameter.
RESULTS: Fifty-six patients (221 experimental sites) were analysed. Pocket closure was achieved in 56.8 and 46.6% of the experimental sites in the test and control group, respectively (p > 0.05), while median PPD and PPD distribution (< 5mm/5mm/ > 5mm) differed significantly between groups in favour of the test group, at 12 months. Further, significantly fewer sites in the HyA group required re-instrumentation at 3 months, and sites in the HyA group showed a tendency for lower odds to remain diseased compared to the control group (OR 0.48, 95%CI 0.22-1.06). The odds for a site to remain diseased after 12 months increased significantly in the presence of plaque (OR 7.94, 95%CI 4.12-15.28), but in general, decreased significantly over time (OR 0.48, 95%CI 0.28-0.81).
CONCLUSIONS: Re-instrumentation of residual pockets in SPC patients, per se, leads to a significant increase in pocket closure over time; this was impeded by poor plaque control. Repeated local application of HyA results in fewer sites requiring re-instrumentation and might slightly improve the rate of pocket closure. (clinicaltrials.gov registration nr. NCT04792541).
CONCLUSIONS: HyA gel is easy to apply, well accepted by patients, and may have some positive effect in terms of fewer sites requiring re-instrumentation at 3 months and higher pocket closure rate at 12 months.
摘要：
目的：评估透明质酸（HyA）作为常规支持牙周护理（SPC）患者残余袋再器械的辅助应用效果。
方法：慢性牙周炎患者（III期和IV期，B级和C级)有4个邻间残袋,随机分为试验组(HyAgel)或对照组(生理盐水).牙龈下检查后，测试或对照物质应用于牙龈下，然后每天持续3个月，如果需要，在3个月后再次使用龈下器械。连续12个月，每3个月记录临床和患者报告的结果参数。口袋闭合[探查袋深度（PPD）≤4mm，探查时无出血（BoP），PPD=4mm]是主要结果参数。
结果：分析了56名患者（221个实验地点）。在测试组和对照组中，分别在56.8和46.6％的实验部位实现了口袋闭合，分别(p>0.05)，而中位数PPD和PPD分布（<5mm/5mm/>5mm）在各组之间存在显着差异，有利于测试组，在12个月。Further,在3个月时，HyA组中需要重新仪器的站点明显减少，与对照组相比，HyA组的部位显示出更低的患病几率（OR0.48，95CI0.22-1.06）。在存在斑块的情况下，12个月后仍有病变的部位的几率显着增加（OR7.94，95CI4.12-15.28），但总的来说,随着时间的推移显着降低（OR0.48，95CI0.28-0.81）。
结论：SPC患者残留口袋的重新仪器，本身，随着时间的推移，导致口袋闭合显着增加；这受到不良斑块控制的阻碍。HyA的重复局部应用导致需要重新仪器的站点减少，并且可能会稍微提高口袋闭合率。（clinicaltrials.gov注册编号。NCT04792541)。
结论：HyA凝胶易于应用，被患者接受，并且可能会产生一些积极的影响，因为在3个月时需要重新安装仪器的地点更少，在12个月时需要更高的口袋闭合率。
方法：慢性牙周炎患者（III期和IV期，B级和C级)有4个邻间残袋,随机分为试验组(HyAgel)或对照组(生理盐水).牙龈下检查后，测试或对照物质应用于牙龈下，然后每天持续3个月，如果需要，在3个月后再次使用龈下器械。连续12个月，每3个月记录临床和患者报告的结果参数。口袋闭合[探查袋深度（PPD）≤4mm，探查时无出血（BoP），PPD=4mm]是主要结果参数。
结果：分析了56名患者（221个实验地点）。在测试组和对照组中，分别在56.8和46.6％的实验部位实现了口袋闭合，分别(p>0.05)，而中位数PPD和PPD分布（<5mm/5mm/>5mm）在各组之间存在显着差异，有利于测试组，在12个月。Further,在3个月时，HyA组中需要重新仪器的站点明显减少，与对照组相比，HyA组的部位显示出更低的患病几率（OR0.48，95CI0.22-1.06）。在存在斑块的情况下，12个月后仍有病变的部位的几率显着增加（OR7.94，95CI4.12-15.28），但总的来说,随着时间的推移显着降低（OR0.48，95CI0.28-0.81）。
结论：SPC患者残留口袋的重新仪器，本身，随着时间的推移，导致口袋闭合显着增加；这受到不良斑块控制的阻碍。HyA的重复局部应用导致需要重新仪器的站点减少，并且可能会稍微提高口袋闭合率。（clinicaltrials.gov注册编号。NCT04792541)。
结论：HyA凝胶易于应用，被患者接受，并且可能会产生一些积极的影响，因为在3个月时需要重新安装仪器的地点更少，在12个月时需要更高的口袋闭合率。
