AimTo evaluate the clinical outcomes of moderate intrabony defects treated with minimally invasive non‐surgical technique (MINST) with or without adjunctive delivery of cross‐linked hyaluronic acid (xHyA) gel.Materials and MethodsForty‐two patients with 42 interdental intrabony defects were randomly assigned to test (MINST + xHyA) or control procedures (MINST alone). Probing depth (PD), clinical attachment level (CAL), gingival recession (GR) and bleeding on probing (BOP) at the treated sites were assessed at baseline and at 3 and 6 months. Full‐mouth plaque score (FMPS) and full‐mouth bleeding score (FMBS) were recorded at baseline and after 6 months. Radiographic evaluation was performed at baseline and after 6 months, assessing the defect fill (DF) and radiographic defect angle (RDA). The primary outcome variable was PD change.ResultsThirty‐eight patients completed the trial without any adverse events. At 6 months, a statistically significant improvement (p < 0.05) was measured in all clinical parameters except GR (p > 0.05). However, no statistically significant differences were found between the experimental and control procedures (p > 0.05). Statistically significant differences between the test and control sites were observed at 3 months for PD and CAL changes (p < 0.05). The DF change was statistically significant when comparing experimental and control procedures at 6 months (p < 0.05). Both procedures failed to show statistically significant differences in terms of RDA changes at 6 months (p > 0.05).ConclusionWithin their limitations, the present results indicate that (a) treatment of intrabony defects with MINST, with or without application of xHyA gel, resulted in statistically significant improvements in the investigated clinical parameters at 3 and 6 months after therapy, and (b) although the adjunctive use of xHyA gel to MINST improved the clinical outcomes compared with MINST alone up to 3 months, statistically significant differences were not observed at 6 months. The study protocol was registered in ClinicalTrial.gov (NCT05188898).

中文翻译：

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辅助交联透明质酸非手术治疗中度牙周骨内缺损：一项单盲随机对照临床试验


目的评估接受微创非手术技术 （MINST） 治疗且有或没有辅助递送交联透明质酸 （xHyA） 凝胶的中度骨内缺损的临床结果。材料和方法将 42 例牙间骨内缺损患者随机分配到试验组 （MINST + xHyA） 或对照组 （单独使用 MINST）。在基线以及 3 个月和 6 个月时评估治疗部位的探诊深度 （PD） 、临床附着水平 （CAL） 、牙龈萎缩 （GR） 和探诊出血 （BOP）。在基线和 6 个月后记录满口牙菌斑评分 （FMPS） 和满口出血评分 （FMBS）。在基线和 6 个月后进行影像学评估，评估缺陷填充 （DF） 和影像学缺陷角度 （RDA）。主要结局变量是 PD 变化。结果38 例患者完成了试验，无任何不良事件。6 个月时，除 GR （p > 0.05） 外，所有临床参数均测量出具有统计学意义的改善 （p < 0.05）。然而，实验程序和对照程序之间没有发现统计学上的显着差异 （p > 0.05）。在 3 个月时观察到测试部位和对照部位之间的 PD 和 CAL 变化具有统计学意义差异 （p < 0.05）。比较 6 个月时的实验和对照程序时，DF 变化具有统计学意义 （p < 0.05）。两种手术在 6 个月时 RDA 变化方面均未显示统计学意义差异 （p > 0.05）。结论在其局限性内，目前的结果表明 （a） 用 MINST 治疗骨内缺损，无论是否应用 xHyA 凝胶，在治疗后 3 个月和 6 个月时，研究的临床参数都有统计学意义改善，并且 （b） 尽管 xHyA 凝胶与 MINST 的辅助使用相比改善了临床结局，与单独使用 MINST 相比，长达 3 个月， 在 6 个月时未观察到统计学显着差异。该研究方案于 ClinicalTrial.gov （NCT05188898） 注册。