Iorio-Siciliano Vincenzo, Blasi Andrea, Mauriello Leopoldo, Salvi Giovanni E, Ramaglia Luca, Sculean Anton
Department of Periodontology, School of Dental Medicine, University of Naples Federico II, Naples, Italy.
Department of Periodontology, School of Dental Medicine, University of Bern, Bern, Switzerland.
J Clin Periodontol. 2025 Feb;52(2):310-322. doi: 10.1111/jcpe.14078. Epub 2024 Oct 14.
To 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.
Forty-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.
Thirty-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).
Within 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).
评估采用微创非手术技术（MINST）联合或不联合交联透明质酸（xHyA）凝胶治疗中度骨内缺损的临床效果。
42例患有42个牙间骨内缺损的患者被随机分配至试验组（MINST + xHyA）或对照组（单纯MINST）。在基线、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）、牙龈退缩（GR）和探诊出血（BOP）。在基线和6个月后记录全口菌斑评分（FMPS）和全口出血评分（FMBS）。在基线和6个月后进行影像学评估，评估缺损充填（DF）和影像学缺损角度（RDA）。主要结局变量为PD变化。
38例患者完成试验，无任何不良事件。在6个月时，除GR外（p > 0.05），所有临床参数均有统计学显著改善（p < 0.05）。然而，试验组和对照组之间未发现统计学显著差异（p > 0.05）。在3个月时，试验组和对照组在PD和CAL变化方面存在统计学显著差异（p < 0.05）。在6个月时，比较试验组和对照组的DF变化有统计学显著差异（p < 0.05）。两种治疗方法在6个月时RDA变化方面均未显示统计学显著差异（p > 0.05）。
在其局限性范围内，目前的结果表明：（a）采用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，所研究的临床参数均有统计学显著改善；（b）虽然与单纯MINST相比，MINST联合使用xHyA凝胶在3个月内改善了临床效果，但在6个月时未观察到统计学显著差异。该研究方案已在ClinicalTrial.gov（NCT05188898）注册。
